Brain Mechanisms For Clinical Placebo in Chronic Pain: A Randomized Clinical Trial of Placebo, Active Treatment, and No Treatment in Chronic Back Pain
Phase: PHASE4
Conditions: Chronic Low Back Pain
Sponsor: Apkar Apkarian

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Version 8.0 (Phase 2), Date: 03/28/2018 
BRAIN MECHANISMS FOR CLINICAL PLACEBO IN CHRONIC PAIN:
A Randomized Clinical Trial of Placebo, Active Treatment, and No Treatment in Chronic Back Pain
Principal Investigator:
Apkar Vania Apkarian, PhD
Northwestern University, Feinberg School of Medicine
Tarry Bldg, 310 E. Superior St., Office 7-705
Chicago, IL 60611
(312) 503-0404 
(312) 503-5105
a-apkarian@northwestern.edu
Co-Investigator(s):
Todd B. Parrish PhD, General Radiology
Thomas J. Schnitzer MD/PhD, Physical Medicine and Rehabilitation
David Cella PhD, Medical Social Sciences
Richard Gershon PhD, Medical Social Sciences
Biostatistician:
James Griffith
Northwestern University
633 N. St. Clair, 19th floor
Chicago, IL 60611
(312) 503-5345
(312) 503-4800
j-griffith@northwestern.edu
Participating Site:
Northwestern University, Feinberg School of Medicine
Olson Pavilion, 710 N Fairbanks Ct
Center for Translational Imaging (CTI), LC 0-255
Chicago, IL 60611
Northwestern University, Feinberg School of Medicine
10th floor Abbot Hall, 710 N Lake Shore Dr
Chicago, IL 60611
For additional sub-sites/locations, please see appendix.
Study Drug/Study Device:
Placebo, Naproxen, and Omeprazole
Funding Source: 
National Center for Complimentary and Integrative Health (NCCIH),
National Institutes of Health
Initial version:
6/1/2016 (Phase 2)
Amended:
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Version 8.0 (Phase 2), Date: 03/28/2018 
TABLE OF CONTENTS
*  TITLE PAGE  - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1
TABLE OF CONTENTS - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2
*   STUDY SCHEMA AND DESIGN - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3
*   STUDY SUMMARY - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4
1. BACKGROUND AND RATIONALE - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5
2. STUDY OBJECTIVES - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -9
3. PATIENT ELIGIBILITY: SELECTION AND ENROLLMENT OF PARTICIPANTS - - - - - - - - - - - - - - - 10
4. TREATMENT PLAN AND STUDY INTERVENTION - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12
5. STUDY PROCEDURES - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -16 
6. RESPONSE CRITERIA - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 20
7. ADVERSE EVENTS AND SAFETY ASSESSMENTS - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 20
8. STATISTICAL CONSIDERATIONS - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -22 
9. STUDY MANAGEMENT, DATA COLLECTION, AND QUALITY ASSURANCE - - - - - - - - - - - - - - - - 25
10. PARTICIPANT RIGHTS - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 26
11. PUBLICATIONS - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -27
12.  REFERENCES - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -28
13. SUPPLEMENTS/APPENDICES - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 32
I 
CONSENT FORM TEMPLATE - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 32
II
LIST OF QUESTIONNAIRES - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 40
III
AE COLLECTION FORM TEMPLATE - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 41
IV 
DSMP - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 42
V
STUDY ROSTER - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -111
VI
SCHEDULE OF EVALS & ASSESSMENTS - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 114
VII
BIOSTATISTICIAN CV - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 117
VIII
LABORATORY PROCEDURES & EVALUATIONS - - - - - - - - - - - - - - - - - - - - - - - - - 126
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STUDY SCHEMA AND DESIGN
Design Schema for Objective 2 (Phase 2):
We intend to randomize 210 CBP patients into the study with the expectation that 140 will finish successfully. The 
entire duration of the study will be 12 weeks with an initial 3-week baseline period (visits 1-3), a 6-week treatment 
period (visits 3-5), and a final 3-week washout period (visits 5-6).  During the baseline period eligible participants 
will be predicted as placebo responders and non-responders based upon baseline brain scan results and 
specific questionnaire answers (properties determined from the results of Phase 1) and then classified on that 
basis. Participants will then be randomized within each classification group (placebo responders and placebo non-
responders) at a ratio of 3:3:1 such that 42.5% receive active medication (naproxen/omeprazole, 500/20mg, bid), 
42.5% receive matching placebo treatment and 15% no treatment.    Brain imaging, self-report questionnaire, and 
pain/mood rating measurement regimens are shown in Figure 1.  Pain, mood, and pill ingestion will all be monitored 
by smart phone for the duration of the study, as well as determined in person at each visit.
Figure 1. Experimental schema for Phase 2. Expected changes in pain are shown in solid and dashed horizontal lines.  
We expect to see different pain outcomes for the various placebo and treatment combination groups. To be noted, we 
predict that the No Treatment group will have similar pain trajectory as those classified Non-responders and treated with 
placebo. As well, in the No Treatment group participants will be classified as placebo responders and placebo non-
responders, but will not receive any treatment agent, therefore, their pain trajectory will be constant throughout the study. 
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STUDY SUMMARY
Title
BRAIN MECHANISMS FOR CLINICAL PLACEBO IN CHRONIC PAIN 
Short Title
PLACEBO IN CHRONIC PAIN (PICP)
Protocol Number
Grant:
Phase
Grant Phase 2
Methodology
Double blind, randomized (see section 5.4 for more specifics on blinding)
Study Duration
12 weeks
Study Center(s)
Northwestern University
Objectives
The overall purpose of Phase 1 was to identify brain mechanisms and 
behavioral markers of placebo analgesia propensity in chronic back pain 
patients.  The markers identified in that phase will now be used in Phase 
2 to predict placebo propensity in a separate cohort of chronic back pain 
patients and in turn, validate the markers’ reliability to detect response. 
An additional objective of Phase 2 is to study the interaction of placebo 
propensity with active treatment.
Number of Subjects
A total of 340 participants will be enrolled across both phases. 
Phase 1 will have an expected enrollment of 130 participants to attain 64 
completed participants
Phase 2 will have an expected enrollment of 210 participants to attain 
140 completed participants. 
Diagnosis and Main 
Inclusion Criteria
Chronic back pain (history of low back pain for a minimum of 6 months 
with or without signs and symptoms of radiculopathy)
Study Product(s), Dose, 
Route, Regimen
Naproxen, 500mg, po and Omeprazole, 20 mg, po, and matching 
placebo capsules, all po bid
Duration of administration
6 weeks total for Phase 2 for all study products and treatments
Active Treatment 
1 capsule Naproxen (500mg) /1 capsule Omeprazole (20 mg), both oral 
b.i.d.
Statistical Methodology
Brain activity contrasts are done as a two-way (treatment groups)
repeated measures (time: start vs. end) ANOVA (two-way repeated 
measures-ANOVA). For responders, based on our preliminary results, we 
anticipate a mean decrease of 2.5 units on a 0-10 scales with an 
estimated SD of 3. Thus, the estimated Cohen’s d effect size across time 
is an effect size estimate of 0.83. 
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1.0
BACKGROUND AND RATIONALE
1.1
Disease Background
The prevalence of chronic back pain (CBP) ranges from 15% to 45%, with the point prevalence averaging 
30% (Andersson and Frymoyer, 1997). In the USA, chronic and acute back pains are the most common 
causes of activity limitation in people under 45, and the second most frequent reason for physician visits 
(Praemer et al., 1992; Hart et al., 1995). Whereas the few short-term (i.e. only weeks in length) placebo-
controlled trials conducted to date have found some support for the use of non-steroidal anti-inflammatory 
drugs (NSAIDs) and antidepressants in treating lower back pain, their modest improvements in pain are 
not sufficient to achieve clinically-meaningful effectiveness. With efficacy requiring a minimum 20% 
decrease in pain compared to placebo, a meta-analysis of NSAID studies found no evidence that these 
drugs were more effective than placebo in treating CBP (van Tulder et al., 2000). Similar results have 
been observed for other classes of analgesics. The World Health Organization Advisory Panel has 
concluded that there is no single treatment superior to others for relieving CBP (Ehrlich, 2003).
Here we propose to study the brain circuitry, functionally and anatomically, for the placebo effect in 
treatment of patients with CBP. Our laboratory has extensively characterized the brain properties in CBP 
over the past 10 years. We have shown that brain activity in CBP is specific and distinct from that for 
acute pain (Baliki et al., 2006); brain resting state activity is disrupted in CBP (Baliki et al., 2008a; Baliki et 
al., 2011b); brain gray matter density is decreased in specific regions (Apkarian et al., 2004) and 
continues to reorganize on the time scale of 10 years (Baliki et al., 2011c). More recently, we have 
completed the first longitudinal brain imaging trial evaluating brain properties that predict pain 
persistence, and we have determined that brain functional properties measurable during the subacute 
phase (< 3 months back pain duration) can predict who will transition to CBP one year later (Baliki et al., 
2012). These studies provide a solid scientific background upon which we can study brain characteristics 
of the placebo response in CBP. 
1.2
Rationale
The placebo effect – an improvement in symptoms caused by receiving a sham treatment disguised to be 
indistinguishable from an active medical treatment - is a psychobiological phenomenon, coupled with 
underlying identifiable neurobiology. It has been observed across diseases, biological systems, and for a 
variety of treatments (Benedetti, 2008). Placebo shows the largest and most consistent effects in the 
realm of pain, and its potential clinical utility for analgesia has been recognized since the first studies of 
the topic (Beecher, 1955; Harrington, 1997). Moreover, a recent national survey of internists and 
rheumatologists in the US found that
approximately 50% of physicians prescribe medications they consider to have no effect on patients’ 
conditions and are purposely used as placebos (Tilburt et al., 2008; Fassler et al., 2010). Thus, use of 
placebo in the clinic, whether knowingly or unknowingly, is highly prevalent. Given that there is no 
single empirically-supported treatment for CBP, the use of placebo is justified in treatment studies 
of CBP.
The bulk of the science of placebo has studied experimental manipulations in healthy subjects, and has 
convincingly established the psychobiological basis of placebo (Benedetti et al., 2011; Wager and Fields, 
2012). In healthy subjects, placebo responses appear to reflect altered transmission in pain pathways, 
including a) reduced activity in many brain regions involved in acute pain perception; b) activation with 
placebo treatment of areas important for modulation of pain-related regions and engagement of 
descending pain modulating circuits; and c) activation of endogenous opioid and dopamine systems 
(Atlas et al., 2009; Tracey, 2010; Wager and Fields, 2012). Personality differences can contribute to 
placebo response magnitude, including high suggestibility (De Pascalis et al., 2002; Morton et al., 2010), 
optimism (Morton et al., 2009), expectation (Vase et al., 2003; Zubieta et al., 2005; Morton et al., 2010), 
behavioral activation (Schweinhardt et al., 2009), and sensitivity to opiates (Amanzio and Benedetti, 
1999). These results are consistent with individual differences in how healthy subjects may respond 
differentially to trivial changes in placebo-related manipulations or contexts; however, no consistent 
evidence has supported a particular personality or psychological variable in mediating the placebo 
response. Perhaps most importantly, given the extensive brain reorganization with chronic pain, placebo 
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properties for pain modulation in chronic pain are likely distinct from those of healthy subjects.
Analgesia in the placebo arm is unequivocally observed in clinical trials, especially for chronic pain drug 
studies (Finniss et al., 2010). Until recently, placebo effects in the clinical setting have mostly been 
addressed using metaanalysis of such clinical trials (Enck et al., 2011). Recent studies show quite large 
placebo effects in clinical treatments (Kaptchuk et al., 2006; Haake et al., 2007; Kaptchuk et al., 2008b)), 
and in one case repeated sham treatment showed greater analgesia than conventional therapy in CBP 
patients (Haake et al., 2007). Similarly, comparing placebo effects in experimental and clinical back pain 
shows larger placebo effects for clinical pain (Charron et al., 2006), and placebo effects are larger with 
more sustained pain and in the presence of hyperalgesia (Vase et al., 2009). Therefore, placebo 
treatment in CBP has demonstrated effectiveness, and given the lack of evidence favoring any specific 
treatment for CBP, the study of placebo is warranted in this population.
OA
CBP
n=128
n=128
n=199
n=195
Figure 2: Effect magnitude for placebo and active treatment in OA and CBP for 12 weeks, (on a 
0-10 scale). Data are from (Chappell, Desaiah et al. 2010, Skljarevski, Zhang et al. 2010, 
Skljarevski, Zhang et al. 2010).
Figure 3: Percent CBP responders to active treatment and placebo, in time (left panels), and per 
category (right): marginal or worse <15%, minimal 15-30%, moderate 30-50%, substantial >50% 
decrease in pain. Data are from (Moore, Smugar et al. 2010).
The placebo effect is large and clinically significant in chronic pain. Figures 2 and 3 depict recent (best 
quality) examples of phase 3 multi-center double-blind placebo-controlled drug trials in CBP and 
osteoarthritis (OA). These studies resulted in FDA approval for these drugs as effective therapies. Here 
we are interested in the reported placebo responses. It is evident how robust and similar the placebo 
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responses are across these studies, and how they are sustained for the entire study duration. In all three 
studies placebo decreases pain by at least 10% within 2-4 weeks and then by an additional 10-30% 
within 3 months. In figure 3 (Cox2 NSAID study), placebo treatment decreased CBP pain by >50% in 
approximately 35% of the group. To unequivocally state that these are placebo responses, it is necessary 
to have a no-treatment, observation only, control group. Nonetheless, figure 3 strongly suggests that the 
placebo effect may be dichotomous, hinting at the notion of two groups: responders and non-
responders—this very notion is consistent with our preliminary results. Thus, if we can identify chronic 
pain patients who will respond to placebo, then we can potentially decrease the pain in this group by 
about 30-50%, which would be highly clinically significant.
Figures 2 and 3 also illustrate an important property of clinical placebo, namely a sustained relief from 
pain for many weeks. In contrast, experimental placebo studies, by design, only examine very short 
duration (hours to a few days) effects. Thus, brain circuitry identified for experimental placebo is unlikely 
to generalize to the clinically observed placebo effects. To our knowledge, using brain circuitry to predict 
the placebo response in the clinical setting has not been studied outside of our lab.
The current study design specifically addresses aspects of placebo trial design that have received ethical 
and scientific criticism. A recent review identifies 9 distinct potential sources of bias in placebo effect 
studies (Hrobjartsson et al., 2011). To circumvent these problems, we rely on randomized controlled trials 
(RCTs) and within-subject control washout periods, perform all procedures identically across all groups, 
all preliminary analyses are done blinded, un-blinding occurs only after the completion of data collection, 
and all primary outcomes are objective brain parameters. By controlling for these factors, the natural, 
biologically-based propensity for some subjects to be better placebo responders than others can be 
objectively identified based on the proposed clinical trials.
The proposed study of placebo analgesia in CBP is justified because there is currently no single 
empirically supported treatment for CBP pain. Given our ignorance of basic properties of placebo 
analgesia, such as reproducibility within individuals, duration of the response, and interactions with active 
medications, short-term studies are appropriate to address these issues. Furthermore, the active 
medication control group taking naproxen will receive a standard-of-care treatment , and all participants 
will be allowed to take acetaminophen (rescue medication) as needed. Although placebo is associated 
with side effects, there is evidence that symptom base rates associated with placebo are lower than those 
observed in the general population (Barsky et al., 2002). For these reasons, the scientific benefits 
outweigh potential risks that are attributable to placebo use.
In phase 1 of this grant, we expect to confirm our hypothesis that about 50% of CBP patients respond to a 
2 weeks placebo treatment using smartphone to collect daily measurements of chronic pain intensity. On 
average and so far, participants showed very good compliance rate on the use of smartphone, reaching 
on average of 75%. Using these continuous measurements of chronic pain intensity, we expect to 
demonstrate that patients responding to a placebo treatment will show a robust reduction of about 25% of 
their pain intensity compared to their visit 1 to visit 2 ratings. This would confirm our preliminary 
observations that about half of enrolled CBP will respond to placebo treatment and that expected pain 
analgesia will be clinically meaningful.
1.3
Predictive neural and behavioral biomarkers for clinical placebo 
Summary of main findings from Phase 1 Report:
1.
Using the smart phone pain ratings and within subject permutation method provides a robust method 
for classifying placebo responders and non-responders. 
2.
Three emotion-related personality outcome measures (MAIA-not worry, MAIA-emotion, ERQ-
suppress) together predict future placebo response at 94% accuracy. These measures are also 
correlated to questionnaires regarding alternative and complementary medicine including MISS 
(suggestibility),HCAMQ (holistic subscale) , and MLHC (health locus of control).
3.
Resting state fMRI brain network information sharing between the frontal cortex and somatosensory 
cortex predicts placebo response at a very high accuracy.
4.
Somatosensory cortex grey matter density predicts placebo response.
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5.
Brain white matter myelination properties do not predict placebo response.
6.
Brain grey matter neurite orientation properties do not predict placebo response.
7.
Limbic brain right to left asymmetry predicts placebo response.
8.
The combined brain and personality final model predicts placebo response at 94% accuracy.
Conclusions from Phase 1 report:
1.
The primary conclusion of these results is our ability to demonstrate that clinical placebo response is 
predictable from personality and from brain properties. 
2.
Identified personality parameters are distinct from those hypothesized in healthy subjects for 
experimental manipulations, and are consistent with CBP involving emotional circuitry. The 
relationship between these and attitudes to alternative medicine suggest common underlying 
mechanisms.
3.
Functional information sharing results are based on a specific hypothesis we derive from our earlier 
similar study conducted in osteoarthritis patients, suggesting shared mechanisms of clinical placebo 
response predictive circuits.
4.
The cortical gray matter prediction of placebo seems linked to the functional information sharing 
circuit and probably reflects inter-related measures.
5.
The fact that we did not find a whole-brain contrast in white matter myelination properties to predict 
placebo response was expected and not surprising. It is possible that the white matter connectivity 
between the functional networks may still be distinct (remains to be tested).
6.
Perhaps the most surprising and intriguing result is the observation that limbic brain hemispheric 
volume asymmetry predicts placebo response. Our earlier work (paper submitted) shows that these 
brain volumes are invariant over up to 3 years even when subjects develop chronic pain, which 
implies that these structures are mostly fixed in adulthood and thus suggest that clinical placebo 
propensity is, at least in part, a trait.
1.4
Correlative Studies
Brain imaging as a tool for making clinical decisions in chronic pain populations is
not a practical option, as it requires highly sophisticated technology and analysis tools. No existing scale 
(or combination of scales) can predict the likelihood that a given individual with chronic pain will respond 
positively to a placebo treatment. There has been a strong bias against the development of such tools 
based on observations that placebo response in healthy subjects is highly variable, despite some 
progress in the topic (Shapiro et al., 1975; Wilcox et al., 1992; Geers et al., 2005; Geers et al., 2010). In 
contrast, our preliminary results strongly suggest that a Tool for Placebo Propensity Prediction (or 
TOPPP) can be developed because, in chronic pain, the placebo response is an objective, predictable 
phenomenon. Given the considerable potential clinical benefits of a measure like TOPPP, there is a need 
for a measurement system that is sufficiently sensitive to identify propensity for placebo analgesia that is 
brief, yet precise, easy to implement, and correlates with objective parameters of placebo response, such 
as brain imaging parameters. 
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2.0
STUDY OBJECTIVES
2.1
Primary and Secondary Objectives
.
2.1.1
To evaluate the interaction between placebo response and active treatment in individuals 
classified as placebo responders vs non-responders. Individuals in the No Treatment 
group will be used as a negative control to control for regression to the mean, duration of 
pain, and other potential confounds. 
Hypothesis: Brain functional and anatomical properties between groups after 6 weeks of 
treatment will identify separate circuitry for placebo analgesia and active treatment analgesia; and 
these groups will show distinct time courses and magnitudes of analgesia.
2.1.2
To test and validate brain imaging and personality parameters identified in Phase 1 that 
predict the propensity for placebo response and use the results to classify participants 
into responders vs non-responders before study intervention.
Hypothesis: Brain- and behavioral- based parameters identified as markers of placebo response 
in the first phase of the study will accurately predict potential responders from non-responders at 
first scan. The classification before study intervention will closely correspond to the responses 
observed at the end of treatment period. 
2.1.3
To identify gender dependence of placebo analgesia propensity and examine brain and 
personality gender differences that underlie the seeming higher propensity of females for 
placebo response. 
Hypothesis: Sexual dimorphism of the human brain and behavioral/personality differences may 
have a potential interaction effect and predisposition on placebo propensity. We expect to identify 
gender-specific biomarkers that are sexually dimorphic with regard to placebo response.
2.1.4
Classification of placebo responders versus non-responders for 2.1.2 will be based on 
Equation 1 below: 
p = (ef(x) )/(ef(x) +1)
f(x) = -3.3586 + 1.6676*Maia_Emotion - 0.2127*Erq_Suppress + 34.8608*sign_permutation 
where a probability (p) <0.5 = predicts non-responder and a probability (p) ≥0.50  predicts 
responder.
These objectives evaluate the notion that placebo effects can be reduced, and perhaps 
eliminated, from drug trials, by showing that identifiable, separate circuits underlie modulation of 
pain by each. Additionally, we test the utility of combining a drug treatment with placebo effects. 
The RCT literature for testing drug efficacy has repeatedly stumbled, in that one study may be 
successful yet the next fails. One can envision that chance differences in the number of placebo 
responders and non-responders entering the study may dictate the success of many RCTs. This 
aim intends to clarify whether placebo responders show medication treatment responses superior 
to the placebo response, or whether the two independently summate for resultant analgesia. This 
provides the first effort for dissociating brain activity when pain is modulated by placebo versus 
medication. As the medication we will study is an NSAID, we assume that its main site of action is 
the peripheral nervous system and the spinal cord, whereas the placebo effect is obviously 
mediated through cortical control. Thus, we also dissociate between bottom up and top down 
modulation of chronic pain. Furthermore, we will begin to identify gender-dependence interactions 
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on placebo propensity and elucidate sexual dimorphisms in functional and anatomical brain 
properties in the domain of placebo response. 
2.2
Exploratory Objectives
Self-report data from Phase 1, in the form of questionnaire answers and interview answers, will 
be used to develop and validate a self-measurement Tool for Placebo Propensity (TOPPP) to be 
tested here in Phase 2. Additionally, biomarkers for placebo response identified in Phase 1 will be 
validated in this phase via the initial stratification into predicted responders versus non-
responders at the beginning of the study.
Specifically, the brain circuits we observe for placebo propensity reflect interactions between the 
lateral prefrontal cortex and pain processing areas, (this is now confirmed from Phase 1 results), 
and these pain and disease properties should be readily identified in personality, expectation, and 
medical exposure appraisals (measurements we collected from specific questionnaires; 
emotional responses seem to best capture placebo propensity in Phase 1 results), as well as 
captured from themes and patterns seen in qualitative interview responses (this data remains to 
be analyzed from Phase 1 data) from the previous phase.  Significant differences in questionnaire 
scores (total scores and/or specific subscores) between placebo responders and non-responders, 
as well as qualitative and quantitative differences seen between these groups in their responses 
to interview questions, will inform us as to which variables we should use in our new tool tool (we 
now have such a tool from Phase 1 results) that may have predictive capacity. This tool will be 
used in combination with brain biomarkers in the second phase to help stratify participants into 
responders versus non-responders at the first scan, using all new CBP participants as a 
validation group. 
This multi-method approach maximizes the likelihood that we will identify self-report variables 
uniquely linked to the placebo response and its neural signature by including items that capture 
the unique characteristics of chronic back pain and their treatment effects, spanning the disease 
continuum and producing scores calibrated onto a common metric. Importantly, a system that 
meets these needs is likely to be accepted and routinely used in clinical and research settings.
2.3
Endpoints
2.3.1
Endpoint for primary objective: (1) Placebo response (defined as > 20% reduction in pain 
intensity following placebo treatment, or defined from pain app ratings using permutation 
with 0.05 p-value cut-off)) versus active treatment response (reduction in pain intensity 
following naproxen/omeprazole treatment)
2.3.2
Endpoints for secondary objective: (1) Testing the specificity and sensitivity of the brain 
and behavioral parameters from Phase 1, in combination with the TOPPP developed 
from the study interviews, as predictive markers for response in Phase 2. These 
parameters will be considered validated if together are at least 80% accurate in stratifying 
responders from non-responders.
2.3.3
Endpoint for gender objective: (1) Testing for females showing higher incidence of 
placebo response using combined outcomes from phase 1 and phase 2 data.
3.0
PATIENT ELIGIBILITY: SELECTION AND ENROLLMENT OF PARTICIPANTS
Subjects must meet all of the inclusion and exclusion criteria to be registered to the study. Study 
treatment may not begin until a subject is registered.
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3.1
Inclusion Criteria
3.1.1
History of low back pain for a minimum of 6 months with or without signs and symptoms 
of radiculopathy
3.1.2
Male or female, between the ages of 18 and 75 years, with no racial/ethnic restrictions
3.1.3
Must have a Visual Analog Scale (VAS) pain score   5 mm (of 10 mm maximum) at the 
screening visit (for which 0mm = no pain, and 10 mm = worst pain imaginable); 
3.1.4
Must be able to read and speak English and be willing to read and understand 
instructions as well as questionnaires;
3.1.5
Must be in generally stable health; 
3.1.6
Must sign an informed consent document after a complete explanation of the study 
documenting that they understand the purpose of the study, procedures to be 
undertaken, possible benefits, potential risks, and are willing to participate
3.1.7
Must have, on average,  to 5/10 units of pain over the course of a two-week period prior 
to visit 1; rounding up from 4.5/10 is permissible. 
3.1.8
Must be willing to complete daily smart phone/computer app ratings.
3.2
Exclusion Criteria
3.2.1
Low back pain associated with any systemic signs or symptoms, e.g., fever, chills;
3.2.2
Evidence of rheumatoid arthritis, ankylosing spondylitis, acute vertebral fractures, 
fibromyalgia, history of tumor in the back;
3.2.3
Other comorbid chronic pain or neurological conditions;
3.2.4
Involvement in litigation regarding their back pain or having a disability claim or receiving 
workman’s compensation or seeking either as a result of their low back pain;
3.2.5
Diagnosis of current depression or psychiatric disorder requiring treatment, or such a 
diagnosis in the previous 6 months;
3.2.6
Beck Depression Inventory (BDI) Ia score >=19 for two consecutive completions; if the 
first score meets this criteria, the participant must be re-tested before his/her next visit, 
but if the second score does not meet this criteria, the participant will be included and 
followed closely throughout the study
3.2.7
Use of therapeutic doses of antidepressant medications (i.e., tricyclic depressants, 
SSRIs, SNRIs; low doses used for sleep may be allowed);
3.2.8
Significant other medical disease such as unstable diabetes mellitus, congestive heart 
failure, coronary or peripheral vascular disease, chronic obstructive lung disease, or 
malignancy;
3.2.9
History of gastrointestinal ulcer during the past year;
3.2.10
History of myocardial infarction in the past year;
3.2.11
Uncontrolled hypertension;
3.2.12
Renal insufficiency;
3.2.13
Allergic to, or non-tolerant of, NSAIDs;
3.2.14
History of aspirin-sensitive asthma;
3.2.15
Current use of recreational drugs or history of alcohol or drug abuse;
3.2.16
Any change in medication for back pain in the last 30 days only applicable for visit 1 
3.2.17
High dose opioid prophylaxis, as defined as > 50mg morphine equivalent/day;
3.2.18
Any medical condition that in the investigator’s judgment may prevent the individual from 
completing the study or put the individual at undue risk;
3.2.19
In the judgment of the investigator, unable or unwilling to follow protocol and instructions;
3.2.20
Evidence of poor treatment compliance, in the judgment of the investigator;
3.2.21
Intra-axial implants (e.g. spinal cord stimulators or pumps);
3.2.22
All exclusion criteria for MR safety: any metallic implants, brain or skull abnormalities, 
tattoos on large body parts, and claustrophobia; 
3.2.23
Pregnancy, or inability to use an effective form of contraception in women of child-bearing 
age; 
3.2.24
Diabetes (Type I or Type II);
3.2.25
< 5/10 pain on average over the two-week period before the visit 2; 
3.2.26
Lactose intolerance or sensitivity to lactose; and
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3.3
Recruitment
Potential subjects will be recruited initially from a database maintained by the PI and from 
Northwestern’s EDW. Once these sources are depleted, it is envisioned that recruitment will 
occur via community, online, and flyer-based methods, including ads. Potential subjects from our 
internal database who have provided agreement to be contacted will be called by the research 
staff. Those identified via EDW will be contacted once permission is granted by their physician, 
either by phone or by an IRB-approved mailing to be generated.  Potential subjects may also be 
recruited online through websites including but not limited to ClinicalTrials.gov; sites for 
professionals who see patients with low back pain or related conditions; social media websites 
such as Facebook and Twitter; and/or people with low back pain or related conditions. This study 
will also use another online recruitment tool called Research Match, which is a secure online, 
national recruitment tool that is maintained by Vanderbilt University. ResearchMatch.org allows 
researchers to conduct feasibility or recruit potential study participants.
If potential subjects are interested in the study, they will be able to contact the research staff via 
the telephone number given on the website or click on a link to complete a brief online screener. 
To facilitate the recruitment of similar studies on low back pain conducted by Dr. Apkarian’s lab at 
Northwestern, participants who are screened will be asked if they are interested in learning about 
and participating in other studies on low back pain. If participants agree, they will be referred to 
and pre-screened for the other low back pain studies.
3.4
Screening
Before a person can be enrolled in the study and participate in Visit 1 (Screening Visit), s/he must 
first go through a maximum of two screening procedures over the phone.  For potential 
participants who are recruited through community, online (including ClinicalTrials.gov), and 
flier/ad-based methods, the telephone number they contact will direct them to either NUCATS or 
research personnel associated with this study.  NUCATS will go over a very brief pre-screening 
phone interview with interested individuals to verify that they are eligible to participate in the study 
at the most basic level (for example, verifying that they don’t have any comorbid pain conditions 
and average pain prior to study enrollment). Those individuals who pass this pre-screening phone 
interview will have their contact information given to the study coordinators for a more thorough 
phone screening process. For these potential subjects and for individuals being recruited from the 
databases mentioned in 3.3, research coordinators will contact them and ask a series of more 
detailed questions to verify eligibility to enroll. This phone screening will go over all inclusion and 
exclusion criteria as indicated in the protocol, and it will also briefly explain the purpose of the 
study and the general outline the study.  If the individual is eligible and still interested in 
participating at the end of this longer phone screening, the coordinator will schedule a time for 
them to come in for Visit 1.  Additional screening procedures will happen at the first and second 
visits (for example, a pain rating >5/10 and discontinuation of contradictory medicines), and final 
eligibility will not be determined until the day before the first scan at visit 3.
4.0
TREATMENT PLAN AND STUDY INTERVENTION
4.1
Treatment Dosage and Administration
4.1.1
Placebo Treatment: Placebo capsules (gel caps filled with lactose NF), which will look 
identical to the active treatment capsules (see below), will be taken twice daily during 
treatment periods. During Phase 2, after a initial rating period and a 2-3 week washout of 
any of participant’s current pain medications, participants will take placebo orally bid for 6 
consecutive weeks (coming in every 3 weeks for follow-up visits and medication refills), 
followed by an additional 3 week washout period before study completion.  One placebo 
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pill will be capsulated similarly to naproxen and the other will be encapsulated similarly to 
omeprazole.
The manufacturer for the placebo is Humco. The capsule shells (hard gelatin) will be 
manufactured by Capsugel (Coni Snap Size 00). Capsugel provides a certificate of 
analysis with each capsule batch ordered. Capsugel manufactures gelatin capsules from 
gelatin that complies with BSE requirements. Capsugel provides confidential detailed 
information about facilities, processes, articles used in manufacturing, processing, 
packaging, and storing of empty capsules through Type IV (Excipient) Drug Master Files 
submitted to the FDA.  Inactive ingredients are cellulose and gelatin. Placebo capsules 
also contain FDC Blue #1 and FDC White.
4.1.2
Active treatment: 1 capsule of naproxen (500mg) and 1 capsule of omeprazole (20mg) 
will be taken orally twice daily based on the protocol for Phase 2 outlined in [3.1.1]. Each 
of these pills is encapsulated differently to avoid potential confusion when taking the 
medication. The active ingredient for the Naproxen tablets manufactured by Teva 
Pharmaceuticals or Amneal Pharmaceuticals, and the active ingredient for omeprazole is 
manufactured by Kremers.  The capsule shells for both naproxen and omeprazole are 
manufactured by Capsugel and are the same material, size and color as those for the 
placebo (see 3.1.1. above).
4.1.3
No-treatment: For individuals assigned to the no treatment group, they will have the 
opportunity at the end of the study (when the study is un-blinded and when the efficacy 
results have been analyzed) to try the study medication that worked the best in alleviating 
back pain in the other participants, regardless of whether it was the NSAID or the 
placebo. If requested, this medication will be given to them at the same dosage and 
frequency that was used in the study, and the amount provided will last 6 weeks.
4.1.4
Acquisition: The study medications – lactose NF, Naproxen, and Omeprazole – will be 
purchased by the Investigational Research Pharmacy at NMH, 251 E Huron St. LC-700, 
Chicago, IL 60611.  Lactose NF will be purchased in bulk and the naproxen and 
omeprazole as capsules from the manufacturers noted above.
4.1.5
Formulation, Packaging, and Labeling: Over-encapsulation is conducted in the 
Investigational Pharmacy on a segregated and cleaned countertop. Active capsules are 
prepared by putting the active drug capsule inside an empty gel cap and further filling it 
with lactose. Placebo capsules are made by filling an empty gel cap with lactose.
4.1.6
Product Storage and Stability:  Study agents will be stored at temperatures between 
68-77 ºF. Shelf life for Placebo and Omeprazole is 6 months; shelf life for Naproxen is 6 
months. Shelf life for the rescue medication (acetaminophen) will be determined by the 
expiration date provided on the purchased bottles. Study medications will be stored and 
monitored at the Research Pharmacy; rescue medication will be stored in a designated 
locked filing cabinet in a locked room and will be monitored daily via temperature and 
accountability logs. 
4.1.7
Accountability Procedures: Study product will be purchased by Northwestern Memorial 
Hospital Investigational Pharmacy for over-encapsulation; the rescue medication – 
Acetaminophen – will be bought in bulk from a nearby Walgreens pharmacy by the 
research staff. A defined quantity of capsules of study agent (naproxen, omeprazole, and 
placebo) will be supplied by NMH Investigational Pharmacy for distribution to participants. 
Each bottle of study agent will be filled with 52 capsules of the study agent designated by 
the randomization scheme – this number was calculated based on having two 
consecutive 3-week (21 day) treatment periods plus the additional 5 day possible visit 
window (26 days) multiplied by two pills a day; participants would receive a set of 2 
bottles (one with 52 blue pills and another with 52 bi-colored pills) at visit 3 and another 
set of 2 bottles and visit 4. Regarding rescue medication, 8 pills of acetaminophen 
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(500mg each) will be provided at visits 1 through visit 5 by the research staff. This low 
number is to diminish the likelihood that participants will have a placebo response to the 
rescue medication and encourage them to only use the medication IF they truly need it. 
Participants will be required to record all medication usage using the phone/computer 
app. These data are immediately logged into our server, which provides us routine 
overview of participants’ participation and compliance, and further enhances retention of 
participants. If participants repeatedly miss entering these values, they are contacted by 
phone and instructed for compliance. A member of the research staff, unblinded monitor 
(Taha Abdullah, Back up: Ian Lukidis), will contact those participants who are non-
compliant with phone app ratings. Thus she will be the only staff member who will be 
unblinded to treatment allocation (treatment vs no treatment) Participants will be asked to 
return all unused study medication for each treatment visit and it will be accounted by the 
research pharmacy.   An overall usage rate of 80% is required to be considered 
compliant; if a participant falls below this percentage, we will still keep them in the study 
but we may or may not end up using their data for future analyses. A final inventory at 
study conclusion will be compared with drug supplied, drug participant recorded taking, 
drug participants actually took, and drug returned. Returned medication will be destroyed 
through NMH pharmacy drug disposal services after final accountability is determined. 
The pharmacy will be responsible for updating and checking the study agent 
accountability logs. Rescue medication will only be dispensed for visits 1-5 and 
accountability will be determined by the research pharmacy and documented in a rescue 
agent accountability log. Returned medication will be destroyed through NMH pharmacy 
drug disposal service after final accountability is determined. 
4.1.8
Concomitant Medications/Treatments: Participants must discontinue all concomitant 
pain medications prior to starting study treatment. Participants will be required to restrict 
all medications for relief of pain to only those provided during the course of this study 
(i.e., rescue medication, acetaminophen). Participants will be allowed to continue their 
existing non-pain medications as long as they are not exclusionary for study enrollment. 
Concomitant Medications/Treatments. Any changes in pain medication during the 30 
days prior to visit 1 are not permitted, and a history of alcohol or drug abuse within the 
last 3 years is prohibited. Prior cannabinoid drug use is not exclusionary, but must be 
stopped for the duration of the study; if there is evidence that the participant is currently 
using cannabinoids or other recreational drugs while enrolled in the study, s/he will be 
dropped.  Participants will be queried at each visit about other medications they are taken 
and any changes to this list. A cumulative log of medications will be kept in their 
designated study folder. Additionally, Northwestern University has an online database 
called eNOTIS, which is a web-based study enrollment log run by NUCATS that helps 
improve safety and security for participants.  eNOTIS allows investigators to track 
participants involvement in other studies and in turn monitor if they are using other 
interventions from these studies at the same time.  All participants are entered into 
eNOTIS at the beginning of the study so that we can record any of these possible 
interventions throughout the person’s time in the study.
4.2
Duration of Therapy
Treatment may continue for 6 weeks or until:

Inter-current illness prevents further administration of treatment;

Unacceptable adverse event(s);

Patient decides to withdraw from the study; OR

General or specific changes in the patient’s condition render the patient unacceptable 
for further treatment in the judgment of the investigator.
4.3
Intervention Discontinuation: Removal of Patients from Protocol Therapy
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Subjects have the right to withdraw fully or partially from the study at any time and for any reason 
without prejudice to his or her future medical care by the physician or at the institution. 
Withdrawal of full consent for a study means that the subject does not wish to receive further 
investigational treatment and does not wish to or is unable to continue further study participation; 
subject data up to withdrawal of consent will be included in the analysis of the study. Any subject 
may withdraw full consent to participate in the study at any time during the study. The investigator 
will discuss with the subject appropriate procedures for withdrawal from the study.
Withdrawal of partial consent for a study means that the subject does not wish to take
protocol-required interventions any longer but is still willing to collaborate in providing further data 
by continuing on study (e.g., participate in all subsequent study visits or procedures). Subjects 
may decline to continue receiving interventions at any time during the study. If this occurs, the 
investigator will discuss with the subject appropriate procedures for withdrawal from protocol-
required therapies (since this is placebo, there will be not withdrawal period; they can simply stop 
treatment). Should a subject (or a legally acceptable representative) request or decide to 
withdraw from the study, all efforts will be made to complete and report the observations as 
thoroughly as possible up to the date of withdrawal. All information should be reported on the 
applicable forms.
Reasons for intervention discontinuation might include:
• partial withdrawal of consent
• withdrawal of full consent
• administrative decision by the investigator 
• pregnancy in a female subject (cannot be scanned)
• sudden ineligibility due to another intervention, accident, etc
• significant protocol deviation
• patient noncompliance, which may include but is not limited to:
1.
not taking the study medication (if applicable) according to the instructions given this 
will be monitored according to the phone/computer apps and in-person visits; if a 
participant has multiple indications of medication non-compliance, s/he will be 
disqualified and the intervention will be stopped
2.
taking non-approved concomitant medication (section 4.2)
a.
this will be monitored according to the phone/computer apps, in-person visits, 
and eNOTIS
3.
not completing required study tasks, such as the daily phone/computer application
a.
more specifically, if a participant misses 3 consecutive ratings, the research 
coordinator will be informed and s/he will call the person to remind them; 
• AE
• other safety concerns by the investigator or NCCIH
• death
• lost to follow-up
If a patient’s intervention is discontinued, the Principal Investigator will be informed, the reason for 
study removal will be documented, and the date the patient was removed will be listed in the 
Case Report Form. 
4.4
Subject Retention and Ensuring an Adequate Sample Size
Although accrual will be monitored on a quarterly basis according to our DSMP, at designated 
time points throughout each aim of the study, we will assess whether or not we need to recruit 
additional participants.  For Phase 2 this will be done at the half-way point and repeated for every 
2 blocks until completion. At these times, if there is not a large enough drop-out rate to 
significantly reduce our sample size or power, we will not attempt to replace participants and 
continue with analysis without any replacement strategy.  However, if the drop-out rate is larger 
than expected and lack of study retention causes us to need to increase our sample size, we will 
recruit additional participants and have NUCATS randomize accordingly until we have enough 
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participants in each group to do adequate analyses. In other words, we will continue to enroll 
subjects until we have an adequate number that meet our criteria, using the original 
randomization list. As addressed previously, we have specific procedures to help minimize 
subject dropout and missing data. These include the collection of detailed contact information 
from subjects, maintaining communications logs regarding our contacts with subjects, and a 
“study identity” that we will use in various communications with subjects (e.g., phone, email, 
letters). The computer/phone application mentioned previously will also aid us in retaining and 
tracking our subjects, as well as keeping up with data collection. As subjects drop out of the 
study, we will document reasons for dropout and address any procedural issues that may be 
related to dropout.  At regular team meetings, we will review the number and percentage of 
missed assessments. Even with our data-retention plan, there will of course be missing data over 
time. We will compare subjects with and without missing data to determine whether any subject 
characteristics are systematically related to missing data. All relationships over time can be 
analyzed using hierarchical linear modeling (HLM), which provides maximum likelihood estimates 
for model parameters when data are missing at random. This model is a mixed-effects repeated 
measures (MMRM) analyses that includes data over time nested within participants. Participant-
level variables are included in the model. For this model, participant level variables will be 
Maia_Emotion, Erq_Suppress, and sign_permutation, just as in the logistic regression model 
(described above).  HLM allows one to model the trajectory of change within subjects, and then 
determine the effects of covariates (e.g., treatment group) on this trajectory. The exact model 
tested will be:
PAINti = β00 + β01*MAIA_EMOi + β02*ERQ_SUPPi + β03*SIGN_PERi + β10*DAYti
+ β11*MAIA_EMOi*DAYti + β12*ERQ_SUPPi*DAYti + β13*SIGN_PERi*DAYti
+ r0i + r1i*DAYti + eti
In the equation above, PAINti is the average pain rating for the tth day for the ith participant. r and 
e terms are error terms. Parameters will be solved for by maximum likelihood estimation. It should 
be noted that all aspects of this model will be inspected in Phase 2 and alternative models will be 
examined as needed. This includes models with more complex pain trajectories (e.g., non-linear 
change over time), and models with additional covariates and/or interactions among covariates
5.0
STUDY PROCEDURES
5.1
Screening and Enrollment Procedures 
Assessments performed exclusively to determine eligibility for this study will be done only after 
obtaining informed consent. Assessments performed for clinical indications (not exclusively to 
determine study eligibility) may be used for baseline values even if the studies were done before 
informed consent was obtained.
All screening procedures must be performed within 28 days prior to randomization unless 
otherwise stated. The screening procedures include:
5.1.1
Informed Consent
Read and discuss informed consent form (ICF) and receive signature from participant 
and study personnel asking for consent. An ICF template is attached to the appendix of 
this protocol.
5.1.2
Medical history
Complete medical and surgical history, history of infections
5.1.3
Demographics
Age, gender, race, ethnicity, socioeconomic status
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5.1.4
Review subject eligibility criteria
See section 2.0 above
5.1.5
Review previous and concomitant medications
See section 3.2 above
5.1.6
Physical exam including vital signs, height and weight
Vital signs (temperature, pulse, respirations, blood pressure), height, weight
5.1.7
Review of pain intensity stability
Pain levels  5/10 intensity are required to be reported prior to study entry. This criteria 
must be maintained on average for 2 weeks during the baseline rating period in order to 
continue in the study at visit 2. 
5.1.8
Adverse event assessment
N/A for Screening; AEs will be collected at Visit 2 and all further visits. See section 6.0 and 
DSMP (in appendix) for Adverse Event monitoring and reporting.
5.2
Procedures During Treatment
5.2.1
Schedule of Events for all participants

Visit 1 (week-3):  Consent, screening, and baseline pain/mood monitoring (45 min).
Participants will complete the informed consent process and are evaluated for initial 
inclusion/exclusion criteria, and they will be asked to assess current back pain intensity 
on a VAS scale.  They will be asked to assess current back pain intensity on a VAS scale 
(0-10mm, no pain to worst possible pain). A medical/pain history and physical 
examination including vitals will be completed.  Blood will be drawn for an initial screen to 
obtain a complete blood count, chemistry panel, and liver function tests (data reviewed by 
TJS). Participants will be asked to discontinue their current pain medications ~14 days (2 
weeks) prior to their first scanning visit. Participants will receive acetaminophen (rescue 
medication) at the time of the visit. They will be shown how to use the smart 
phone/computer application (and given a phone if necessary), and they will be instructed 
to rate their pain and mood with the app two times a day for the duration of the study. 
Participants will complete questionnaires and return within 2 weeks for the first MR 
imaging scans. This length of time is adequate to allow scheduling and permit flexibility 
for subjects’ preferences, and to ensure that pain levels persist at or above 5/10 VAS 
collected from the pain rating app and that participants do not significantly respond 
(>20% decrease) to the acetaminophen rescue medication.  In addition, the entry 
interview will be conducted at this visit. 

Visit 2 (week -1): Baseline Scan (90 min). 
Approximately 14 days after visit 1, participants will return for their second visit. If a VAS 
score of > 5 mm on average over the course of the visit 1-visit 2 rating period is 
calculated and no changes in clinical status are reported or found, they complete a 
battery of questionnaires and undergo MRI procedures (anatomical and functional 
scans). Subjects will be queried about changes to health experienced since the last visit 
and asked if they exceeded 4 acetaminophen per day. In addition one of the pictures for 
visit 2, 4, and 5 will be conducted (see section 13.III). They will be asked to continue their 
phone/computer app ratings and return in approximately one week for visit 3. Participants 
will receive only rescue medication in sufficient quantities until the next visit. Additionally, 
participants will be randomized into a treatment versus no-treatment group at this time 
(information that the pharmacy will produce and keep). 

Interim between Visit 2 and Visit 3: Group classification Based on Predicted Response
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In between visits 2 and 3, participant’s scans will be analyzed by extracting the functional 
connectivity between frontal and sensorimotor networks (called “sign permutation” in 
Equation 1) and 2 questionnaire subscores will be calculated (MAIA emotion and ERQ 
suppression in Equation 1); all 3 parameters will then be entered into Equation 1.  Based 
on the results of the model specified on page 10, participants will be classified  as either 
placebo non-responders (probability < 0.5) or placebo responders (probability ≥ 0.5).  
After baseline scan, the subjects’ MR images and data will be collected by research 
personnel and then will be given to a single member, the blinded assessor (Dr. Huang) 
who will have no interaction with the participants, therefore will remain blinded. The 
research personnel responsible for conducting the visit will download the MAIA and ERQ 
questionnaires from the REDCap database and calculate the scores for MAIA-Emotion 
and ERQ-suppression subscales to be used in the model.
(1)   All MR images collected at the baseline scan will be uploaded to the server and 
pre-processed within 24 hours of the visit using our in-house pipeline.
(2)   The blinded assessor will be responsible for initiating the preprocessing of the 
brain images and extracting the connectivity values between frontal and sensorimotor 
regions ("sign permutation value").  This extraction will be done within 4 days after 
the MRI was collected, which provides enough time to calculate this connectivity and 
the likelihood of response (see below), as well as adequate time to give the result to 
the pharmacy (see below). 
(3)   After obtaining the connectivity values, the blinded assessor will enter these 
along with the 2 questionnaire subscores into the model on page 10 to determine 
subject group identification. The model generates a response likelihood from 0 to 1, 
and those individuals with a p-value ≥ 0.5 will be labeled as responders; all others will 
be labeled as non-responders.
(4)    After response group identification, the blinded assessor will then send an email 
with subject ID, classification group, and randomization code to the Northwestern 
University Research Pharmacy email NMInvestigationalDrugService@nm.org. The 
research pharmacy will have two independent randomization sequences for 
responders (Group A) and non-responders (Group B). Each group independently will 
be allocated in a 3:3:1 ratio (active treatment, placebo treatment, and no treatment, 
respectively) by the research pharmacy. Therefore, the pharmacist will be unblinded 
to identification and treatment allocation. 
The unblinded monitor who is responsible for phone app compliance will be partially 
unblinded, remaining blinded to active vs placebo assignments but unblinded with 
respect to treatment vs no treatment groups, as the pain rating app will query participants 
“Have you taken today’s medication?” The remaining staff members will be completely 
blinded to both treatment vs no-treatment allocation and within the treatment allocation to 
active vs placebo treatments
A one-week interim period was chosen to allow enough time for selected study staff to 
run the prediction analysis and send this information to the pharmacy, as well provide 
another week of additional baseline pain app ratings. The duration of this period might be 
slightly longer or shorter depending upon how quickly the model is run, but it will be within 
the visit window specified in this protocol, which is ± 5 days 

Visit 3 (week 0): Start of Treatment Period (30-45 min). 
Once classification has been made with regard to responder vs non-responder status 
participants will return for the next visit (V3). A set of questionnaires will be administered 
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and participants will be queried about changes to health experienced since the last visit. 
Vitals will also be collected. Participants who remain eligible will then be randomized to 
active treatment, placebo, or no treatment groups in a blinded fashion, which will be 
completed by the research pharmacy. The unblinded monitor will pick up study drug from 
the pharmacy prior to visit 3, if the participant is assigned to the treatment arm. 
Additionally, participants will receive only rescue medication in sufficient quantities until 
the next visit. The unblinded monitor will explain the medication regimen to the participant 
at that time. This is to ensure that the remaining study staff remain blind to treatment 
versus no-treatment group assignment. The placebo group, made up of predicted 
responders and non-responders, will receive two placebo capsules bid, and the active 
treatment group, also made up of predicted responders and non-responders, will receive 
one naproxen capsule (500mg) and one omeprazole capsule (20 mg) bid for the 
treatment period. Study medication will be dispensed in sufficient quantities until the next 
visit. The no treatment group and all participants in all groups will receive rescue 
medication by the research pharmacy in sufficient quantities to last them until the next 
visit. They will be asked to continue their daily pain/mood ratings, and to come back in 3 
weeks for an interim visit, bringing back any remaining study medication at that time 
which will be accounted for by the research pharmacy. 
Visit 4 (week 3): Continuing Assessment  (30-45 min). 
This visit will be completed entirely by the unblinded monitor; there is no clinical data 
being collected here – only safety data. All procedures will be performed as described for 
Visit 3. Adherence will be assessed by pill counting for those on treatment group, and 
participants will be queried about any side effects experienced. In addition one of the 
pictures for visit 2, 4, and 5 will be conducted (see section 13.III). Study medication and 
rescue medication will be dispensed in sufficient quantities until the next visit, as 
described in Visit 3. They will be asked to continue using the phone/computer app and to 
come back in 3 weeks for their end-of treatment (final) scan.

Visit 5 (week 6): End of Treatment/Start of Washout and Final Scan (60-90 min):
Participants will undergo the same brain scanning session that they had on Visit 2, and 
all questionnaires, AE assessment, and treatment medication adherence procedures will 
be performed as they were in previous visits. Participants will be asked to stop the study 
medication (if applicable) and to start the washout period, and they will only be given 
rescue medication at this visit by the research staff (enough to last them until the last 
visit). In addition one of the pictures for visit 2, 4, and 5 will be conducted (see section 
13.III). They will be asked to continue rating their pain and mood on the app and to return 
for the final visit in 3 weeks. Note that apart from the scanning session and administration 
of questionnaires via REDCap, all other aspects of this visit will be completed by the 
unblinded monitor to aid in the maintenance of the double-blind on the part of the study 
staff.

Visit 6 (week 9): Final Visit/End of Washout (30-45 min):
Any changes to health will be documented, and vitals will be collected.  A short battery of 
questionnaires will be administered and participants will be compensated for all app 
ratings completed during the study.

Interim periods: During weeks in between visits, participant data will be tracked with the 
assistance of a smart phone/computer application designed for the study (available through 
a secure website). Depending upon preference, we will download an app onto participants’ 
phones or give them a link to use on their computers; in the case that a participant does 
not have a smart phone or easy access to a computer/internet, we will provide him/her with 
a smart phone that has the app already installed. Participants will be given a login and will 
be asked to use this application twice a day, morning and night for baseline and washout 
and right after they take their medication for treatment (if applicable). The app asks them 
to rate the severity of their pain and their mood on a Likert scale, and probes them as to 
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whether or not they took their medication. This will allow us to keep track of the stability 
and magnitude of pain and mood, as well as treatment compliance. To encourage them to 
keep up with this requirement, each time they submit these answers, they will receive 25 
cents.  Responses and payments will be logged automatically into a secure database that 
only study personnel will have access to; if participants miss more than 3 consecutive 
ratings in a row, research personnel will call or text them to remind them to rate or verify 
that their app is still working (they are automatically alerted via email by a program 
designed by the lab). The unblinded monitor designated for this study will check 
participants ratings bi-weekly to verify that ratings are being completed.

Follow up: Patients will be asked if they wish to be added to our contact list to participate 
in future studies of the lab. They will also be asked if they accept to be contacted by phone 
3 months and 6 months later to assess the long-term effects of the study intervention on 
their chronic pain intensity.
5.3
Randomization:
All randomization (and blinding, see next section) will be completed by NUCATS (see study roster 
in Location 2 for name of personnel). NUCATS will generate two randomization sequences, one
for each group (predicted responders, Group A, and non-responders, Group B). This approach 
will ensure the proper 3:3:1 treatment allocation. We will use a variable block design (size of 5 
and size of 10), throughout Phase 2 of the study to minimize temporal bias that can accompany 
longitudinal scanning studies.  We don’t anticipate much exclusion after randomization and 
enrollment based on our previous studies (although screen failures during the run-in are likely 
due to pain level or pathology lab results, for example. The Phase 2 overall sample size is 210 
randomized 3:3:1, therefore n = 90 active treatment (n = 45 responders/non-responders), n = 90 
placebo treatment (n = 45 responders/non-responders), and n = 30 no treatment (n = 15 
responders/non-responders). We expect an attrition rate of ~33% for a final N = 140. 
5.4
Blinding Procedures
We describe this study as a 3-arm randomized controlled trial in which two treatment arms are 
double blinded and the third arm consists of a no-treatment group that is partially unblinded to 
only the unblinded monitor (who will be unblinded to treatment arm but blinded to treatment 
identity). Other than this person, all the remaining personnel conducting the study, collecting 
study endpoints, and analyzing data, including the PI, will be blind to the allocation of participants 
to study arm, response prediction, and treatment.  All pills will be identically encapsulated to 
ensure blinding for study participants who receive treatment. All pills will be identical in size but 
there will be two colors of masking encapsulation – blue and bi-colored.  This is to help the 
participant remember to take two different tablets (naproxen/placebo and omeprazole/placebo) at 
each time and thus reduce the possibility of ingesting two identical pills. The only person who will 
know which capsules contain active vs placebo will be the unblinded pharmacist responsible for 
ordering the medication, re-encapsulating the agent, filling the numbered medication vials with 
the appropriate drug and number of capsules, and handling drug accountability. This person will 
have no other involvement with study staff or be involved with any study procedures. Unmasking 
should not be required during the study. If allocation assignment needs to be made available, this 
will be done based on the circumstances outlined above. If there should be a question regarding 
proper allocation of treatment product, it would be possible to ascertain placebo from active drug 
product by opening the treatment capsules and determining if there were an enclosed tablet 
present. This will be prevented by sealing of all capsules prior to their being placed in treatment 
vials for dispensing.  As mentioned above, the blinded assessor inquiring about medication 
compliance and adverse events will remain blinded to the treatment arm as the other study staff 
are, but will not be blinded to treatment versus no-treatment group assignment.
Randomization and drug allocation based on this scheme will be completed by NUCATS and 
Northwestern’s Research Pharmacy, respectively, to ensure blinding. A pharmacist not involved 
in any other part of the study and without access to study data will be responsible for dispensing 
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the study medication into bottles and labeling these vials with the PIDs according to the design 
implemented and drug accountability for both rescue and study agents. The randomization list will 
be maintained by the pharmacy and be made available to the study PI and study physician only in 
case of emergency.  Un-blinding will only occur if knowledge of the treatment arm would be 
essential for the safety of the participant. None of the study staff will have access to the 
randomization list and all study supplies will be identical in appearance other than the PID.  All 
study staff, including the statistician, will remain blinded until database lock. Un-blinding will not 
take place until the end of the study when the final neuroimaging contrasts will be performed. 
Preliminary analyses of the data will also be conducted in a blinded fashion using an automated 
method in which all participants are processed in the same way.  An initial platform of analyses 
including pre-processing, regressors for spontaneous pain episodes, and brain connectivity 
during resting states can easily be created while remaining blind to the intervention.  These 
preliminary analyses will be first be re-coded and scrambled by someone in the lab who has no 
other connection to the study, which thus allows other study personnel using this data to remain 
blinded during preliminary analysis and throughout the study’s entirety.  Additionally, since there 
is a no treatment group, measures to continue the partial blind (on the end of the research team) 
will be done. For the duration of the study, separate personnel (a designated unblinded monitor) 
will be involved in organizing participant folders, printing questionnaire responses, evaluating 
interim responses, adverse events, and medication compliance, and walking with participants to 
collect their medication. This is to ensure that those collecting and analyzing the data can 
maintain their blind not only to treatment type but also to whether or not treatment was given. 
Other than the pharmacist and unblinded monitor, the rest of the study staff will remain totally 
double-blinded and will only be involved in scanning procedures, and sending questionnaires 
online.
5.5
Visit Windows
Not all participants will be able to come back for their next visit exactly 7 or 21 days from the 
previous visit.  To account for holidays and individuals’ personal schedules, the acceptable 
window for each visit will be ± 5 days from the target date.  This window will also be incorporated 
into pharmacy ordering and pill counts to ensure sufficient amounts of study medication between 
visits.
6.0
RESPONSE CRITERIA
Treatment response is defined as a reduction in VAS pain intensity > or equal to 20% from visit 1-
visit 2 pain ratings, or by permutation testing for change in pain rating by 0.05 p-value. Such 
individuals are considered treatment “responders,” whereas “non-responders” are defined as 
individuals who experience increased or stable pain levels throughout treatment periods, 
including reductions in pain < 20% of baseline pain intensity.
7.0
ADVERSE EVENTS AND SAFETY ASSESSMENT
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7.1
Adverse Event Collection
7.1.1
We will collect all adverse reactions reported for all treatment groups. We collect all AEs 
(even colds and coughs or any preexisting condition that may have worsened) regardless 
if they are related to the study or not. Our IRB guidelines state "any change in clinical 
condition of the participant obtained upon interaction with the participant during the visit 
or interval, related or unrelated to the study.  Health status will be elicited by asking the 
participants if there has been any change in their overall health or health status rather 
than asking specifically regarding predefined conditions (open-ended questioning)”.
7.1.2
All AEs will be reported to Dr. Thomas Schnitzer, the study physician, for review and 
appropriate follow-up.
7.2
Adverse Event Monitoring
Adverse event data collection and reporting, which are required as part of every clinical trial, are 
done to ensure the safety of subjects enrolled in the studies, as well as those who will enroll in 
future studies using similar agents. Adverse events are reported in a routine manner at scheduled 
times during a trial. Additionally, certain adverse events must be reported in an expedited manner 
to allow for optimal monitoring of patient safety and care. 
All patients experiencing an adverse event, regardless of its relationship to study compound/drug, 
will be monitored until: 

the adverse event resolves or the symptoms or signs that constitute the adverse event 
return to baseline; 

any abnormal laboratory values have returned to baseline; 

there is a satisfactory explanation other than the study compound/drug for the changes 
observed; or

death.
The reporting of adverse events, serious adverse events and unanticipated problems will be done 
according to the guidelines of the Northwestern University IRB and the FDA*. As of August 20, 
2007, Northwestern University IRB requires immediate filing of internal or external adverse events 
reports, or safety reports only if they have been determined by the Principal Investigator to 
contain a report of unanticipated problems involving risks to subjects or others. NU 
considers unanticipated problems, in general, to include any adverse event, incident, experience, 
or outcome that meets all of the following criteria: (1) Unexpected (in terms of nature, severity, or 
frequency) given: (a) the research procedures that are described in the protocol-related 
documents, such as the IRB-approved research protocol and informed consent document; and  
(b) the characteristics of the subject population being studied. 1. The known or foreseeable risk of 
adverse events associated with the procedures involved in the research that are described in: 
a) the protocol-related documents, such as the IRB-approved research protocol, any applicable 
investigator brochure, and the current IRB-approved informed consent document; and b) other 
relevant sources of information, such as product labeling and package inserts; or 2. The expected 
natural progression of any underlying disease, disorder, or condition of the subject(s) 
experiencing the adverse event and the subject's predisposing risk factor profile for the adverse 
event. (2) Related or possibly related to participation in the research (in this guidance 
document, possibly related means there is a reasonable possibility that the incident, experience, 
or outcome may have been caused by the procedures involved in the research); and (3) 
Suggests that the research places subjects or others at a different or greater risk of 
harm (including physical, psychological, economic, or social harm) than was previously known or 
recognized.
NOTE:
The following events are considered a serious adverse event and would place subjects at a 
greater risk of harm: 
• results in death;
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• is life-threatening (places the subject at immediate risk of death from the event as it 
occurred);
• results in inpatient hospitalization or prolongation of existing hospitalization;
• results in a persistent or significant disability/incapacity;
• results in a congenital anomaly/birth defect; or
• based upon appropriate medical judgment, may jeopardize the subject’s health and may 
require medical or surgical intervention to prevent one of the other outcomes listed in this 
definition (examples of such events include allergic bronchospasm requiring intensive 
treatment in the emergency room or at home, blood dyscrasias or convulsions that do not 
result in inpatient hospitalization, or the development of drug dependency or drug abuse).
Unanticipated problems involving risks to subjects or others should be reported to the IRB within 
10 working days (unanticipated deaths of subjects enrolled at NU or Affiliates need to be reported 
within 24 hours). 
All adverse events deemed to be serious, both unexpected and expected, will be reported to the 
medical monitor.
The medical monitor (Dr. Thomas J Schnitzer) is required to review all unanticipated problems 
involving risk to volunteers or others, serious adverse events and all volunteer deaths associated 
with the protocol and provide an unbiased written report of the event to the FDA*.  The medical 
monitor will comment on the outcomes of the event or problem and in the case of a serious 
adverse event or death comment on the relationship to participation in the study.  The medical 
monitor will also indicate whether he/she concurs with the details of the report provided by the 
study investigator.  Reports for events determined by either the investigator or medical monitor to 
be possibly or definitely related to participation and reports of events resulting in death will be 
promptly forwarded to the FDA MedWatch Online Reporting System.  Note that since the study is 
not being conducted under an Investigational New Drug Application (IND), mandatory reporting of 
safety information to the FDA itself is not required. Instead, voluntary reports of adverse events 
observed or suspected for human medical products will be filed in the online system specified 
here.
A summary table of adverse events collected will be submitted at least annually to the 
Northwestern IRB.  Additionally, NCCIH will be informed of serious and non-serious adverse 
events according to the requirements outlined section 6.2.1 below.7.2.1. Reporting of SAEs
SAEs that are unanticipated, serious, and possibly related to the study intervention will be 
reported to the Independent Monitor, IRB, and NCCIH in accordance with requirements.  
o
Anticipated or unrelated SAEs will be handled in a less urgent manner but will 
be reported to the Independent Monitor, IRB, NCCIH, and other oversight 
organizations in accordance with their requirements.
o
Unexpected fatal or life-threatening AEs related to the intervention will be 
reported to the NCCIH Program Officer within 7 days. Other nonserious and 
unexpected AEs related to the intervention will be reported to the NCCIH 
Program Official within 14 days.
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7.3
Unblinding Procedures
Unblinding the study therapy is not commonly necessary but may be done if required to ensure a 
subject’s safety. In most cases, the unblinding will be part of managing an SAE, and will be 
reported with the SAE.  In cases where unblinding was not associated with an SAE, such actions 
will be reported in a timely manner (e.g., notification of IRB within 24 hours by phone or fax, 
followed by a written narrative of the event within 48 hours.).  Otherwise, un-blinding will not be 
done until each phase of the study is complete (that is, when Phase 2 is finished running all 
enrolled participants, we can unblind the data). 
7.4
Stopping Rules/Intervention Discontinuation
This study will be stopped prior to completion if: (1) the intervention is associated with adverse 
effects that call into question the safety of the intervention; (2) difficulty in study recruitment or 
retention will significantly impact the ability to evaluate the study endpoints; (3) any new 
information becomes available during the trial that necessitates stopping the trial; or (4) other 
situations occur that might warrant stopping the trial.
8.0
STATISTICAL CONSIDERATIONS
8.1
Summaries of Design, Endpoints, and Analysis
8.1.1
Phase II: Study Design/Study Endpoints
Enroll and randomize 220 CBP patients into the study. Stratify into placebo responders and non-
responders based on brain scan results at entry. We anticipate that about 50% of the patients will 
be placebo responders. All participants are randomized so that 40 receive placebo treatment, 40 
active medication, and 20 no treatment. If Gender Supplement is awarded then randomization is 
slightly different: 60 receive placebo, 60 active medication, and 20 no treatment.
We assume that placebo responders and non-responders will show differential interaction with 
active medication treatment. We also expect to distinguish the four groups based on brain activity 
at the end of the trial, and show close correspondence between predicted and actual outcomes 
regarding placebo responses. Additionally, placebo non-responders should show a robust 
medication response, especially in comparison to the placebo non-responders receiving placebo 
treatment. Brain activity contrasts are done as a two-way (treatment groups) repeated measures 
(time: start vs. end) ANOVA (2RM-ANOVA). This is the procedure we implemented recently in a 
longitudinal neuroimaging study of pain chronification (Baliki et al., 2012). Post-hoc comparisons 
then reveal: 1) A contrast of brain activity at end of treatment between placebo non-responders 
with and without medication treatment to identify brain activity for bottom-up modulation of chronic 
pain. 2) Brain regions related to chronic pain are identified as areas commonly decreased with 
placebo treatment for placebo responders and medication treatment for placebo non-responders. 
3) Top-down placebo and bottom-up medication effects are distinguished by identifying regions 
that distinctly increase in activity for placebo and medication treatments based on contrasts for 
the same groups. 4) The no treatment group brain activity is used as a higher-level contrast, 
which effectively corrects for this confound.
8.1.2
Sample Size and Accrual
Statistical power can be estimated based on the Cohen’s d effect sizes for differences in pain with 
6 weeks of treatment. For responders, based on our preliminary results, we anticipate a mean 
decrease of 2.5 units on a 0-10 scales with an estimated SD of 3, which results in an effect size 
estimate of 0.83. In non-responders, the mean decrease in pain is negligible and we do not 
expect to have enough power to detect this.
Power analyses in G*Power 3.1.3 indicated that we will have ample power to detect pre-to-post 
changes within a group; with an estimated effect size of d = 0.8, power would exceed 95% with a 
sample of 23 participants. In terms of a between-group comparison, assuming an effect size 
estimate of d = 0.8 across groups, power would exceed 95% for a sample size of n = 42 per 
group. Thus, the total sample size of 210 would provide for adequate power, even accounting for 
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potential dropout and/or lower-then-expected effect sizes. Assuming that we recruited 70 
participants per group, for example, would mean that we could detect between-group effects as 
small as d = 0.5 with power exceeding 80%. 
Power analysis for gender: The preliminary gender analyses from phase 1 subjects provide the 
means to calculate the power necessary for detecting gender effects in placebo propensity. The 
original sample sizes from phase 1 were based on treating gender and age as covariates of no 
interest. Based on an anticipated medium-sized effect using Cohen’s conventions (Cohen, 1992), 
calculations in chi2power in Stata indicated that for n=82 and for alpha = 0.05 we obtain power = 
0.31. Instead if we double the number of subjects then we reach adequate detection power: 
assuming that males have 30% while females 50% placebo incidence rate, for alpha = 0.05 and 
n=160 we obtain just adequate power = 0.74. Therefore all data from phase 1 and 2 will be 
combined to assess effect of gender on placebo response.
Our previous fMRI results show that 20 per group should be adequate given the preliminary 
results and earlier studies. Also, 20 per group allows for 80+% statistical power for effect sizes of 
1 SD difference between groups. For DTI and T1 studies our earlier studies indicate that 20/group 
for within-subject contrasts is adequate but may be just at the limit for whole-brain contrasts for 
detecting between-group differences. We can overcome this obstacle by using targeted analyses 
of relevant brain areas. For example, simply removing the cerebellum and occipital cortex voxels 
from such analyses results in improving on multiple comparison cost by a factor of 2.
The results from Phase 1 affirm the above power calculations. Moreover they indicate that 
increasing the n for each of the treatment groups by 50% (as proposed in the gender supplement 
application) can lead to identifying effects that currently remain either non-significant or borderline 
significant.
8.2
Data Analysis Plans
Summary: For brain imaging contrasts, fMRI results show that 20 per group should be adequate 
given the preliminary results and earlier studies. For DTI and T1 studies our earlier studies 
indicate that 20/group for within subject contrasts is adequate but may be just at the limit for 
whole brain contrasts for detecting between group differences. In Phase 2/Aim 2, we hypothesize 
that brain parameters will predict strength of treatment response among the placebo stratified 
group. The n= 20 per group provides adequate sample size for effect sizes of about 1.0. 
Given the robust results we have seen already in Phase 1, experimental design and data 
collection and analysis methods will closely follow the methods we used in Phase 1. To this end, 
brain imaging data collection details will be identical in Phase 2, all preprocessing and quality 
control pipelines will remain the same and the same modality comparisons performed in Phase 1 
will also be used in Phase 2. Moreover, again we will use a blinded data analysis approach, 
where for each analysis modality the blinded assessor (Dr. Huang) is not involved in any patient 
interaction throughout the course of the study and will provide three codes for responders and 
non-responders one of which is the correct result. This forces all analysis to be done across all 
three codes and the true code is unraveled only when final results are available for all three 
codes. This approach is more burdensome however it protects against bias and also reveals false 
positives (for example figure 7 in report). We have employed this strategy for phase 1 results. 
Given the results from Phase 1 we have decreased the number of personality related 
questionnaires that failed to show even borderline relationships with placebo response. In 
addition, we have extended the washout period to three weeks, as in Phase 1 a one week wash-
out was not long enough. Since the two secondary aims of Phase 2 are to show placebo and 
active drug interaction and persistence of clinical placebo response, we monitor all participants 
over a 12-week treatment (or no-treatment) period. This design provides us with all the same 
contrasts that we have available in Phase 1, in addition to looking at placebo propensity and 
response in relation to active treatment.  
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As power analysis shows that gender effect will require all data from Phase 1 and 2, we will 
combine outcomes from both phases to contrast prevalence of placebo response as a function of 
gender. If this hypothesis is validated then we perform exploratory analyses to distinguish 
between both brain and personality differences by gender.
For the language analysis, It has previously been shown that language can capture subtle changes 
and differences in a person’s physiology and personality, and in some cases, language use can 
even be predictive of someone’s future neuropsychological state (Bedi et al., 2015) Given chronic 
pain’s dependence on an individual’s neurology and psychology, we hypothesize that language 
use (specifically in the form of free speech) in chronic back pain patients will be able to not only 
track treatment response over the duration of the study but also predict patient’s propensity to 
respond to placebo.  
In order to study participant’s language in time, we will record patient interviews at 4 points during 
the study (visits 1, 2, 4, and 5) using two different methodologies.  At visit 1, we will utilize the first 
methodology and conduct a semi-structured open-ended baseline interview consisting of primary 
questions: The questions themselves are taken from sections of the exit interview utilized in the 
Phase 1 of the study (exploratory aim) and can be found on pages 45-46; the choice of questions 
is based on preliminary results from Phase 1 showing that the average semantic similarity of 
patient interviews to 4 different concepts of interest were able to differentiate previous placebo 
responders from non-responders at the end of the study (Berger et al, in preparation). In Phase 2, 
our goal is not only to differentiate responders from non-responders (and validate the preliminary 
results), but also to predict responders from non-responders at the beginning of the trial using 
language.  Interviews will be audio-recorded and later transcribed.
To control for inherent interview confounds (such as interpersonal interaction effects or 
attentionally-biased statements due to pain-related questions) as well as identify how a patient’s 
speech changes over time as a consequence of their pain intensity (and related treatment 
effects), for visits 2, 4, and 5, we will use a second methodology to study participant’s language. 
In these visits, we will ask patients to describe 1 out of a set of 3 pictures; these pictures will be 
selected randomly for each visit for all participants and no picture will be presented more than 
once per person. The pictures utilized have been selected from a set of validated, standardized 
measures used in the fields of psychology and linguistics to commonly study both divided 
attention (in autism and ADHD) and speech pathologies (in aphasias, Parkinson’s disease, and 
Alzheimer’s) (Carragher et al., 2015; Forbes-McKay & Venneri, 2005) each picture has a main 
scene with multiple actors, objects, and potential scenarios that a person can attend to and talk 
about. These pictures are being utilized in this study for four reasons: (1) they provide a language 
prompt that is not biased by either the topic of pain or by interviewer/interviewee personal 
dynamics, (2) they have been shown to pick up syntactic and semantic differences in language 
related to attention and speech effort (these aspects are important for our patients whose 
attention is constantly divided between the outside world and their continuous background pain), 
(3) there is a large body of previous speech samples from healthy participants and patients with 
various ailments that might be able to be used for standardized comparisons, and finally (4) the 
pictures are consistent enough in features while still being different, making them ideal to test 
over time (and therefore will allow us to correlate speech to pain metrics and other objectives 
before, during, and after treatment). Patients will be asked to describe each picture in as much 
detail as they can
Details:
8.2.1 Pain Response Assessment: Phone app or computer pain ratings, NRS and pain memory 
will be used as in Phase 1 as main pain-related outcome measures. In addition pain related 
questionnaires may differentiate between placebo analgesia and treatment analgesia. Also the 
time course of change in these pain parameters can be tested whether they differentiate between 
the 4 treatment groups. 
8.2.2. Resting state: During the resting state protocol, participants are asked to keep their eyes 
open and let their minds wander during the 10 minute scan. We use graph theoretical analyses of 
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functional resting state to assess the treatment on large-scale brain architecture. Phase 1 results 
use this approach and show that brain functional connectivity predicts placebo response. Several 
additional analyses can be used from resting state data to extract the topological properties of 
graph networks such as clustering, global efficiency, maximum modularity, and between-ness 
centrality (for detail see (Achard et al., 2012)). Brain networks identified and validated as 
reflecting placebo propensity can then be explored regarding their interaction with treatment, both 
as predictors and as responses.
8.2.3 and 8.2.4: Fractional Anisotropy (FA) and Probablistic Tractography: Both of these 
techniques are applied to the DTI scans that will be collected at the beginning of each part of the 
study to examine white matter structural integrity and connectivity.  FA is an index of coherence 
of the orientation of water diffusion along a tract and is a measurement of overall tract integrity.  
FA is calculated voxel-wise for each participant over the whole-brain white matter skeleton, 
averaged over all participants in each group, and extracted to contrast between groups.  
The Phase 1 analysis did not show a significant difference in FA relative to placebo response. 
This may be due to insufficient power, which can be tested in the larger cohort when we combine 
Phase 1 and Phase 2 DTI data. Given our earlier paper (Mansour et al., 2013) and the one from 
another group (Stein, Sprenger, Scholz, Wiech, & Bingel, 2012), white matter tracts may still be a 
strong predictor of functional brain properties and behavioral response related to the placebo 
effect. We will also use this approach to examine white matter connectivity both for Phase 1 and 
Phase 2 data. Additionally, we will also calculate radial and axial diffusivity values from this 
method. In contrast, probabilistic tractography is a seed-based measurement looking at structural 
connectivity (anatomical connections) between ROIs as a function of group. Direction of white 
matter patterns are calculated beginning at one seed in the mean FA skeleton and moving a 
small distance in the estimated direction of the next seed over several iterations until the tract is 
terminated; connectivity strength between ROIs can then be compared between groups. We have 
yet to perform this type of analyses for Phase 1 specific brain regions. 
NODDI results pending—will attach once Etienne completes final analysis 
8.2.5. Subcortical Shape and Volumetric Analyses: The Phase 1 results show that limbic brain 
hemispheric asymmetry is a predictor of placebo propensity. We will use the same measure to 
validate this result in Phase 2, using both FSL and Freesurfer measures. So far we only 
examined this unitary measure and have refrained to explore other subcortical shape and volume 
properties. With increased power we can begin such explorations, and test their relationship to 
relevant personality measures. 
.
8.2.6: Personality Analysis: The dimensionality of the self-report items will be investigated using 
standard psychometric techniques to ensure that sets of items are sufficiently unidimensional and 
reliable. The primary test of whether scores from self-report questionnaires can predict treatment 
response can be investigated using logistic regression. The logistic regression model will be used 
to discern self-reported questionnaire items (MAIA and ERQ) in context of TOPPP (Tool for 
Placebo Propensity Prediction).
Phase 1 results identify a robust simple model based on personality that predicts placebo. We will 
use this or some small variant as our primary personality model to be validated in Phase 2. 
Additionally, we have kept some other questionnaires that should trend in being predictive and we 
can test their contribution in the larger cohort in Phase 2. 
8.2.7: Predictive Model/Classifier from Brain/Questionnaire Parameters:
The final model from Phase 1 will be used to categorize participants into responders and non-
responders. The mathematical details can be found on Page 10, and the identification will be a 
1:1 ratio as mentioned in section 5.2.1.This then provides a robust validation for the 
generalizability of the model. 
8.2.8: Language/Interview Analysis:
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We will record patient interviews over 4 visits (visits 1, 2, 4, and 5).  The first will be a short interview 
consisting of questions found on pages 44-45.  In the remaining visits we will ask patients to 
describe 1 of a set of 3 pictures (randomly selected for each visit. 
All audio and text files will be de-identified with the participant’s subject id. Transcripts will be pre-
processed according to standard Natural Language Processing (NLP) procedures, including 
parsing, lemmatizing, and stemming the data. Pre-processed, tokenized text will undergo basic 
language analyses including calculations of verbosity, unique vocabulary, lexical diversity, and 
other syntactic and morphological parameters (Hess et al., 1984) that can be used as features of 
interest or as general quality control measures. 
For more in-depth analyses, text data will be converted into numerical data where each word is 
represented as its alphabetized index in the dictionary. These enumerated data will be fed through 
latent semantic analysis (LSA) to reduce the dimensionality of the data and transform the interviews 
into a vector space that can be then quantified in numerous ways (Landauer et al. 1997), including 
linguistic feature extraction based on singular value decomposition (SVD), calculation of semantic 
similarity (distance) to words of interest, and sentiment analyses, among others. These 
morphological, syntactic, and semantic language features will be used to (a) validate previous 
language results from Phase 1, (b) build additional multivariable models of placebo propensity 
based on language, (c) identify and quantify relationships between language and the neuroimaging 
and personality markers of placebo response, and (d) correlate changes in language with changes 
in pain quality and intensity in time before, during, and after pill treatment.
9.0
STUDY MANAGEMENT, DATA COLLECTION, AND QUALITY ASSURANCE
9.1
Institutional Review Board (IRB) Approval and Consent 
It is expected that the IRB will have the proper representation and function in accordance with 
federally mandated regulations. The IRB should approve the consent form and protocol.
In obtaining and documenting informed consent, the investigator should comply with the 
applicable regulatory requirement(s), and should adhere to Good Clinical Practice (GCP) and to 
ethical principles that have their origin in the Declaration of Helsinki.
Before recruitment and enrollment onto this study, the patient will be given a full explanation of 
the study and will be given the opportunity to review the consent form (see section 9.2). Each 
consent form must include all the relevant elements currently required by the FDA Regulations 
and local or state regulations. Once this essential information has been provided to the patient 
and the investigator is assured that the patient understands the implications of participating in the 
study, the patient will be asked to give consent to participate in the study by signing an 
IRB-approved consent form (see 13.I).
Prior to a patient’s participation in the trial, the written informed consent form should be signed 
and personally dated by the patient and by the person who conducted the informed consent 
discussion.
9.2
Data Management and Monitoring/Auditing
Participants’ safety will be closely monitored by the site clinical investigator and the principal 
investigator. Careful, periodic assessment of all safety data will be undertaken. An 
inclusion/exclusion criteria checklist will be reviewed for each subject enrolled to ensure that only 
appropriate subjects are included. Adverse events will be collected at each visit and tabulated by 
the coordinator during the trial. The site and principal investigators will meet on a monthly basis to 
review these data. Those that are unexpected and considered related will be reported to the IRB 
immediately. An annual report of study progress and adverse effects will be made. A detailed 
draft Data and Safety Monitoring Plan has been developed and is included below in section 13.V. 
This will be amended as needed and submitted to the Northwestern IRB prior to the accrual of 
any participants.
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9.3
Quality Assurance and Training
Lab members that previously participated in the acquisition of neuroimaging data will be 
responsible for collecting data at Northwestern University.   All of these members have gone 
through various kinds of training, including but not limited to Protection of Human Subjects and 
HiPAA online courses, ethics training, collection and shipping of biological specimens, study 
management classes provided by the NU IRB, and MRI scanner operation training. All lab 
members that will be interacting with participants and collecting data have all be approved by the 
IRB as authorized personnel.
Quality control will be ensured throughout preprocessing of the imaging data after each scanning 
sessions. The metrics that will be assessed for quality control are head movements, scanner 
artifact, signal to noise ratio, and visual inspection of the images (most of which is done through 
an automated pipeline designed by our lab). All data will be identified with codes to maintain 
participants’ confidentiality and managed by NUCAT who is responsible for the randomization of 
the participants. IRB and NCCIH will be informed in case of protocol deviation.
9.4
Data Collection and Forms
All data collection will be done by IRB-approved authorized research personnel (see section 8.3 
above).  Data in this case is in the form of PHI, questionnaire answers, interview answers, and 
scans. Participant data (such as PHI) are recorded on paper (stored in coded binders, one per 
participant) and recorded online (all questionnaires) in a format created by the study team. Paper 
data is stored in a locked cabinet in a locked room that only study personnel have access to.  
Online questionnaire data is also automatically coded when participants begin to answer the 
forms, and answers are stored in a secure database (NUCATS REDCap database, which was 
recommended by NIH) that is password protected.. Data entry into REDcap will be completed by 
staff members conducting the visit. Audio recordings from interviews are coded at the start of the 
interview and are uploaded into coded folders that are password protected and stored in a secure 
database that only specific personnel have access to. Audio recordings will be kept permanently 
in the secure database and will have all potential identifying information removed prior to 
uploading onto the server. Scans collected from the MRI are burned on CDs or DVDs at the end 
of the session (using coded PIDs) and kept in the study binder (in a locked room).  When this 
scan data is uploaded, it is put on a secure server. All of this confidentiality information can now 
be found in section 9.3. Note that in most instances, case report forms (CRFs) will not be used as 
source documents. REDCap access will be limited to only visit 1 to ensure documentation of 
consent and safe blood levels.
10.0
PARTICIPANT RIGHTS 
10.1
IRB Review
This protocol and the informed consent document, as well as any subsequent modifications, will 
be reviewed and approved by the Northwestern IRB before beginning the study.
10.2
Informed Consent
A signed consent form will be obtained from each participant.  For participants who cannot 
consent for themselves, such as those with a legal guardian or power of attorney, this individual 
must sign the consent form.  The consent form will describe the purpose of the study, the 
procedures to be followed, and the risks and benefits of participation.  A copy will be given to 
each participant or legal guardian and this fact will be documented in the participant’s record (i.e., 
we make a copy of the signed consent form for our study records). An example of an informed 
consent document can be found in the Supplements and Appendices section, 13.I.
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10.3
Confidentiality
Any data, specimens, forms, reports, audio recordings, and other records that leave the site will 
be identified only by a participant identification number (Participant ID – PID) to maintain 
confidentiality. Audio recordings will be stored on our database and will not be destroyed. All 
records will be kept in a locked file cabinet in a locked room that only specific study personnel 
have access to.  All computer entry and networking programs will be done using PIDS only, and 
they will be done using a secure server.  Access to this data is also password protected and 
shared only between specific study personnel.  Information will not be released without written 
permission for the participant, except as necessary for monitoring by IRB, the FDA, the NCCIH, 
and the OHRP. 
10.4
Study Discontinuation
As part of their duties to ensure that research participants are protected, this study may be 
discontinued at any time by the IRB, the NCCIH, the OHRP, the FDA, or other governmental 
agencies. 
11.0
PUBLICATION OF RESEARCH FINDINGS
Any presentation, abstract, or manuscript will be made available to the NCCIH if requested. 
12.0
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13.0
SUPPLEMENTS/APPENDICES
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Version 8.0 (Phase 2), Date: 03/28/2018 
I.
Informed Consent Form Template 
          Northwestern University
Department of Physiology
Consent Form and HIPAA Authorization for Research
Second Phase
PROTOCOL TITLE:  Brain mechanisms for clinical placebo in chronic pain 
PRINCIPAL INVESTIGATOR: 
A. Vania Apkarian, Ph.D. 
SUPPORTED BY: National Institutes of Health, NCCIH
Introduction
You are being asked to take part in a research study. This document has important information about the 
reason for the study, what you will do if you choose to be in this research study, and the way we would 
like to use information about you and your health.  
What is the reason for doing this study?
You are asked to take part in this study because you are a person over the age of 18 who has 
experienced low back pain for more than 6 months. The purpose of this study is to see how pain is 
represented in the brain in people who have pain relief with placebo (a sugar pill) treatment, as well as to 
understand the effects of different treatments on the body and on the brain. We want to study your back 
pain for 12 weeks, including the characteristics of your pain, and do brain scans using a non-invasive 
brain imaging technique called functional magnetic resonance imaging (fMRI).
What will you do if you choose to be in this study? 
The study requires 6 visits spread out over 12 weeks. You are asked to participate in research that 
compares placebo with a  standard of care drug, a combination of one naproxen capsule (500mg) and 
one omeprazole capsule (20 mg) taken twice daily, two FDA-approved drugs for use as investigational 
agents in this study. If you agree to participate. Please know that this is a double-blinded study, which 
means that neither you nor the study doctor nor the study staff will know whether you are receiving drugs 
or placebo.  However, if there is a safety issue, the study doctor can get this information when warranted. 
Randomization means you will be randomly assigned to study drugs or placebo based on chance, like a 
flip of a coin. Neither you nor the researcher chooses your assigned group. You may be assigned to a 
placebo group, an active drug (naproxen and omeprazole) group, or a no-drugs group (you will not 
receive any pills except Rescue Medication).
If you consent to participate, you will be asked to come to the following location:
710 N. Fairbanks Ct
Olson Pavilion
Center for Translational Imaging (CTI), located in the basement (LC 0-255)
Chicago, IL 60611
All scanning visits will take place at the location listed above.
Northwestern University, Feinberg School of Medicine
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10th floor Abbot Hall, 710 N Lake Shore Dr
Chicago, IL 60611
All other visits will take place at the location listed above.
Visit 1 (week -3): Screening visit (90 min). 
If you agree to participate, you will be evaluated with inclusion/exclusion criteria and complete the 
informed consent documents. A medical/pain history will be taken and physical exam will be completed 
by a physician and you will be asked to rate your current back pain intensity. You will complete a set of 10 
questionnaires that will ask you about your health and medical history, past and current pain levels, 
personality, and emotions.  You will be allowed to take breaks and walk around during this time so that 
you don’t get tired while filling out questionnaires.  Finally, you will have your blood drawn for screening 
purposes including to see if your kidneys and liver are functioning as they should (we will take 40 mL or 
about 8 teaspoons). You will be asked to return in 2 weeks for baseline magnetic resonance imaging 
scans. You will be asked to discontinue your current pain medications 14 days prior to Visit 2 and take 
only the rescue medication (“rescue” medication that is also known as acetaminophen/Tylenol ®), given 
for pain during this time (see below) – this is so that we can assess your baseline amount of pain. You will 
be informed that you may be randomized in the placebo group and/or the no-treatment group (Visit 3) 
once you qualify to continue in the study. You must therefore be willing and able to stop taking the 
medication you take for pain for up to a maximum of 12 weeks during this study. You will be given 
acetaminophen (500 mg, up to 4 times per day) to take if you require pain relief (as rescue medication), a 
dose that can be continued throughout the study. You are free to stop your participation if you feel you 
are not able to deal with the intensity of your pain. If you are randomized to the treatment group (active or 
placebo) you may receive the anti-inflammatory drug naproxen, since it is known to increase the risk of 
stomach and intestinal side effects,  a combined naproxen/omeprazole drug regimen  will be given to you 
to provide some protection for these types of  side effects.  You will also be asked questions about your 
pain and mood in an interview at the end of this visit.  This interview will be recorded with a voice 
recorder.   
Visit 2 (week -1): Baseline Scan (90 min). 
You will rate your pain intensity, complete questionnaires, and undergo brain scanning (anatomical and 
functional scans). You will receive medication, which you can use if the pain becomes too much to handle 
(500 mg four times per day maximum). The researcher will ask you about how often you used the 
“rescue” medication and any changes in health you may have experienced since last visit. You will also 
be asked to describe a picture and will be given up to 5 minutes to describe the picture given. This will be 
recorded on a voice recorder. 
Visit 3 (week 0): Start of Treatment Period and Randomization (30-45 min). 
You will rate your pain intensity and complete questionnaires. You will be randomized into either a drug 
(placebo or naproxen and omeprazole) treatment group or no treatment group; if you are assigned to a 
treatment group (active or placebo), neither you nor the clinical coordinator/assistant will know which 
group you are in. Enough medication will be given to you to last until the next visit. The placebo group will 
receive two placebo capsules twice daily and the active drug group will receive one  naproxen capsule 
(500mg) and one omeprazole capsule (20mg) twice daily (morning and night) for the treatment period. 
The medication (Naproxen or Placebo) needs to be taken with at least one full glass (8 oz) of water and 
the other medication (Omeprazole or Placebo) should be taken one hour before a meal. The researcher 
will provide the study medication; if you were randomized into the no treatment group you will only receive 
rescue medication. The researcher will ask you about how often you used the “rescue” medication and 
any side effects you experienced since Visit 2 took place. Additional “rescue” medication will be given to 
you, and if you are in one of the treatment groups.
Visit 4 (week 3): Continuing Assessment (30-45 min). 
The procedures described for Visit 3 will be repeated during this visit. The researcher will ask you about 
how often you used the “rescue” medication and any side effects you experienced since Visit 3 took 
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place. As well, the researcher will ask you how often you took the study medication (if in a treatment 
group) and document the total pills you ingested. You will also be asked to describe a picture and will be 
given up to 5 minutes to describe the picture given. This will be recorded on a voice recorder. 
Visit 5 (week 6): End of Treatment/Start of Washout and Final Scan (60-90 min):
The procedures described for Visit 2 will be repeated during this visit. The researcher will ask you about 
how often and reliably you took your medication (if in a treatment group), as well as how often you used 
the “rescue” medication and any side effects you experienced since Visit 4 took place.  You will only 
receive the “rescue” medication for the upcoming 3 weeks. You will also be asked to describe a picture 
and will be given up to 5 minutes to describe the picture given. This will be recorded on a voice recorder. 
Visit 6 (week 9): Final Visit/End of Washout (30-45 min):
You will return to complete questionnaires but no brain scans will be done. The researcher will ask you 
about how often you used the “rescue” medication and any side effects you experienced since Visit 5 took 
place. If you are in one of the treatment groups, you will be asked to return all of your study medication 
and rescue medication at this time, and all treatment will be stopped at this visit.
Interim Activities
For the duration of the study, you will be asked to rate your pain and mood twice a day (even in between 
visits). This will be done with an electronic application that we will train you how to use.  We will download 
an application onto your phone or give you a link to use on your computer; if you do not have a smart 
phone or easy access to a computer/internet, we will provide you with a smart phone that has the 
application already installed. You will be compensated for your responses. Please note that if you fail to 
rate your pain too many times in a row, you may be dropped from the study.
fMRI
This study uses functional magnetic resonance imaging (MRI) to look at the brain. Functional magnetic 
resonance imaging is a type of brain scan that uses magnetic fields and radio waves to make an image of 
changes in blood flow in your brain while you do certain tasks.
In order to make sure the MRI procedure will be safe, you will be asked to fill out a screening form before 
starting the study. It is important that you tell the researchers in this study if you have any history of:

Metal fragments in your eyes or face.

Implantation of any electronic devices such as (but not limited to) cardiac pacemakers, cardiac 
defibrillators, cochlea implants or nerve stimulators.

Surgery on the blood vessels of your brain or the valves of the heart

Claustrophobia (fear of enclosed places)

Body piercing or tattoos
You will be given instructions outside the MRI scanner about the scanning. Next you will be asked to lie 
still on the MRI patient table and your head will be placed in a specially-designed head holder. Your head 
will be cushioned by a firm foam pillow. The table will then slide into the enclosed space of the MRI 
scanner. Some people feel tired, uncomfortable or claustrophobic (afraid of small spaces) in the MRI 
scanner. The MRI scanning session will take around 40 minutes to complete once you are in the scanner.
The information from the MRI scanner is only useful if you are able to complete the whole imaging 
session, and hold your head very still the whole time. Therefore you will be encouraged to hold as still as 
possible, and to let the investigators know if you are uncomfortable in any way as soon as possible after 
the imaging session begins.
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The front of the head-holder will be open, which lets you look through a special mirror and be able to see 
outside of the scanner if you want to. The MRI scanner makes loud banging noises while taking a 
measurement, so either ear plugs or specially designed headphones will be used to reduce the noise. 
The researchers will be in communication with you through an intercom system to tell you how the study 
is going.  The earplugs or headphones should not get in the way of communicating with the researchers.
What are some of the possible risks and discomforts? 
The risks from the study procedures include the following, some of which may be serious, including the 
risk of worsening your low back pain condition and related symptoms, especially since you may receive a 
placebo for up to 12 weeks:
Blood Draw:
The risks of taking blood include pain, a bruise at the point where the blood is taken, redness and swelling of the 
vein, infection, and fainting.
Study Agents: 
The side effects for naproxen include: upset stomach, nausea, heartburn, headache, drowsiness, and dizziness.  
They also include less common but serious side effects such as: easy bruising/bleeding, difficult/painful swallowing, 
hearing changes, mental/mood changes, intestinal bleeding, swelling of limbs, sudden unexplained weight gain, 
change in the amount of urine produced, unexplained neck stiffness, vision changes, unusual fatigue, and liver 
damage. To minimize the risk of developing gastrointestinal ulcers and indigestion, if you receive naproxen, you will 
also receive omeprazole.
The side effects for omeprazole (given with a capsule of naproxen) include: headache, drowsiness, diarrhea, 
nausea, stomach pain, and dry mouth.  Less common but serious side effects include: dizziness, confusion, fast or 
uneven heart rate, jerking muscle movements, jittery feeling, muscle cramps, muscle weakness or limp feeling, a 
choking feeling, or seizure/convulsions.
The side effects for acetaminophen (the “rescue medication”) include: nausea, rash, and headache.  However, 
acetaminophen may cause liver damage and rarely death due to overdosing and/or mixing with alcohol. Because 
alcohol interacts with acetaminophen, you should avoid alcohol during this study and/or limit yourself to the 
equivalent of one beer per day. If you drink 3 or more alcoholic beverages per day, you should tell the study doctor.  
Liver problems may result from taking acetaminophen.. Early symptoms of liver damage include, but are not limited 
to, nausea, vomiting, sweating, and general malaise (not feeling well). Subjects should not take more than four 500 
mg tablets (rescue medication daily maximum) during a 24-hour period. Regular use of acetaminophen may 
increase the risk of chronic kidney failure, especially  in those individuals with pre-existing kidney disease.  
The side effects for placebo include: [relate the side effects relevant for the composition of the placebo]   There 
are no expected side effects other placebo because it contains no active drug.
Scanning:
Risks associated with  MRI or fMRI scanning include l an increase in your level of chronic back pain 
because you will be asked to lie down in the scanner bed for around 40 minutes at a time. You may 
experience mild discomfort from trying to keep still, or you may feel anxious or claustrophobic (afraid of 
small spaces) in the scanner.  During one of the scans, the scanner may vibrate or be louder than usual. 
You will always be in contact with a researcher in the scanning room, and he/she can stop the scanning 
session if you have too much pain to continue.
Some people cannot have an MRI because they have some type of metal in their body.  For instance, if 
you have a heart pacemaker, artificial heart valves, metal implants such as metal ear implants, bullet 
pieces, chemotherapy or insulin pumps or any other metal such as metal clips or rings, you cannot have 
an MRI.  During this test, you will lie in a small closed area inside a large magnetic tube. Some people are 
scared or anxious in small places (claustrophobic).  The MRI scanner makes loud banging noises while 
taking a measurement, so either ear plugs or specially designed headphones will be used to reduce the 
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noise.
The MRI pictures from this study will not be in a form readable by either you or your doctor. Therefore, a 
copy of the MRI pictures or the results of your individual study will not be given either to you or your 
doctor. While the MRI pictures in this study are not formally reviewed by a radiologist, if in the course of 
processing the images we notice any abnormality that would be possibly important to your health we will 
tell you and a doctor you name.
Questionnaires and Interviews:
Some of the questions asked in the interviews throughout the study are personal and may make you 
uncomfortable. Some of the questions in the questionnaires may be upsetting or you may be uncomfortable 
answering them.  If you do not want to answer a question or set of questions at any time, you can tell the 
researcher to skip it/them.
What do I need to know about reproductive health/sexual activity if I am in this study? 
If sexually active, both men and women should use an effective method of birth control while taking the 
study drugs. Barrier contraceptives (condoms or diaphragm) with spermicide, intrauterine devices (IUDs), 
hormonal contraceptives, oral contraceptive pills, surgical sterilization, and complete abstinence are 
examples of effective methods. If you or your partner become pregnant while taking the study drugs, it is 
important that you tell your study doctor immediately. You may have to stop the study drugs.  The study 
drugs have been shown to be harmful to developing fetuses and should only be taken by pregnant 
women when there is no other alternative and their health care providers have determined that the 
benefits of taking the study drugs outweigh the risks.  Other treatment options will be discussed with you 
if you stop the study drugs. If you are considered to be postmenopausal, you are not required to use 
contraception while in this study.  Rarely, women considered to be postmenopausal become pregnant.  If 
you suspect that you become pregnant while taking the study drugs, it is important that you tell the study 
doctor immediately.  You may have to stop the study drugs.  Other treatment options will be discussed 
with you if you stop the study drugs.
What are the Possible Benefits for Me or Others?
The possible benefits to you from this study include reduced back pain due to placebo or standard-of-care 
treatment during the study. Taking part in this study may help scientists to better understand why some 
people get pain relief from different types of treatments for chronic low back pain. This knowledge can 
improve daily life and suffering for many people who live with back pain who currently do not experience 
pain relief from commonly used pain treatments. Ultimately, this research could lead to improved 
treatment of back pain, you may also benefit from pain relief in the long term, regardless of which group 
you are assigned to.. If you are randomized in the no treatment group, we will provide most effective 
study medication at the end of the study for a single 3 week treatment period.
It is important to note, however, that there also may not be any direct benefit to taking part in this study.
What other procedures or courses of treatment might be available to me?   
You do not have to take part in this research study.  Instead of being this study, you can seek treatment 
from your family doctor, physical therapist, and pain management specialists.  You may request 
additional information on these resources from the researcher.
Are there any financial costs to being in this study?
There are  no costs to you for being in this study other than the costs of transportation to and from the 
study visits..
Travel Expenses: 
You will be given assistance, such as parking vouchers, and/or reimbursement for expenses related to 
travel up to $20 per study visit. If you take public transportation or a taxi you must bring receipts and your 
reimbursement will be provided to you in cash at the time of your visit. If you drive your own vehicle, you 
will be reimbursed for gas mileage from your home address to the study clinic and receive a parking 
voucher for free parking for up to 6hours.. To receive free parking, you must park in the garage at 222 
East Huron Street and we will give you a voucher to use that day.
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Will I receive payment for participation in this study?   
You will get up to $242 for completion of all procedures and study visits  in this research study (not 
counting transportation reimbursement as  explained above). Upon completion of each scanning visit 
(visit 2 and visit 5), you will receive: $50. For the remaining visits (visit 1, visit 3, visit 4, and visit 6) you will 
be paid  $25. You will be paid $0.25 for each time you use the electronic application (maximum of 2 times 
per day). You will  be paid only for the visits and the ratings you complete. You will receive payments 
either by cash at the end of each visit, or by check that is sent to you in the mail. You will receive a check 
if you have to end the study early and will receive compensation for pain ratings. If you are paid by check, 
the Accounting Services at Northwestern University will be given your name, address, and Social Security 
Number in order to issue a check for your study participation. Study payments are considered taxable 
income and reportable to the IRS. A Form 1099 will be sent to you if your total payments are $600 or 
more in a calendar year.
For individuals assigned to the no treatment group who elect to receive treatment after the study is 
completed and all participants are unblinded. You will be given the option to have the treatment at no cost 
to you at that time.  However, you will not be paid for receiving this treatment. This is optional for those 
individuals who would like to try the most effective treatment (Active or Placebo). Those interested 
individuals will be asked to arrive to Abbott Hall to pick up a 3 week treatment supply after the study has 
ended. 
What should I do if I am injured as a result of being in this study? 
If you become ill or get an injury or illness as a result of study (medications or procedures), you should 
seek medical treatment through your doctor or treatment center of choice. You should promptly tell the 
study doctor about any illness or injury.  
Northwestern Memorial Hospital, Northwestern University, and the investigators of this study will not pay for 
medical care required because of a bad outcome resulting from your participation in this research study. This 
does not keep you from seeking to be paid back for care required because of a bad outcome.
The coverage for such injury or illness is only available if the Northwestern University principal 
investigator have decided that the injury/illness is directly related to the study drug or study procedures 
and is not the result of a pre-existing condition or the normal progression of your disease, or because you 
have not followed the directions of the study doctor. If your insurance is billed, you may be required to pay 
deductibles and co-payments that apply.  You should check with your insurance company about any such 
payments.
If I have questions or concerns about this research study, whom can I call?
You can call us with your questions or concerns. If you have any illness or injury during your time on this 
study, you should call us promptly. You can contact the study Clinical Coordinator (Monday through 
Friday, 9:00am – 5:00pm at 312-503-2886). For problems arising evenings or weekends, you may call Dr. 
Thomas Schnitzer at 312-649-2964 (24 hours a day, 7 days a week). Dr. A. Vania Apkarian is the person 
in charge of this research study.  You can call him at 312-503-0404 (Monday through Friday, 9:00am – 
5:00pm).
What are my rights as a research subject? 
If you choose to be in this study, you have the right to be treated with respect, including respect for your 
decision whether or not you wish to continue or stop being in the study.  You are free to choose to stop 
being in the study at any time. Additionally, if you are interested, you will have an option to participate in 
other low back pain studies at Northwestern University.
Choosing not to be in this study or to stop being in this study will not result in any penalty to you or loss of 
benefit to which you are entitled.  Specifically, your choice not to be in this study will not negatively affect 
your right to any present or future medical treatment to which you are otherwise entitled.
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Your participation in this study may be stopped by the investigator without your consent if you do not 
follow the directions of the study staff. If this occurs, you will be informed by the study staff and will not 
continue with the remaining visits. You will still be reimbursed for the portions of the study that you have 
completed.
If you want to speak with someone who is not directly involved in this research, or have questions about 
your rights as a research subject, please contact the Northwestern University Institutional Review Board 
(IRB) Office. You can call them at 312-503-9338.
What about my confidentiality and privacy rights?  
We are committed to respect your privacy and to keep your personal information confidential.  When choosing to 
take part in this study, you are giving us the permission to use your personal health information that includes 
health information in your medical records and information that can identify you. For example, personal health 
information may include your name, address, phone number or social security number. Your health information 
we may collect and use for this research includes: 

Medical history

Lab tests, or certain health information indicating or relating to a particular condition as well diaries and 
questionnaires

Records about study medication or drugs

Records from brain scans

Billing information

Audio recordings
This consent expires on 04/24/2017. After this date, Northwestern University may not gather new information 
about you, use or disclose your personal health information collected in this study for any purpose other than 
the research study described in this consent unless Northwestern University obtains permission to do so 
from you.  Illinois State Law permits use and disclosure of your mental health information only to the extent 
specified in this document.
During this study you may be coming to a Northwestern Memorial Healthcare Corporation entity (for 
example, Northwestern Memorial Hospital, Prentice Women’s Hospital) for research appointments or to get 
clinical services, such as lab tests, needed for the study.  When that happens, you will be scheduled for 
these services through the NMHC computer system.  When a clinical exam or lab is done by NMHC or one 
of its employees for the purpose of this research study, that information will be kept in both NMHC’s clinical 
records and in the study records.
The following groups of people may give the researchers information about you:  

Authorized members of the Northwestern University and the Rehabilitation Institute of Chicago workforce, 
who may need to see your information, such as administrative staff members from the Office for 
Research, Office for Research Integrity and members of the Institutional Review Board.

Clinical affiliates, including but not limited the Rehabilitation Institute of Chicago (RIC), Northwestern 
Medical Group (NMG), Northwestern Memorial Hospital (NMH), Northwestern Lake Forest Hospital 
(NLFH), and the Ann & Robert H. Lurie Children’s Hospital of Chicago (Lurie Children’s).  Your 
participation in this clinical trial may be tracked in an electronic database and may be seen by 
investigators running other trials that you are enrolled in and by your healthcare providers

Clinical affiliates, including but not limited to Northwestern Medical Group (NMG), Northwestern Memorial 
Hospital (NMH), and Northwestern Lake Forest Hospital (NLFH), for purposes including, but not limited to, 
the affiliate’s provision of care to you and/or the affiliate’s scheduling of appointments and/or billing 
activities.

Other University research centers and University contractors who are also working on the study

Study monitors and auditors who make sure that the study is being done properly, National Center for 
Complementary and Integrative Health (NCCIH) who is sponsoring the study, and that company’s 
contractors and partners.

Government agencies and public health authorities, such as the Food and Drug Administration (FDA) and 
the Department of Health and Human Services (DHHS).
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Those persons who get your health information may not be required by Federal privacy laws (such as the 
Privacy Rule) to protect it. Some of those persons may be able to share your information with others 
without your separate permission.
The results of this study may also be used for teaching, publications, or for presentation at scientific 
meetings.  Furthermore, any audio recordings used in any publications, teaching or scientific meetings 
will have no identifying information such as your name. The researcher will ask you to refrain from using 
your name or any other potential identifying information during the recording sessions. In the case, which 
any recordings have any potential identifying information they will be deleted and we will ask you to 
perform the audio recording session again. Once the recording is completed a research staff member will 
upload it to our secure data server, only accessible by research staff, and will then be deleted off the 
voice recorder. 
Unless you revoke your consent, it will expire 04/24/17
Although you may revoke consent to participation in this research at any time and in any format, you must 
revoke authorization for use or disclosure of your health information in writing. To revoke your 
authorization, write to:
A. Vania Apkarian, Ph.D.
Northwestern University, Department of Physiology
310 E. Superior Street #7-705
Chicago, IL 60611
You do not have to authorize the use or disclosure of your health information; however, you will not be 
allowed to take part in this research study. If you do not authorize the use or disclosure of your health 
information, it will not affect your treatment by health care providers, or the payment or enrollment in any 
health plans, or affect your eligibility for benefits.
A copy of this signed consent document, information about this study, and the results of any test or 
procedure done may be included in your medical records and may be seen by your insurance company.
ClinicalTrials.gov 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov as required by U.S. Law. 
This Web site will not include information that can identify you. At most, the Web site will include a 
summary of the results. You can search this Web site at any time.  
Optional Elements:
The following research activities are optional, meaning that you do not have to agree to them in order to 
participate in the research study. Please indicate your willingness to participate in these optional activities by 
placing your initials next to each activity.
I agree
I disagree
_______
________
The researcher may contact me in the future to see whether I am interested in 
participating in other research studies such as Electroencephalogram recording and 
Saliva collection.
Consent Summary: 
I have read this consent form and the research study has been explained to me. I have been given time 
to ask questions, and have been told whom to contact if I have more questions.  I agree to be in the 
research study described above. 
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A copy of the consent form will be provided to me after I sign it.  A copy of this signed consent document, 
information about this study and the results of any test or procedure done may be included in my medical 
record and may be seen by my insurance company.
_____________________________ / _________________________     Date___________
Subject’s Name (printed) and Signature
_____________________________ / ___________________________ Date___________
Name (printed) and Signature of Person Obtaining Consent
Time of Consent _____________
II.
List of Questionnaires  
(A) General Information:
1. MQS - Medicine Quantification Scale – Completed at visit 1
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Provides us with a measurement of the amount and kinds of medication they are taking prior to 
beginning the study
2. MRI Screening Form – Completed at each scanning visit
Makes sure that participants are safe to go into the MRI scanner before each visit
3. NIH Demographics Form – Completed at visit 1 
Collects standard demographics – age, gender, race, ethnicity
4. PHI - Patient Health Information – Completed at visit 1
Collects contact information and other standard demographics (such as level of education and annual 
income), as well as a very basic medical/health history
5. ODI – Oswestery Low Back Disability Index – Completed at visit 1 and visit 5   
Collects information about how much pain impacts various aspects of quality of life and how disabled 
participants feel on account of their pain
(B) Pain-related:
1. PCS - Pain Catastrophizing Scale - Completed at visit 1
Measures how much people worry about their pain and its possible causes (which may tie into the 
placebo response). 
2. MPQ-sf - McGill Pain Questionnaire (short form) – Completed at each visit
Measures location, duration, intensity, and quality/qualia of pain.  Allows us to not only track change in 
pain over time, but also correlate these qualities to brain imaging data collected on the same days. 
3. PDt -  Pain Detect – Completed at each visit
Provides information about location, duration, intensity, and quality of pain, but does so at different time 
scales (now, 24 hrs, 1 week) and with more unique time information (fluctuating, intermittent, etc).  We 
can also correlate changes in these scores to brain data. 
4. PIC - Patient Impressions of Change - Completed at each visit
One question provides an overall score for the extent to which pain changed (increased/decreased) or 
remained the same from visit to visit (another way to measure the placebo response).
10. NRS – Numeric Rating Scale – Completed at each visit (this is a component of many of the 
questionnaires that we have simply put into one measurement for simplicity; they rate their pain from 0 to 
10 with either a sliding bar that gives a number or on a bar with numbers clearly marked)
(C) Expectation Related to Medication/Medicine Beliefs
1. HCAHQ - Holistic Complementary and Alternative Health Questionnaire- Completed at visit 6
Measures participant’s opinions and beliefs about whether alternative/complementary medicinal 
techniques work and should be used, including questions that subtly ask about the placebo response 
(e.g., mind-body connection and positive thinking as an important treatment). We can see if beliefs about 
these types of therapies influence the placebo response.
2. MHLC - Multidimensional Health Locus of Control – Completed at visit 6
Provides information on how well participants believe they themselves (as opposed to medicine or the 
health care system and/or “luck/fate”) are responsible for and in control of their health.
3. TSS – Treatment Satisfaction Survey – Completed at visit 4 and visit 5 (after they have taken all of their 
medication for treatment period and continuing assessment, respectively
Self-developed 2-question survey that asks participants to rate how satisfied or dissatisfied they are 
with the study medication and to explain why. 
(D) Mindfulness, Interoceptive Awareness, and Emotional Control/Regulation
1. MAIA - Multidimensional Assessment of Interoceptive Awareness – Completed at visit 1
Measures how aware someone is of his/her body and how well they can focus on bodily sensations 
(such as pain) or distract themselves from these sensations.  Such a quality may also link to the 
propensity to respond or not respond to a placebo.  The ability to control awareness or to just be more 
aware of one’s body in general may also link to brain imaging data related to the functional connectivity of 
the insula and the mPFC.
2. ERQ - Emotional Regulation Questionnaire – Completed at visit 1
Measures how well a person can control his/her emotions (includes reappraisal and suppression of 
both positive and negative emotions).  May correlate with amygdala- or prefrontal region-related imaging 
data.
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(E) Suggestibility
1. MISS - Multidimensional Iowa Suggestibility Scale (we are interested in the Persuadability, Sensation 
Contagion, and Psychosomatic Control subscales) – Completed at visit 6
Measures the extent to which a participant is/can be influenced by a variety of other external and 
internal factors.  Suggestibility has been shown to influence the placebo response in some previous 
studies.
(F) Personality and Current Emotional States
1. BDI – Beck Depression Index – Completed during the screening visit
Measures whether someone may or may not be clinically depressed.  Because depression can also 
influence brain states and anatomy, a high BDI score (>=19) is an exclusion criteria for the study. 
2. LAQ – Loss Aversion Questionnaire – Completed at visit 1
Measures how sensitive individuals are to a wide variety of potential “losses” in their lives. Our 
research has shown that people with chronic back pain tend to be more gain sensitive than healthy 
counterparts (paper submitted to Molecular Pain), which may correlate not only to the presence of pain 
but also to the propensity to respond to medications (as in less sensitive to lower efficacy medications).  
LAQ answers may also correlate with NAc, prefrontal, and amygdala brain imaging data. 
III.
Interview Scripts
Visit 1 Script:
As you know, this is a study about understanding chronic pain. We are really interested in 
understanding chronic pain and people’s responses to medication, with the hope that we will be able to 
help treat or prevent chronic pain in the future.  We are especially interested in how chronic pain 
impacts people’s day-to-day experiences and their quality of life – we think that it is very important to 
hear from you directly about what your pain is like and how it affects you.  We think YOU are an expert 
on your own pain, so we want to learn from you.  
Today I’ll be asking you some questions about your life experiences dealing with chronic pain. I 
would like you to answer them as fully and honestly as you can. There are no right or wrong answers, 
and you can skip any questions that you don’t feel comfortable answering. There is no specific order or 
time limit, so you can feel free to come back to a question if you need more time to think about it. You 
can tell me as little or as much as you want to.  Some of the questions might be personal to you – if you 
feel uncomfortable with any question and do not want to answer it, please let me know.  The interview 
will be around 45 minutes, but for some people it may be shorter or longer, depending upon how much 
we talk. 
I will be recording our conversation with this voice recorder.  This is to help me remember what we 
talked about and to be as accurate as possible in reporting what I’ve heard. When the interview is done, 
the conversation will be typed out and stored in a secure folder on our server that only myself and my 
team will have access to.  The recording will be deleted from the device so that no one else can listen 
to it.  I will also not use your name in the interview so that your name is not directly connected to the 
recording. Do you have any questions about this?
Do you have any questions or concerns that you would like to ask before we begin? 
1. To begin, tell me about your experience with your back pain. 
Follow up: How has your pain been recently?
Follow up: How long have you had your pain?
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Follow up: What do you think may have caused it?
Follow up: How has your pain changed over time?
Follow ups: What does your pain feel like? What words would you use to 
describe what your pain feels like right now?
Follow ups: How has your pain changed over the course of the study (in the last 
6 weeks)? Was this because of the treatment?
Follow up:  Do you see yourself differently because of your pain?
Follow up: What are some things that influence your pain? 
Follow ups: What makes it worse?  What makes it better? 
Follow up: How do you manage your pain?  How do you cope with your pain?
Probes:  increased/decreased/specific physical activity, sleep quality, body 
position, medications, faith/spirituality, weather, working, bad day, other 
distractions including: smoking or drinking, social activities, family, support 
system, etc…
Follow up: What do you understand about your back? Explain to me how you think your back 
pain works (what do you think is happening in your body?). 
Follow up:  Do you think back pain is different for different people? 
Follow up:  Do you have a family history of chronic pain?  Please explain.
Follow up: [If not] Do you know anyone else who had/has chronic pain? Tell me 
more about that/him/her.
Follow up: How do/did they deal with their pain?
Follow up: Did this affect/change how you deal with your pain? 
Follow up: How do you think your pain will be a year from now? 
Follow up: Why do you say that?
Follow up: Have you ever woken up and thought that the pain was gone?
Follow up: Do you believe your pain will disappear one day?  
Follow up: How does your pain affect your mood?
Follow up: Has pain ever made you feel angry?
Follow up: Has pain ever made you feel sad?
Follow up: Has pain ever made you feel anxious?
Follow up: Has pain ever made you frustrated? 
Follow up: And now the reverse – how does your mood affect your pain?
Probes:  definition of mood, happiness helped alleviate the pain or made it easier to 
ignore, sadness or anger made it worse, 
Follow up: Does pain affect your concentration or decision-making? Tell me more about that.
Follow up: Or your memory? Please explain.
Visit 2, Visit 4, and Visit 5 Scripts:
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Participants will be given three pictures (see below) and will be asked to freely explain the 
picture in their own words. Participants will have at most 5 minutes to explain the picture in their 
own words before the research personnel terminates the recording. The three pictures will be 
sorted at random per participant, therefore, picture 1 may be given at visit 5 and picture 3 given 
at visit 4 for one participant, which can be the different order for another participant. 
Picture 1 
Picture 2
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Picture 3
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IV.
AE Collection Form Example
V.
Data and Safety Monitoring Plan (DSMP)
Data and Safety Monitoring Plan (DSMP)
Independent Monitor
1) Study Identification Information
A) NIH Study Number  RO1 AT007987-01A1
B) Study Title Brain mechanisms for clinical placebo in chronic pain 
C). Name of Principal Investigator (PI) Apkar V. Apkarian, Ph.D.
2)
Study Overview
A) This is a randomized, partially-blind clinical trial addressing the topic of placebo mechanisms in 
management of chronic pain. The overall purpose of this study is to identify brain mechanisms 
and characteristics of the placebo analgesia response in chronic pain patients (CPP) and utilize 
them as potential predictors of response to placebo based analgesia.
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Version 8.0 (Phase 2), Date: 03/28/2018 
B) The Data and Safety Monitoring Plan (DSMP) outlined below will adhere to the protocol 
approved by the Northwestern University IRB.
3)
Confidentiality 
A) Protection of Subject Privacy
During this study, medical history and physical examination will be performed at visit 1 and at 
regular intervals for various potential aversive side effects. All of the materials collected are for 
research purposes only, and data will be kept in strict confidence. No information will be given to 
anyone without permission from the subject. The consent form includes the informed consent 
statement required by Northwestern University for studies involving human subjects. This 
statement guarantees confidentiality and identifies the subject as the owner of the information 
provided. Confidentiality will be ensured by use of identification codes. All data, whether 
generated in the laboratory or at the scanner, will be identified with a randomly generated 
identification code unique to the subject.
B) Database Protection 
The database will be secured with password protection. The informatics manager will receive 
only coded information that is entered into the database under those identification numbers. 
Electronic communication with outside collaborators will involve only unidentifiable information. 
Adverse event reports and annual summaries will not include subject- or group-identifiable 
material. Each report will only include the identification code.
4)
Adverse Event Information
A)
Definition
An adverse event (AE) is any untoward medical occurrence in a subject during participation in 
the clinical study or with use of placebo or naproxen/omeprazole. An adverse finding can 
include a sign, symptom, abnormal assessment (laboratory test value, vital signs, 
electrocardiogram finding, etc.), or any combination of these.
A serious adverse event (SAE) is any adverse event that results in one or more of the following 
outcomes:

Death

A life-threatening event

Inpatient hospitalization or prolongation of existing hospitalization 

A persistent or significant disability/incapacity

A congenital anomaly or birth defect

An important medical event based upon appropriate medical judgment
B) Classification of AE Severity 
AEs will be labeled according to severity, which is based on their impact on the patient. An AE 
will be termed “mild” if it does not have a major impact on the patient, “moderate” if it causes the 
patient some minor inconvenience and “severe” if it causes a substantial disruption to the 
patient’s well-being.   
C) AE Attribution Scale 
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Version 8.0 (Phase 2), Date: 03/28/2018 
AEs will be categorized according to the likelihood that they are related to the study intervention. 
Specifically, they will be labeled definitely unrelated, definitely related, probably related, or 
possibly related to the study intervention.
D) Expected Risks 
Naproxen/omeprazole magnesium is used to treat signs and symptoms of osteoarthritis when 
there is a high risk for stomach ulcer/bleeding. The fact that it contains naproxen (NSAID) 
increases certain risks including the chance of heart attack, inflammation of the stomach lining, 
indigestion, diarrhea, or stomach ulcers.
These risks are considered to range from minimal to severe and are addressed in the protocol 
and consent form.
Dr. Thomas Schnitzer will review adverse effects every four weeks. Any adverse event will be 
reported to the Northwestern IRB and NIH/NCCIH. 
E) AE Reporting and Followup 
Please refer to Tables 4, 5, and 6 in DSMP Appendix A for formats for AE data collection and 
reporting. 
F). SAE Reporting
SAEs that are unanticipated, serious, and possibly related to the study intervention will be 
reported to the Independent Monitor, IRB, and NCCIH in accordance with requirements.  

Unexpected fatal or life-threatening AEs related to the intervention will be reported to the 
NCCIH Program Officer within 7 days. Other serious and unexpected AEs related to the 
intervention will be reported to the NCCIH Program Official within 14 days.

Anticipated or unrelated SAEs will be handled in a less urgent manner but will be reported to 
the Independent Monitor, IRB, NCCIH, and other oversight organizations in accordance with 
their requirements.

The medical monitor (Dr. Thomas J Schnitzer) is required to review all unanticipated 
problems involving risk to volunteers or others, serious adverse events and all volunteer 
deaths associated with the protocol and provide an unbiased written report of the event to 
the FDA.  The medical monitor will comment on the outcomes of the event or problem and in 
the case of a serious adverse event or death comment on the relationship to participation in 
the study.  The medical monitor will also indicate whether he/she concurs with the details of 
the report provided by the study investigator.  Reports for events determined by either the 
investigator or medical monitor to be possibly or definitely related to participation and reports 
of events resulting in death will be promptly forwarded to the FDA.
G) Data Quality and Management
i.
Description of Plan for Data Quality and Management:
 The unblinded monitor will have access to review all data collection forms on an 
ongoing basis for data completeness and accuracy as well as protocol compliance. 
Logs of scanned participants as well as drug dispension and follow-up will be 
regularly assessed by the unblinded monitor . Data verification will be performed by 
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someone other than the individual originally collecting the data at interim visits and 
after study completion. In REDcap, double data entry will be used as a quality 
assessment measure for paper source documents used as CRFs that will be 
uploaded into the database; initial entry by research personnel will be left unverified 
and only after a second person has completed this entry will the form become 
complete and verified. A statement reflecting the results of the ongoing data review 
will be incorporated into the Annual Report for the Independent Monitor.   
ii.
Frequency of Review
The frequency of data review for this study differs according to the type of data and 
can be summarized in the following Table:
Frequency of Review TABLE
Data type
Frequency of review
Reviewer
Subject accrual (including 
compliance with protocol 
enrollment criteria)
Quarterly
PI, Independent Monitor 
Status of all enrolled 
subjects, as of date of 
reporting 
Quarterly
PI, Independent Monitor 
Adherence data regarding 
study visits and 
intervention
Quarterly
PI, Independent Monitor 
AEs and rates (including 
out-of-range lab values)
Quarterly
PI, Independent Monitor 
SAEs
Per occurrence
PI, Independent Monitor, 
NIH/NCCIH
H) 
Subject Accrual and Compliance
iii.
Measurement and Reporting of Subject Accrual, Compliance with Inclusion/Exclusion 
Criteria: 
Review of the rate of subject accrual and compliance with inclusion/exclusion 
criteria will occur monthly during the recruitment phase and then every 3 months to 
ensure that a sufficient number of participants are being enrolled and that they meet 
eligibility criteria and the targeted ethnic diversity goals outlined in the grant 
proposal (Targeted/Planned Enrollment Table).
iv.
Measurement and Reporting of Participant Adherence to Treatment Protocol 
Data on adherence to the treatment protocol will be collected for individual subjects 
at each visit and reviewed quarterly by the PI, the study coordinator, and the safety 
officer. Adherence of participants will be evaluated by performing pill counts and by 
monitoring the appropriate vital signs at each visit. If adherence falls below the rate 
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of 75%, which might inhibit the ability of the study to test its primary hypotheses, the 
safety officer will suggest a conference call for study investigators to discuss 
methods for improving adherence.
I)
Justification of Sample Size 
We examine the differences in change in pain for placebo responders versus non-responders and 
the interaction between active treatment and response type. We can estimate statistical power based 
on the Cohen’s d effect sizes for differences in pain with 6-week placebo treatment. For responders, 
based on our preliminary results, we anticipate a mean decrease of 3 units on a 0-10 scales with an 
estimated SD of 15, which results in an effect size estimate of 2.0.  In non-responders the mean 
decrease in pain is negligible and we do not expect to have enough power to detect this. Power 
analyses in G*Power 3.1.3 indicated that we will have ample power. Even with a conservative 
estimated effect size of d = 1.0, power would be 80% for a sample size of n = 17 per group which 
would allow to also detect the interaction effects. In addition, it ensures adequate sample sizes even 
assuming some attrition in each group. For brain imaging contrasts, fMRI results show that 20 per 
group should be adequate given the preliminary results and earlier studies. For DTI and T1 studies 
our earlier studies indicate that 25/group for within subject contrasts is adequate but may be just at 
the limit for whole-brain contrasts for detecting between-group differences.  
Phase 1 results are consistent with above power calculations. They also show that a number of 
predictors were only borderline significant. Thus, increasing the number of treatment arm subjects by 
an additional 40 patients would provide opportunity to detect smaller effects and to test for gender 
dependence of placebo response.
J)
Stopping Rules 
This study will be stopped prior to its completion if: (1) the intervention is associated with 
adverse effects that call into question the safety of the intervention; (2) difficulty in study 
recruitment or retention will significantly impact the ability to evaluate the study endpoints; (3) 
any new information becomes available during the trial that necessitates 
stopping the trial; or (4) other situations occur that might warrant stopping the trial.
K)
Designation of an Independent Monitor 
The Independent Monitor for this study is Dr. James (Jim) W. Atchison.  Dr. Atchison is not 
associated with this research project and thus works independently of the PI, Dr. Apkarian.  
Since Norm is leaving, we need a new person to do this for us.
Dr. Atchison is not a part of the key personnel involved in this grant, and is qualified to review 
the patient safety data generated by this study because of his/her unique expertise in the area 
of chronic pain. Dr. Atchison’s CV is included at the end of this DSMP.
L)
Safety Review Plan 
Study progress and safety will be reviewed quarterly (and more frequently if needed). Progress 
reports, including patient recruitment, retention/attrition, and AEs, will be provided to the 
Independent Monitor following each of the monthly reviews. An Annual Report will be compiled 
and will include a list and summary of AEs. In addition, the Annual Report will address (1) 
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whether AE rates are consistent with pre-study assumptions; (2) reason for dropouts from the 
study; (3) whether all participants met entry criteria; (4) whether continuation of the study is 
justified on the basis that additional data are needed to accomplish the stated aims of the study; 
and (5) conditions whereby the study might be terminated prematurely. The Annual Report will 
be sent to the Independent Monitor and will be forwarded to the IRB and NCCIH ,FDA, and 
sponsoring industry collaborator. The IRB and other applicable recipients will review progress of 
this study on an annual basis.
M) 
Study Report Outline for the Independent Monitor (Interim or Annual Reports) 
The study team will generate Study Reports for the Independent Monitor and will provide 
information on the following study parameters: Progress reports, including patient recruitment, 
retention/attrition, and AEs  
Study Report tables will be generated only from aggregate (not by group assignment) baseline 
and aggregate safety data for the study population. A separate Closed Safety Report, with 
masked group baseline and safety data, will be generated for the Independent Monitor(s) by a 
designated unmasked member of the team but will not be reviewed by the study team.
N) Informed Consent
Written informed consent will be obtained from each subject at entry into the study. Informed 
consent is obtained by the following process:
1.
The subject (if applicable, parent/guardian) will be asked to review the study consent form.
2.
The PI or Co-Investigator (Co-I), or study coordinator will meet with the subject to review the 
form, to confirm the subject’s understanding of the study, and to answer any questions the 
subject might have.
3.
Once the subject demonstrates understanding of the study and agrees to participate in the 
study, the consent will be signed in the presence of the research coordinator or PI (or Co-I) and 
a witness.
O)
Reporting Changes in Study Status
During the funding of this study, any action by the FDA (if applicable), an IRB, or one of the study 
investigators that results in a temporary or permanent suspension of the study will be reported to 
the NCCIH Program Official within 1 business day of notification.
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Data and Safety Monitoring Plan
Appendix A
The tables below are EXAMPLE TABLES that can be used or modified to report study progress 
and patient safety data to oversight groups including the IRB, Independent Monitor(s), NCCIH, 
and the FDA.
Table 1. Enrollment by Month of Study
Mont
h
# 
Expect
ed
# 
Screen
ed
# Enrolled 
or 
Randomiz
ed
# 
Withdraw
n
# Actual
(# Enrolled - # 
Withdrawn)
# Cumulative
(Sum of # Actual 
by Month)
2
6
4
3
0
3
3
4
8
6
5
1
4
7
*Enrollment can also be displayed graphically in a Figure, with cumulative subject accrual plotted 
over time.
Table 2. Demographics
Characteristics
N
N%
Gender
Female
Male
Ethnicity
Hispanic or Latino
Not Hispanic or 
Latino
Unknown
Age
Mean (SE)
Median (min, max)
Race
AIAN
Asian
Nat Hawaiian/Other 
Pac Islander
Black or African 
American
White
Other
More than one race
Unknown
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Table 3. Subject Status
Status:
% Compliance to Intervention:
A = Active
(# tablets taken/total # per protocol)*100
C = Completed
or
W = Withdrew
(# classes taken/total # of sessions should have attended 
L = Lost to followup 
per protocol)*100
Pt 
Identifier
Date 
Enrolled
Date 
Complete
d Study
Study 
Status
Reason for 
Withdrawal
% Adherence 
to Intervention
Interventio
n Duration
(Weeks)
Subj001
08/02/2010
N/A
A
Subj002
07/26/2010
9/20/201
0
C
87%
8 weeks
Subj003
08/04/2010
N/A
W
Injury unrelated 
to intervention
Table 4. Adverse Events
Pt 
Identifie
r
AE Onset
AE 
End
AE 
Code 
(Med
RA, 
CTC
AE)
Sever
ity
SA
E? 
(Y/
N)
Relat
ed-
ness
Actio
n 
Take
n
Outco
me
Comments
Subj001
08/02/201
0
1
2
1
4
Subj felt Achilles 
tendon pain during 
yoga class; history of
tendonitis; will not 
attend class next 
week
Subj002
07/26/201
0
2
2
1
1
Subj003
08/04/201
0
3
0
4
4
Subj broke leg while 
skiing; withdrew from
study
Severity of AE:
Relatedness to Intervention:
1 = Mild
0 = Definitely unrelated
2 = Moderate
1 = Unlikely
3 = Severe
2 = Possibly related
4 = Life threatening or disabling
3 = Probably related
4 = Definitely related
Action Taken:
0 = None
Outcome:
1 = Dose modification
1 = Resolved
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2 = Medical intervention 
2 = Recovered with minor sequelae
(specify in comments)
3 = Recovered with major sequelae
3 = Hospitalization
4 = Continuing treatment
4 = Intervention discontinued 5 = Condition worsening
5 = Other
6 = Patient death**
**Provide further details regarding all reported serious AEs and deaths in the SAE and Subject 
Deaths tables listed at the end of this section.
Table 5. Frequency of Specific Symptoms
Symptoms
AE Code
(MedRA, 
CTCAE)
N%
Fatigue
Malaise
Nausea
Dizziness
Muscle Aches
Table 6. Out-of-Range Laboratory Values
Pt ID
Visit 
#
H
C
T
WB
C
PL
T
Prote
in
Urin
e 
RB
C
Creatin
ine
AL
T
AS
T
Cholest
erol
Amyla
se
BU
N
CP
K
Related 
to 
Interven
tion
Subj001
Subj002
Subj003
*If the study is collecting data on patient-reported outcomes or other assessments, which should 
be regularly assessed with safety data during the study, a similar table listing out-of-range 
values or scores can be generated for the report.  
Table 7. Serious Adve9rse Events
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Pt 
Identifier
Age
Treatment 
Date
SAE
SAE Date
Related to 
Intervention
Description of Actions and 
Outcomes (e.g., 
hospitalization, withdrawn 
from study)
Subj001
Subj002
Subj003
Table 8. Subject Deaths
Pt 
Identifier
DOB
Date 
Enrolled
Treatment 
Date
Cause of Death
Date of 
Death
Comments
Subj001
08/02/2010
Subj002
07/26/2010
Subj003
08/04/2010
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Table 9. Procedural Events 
Visits
1
Interim
2
Interim
3
4
5
6
Informed Consent
X
Medical History 
X
Concomitant Mediactions
X
X
X
X
X
X
Physical Exam
X
Vitals
X
X
X
Demographics 
X
Adverse Assessment
X
X
X
X
X
X
Phone app usage 
X
X
X
X
X
X
X
X
Pain Rating Stability/Elgibility 
X
Stratification (1 week)
X
MRI Screening and Collection
X
X
Study Agent Dispension  
X
X
Drug Compliance 
X
X
PHH
X
Biological Speciman Collection
X
Protocol Deviations (if app)
X
X
X
X
X
X
eNOTIS
X
Study Completion 
X
NRS  
X
X
X
X
X
X
MPQ 
X
X
X
X
X
X
PDt
X
X
X
X
X
X
PIC
X
X
X
X
X
X
ODI 
X
X
X
X
X
X
BDI
X
X
X
X
X
PCS
X
ERQ
X
MAIA
X
LAQ
X
TSS
X
X
MHLC-C
X
MISS
X
HCAHQ
X
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Curriculum Vitae
James W. Atchison, D.O.
Medical Director
Center for Pain Management
Rehabilitation Institute of Chicago
980 N. Michigan Ave., Suite 800
Chicago, IL 60611
312-238-7825/312-238-7881 Fax
MEDICAL LICENSURE
Illinois #036131304, Sept 2012 
Florida #OS 7098, Sept 1995
Ohio #4622, Sept 1988 - Inactive
DIPLOMATE
National Board of Osteopathic Medical Examiners, #14972, July 1988
SPECIALITY BOARDS
American Board of Physical Medicine and Rehabilitation, #3373, May 1992
American Board of Physical Medicine and Rehabilitation, Pain Medicine, #360, Sept 2003
American Board of Electrodiagnostic Medicine, #1685, April 1993
HIGH SCHOOL/UNDERGRADUATE EDUCATION
1969 – 1973
Carrollton High School; Carrollton, OH; Degree:  Diploma
1973 – 1977
Wittenberg University; Springfield, OH; Degree:  Bachelor of Arts in Biology
-
Phi Gamma Delta – Men’s Social Fraternity
-
Men’s Intercollegiate Basketball, 1973-74, 1974-75
-
Student Assistant Coach, Men’s Intercollegiate Basketball, 1975-76, 1976-77.  
(NCAA Division III National Champions, 1977; National Runners-up, 1976)
HIGH SCHOOL TEACHING
1977 – 1978
Greenon High School; Enon, OH
-
Instructor:  Physics, Introductory Science
-
Coach:  Varsity Assistant Football, Basketball and Baseball
1978 – 1980
Triad High School; North Lewisburg, OH
-
Instructor:  Physics, Chemistry, General Science
-
Coach:  Head Men’s Basketball, Head Men’s and Women’s Track, Varsity 
Assistant Football
1980 – 1983
Springboro High School; Springboro, OH
-
Instructor:  Introductory Chemistry and Physics, Biology
-
Coach:  Head Men’s and Women’s Cross Country, Head Women’s Track, 
Assistant Men’s Basketball
14.0
MEDICAL SCHOOL
1983 – 1987
Ohio University College of Osteopathic Medicine (OUCOM); Athens, OH; Degree:  Doctor 
of Osteopathy
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President OUCOM Sports Medicine Club, 1984 – 1985
-
Social Chairman OUCOM Student council, 1984 – 1985
INTERNSHIP
1987 – 1988
Rotating; Cuyahoga Falls General Hospital; Cuyahoga Falls, OH
RESIDENCY
1988 – 1991
Physical Medicine and Rehabilitation; The Ohio State University; Columbus
-
Resident Liaison to the Resident Physician Council of the American Academy of 
Physical Medicine and Rehabilitation (AAPM&R), 1990, 1991
-
AAPM&R Resident Physician Council Membership Committee, 1991
ACADEMIC APPOINTMENTS
8/1/91 - 1996
Assistant Professor; University of Kentucky, College of Medicine,
Department of Physical Medicine and Rehabilitation; Lexington, KY
01/96 – 2001
Associate Professor; University of Florida, College of Medicine, 
Departments of Orthopaedics and Rehabilitation and Neurological Surgery; 
Gainesville, FL
01/02 – 06/05
Clinical Associate Professor University of Florida, College of Medicine, 
Departments of Orthopaedics and Rehabilitation and Neurological Surgery
07/05- 09/12
Clinical Professor University of Florida, College of Medicine, Department 
of Orthopaedics and Rehabilitation, Division of Physical Medicine and 
Rehabilitation 
8/27/12-Present
Professor in Physical Medicine and Rehabilitation, Northwestern University, 
Feinberg School of Medicine
15.0
CLINICAL APPOINTMENTS
08/01/91 – 1996
Cardinal Hill Rehabilitation Hospital, Department of Rehabilitation
Medicine, Lexington, KY
08/01/91 – 1996
Chandler Medical Center, University of Kentucky, Department of 
Physical Medicine and Rehabilitation, Lexington, KY
08/01/96 – 1996
Veterans Administration Hospital, Cooper Drive, Lexington, KY
0 8/01/91 – 1996
Shriner's Hospital, 1900 Richmond Road, Lexington, KY
08/01/94 – 1996
Highlands Regional Medical Center, Prestonsburg, KY
01/02/96 – 8/27/12
Shands Medical Center at University of Florida, Gainesville, FL
02/01/97 – 8/27/12
Shands Rehabilitation Hospital, Gainesville, FL
06/25/97 – 2010
Shands at Alachua General Hospital, Gainesville, FL (Hospital Closed)
8/27/12- Present
Rehabilitation Institute of Chicago, Chicago, IL 
ADMINISTRATIVE APPOINTMENTS
01/01/96-09/2011
Medical Director; SpineCare Center, Department of 
Orthopaedics and Rehabilitation, University of Florida, Gainesville, FL
02/01/97-8/27/12
Medical Director; Shands Rehabilitation Hospital, Gainesville, FL
02/01/97-06/30/98
Interim Chief; Division of Physical Medicine and Rehabilitation,
Department of Orthopaedic Surgery, University of Florida, Gainesville, FL
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07/01/98-09/2011
Chief; Division of Physical Medicine and Rehabilitation, Department of
Orthopaedics and Rehabilitation, University of Florida, Gainesville, FL
8/27/12-Present
Medical Director, Center for Pain Management, Rehabilitation Institute of 
Chicago, Chicago, IL
CONSULTING
1989 – 1991
Rehabilitation Service Commission of Ohio, Bureau of Disability
Determination; Columbus, OH
1089 – 1991
Ohio Bureau of Workers’ Compensation; Columbus, OH
1992 – 1996
University of Kentucky Student Health Services; Lexington, KY
1992 – 1996
University of Kentucky Athletic Department; Lexington, KY
CONSULTING (Continued)
2005 – 2011
Florida C.A.R.E.S.; Gainesville, FL 
2009 – 2012
Best Doctors, Inc.; Boston, MA
2014- Present Best Doctors, Inc., Boston, MA
2015- Present INSPE Associates Ltd., Chicago, IL
16.0
REVIEWER
American Journal of Physical Medicine and Rehabilitation
-
Article Reviewer: 1991 – 2006, 2012
-
Editorial Board; 2001 – 2006 
17.0
Archives of Physical Medicine and Rehabilitation
-
Article Reviewer:  1996 – 2009
Pain Medicine
-
Article Reviewer: 2011 – Present 
Association of Academic Physiatrists
-
Education Committee
-
White Paper on Fellowships, March 1993
-
“Spinal Biomechanics I and II,” September 1997
American Academy of Physical Medicine and Rehabilitation
-
Practice Parameters Committee
-
AHCRP Clinical Practice Guidelines for “Acute Low Back Problems in Adults,” 
November 1994
-
American Academy of Orthopedic Surgeons Algorithms for “Hip Pain, Knee 
Pain, Knee Injury, Wrist Pain, Shoulder Pain, and Low Back Pain,” September 1995
-
American Academy of Orthopedic Surgeons Algorithms for “Herniated Lumbar Disc, 
Spinal Stenosis, Low Back Musculoligamentous Injury, Phase I Ankle Injury, Phase II Knee 
Pain, Hallus Valgus, and Pes Planus,” Aug 1996
-
“The Fibromyalgia Syndrome: A Consensus Report on Fibromyalgia and Disability,” Jul 
1997
-
“AAOS Phase I Wrist Pain Guideline” and “AAOS Phase I Ankle Injury
Guideline,” May 1999
18.0
Journal of Back and Muscloskeletal Rehabilitation
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Editorial Board; 1999 - Present
-
Article Reviewer; 1999 - Present
19.0
Foundation for Physical Medicine and Rehabilitation
-
ERF Best Research Paper Applications, August 2003
20.0
The Retirement Research Foundation
-
Proposal Reviewer, June 1998
21.0
U.S. Dept of Education, Office of Special Education & Rehabilitative Services
-
Proposal Reviewer for Brain Injury Model System Sites, August 1998
-
Proposal Reviewer for Work Training/Vocational Rehab Programs for the 
Disabled.  
July 2002
-
Proposal review for SCI Model Systems Sites, August 2011
iSpine 
-
Text Reviewer; 2011
21.1
HIGHER EDUCATION TEACHING
Summer 1984
Ohio University College of Osteopathic Medicine. Athens, OH
HIGHER EDUCATION TEACHING (Continued)
-
Laboratory Teaching Assistant for Gross Anatomy and Osteopathic 
Clinical Principles Course for the Summer Studies Program for 
Disadvantaged Candidates
Summer 1991
University of Kentucky Medical School
08/1991 – 1996
University of Kentucky Department of Rehabilitation Medicine Residents
-
Daily Rounds on Stroke Module I and II
-
Weekly Grand Rounds
-
Biweekly Case Conferences
-
Biweekly EMG Case Conferences
-
Monthly Journal Club
-
Weekly Tuesday Morning Resident Course
-
Biweekly Supervision of Outpatient Clinic at VA Medical Center
-
Biweekly Supervision of Outpatient Clinics at PM&R Offices
1991 – 1992
University of Kentucky Medical Students: 4 students for 4-week rotation 
in Medicine
Summer 1992
University of Kentucky Medical School
-
Conjoint 831 for 3rd year Medical Students
University of Kentucky Office for Experimental Education Internship
-
1 post-graduate student, 6 hours/week, 8 weeks
1992 – 1993
University of Kentucky Medical Students:  2 students for 4-week 
rotation in Medicine
Spring 1993
University of Kentucky Medical School
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Introduction to Physical Diagnosis – Medicine 821; weekly group 
sessions for 2nd year medical students, 4 students
1993 – 1994
University of Kentucky Medical Students
-
3 students for 4-week rotation in Medicine
-
Elective in Physical Medicine and Rehabilitation:  2 students
for 4-week rotation
22.0
1993 -1994
University of Kentucky Medical Students (continued)
23.0
-
Introduction to Physical Diagnosis – Medicine 821: 
biweekly
group sessions for 2nd year medical students, 4 students
University of Kentucky Department of Biomechanical Engineering
-
Graduate student interaction/partial supervision of ongoing
research projects, 4 students
Summer 1994
University of Kentucky Medical Students
-
Summer research projects:  2 students for 8 weeks
-
Medical Student Elective in Physical Medicine and Rehabilitation
-
Visiting medical student from Southeastern College of
Osteopathic Medicine
1994 – 1995
University of Kentucky Medical Students:  6 students for 4-week
rotation in medicine
-
Daily Rounds on Stroke Rehabilitation Module I and II
-
Weekly Grand Rounds
-
Monthly Student Report on a Rehabilitation topic of Choice
1994 – 1995
University of Kentucky Medical School
-
Introduction to Physical Diagnosis – Medicine 821, biweekly group 
sessions for 2nd year medical students, 4 students
23.1
HIGHER EDUCATION TEACHING (Continued)
-
4th Year Gerontology Clerkship
-
Five times/week clinical/didactic session, 14 students
-
Problem based learning tutor, 8 sessions, 5 students
1994 - 1995
University of Kentucky Department of Biomechanical Engineering
-
Graduate student interaction/partial supervision for ongoing research 
projects, 2 students
1995 
University of Kentucky Medical School
-
4th Year Gerontology Clerkship, 5 times/week clinical/didactic
sessions, 4 students
University of Kentucky Department of Biomechanical Engineering
-
Masters committee for thesis candidate, Liz Knapp
1996 – 2012
University of Florida College of Medicine
-
2nd Year Geriatrics Rotation (1996, 1997)
-
Assistance Technology for Geriatric Rehabilitation.  Introduction 
to Gerontology and Geriatrics
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3rd Year Geriatrics Rotation (1996 – 2005)
-
Introduction to Rehabilitation Principles – Immobility/
Deconditioning, 10 students, 1 time/month
-
Introduction to the Aging Spine – Rehabilitation Treatment 
Approach to Arthritis, Spinal Stenosis, and Osteoporosis, 10 
students, 1 time/month
-
3rd Year Clerkships (1996 – 2005)
-
Clinical Instruction in SpineCare Center
-
Department of Orthopaedics and Rehabilitation
-
Lectures on Evaluation and Treatment of Low Back Pain
and Neck Pain
-
Clinical Training of Orthopaedics Spine Fellow in SpineCare Center
-
Weekly Spine Conference with Orthopaedics/ Neurosurgery
Residents
-
Physician Assistant Students
-
Lectures on Evaluation and Treatment of Low Back Pain
and Neck Pain
-
Rheumatology
-
Rheumatology Spine Fellowship
-
Clinical Instruction in SpineCare Center
-
Psychiatry
-
Special Topics Seminar, Geriatric Psychiatry Fellowship
-
Lecture on Physical Medicine and Rehabilitation
in Geriatrics – Enabling the Elderly
2006 – 2012
University of Florida Medical Students
4th Year Elective in Physical Medicine and Rehabilitation: 2-Week 
Rotation
4th Year Elective in Musculoskeletal Medicine: 2-Week Rotation
4th Year Geriatric Clerkship: 2-Week Rotation 
1996 – 2012
University of Florida College of Nursing
-
Clinical Rotations in SpineCare Center for ARNP Students
2012 – Spring
-
Nurse Practitioner Practicum for spring 2012 semester at 
the Shands Rehab Hospital. (288 hours)
1997 – 2001
University of Florida College of Health Professions
HIGHER EDUCATION TEACHING (Continued)
-
Department of Clinical and Health Psychology
-
Dissertation Committee for John Otis, Ph.D. Candidate
1999 – 2011
University of Florida, Department of Orthopaedics & Rehabilitation
-
Spine & Musculoskeletal Medicine Fellowship Director 
(1999-2011)
-
1999-2000 Michael Meighen, M.D.
-
2000-2001 Ephraim K. Brenman, D.O.
-
2001-2002 Carlos J. Placer, M.D.
-
2002-2003 Arthur J. Kalman, D.O.
-
2003-2004 Mara Isser, D.O.
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2004-2005 Alberto Rivera, M.D.
-
2005-2006 Nandita S. Keole, M.D.
-
2005-2006 Javier A. Placer, M.D.
-
2006-2007 Joseph Ferraro, M.D.
-
2006-2007 Samuel Nortman, M.D.
-
2007-2008 Don Mascarenhas, M.D.
-
2007-2008 Marisol Arcila, M.D.
-
2008-2009 Adam Berliner, D.O.
-
2008-2009 Stanford Williamson, D.O.
-
2009-2010 Robert “Jamie” Spicer, D.O.
-
2010-2011 Maximillian Shokat, D.O.
-
2010-2011 Maureen Noh, M.D.
-
2011-2012 A. Scott Hamilton, M.D.
-
2011-2012 Quang T. (Wayne) Nguyen, M.D.
1999 – 2012
University of Florida, College of Medicine
-
Geriatric Medicine Fellow Rotations
2002 – 2004
University of Florida College of Health Professions
-
Department of Health Services Administration, 
Brooks Center for Rehabilitation Studies
-
Physician Collaborator for Steven George, PhD, PT
2012 – 2012
University of Florida, College of Medicine
-
Stroke Fellowship/Neurorehabiltation Inpatient Care Rotation
March 2012
University of Florida, College of Medicine
-
AHMA Back Pain Seminar – Medical Student
University of Florida/North Florida/South Georgia Veterans Health 
System
-
Geriatric Research Education & Clinical Centers – 
Geriatric Fellowship Noon Conference – Principles of Pain Management
24.0
25.0
TEACHING AT THE NATIONAL LEVEL
1999 - Present
-
“Principles of Manual Medicine.”  American Academy of Physical 
Medicine and Rehabilitation Annual Meetings. 
May 2004
-
“Emerging concepts in the diagnosis and treatment of pain.  An intensive 
and comprehensive review.”  American Academy of Physical Medicine and 
Rehabilitation.  New Orleans, LA (Program Committee Co-Chair)
May 2005
-
“Emerging concepts in the diagnosis and treatment of pain.  An intensive 
and comprehensive review.”  American Academy of Physical Medicine and 
Rehabilitation.  
26.0
TEACHING AT THE NATIONAL LEVEL (Continued)
New Orleans, LA (Program Committee Co-Chair)
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June 2005
-
“Emerging concepts in the diagnosis and treatment of pain.  An intensive 
and comprehensive review.”  (Program Committee Co-Chair) American Academy 
of Physical Medicine and Rehabilitation.  San Francisco, CA.
27.0
RESIDENT LECTURES
Aug 1991
-
Bladder Anatomy and Dysfunction (CHRH)
-
Upper and Lower Limb – Neuromusculoskeletal Examination and 
Clinical/Anatomic Correlates (CHRH)
Sep 1991
-
Basics of Electromyography/Nerve conduction Studies (CHRH) 
-
Radial Nerve Studies (CHRH)
-
Prevention and Treatment of Pressure Ulcers (CHRH)
Oct 1991
-
Aphasia – diagnosis and classification (CHRH)
-
Upper Limb – Neuromusculoskeletal Examination and Clinical/Anatomic 
Correlates (CRRH)
-
Diagnosis and Treatment of Reflex Sympathetic Dystrophy (CHRH)
-
Median Motor and Sensory Nerve Conduction Studies (CHRH)
-
Knee Anatomy and Examination (VA)
-
Knee Rehabilitation and Bracing (VA)
Nov 1991
-
Bladder Anatomy and Dysfunction (CHRH)
-
Lower Limb – Neuromusculoskeletal Examination and Clinical/Anatomic 
Correlates (CHRH)
-
Neuroradiology – Central Nervous System Course (ALL)
-
Use of Nerve and Motor Point Blocks (CHRH)
-
Facial EMG and Nerve conduction Studies (CHRH)
Dec 1991
-
Diagnosis and Treatment of Parkinson’s Disease (CHRH)
-
Ulnar Motor and Sensory Nerve Conduction Studies (CHRH)
-
Upper and Lower Limb – Neuromusculoskeletal Examination and 
Clinical/anatomic Correlates (VA)
Jan 1992
-
Biomechanics of Normal Human Locomotion (VA)
-
Therapeutic Exercise and Strength Training (VA)
-
Treatment of Upper Motor Neuron Spasticity (CHRH)
-
Prophylaxis, Diagnosis, and Treatment of Deep Venous Thrombosis (CHRH)
-
Use of Antidepressants and Antianxiolytics Following Stroke (CHRH)
-
Multiple Sclerosis and Amyotrophic Lateral Sclerosis for CNS Course
(ALL)
Feb 1992
-
Prophylaxis of Seizures Following Stroke (CHRH)
-
Bladder anatomy and Dysfunction (CHRH)
-
Differential Diagnosis of Low Back Pain (VA)
-
Use of Cervical Traction (VA)
Mar 1992
-
Pulmonary Rehabilitation (VA)
-
Diagnosis and Treatment of Spinal Stenosis (VA)
-
Lower Limb Nerve Conduction Studies
-
Differentiation of Upper Motor Neuron vs Lower Motor Neuron Firing
Pattern by EMG (CHRH)
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Use of F Waves and H Reflexes (CHRH)
RESIDENT LECTURES (Continued)
Apr 1992
-
Diagnosis and Treatment of Fibromyalgia (VA)
-
Examination and Biomechanics of Shoulder Function (VA)
May 1992
-
Myasthenia Gravis, Myastenic Syndrome, and Repetitive Stimulation
(VA)
-
Treatment of Plantar Fascitis (VA)
-
Aphasia – Diagnosis and Classification (CHRH)
-
Use of Antidepressants and Antianxiolytics Following Stroke (CHRH)
-
Prophylaxis of Seizures Following Stroke (CHRH)
Jun 1992
-
Ankylosisng Spondylitis and the Arthridites (VA)
-
Diagnosis and Treatment of Spinal Stenosis (VA)
-
Analysis of Normal and Pathologic Gait (CHRH)
-
Use of Manual Medicine (CHRH)
Jul 1992
-
Bladder Anatomy and Dysfunction (CHRH)
-
Prophylaxis, Diagnosis, and Treatment of Deep Venous Thrombosis (CHRH)
-
Asphasia – Diagnosis and Classification (CHRH)
-
Prophylaxis of Seizures Following Stroke (CHRH)
-
Lower Limb Nerve Conduction Studies (VA)
-
Introduction of Electrodiagnostic Instrumentation (ALL)
-
Introduction to Electrodiagnostic Needle Examination (ALL)
Jul 1992
-
Manual Medicine Mini-Course Within Musculoskeletal Course (ALL)
-
Introduction to Anatomy and Biomechanics of the Spine
-
Evaluation and Treatment of the Cervical Spine
-
Evaluation and Treatment of Ribs and the Thoracic Spine
-
Evaluation and Treatment of Lumbar Spine, Pelvis, and Sacrum
Aug 1992
-
Motor Nerve Conduction Studies (ALL)
-
Sensory Nerve Conduction Studies (ALL)
-
Electrodiagnostic Evaluation of Tarsal Tunnel Syndrome (VA)
-
Diagnosis and Treatment of Lumbar Stenosis (VA)
-
Classification of Impairment, Handicap, and Disability (Conjoint 831)
Sep 1992
-
Motor Unit Analysis, Part I (ALL)
-
Basic Carpal Tunnel Analysis/Screen (ALL)
-
Introduction to F Waves/H Reflexes (ALL)
Oct 1992
-
Motor Unit Analysis, Part II (ALL)
-
Electrodiagnostic Analysis of the Fascial Nerve (ALL)
-
How to Evaluate a Patient With Low Back Pain (CHRH-AIs)
-
Medial Calcaneal Nerve Conduction Studies (VA)
-
Lateral Femoral Cutaneous Nerve Studies (VA)
-
Bladder Anatomy and Dysfunction (CHRH)
-
Prophylaxis, Diagnosis, and Treatment of Deep Venous Thrombosis (CHRH)
Nov 1992
-
Averaging/F Wave Techniques (VA)
-
Lower Limb Nerve Conduction Screen (ALL)
-
Use of Antidepressants and Antianxiolytics Following Stroke (CHRH)
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Prophylaxis of Seizures Following Stroke (CHRH)
RESIDENT LECTURES (Continued)
Dec 1992
-
Principles in Orthotic Use and Bracing Following CVA (CHRH)
-
Saphenous Nerve Studies (VA)
-
Controversies in the Use of Steroids Following CVA (CHRH)
-
Superficial Peroneal Nerve Studies (VA)
Jan 1993
-
Electrodiagnosis of Peroneal N. Palsy (VA)
-
Lateral Antebrachial Cutaneous Nerve Studies (CHRH)
-
How to Evaluate a Patient With Low Back Pain (CHRH-AIs)
Feb 1993
-
Anterior Interosseous Syndrome (VA)
-
Diagnosis of Hereditary Sensory Motor Neuropathies (VA)
-
Evaluation of the Hemiplegic Shoulder (CHRH)
-
Diagnosis and Classification of Peripheral Neuropathy (VA)
-
How to Evaluate a Patient With Low Back Pain (CHRH-AIs)
-
Use of Antispasticity Medicine Following Stroke (CHRH)
Mar 1993
-
Analysis of Normal and Pathologic Gait (CHRH)
-
Alternative Ulnar Nerve Conduction Studies (VA)
-
Controversies in the Use of Steroids Following CVA (CHRH)
-
Techniques in Repetitive Stimulation (VA)
-
Principles in Orthotic Use and Bracing Following CVA (CHRH)
Apr 1993
-
Motor Unit Analysis, Part I (CHRH)
-
Comparison of Lower Limb Sensory Nerve Studies (VA)
-
Evaluation of Spontaneous EMG Potentials (CHRH)
May 1993
-
Motor Unit Analysis, Part II (ALL)
-
How to Evaluate a Patient With Low Back Pain (CHRH-AIs)
-
Evaluation and Treatment of the Hemiplegic Shoulder (CHRH)
Jun 1993
-
Analysis of Normal and Pathologic Gait (CHRH)
-
Controversies in the Use of Steroids Following CVA (CHRH)
-
Use of Antispasticity Medicine Following Stroke (CHRH)
Jul 1993
-
Principles in Orthotic Use and Bracing Following CVA  (CHRH)
-
Prophylaxis, Diagnosis, and Treatment of Deep Venous Thrombosis
(CHRH)
-
Analysis of Normal and Pathologic Gait (CHRH)
-
Principles of Geriatric Rehabilitation (ALL)
Aug 1993
-
Introduction to Electrodiagnostic Instrumentation (ALL)
-
Introduction to EMG Need Examination (ALL)
Sep 1993
-
Motor Nerve Conduction Studies (ALL)
-
Sensory Nerve Conduction Studies (ALL)
-
How to Evaluate a Patient With Low Back Pain (CHRH-AIs)
-
Motor Unit Analysis, Part I (ALL)
Oct 1993
-
How to Evaluate a Patient With Low Back Pain (CHRH-AIs)
-
Basic Carpal Tunnel Analysis/Screen (ALL)
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Introduction to F Waves/H Reflexes (ALL)
Nov 1993
-
Motor Unit Analysis, Part II  (ALL)
-
Evaluation and Treatment of Shoulder Pain/Dysfunction (UK)
-
How to Evaluate a Patient With Low Back Pain (CHRH-AIs)
-
Neuroradiology for CNS Course (ALL)
RESIDENT LECTURES (Continued)
Dec 1993
-
Basic Lower Limb Nerve Conduction Screen (ALL)
Jan 1994
-
How to Evaluate a Patient With Low Back Pain (CHRH-AIs)
-
Electrodiagnostic Analysis of the Facial Nerve (ALL)
-
Bladder Anatomy and Dysfunction (CHRH)
-
EMG Waveform Analysis, Part I (ALL)
-
Principles in Orthotic Use and Bracing Following CVA (CHRH)
Feb 1994
-
Prophylaxis, Diagnosis, and Treatment of Deep Venous Thrombosis
(CHRH)
-
Prophylaxis of Recurrent CVA (CHRH)
-
Evaluation and Treatment of the Hemiplegic Shoulder (CHRH)
-
EMG Waveform Analysis, Part II (ALL)
-
Ulnar Motor and Sensory Nerve Conduction Studies (ALL)
Mar 1994
-
Multiple Sclerosis and Amyotrophic Lateral Sclerosis for CNS Course 
(ALL)
-
How to Evaluate a Patient With Low Back Pain (CHRH-AIs)
-
Needle Stimulation and Recording for Difficult Nerve Conduction
Studies (ALL)
-
Repetitive Stimulation Techniques (ALL)
Apr 1994
-
Unusual Nerve Conduction Studies (ALL)
-
How to Evaluate a Patient With Low Back Pain (CHRH-AIs)
-
EMG Needle Exam – Upper Limb Anatomy and Screening Exam (ALL)
-
Evaluation and Treatment of the Hemiplegic Shoulder (CHRH)
May 1994
-
Controversies in the Use of Steroids Following CVA (CHRH)
-
Use of Antispasticity Medicine Following Stroke (CHRH)
-
EMG Needle Exam – Lower Limb Anatomy and Screening Exam 
(ALL)
-
Principles in Orthotic Use and Bracing Following CVA (CHRH)
-
Review of EMG/NCS for Carpal Tunnel Analysis (ALL)
Jun 1994
-
Analysis of Normal and Pathologic Gait (CHRH)
-
Review of Difficult EMG/NCS Cases (ALL)
Jul 1994
-
Manual Medicine Mini-Course Within Musculoskeletal Course (ALL)
-
Evaluation and Treatment of the Cervical Spine (ALL)
-
Evaluation and Treatment of the Lumbar Spine (ALL)
-
Evaluation and Treatment of Pelvis and Sacrum (ALL)
Aug 1994
-
Introduction to Electrodiagnostic Instrumentation (ALL)
-
How to Evaluate a Patient With Low Back Pain (CHRH-AIs)
-
Analysis of Normal and Pathologic Gait (CHRH-AIs)
-
Evaluation and Treatment of the Hemiplegic Shoulder (CHRH-AIs)
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Prophylaxis, Diagnosis, and Treatment of Deep Venous Thrombosis (CHRH-AIs)
-
Principles in Orthotic Use and Bracing Following CVA (CHRH-AIs)
-
Bladder Anatomy and Dysfunction (CHRH-AIs)
-
Use of Antidepressant and Antianxiolytics Following Stroke (CHRH-
AIs)
RESIDENT LECTURES (Continued)
Sep 1994
-
Evaluation and Treatment of the Hemiplegic Shoulder (CHRH/Ger)
-
Analysis of Normal and Pathologic Gait (CHRH/Ger)
-
Principles in Orthotic Use and Bracing Following CVA (CHRH/Ger)
-
Alternative Treatments for Pain in the Elderly (CHRH/Ger)
-
Bladder Anatomy and Dysfunction (CHRH/Ger)
-
Use of Unconventional Medication in Geriatric Rehabilitation (CHRH/Ger)
-
Principles of Diagnosis and Treatment of Reflex Sympathetic Dystrophy 
(CHRH/Ger)
-
Use of Antidepressants and Antianxiolytics Following Stroke 
(CHRH/Ger)
-
Prophylaxis of Seizures after Stroke (CHR/Ger)
-
Medications to be Avoided in the Elderly (CHRH/Ger)
Oct 1994
-
How to Evaluate a Patient With Low Back Pain (CHRH-AIs/Ger)
-
Analysis of Normal and Pathologic Gait (CHRH/AI/Ger)
-
Prophylaxis, Diagnosis, and Treatment of Deep Venous Thrombosis 
(CHRH/AI/Ger)
-
Use of Antispasticity Medicine Following Stroke (CHRH/AI/Ger)
-
Use of Unconventional Medication in Geriatric Rehabilitation (CHRH/AI/Ger)
-
Use of Antidepressants and Antianxiolytics Following Stroke
(CHRH/AI/Ger)
-
Medications to be Avoided in the Elderly (CHRH/AI/Ger)
-
Evaluation and Treatment of the Hemiplegic Shoulder (CHRH/AI/Ger)
-
Alternative Treatments for Pain in the Elderly (CHRH/AI/Ger)
Nov 1994
-
Introduction to EMG Needle Examination (ALL)
-
How to Evaluate a Patient with Low Back Pain (CHRH-AIs/Ger)
Dec 1994
-
Motor Unit Analysis, Part I (ALL)
Jan 1995 
-
EMG Needle Exam – Upper Limb Anatomy and Screening Exam
(ALL)
-
Evaluation and Treatment of the Hemiplegic Shoulder (CHRH/Ger)
-
Analysis of Normal and Pathologic Gait (CHRH/Ger)
-
Bladder Anatomy and Dysfunction (CHRH/Ger)
-
Medications to be Avoided in the Elderly (CHRH/Ger)
Feb 1995
-
Physiology of Exercise (ALL)
-
Needle Stimulation Techniques (ALL)
-
Cancer Rehabilitation (ALL)
-
EMG Needle Exam – Lower Limb Anatomy and Screening Exam (ALL)
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-
Use of Unconventional Medication in Geriatric Rehabilitation (CHRH/Ger)
-
Principles of Diagnosis and Treatment of Reflex Sympathetic Dystrophy
(CHRH/Ger)
-
Use of Antidepressants and Antianxiolytics Following Stroke (CHRH/Ger)
-
Medications to be Avoided in the Elderly (CHRH/Ger)
Mar 1995
-
EMG Waveform Analysis: Video Review (ALL)
-
How to Evaluate a Patient With Low Back Pain (CHRH/AI/Ger)
-
The Essentials of Electrodiagnostic Instrumentation (ALL)
-
Analysis of Normal and Pathological Gait (CHRH/Ger)
-
Principles in Orthotic Use and Bracing Following CVA (CHRH/Ger)
RESIDENT LECTURES (Continued)
-
Bladder Anatomy and Dysfunction (CHRH/Ger)
-
Use of Antidepressants and Antianxiolytics Following Stroke (CHRH/Ger)
-
Medications to be Avoided in the Elderly (CHRH/Ger)
Apr 1995
-
The Basics of Electrodiagnostic Examination and Interpretation (ALL)
-
Repetitive Stimulation Techniques (ALL)
-
Unusual Stimulation Techniques (ALL)
-
Evaluation and Treatment of the Hemiplegic Shoulder (CHRH/Ger)
-
Medications to be Avoided in the Elderly (CHRH/Ger)
-
Use of Unconventional Medication in Geriatric Rehabilitation 
(CHRH/Ger)
-
Principles of Diagnosis and Treatment of Reflex Sympathetic Dystrophy 
(CHRH/Ger)
May 1995
-
Electrodiagnostic Evaluation of Motor Neuron Disease (ALL)
-
Principles of Diagnosis and Treatment of Reflex Sympathetic Dystrophy (CHRH)
-
Principles in Orthotic Use and Bracing Following CVA (CHRH)
-
Bladder Anatomy and Dysfunction (CHRH)
June 1995
-
Evaluation and Treatment of the Hemiplegic Shoulder (CHRH)
-
Use of Unconventional Medication in Geriatric Rehabilitation (CHRH)
-
Analysis of Normal and Pathologic Gait (CHRH)
Jul 1995
-
Department of PM&F Orientation for PGY-IS
-
Department of PM&R Orientation for PGY-II
-
Bladder Anatomy and Dysfunction (CHRH/Ger)
-
Analysis of Normal and Pathologic Gait (CHRH)
Aug 1995
-
Introduction to Electrodiagnostic Instrumentation (ALL)
-
Anatomy and Kinesiology of the Lower Leg (ALL)
-
Sensory Nerve Conduction Studies (ALL)
Sept 1995
-
Anatomy and Kinesiology of the Cervical Spine (ALL)
Oct 1995
-
Motor Unit Analysis, Part I (ALL)
Nov 1995
-
Rehabilitation of the Acute Stroke Patient (ALL)
Dec 1995
-
Needle Stimulation and Pin Pick-up Techniques (ALL)
Sep 2011
-
Spine – Spinal Cord Injury (OSMI – Ortho Morning Conference)
Jan 2014
-
Overview of Opioid Management- PGY-2 (RIC)
-
Rational Polypharmacy- PGY-2 (RIC)
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March 2014
-
Opioids II -advanced series – (RIC)
August 2014
-
Intro to Pain Management- PGY-2 (RIC)
Oct 2014
-
Opioids I- (RIC)
-
Opioids II- (RIC)
Dec 2014
-
Functional Measures- (RIC)
Feb 2015
-
WC/ SSI/ Disability/ Impairment- (RIC)
March 2015
-
Outcomes for CRPM/WC/CRPS- (RIC)
April 2015
-
Opioids I- (RIC)
-
Opioids II- (RIC)
May 2015
-
Worker’s Comp- PGY-3 and PGY-4 (RIC)
-
Interdisciplinary Approach to Chronic Pain- PGY-2 (RIC)
-
FCE and Impairment Ratings- PGY- 3 and PGY-4 (RIC)
-
WC/ IME’s
28.0
ADVISING ACTIVITY
1991 – 1992
-
University of Kentucky – Medical Students (1)
-
University of Kentucky , Department of Rehabilitation Medicine – Residents for 
Research Requirements (3)
Summer 1992 -
University of Kentucky, Office for Experimental Education Internship (1)
1992 – 1993
-
University of Kentucky, Department of Rehabilitation Medicine – 
Residents for Research Requirements (5)
-
University of Kentucky – Medical Students (4)
1993 – 1994
-
University of Kentucky, Department of Rehabilitation Medicine –
Residents for Research Requirements (4)
1994 – 1995
-
University of Kentucky, Department of Physical Medicine and
Rehabilitation – Residents for Research Requirements (5)
-
University of Kentucky, College of Nursing.  Doctoral Candidate:
Deborah Reed
-
University of Kentucky, Department of Biomechanics.  Master’s 
Candidate:  Liz Knapp
1995 – 1996
-
University of Kentucky, Department of Biomechanics.  Master’s 
Candidate:  Liz Knapp
1996 – 2001
-
University of Florida, Department of Clinical & Health Psychology.
Ph.D. Candidate:  John Otis
2002 – 2003 -
University of Florida, College of Medicine.  4th Year Medical Student: 
Kevin Vincent, Ph.D. 
-
University of Florida, College of Medicine.  4th Year Medical Student:
Marisol E. Arcila.
29.0
2003 - 2004 -
University of Florida, College of Medicine.  4th Year Medical 
Student
James Lopez
-
University of Florida, College of Medicine.  4th Year Medical Student
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David James Kennedy 
2004 – 2005
University of Florida, College of Medicine.  4th Year Medical Student
Sheryce Andrews
2006 – 2007
University of Florida College of Medicine.  4th Year Medical Student 
Matthew T. Smith
University of Florida College of Medicine.  4th Year Medical 
Student Wesley Chay
University of Florida College of Medicine.  4th Year Medical 
Student
Timi Tuamokumo
2008 – 2009 
University of Florida College of Medicine.  4th Year Medical Student
Jeffrey Faricielli
30.0
31.0
ADMINISTRATIVE ACTIVITY
1991 – 1996
University of Kentucky, College of Medicine
-
Search Committee for Chair, Department of Physical Medicine &
Rehabilitation; 1995
-
Clinical Sciences Self-Study Committee; 1995
-
Graduate Medical Education Committee; 1995
-
Internal Residency Review Committee for Occupational/Preventive Medicine; 
1995
-
Research Committee; 1995
ADMINISTRATIVE ACTIVITY (Continued)
1991 – 1996
University of Kentucky, Dept of Physical Medicine & Rehabilitation
-
Research Committee
-
Resident Recruitment Committee
-
Organization of Resident Recruitment; 1994–1995
-
Education Committee
-
Development of Course:  “Introduction to Rehabilitation Medicine for Medical 
Students”
-
Development of Dept of Rehabilitation Medicine Evaluation Forms
-
Student Evaluation of Faculty Lectures – “Introduction to Rehab Medicine” 
-
Student Evaluation of Departmental Rotations
-
Resident/Faculty Evaluation of “Chief Rounds” Lectures
-
Development of Educational Syllabus for Stroke Rotation
-
Co-Development of Educational Syllabus for General Rehabilitation Rotation
-
Co-Development of the Required Teaching Guidelines for the VA Residents
-
Development of PM&R Student Health Clinic – ½ day/week (Jan 1992)
-
Co-Course Director: Residents Thursday Course – “Manual Medicine” (with 
Musculoskeletal Course, Jul 1992, Jul 1994)
-
Development of PM&R/Manual Medicine Consultation Services for Department 
of Athletics (Aug 1992)
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-
Course Director: “Introduction to Electrodiagnosis for Resident” (Jul 1992 – Dec 
1992, Aug 1993 – Jun 1994, Aug 1994 – Jun 1995)
-
Co-Course Director:  Residents Thursday Course – “Prosthetics and Orthotics “ 
(Spring 1992)
-
Development of Yearly Evaluation for Resident Competency/Skills in EMG/NCS
-
Course Director for Tuesday Morning Residents Lecture Series (Aug 1994-1996)
-
Course Director:  Residents Thursday Course “Electrodiagnosis (Spring 1995)
1993 – 1994
-
Assistant Residency Program Director
-
Departmental Coordinator of Medical Student Rotations
-
Research Committee, Chair
1994 – 1995
-
Departmental Coordinator of 4th Year Gerontology Clerkship, MD 841
-
Departmental Coordinator of Medical Student Rotations
-
Research Committee, Chair
-
Preparation of Document for Residency Review Committee – 1994
-
Course Director for CME Course “Clinical Osteopathic Manual Medicine:  An 
Introductory Hands-on Course for Physicians and Therapists"
1994 – 1995
-
Residency Program Director
1991 – 1995
Cardinal Hill Rehabilitation Hospital
-
Utilization Review Committee
-
Dysphagia Committee
-
Development of Dysphagia Survey mailed to all hospitals in Kentucky to establish 
areas of service/need
-
Long Range Planning Committee – Stroke
1993 – 1995
-
Research Committee, Chair
1996-2012
University of Florida, College of Medicine
-
Medical Director, SpineCare Center 1996 – 09/2011
-
UF Health Systems Worker’s Compensation Provider Network Project Team – 
08/1996
ADMINISTRATIVE ACTIVITY (Continued)
-
Post-Acute Hospitalization Planning Committee – 09/1996
-
Chair, Sub-Acute Rehabilitation Subcommittee – 09/1996
-
HealthSouth Project Team – 09/1996
-
Interim Chief Division of Physical Medicine and Rehabilitation, Department of 
Orthopaedics Surgery – 02/1997 – 07/1998 
-
Medical Staff Executive Committee – 07/1997
-
Rehabilitation Medical Advisory Committee – Jul 1997
-
Chair – Jul 1997
-
Physiatry Steering Committee – May 1997
-
Rehabilitation Operations Group – Feb 1997
-
Chief, Division of Physical Medicine and Rehabilitation, Department of 
Orthopaedics and Rehabilitation – Jul 1998 – Sep 2011
-
Advisory Board, Gator Sports Camp – Jul 1998
-
VA Rehab Task Force – Jul 1998
-
Program Director, PM&R Fellowship Program – July 1999 – Sep 2011
-
Shands Pain Committee – Jul 2001 – 07/2003
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-
Shands Spinal Cord Injury Committee – July 2001 – July 2003
-
Chair, Shands Pain Management Subcommittee – July 2004 – July 2008
02/97-2012
Shands Rehab Hospital
-
Medical Director
07/01-2012
Shands Rehab Hospital
-
Medical Director, Spinal Cord Injury Continuum of Care 
1993-2005
Commission on Accreditation of Rehabilitation Facilities (CARF)
-
Surveyor Training – Tucson, AZ – Jul 1993
-
Site Survey; New Hampshire Rehabilitation Hospital;/Health South Concord, NH; 
November 1993
-
National Advisory Committee – Outpatient Medical Rehabilitation – Tucson, AZ – 
March 1994
-
Site Survey; Yonkers Rehab Center; Des Moines; IO; April 1994
-
Site Survey; Holzer Medical Center Rehabilitation Unit; Gallipolis, OH; June 1994
-
Site Survey; Union Memorial Hospital; Baltimore, MD; January 1995
-
Site Survey; Rehab Institute of Chicago; Chicago, IL; May 1995
-
Site Survey; Rehab Institute of Michigan; Detroit, MI; September 1995
-
Site Survey; Stratton VA Medical Center, PM&R Services; Albany, NY; April 1996
-
Site Survey; Coghlin Rehabilitation Hospital of the Medical College of Ohio; 
Toledo, OH; June 1996
-
Site Survey; Magee Rehab Hospital; Philadelphia, PA; December 1996
-
Site Survey; Edward Hines Jr VA Hospital; Hines, IL; June 1997
-
Site Survey; Aultman Comprehensive Medical Rehabilitation Center; Canton, OH; 
December 1997
-
Site Survey; Broken Arrow Rehabilitation; Broken Arrow, OK; February 1998
-
Site Survey; St. Francis Medical Center, the Center for Physical Rehabilitation; 
Pittsburgh, PA; September 1998
-
Site Survey; Doctors Hospital of Stark County Rehab Center; Masillon, OH; March 
1999
-
Site Survey; Barberton Citizens Hospital Rehabcare Center; Barberton, OH; May 
1999
-
ADMINISTRATIVE ACTIVITY (Continued)
-
Site Survey; Rehabilitation Institute at Tennessee Christian Medical Center; 
Nashville, TN;  November 1999
-
Site Survey; St. Elizabeth Health Center Acute Rehab Unit; Youngstown, OH; May 
2000
-
Site Survey; Louis Stoke Cleveland Dept of Veteran Affairs medical Center; 
Cleveland, OH; June 2000
-
Site Survey; Firelands Regional Health System; Sandusky, OH; October 2000
-
Site Survey; Meridia Center for Rehabilitation and Pain Management;  Euclid, 
OH; December 2000
-
Site Survey; University of North Carolina Hospitals – Rehab Center, Chapel Hill; 
NC; August 2001
-
Site Survey; Avante at Leesburg; Leesburg, FL; October 2001
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-
Site Survey; The Rehab Program at Hollywood Medical Center; Hollywood, FL; 
September 30-October 1,2002
-
Site Survey; Marion General Hospital; Marion, OH; June 2003
-
Site Survey; Middleton Regional Hospital/Inpatient Rehab Unit; Middleton, OH; 
June 2004
-
Site Survey; Ohio Valley Rehabilitation Network, Inc.; Bridgeport, OH; August 
2004 
2012–2012
Surveyor Training – Tucson, AZ – Feb 2012
-
Site Survey; Northeastern Rehabilitation at Heritage Hospital; Tarboro, NC; May 
2012
1997-2012
Florida Department of Labor & Employment Security, Division of 
Vocational Rehabilitation, Florida Brain and Spinal Cord Injury Program
-
Inpatient/Outpatient Rehabilitation Committee – Apr 1997
-
Site Survey: Tampa General Rehabilitation Center – Dec 2000
-
Site Survey: Lee Memorial Hospital, Ft. Myers, FL – May 2008
2001-2003
University of North Texas Health Science Center, Texas College of Osteopathic 
Medicine
-
External Board of Scientific Counselors
HONORS
Undergraduate
-
Sigma Sigma Sigma – National Biology Honorary Society
-
Phi Eta Sigma – National Men’s Freshman Honorary Society
Medical School
-
Sigma Sigma Phi – National Osteopathic Honorary Society
-
Outstanding Academics & Community Service Award, 1985
-
Dean’s Award for Outstanding Academic, Personal integrity, and Anticipated Contribution to 
the Field    of Osteopathic Medicine, 1987
-
Outstanding Clinical Student at OUCOM NE Ohio Regional Teaching Site, Brentwood 
Hospital, Warrensville Heights, OH, 1987
32.0
Internship
-
Intern/Resident Research Paper Contest Winner (chosen by clinical faculty); Title:
“Recognition and recovery from ankle sprains: a step-wise treatment and 
rehabilitation program.”
Residency
-
Senior Resident Academic Achievement Award, 1991
Academia
-
Teacher of the Year (chosen by residents), Department of Rehabilitation Medicine,
University of Kentucky, College of Medicine, 1991-1992
HONORS (Continued)
-
Master Teacher Award for Leadership, University of Kentucky, College of Medicine, 1995
-
Exemplary Teacher, College of Medicine, University of Florida, 2003-2004
-
Distinguished Clinician Award, American Academy of Physical Medicine and Rehabilitation, 
2010 (National)
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VOLUNTEER PROFESSIONAL ACTIVITIES
Ohio High School Athletic Association
-
On-site physician, Central Ohio District Basketball Tournament; Mar 1989, Mar 1990
-
On-site physician, State Soccer Final; Nov 1989
-
On-site physician, State Football Finals; Nov1989
-
On-site physician, State Track Finals; Jun 1990, Jun 1991
-
On-site physician, State Basketball Finals; Mar 1991
33.0
Ohio State Wheelchair Olympics
-
On-site physician, May 1989, May 1990, May 1991
34.0
Ohio State Fair Golden Gloves Boxing Tournament
-
On-site physician; Aug 1989
35.0
Great Ohio Bike Adventure
-
On-site physician; Jun 1990
36.0
United States Olympic Committee (Drug Testing)
-
Columbus Marathon, Columbus, OH; Nov 1988
-
TAC/USA Track & Filed Junior National Championships, Columbus, OH; Jun 1989
-
USA National Baseball Team, Millington, TN; Jun 1989
-
USA National Karate Championships, Akron, OH; Feb 1990
Cardinal Hill Hospital
-
Physician liaison for Stroke Support Group; Fall 1991 – 1996
-
Live Television Interview – 21st Annual Telethon’ Apr 1992
-
Celebrity/physician 3-on-3 Kick-off, Downtown Showdown Shoot-out; May 1992
Kentucky Bluegrass Games
-
On-site physician; Jul 1992, Jul 1993
Salvation Army Free Clinic, Lexington, KY
-
Physician; Sep 1992, Nov 1992, May 1993, Aug 1993, Dec 1993, Feb 1994, Jan 1995,
Apr 1995, Aug 1995, Sep 1995
TOPP Soccer Program
-
Co-Director of the creation of local TOPP Soccer Program for kids with disabilities; 2006-2007
Shands Healthcare Marketing, Gainesville, FL
-
Healthcast audio recording to be used on hospital website.  Oct 2008
AOA/AOF iLEARN Mentor Exchange Program
-
Offer guidance and wisdom to student doctors, interns, residents and DOs. 
PROFESSIONAL AFFILIATIONS
American Academy of Physical Medicine and Rehabilitation  
American Association Neuromuscular & Electrodiagnostic Medicine
American Osteopathic Association 
American Osteopathic College of Physical Medicine and Rehabilitation
American Pain Society
American Society of Interventional Pain Physicians
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American Spinal Cord Injury Association
PROFESSIONAL AFFILIATIONS (continued)
Association of Academic Physiatrists 
Florida Osteopathic Medical Association
Florida Society of Physical Medicine and Rehabilitation
North American Spine Society
American Academy of Pain Management (2012)
American Academy of Pain Medicine (2012)
NATIONAL/STATE COMMITTEES
1992–Present American Academy of Physical Medicine & Rehabilitation
-
Subcommittee on Electronic Enhancement of PM&R Educational Opportunities; 
1992, 1993, 1994, 1995
-
Liaison to Medical Education Committee; 1993
-
Program Planning Committee, 1996-2007
-
Chair, 2004 - 2007
-
PASSOR Liaison; 2002 to 2010
-
Pain Course Co-Chair; 2004 to 2006
-
Awards Committee; 2008, 2009
Geriatric Special Interest Group
-
Nominating Committee; 1995, 1996
-
Presentation of Breakfast Focus Session at AAPM&R National Convention on 
Controversial Issues; 11/1992
-
Survey on The use of Unconventional Medications and Treatments in Geriatric 
Rehabilitation; 10/1994
Manual Medicine Special Interest Group
-
Chairman; 1995, 1996
-
Co-Chairman National Program Committee; 1993, 1994
-
Submissions for 1993
-
Manual Medicine Techniques in the Elderly
-
The Sacroiliac Joint and its Relationship to Low Back Pain
-
Mechanical Thoracic Pain – An Interdisciplinary Approach: the Integration 
of Manual Medicine and Myofascial Pain Concepts in Physiatric Practice
-
Submissions for 1994
-
Manual Medicine and Quality Management
-
The Use of Manual Medicine in Performing Artists
-
Manual Medicine Approach to Shoulder Pain:  Adhesive Capsulitis, Neck, 
Scapula or Rib Dysfunction?
-
Exercise, Prescription as a Continuum of Manual Medicine
-
Application of Manual Medicine for the Young Physiatrist
-
National Survey of Residency Programs to Determine Level and Source of 
Instruction of Manual Medicine
-
National Survey of Special Interest Group Members to Produce a List of 
Physiatrists Willing to Teach Manual Medicine to Residents and Other 
Practitioners
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-
Special Interest Group Chairs Committee; 1994
Stroke and Neurological Diseases Rehabilitation Special Interest Group
-
Review of Practice Parameter Paper on Venous Thromboembolism in Stroke; 
03/1993
NATIONAL/STATE COMMITTEES (Continued)
Opioid REMS Task Force Planning Committee
-
Chairman; 2012
1997-2003       American Association of Electrodiagnostic Medicine
-
Journal Committee; 2001-2003
-
Marketing & Public Relations Committee; 1998-2001
1997-2001
American Board of Electrodiagnostic Medicine
-
Oral Board Examiner; 1997- 1998, 1999, 2000, 2001
2003-Present American Spinal Cord Injury Association
-
Prevention Committee – 2003, 2004
-
Membership Committee – 2003, 2004
-
Program Committee – 2009-2012
1992-Present Association of Academic Physiatrist
-
Review of Fellowship White Paper; 02/1993
-
Education Committee; 1992, 1993, 1998
-
Undergraduate Medical Education Committee; 1994-1997
-
Principal Author of White Paper on Medical Student Education 
and PM&R; 1995, 1996
-
Research Coordinators Council; 1994, 1996-1998
-
Residency Program Directors Council; 1994, 1995
1992 – 1995
Kentucky Academy of Physical Medicine and Rehabilitation
-
Education Committee; 1992-1995
1993-2005
Commission on Accreditation of Rehabilitation Facilities (CARF)
2012-
-
Site Surveyor; 1993-2005; 2012
-
National Advisory Committee: Outpatient Medical Rehabilitation; 1994
1997-2012
Florida Department of Labor and Employment Security, Division of 
Vocational Rehabilitation, Florida Brain and Spinal Cord Injury Program
-
Inpatient/Outpatient Rehabilitation Committee, 04/1997
2012-Present American Academy of Pain Medicine
-
2013 Annual Meeting Planning Committee
37.0
38.0
INVITED LECTURES
Feb 1990
-
"Entrapment syndromes." The Ohio State University School of Allied 
Health Science, Columbus, OH
Sep 1990
-
"Social Security Administration disability guidelines for the
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musculoskeletal and neurologic systems."  Rehabilitation Services Commission of 
Ohio, Bureau of Disability Determination, Adjudicator Training Classes, 
Columbus, OH
Nov 1990
-
"Spinal manipulation and massage."   The Ohio State University, Physical 
Medicine Course 736, Columbus, OH
Jan 1991
-
"Spinal infection."  The Ohio State University Department of Physical
Medicine, Grand Rounds,  Columbus, OH
-
"Musculoskeletal and neurologic systems examination in relation to the 
Social Security Administration disability guidelines."   University of Kentucky 
Department of Rehabilitation Medicine Grand Rounds, Lexington, KY
INVITED LECTURES (Continued)
June 1991
-
"Social Security Administration disability guidelines for the musculo-
skeletal and neurologic systems."  Rehabilitation Services Commission of Ohio, 
Bureau of Disability Determination, Adjudicator Training Classes, Columbus, OH
Sep 1991
-
“Spinal manipulation for low back pain.”   University of Kentucky Fourth 
Annual Rehabilitation Management Conference for the Primary Care Physician, 
Lexington, KY
Nov 1991
-
"Multiple sclerosis:  diagnosis, treatment and rehabilitation." Rockcastle
County Hospital, Medical Staff Grand Rounds, Rockcastle, KY
Dec 1991
-
"Medical complications of stroke."   Veterans Medical Center Nursing 
Inservice Lexington, KY
Jan 1992
-
"Complications of medications following central nervous system injury."
Veterans Medical Center Therapy Inservice, Lexington, KY
-
"What is physical medicine and rehabilitation?”  University of Kentucky
-
Department of Student Health, Grand Rounds, Lexington, KY
Mar 1992
-
"Use of exercise in the elderly to enhance functional mobility."  University
of Kentucky, Department of Rehabilitation Medicine, Grand Rounds, Lexington, 
KY
-
"Principles of cervical manipulation."  Cardinal Hill Rehabilitation
Hospital Physical Therapy Inservice, Lexington, KY
-
"Use of exercise in the elderly to enhance functional mobility."  University
of Kentucky, CME Outreach Program at Carter Cave Resort Park, KY
April 1992
-
"Introduction of physical medicine and rehabilitation: what does it have 
to offer you?"   
University College of Osteopathic Medicine, Professional Counseling 
Week, Athens, OH
May 1992
-
"Use of exercise in the elderly to enhance functional mobility."  University 
of Kentucky, Department of Rehabilitation Medicine, Resident Research Day, 
Lexington, KY 
June 1992
-
"Diagnosis and treatment of cervical and lumbar radiculopathy."  
Veterans
Medical Center Therapy Inservice, Lexington, KY
Aug 1992
-
"Use of exercise in the elderly to enhance functional mobility."  University 
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of Kentucky and Sanders-Brown Center on Aging, The 9th Annual Summer Series 
on Aging, Lexington, KY
Sept 1992
-
"Use of exercise in the elderly to enhance functional mobility." 
University of Kentucky, Fifth Annual Rehabilitation Management 
Conference for the Primary Care Physician, Lexington, KY
Oct 1992
-
"Diagnosis and treatment of entrapment neuropathies."   Veterans 
Medical 
Center, Therapy Inservice, Lexington, KY
-
"Low back pain: diagnosis and aggressive conservative management."  
South Williamson Appalachian Regional Hospital Medical Staff Grand Rounds, 
South Williamson, KY
Dec 1992
-
"Osteopathic medicine: its history and use."  University of Kentucky 
Athletic Training Staff and Student Trainers Grand Rounds, Lexington, KY
-
"Low back pain and spinal injury in athletes: causes, evaluation, treatment, 
and outcome."  University of Kentucky Department of Rehabilitation Medicine 
Grand Rounds, Lexington, KY
Feb 1993
-
"Medical complications following stroke."  University of Kentucky 24th 
Annual Family Medicine and Primary Care Review, Lexington, KY
-
Workshop on "Aggressive conservative management of back and neck 
pain."  University of Kentucky 24th Annual Family Medicine & Primary Care 
Review, Lexington, KY
INVITED LECTURES (Continued)
Mar 1993
-
"Falls in the elderly."  University of Kentucky Division of Geriatrics and 
Sanders-Brown Center on Aging Updates in Geriatrics, Lexington, KY
May 1993
-
"Medical complications following stroke."  University of Kentucky 24th
Annual Family Medicine and Primary Care Review, Lexington, KY
-
Workshop on "Aggressive conservative management of back and neck pain."  
University of Kentucky 24th Annual Family Medicine & Primary Care Review, 
Lexington, KY
June 1993
-
"The use of exercise in prevention and rehabilitation of falls and hip 
fractures."  The Ohio Valley Appalachia Regional Geriatric Education Center Teleconference, 
Lexington, KY
Jul 1993
-
"The use of exercise in prevention, rehabilitation, and outcome of falls 
and hip fractures." University of Kentucky Department of Rehabilitation 
Medicine, Grand Rounds, Lexington, KY
Aug 1993
-
"Medical considerations and complications following common orthopedic 
procedures: total hip replacement, total knee replacement, repair of hip 
fracture, and the Ilizarov technique."  Cardinal  Hill Rehabilitation Hospital 
General Rehabilitation/ Orthopedic Update 1993, Lexington, KY
Sept 1993
-
"Updates in the management of stroke."  Cardinal Hill Rehabilitation 
Hospital Patient/ Family Stroke Support Group, Lexington, KY
-
"Treatment of back pain in the elderly and following stroke."  Cardinal Hill 
Rehabilitation Hospital Stroke Program Team Meeting, Lexington, KY
Oct 1993
-
"Medical rehabilitation issues following stroke."  Johnson Mathers
Hospital Medical Staff Meeting, Carlisle, KY
IRB #: STU00080585 Approved by NU IRB for use on or after 3/29/2018 through 3/25/2019.

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-
"New developments in the acute management of persons 
following stroke."  Cardinal Hill Rehabilitation Hospital,  Stroke Update 1993, 
Lexington, KY
Feb 1994
-
Workshop on "Falls assessment." University of Kentucky 24th Annual 
Family Medicine and Primary Care Review, Lexington, KY
May 1994
-
"Spinal injury in athletes: causes, evaluation, treatment, and outcome."  
University of Kentucky Department of Rehabilitation Medicine Grand Rounds, 
Lexington, KY
Jun 1994
-
"Falls Assessment."  Johnson Mathers Hospital Medical Staff Meeting,
Carlisle, KY
-
"The use of unconventional medications in geriatric rehabilitation."  The 
Ohio State University Department of Physical Medicine and Rehabilitation 
Resident Farewell Day, Columbus, OH.
Jun 1994
-
"Alternative uses of electromyography as a research tool."  The Ohio 
State
University Department of Physical Medicine and Rehabilitation Resident Farewell 
Day, Columbus, OH
-
"Incorporating manual medicine into an exercise prescription."  The Ohio 
State University Department of Physical Medicine and Rehabilitation Resident 
Farewell Day, Columbus, OH
July 1994
-
"Enabling the elderly."  University of Kentucky and Sanders-Brown 
Center on Aging, The 11th Annual Summer Series on Aging, Lexington, KY
-
"Medical rehabilitation issues following stroke."  Medical Staff Meeting,
London, KY
Aug 1994
-
"New CARF standards for comprehensive and subacute rehabilitation and
new levels of rehabilitation care."  University of Kentucky Dept of 
Physical Medicine and Rehabilitation Seventh Annual Rehabilitation Conference, 
The Rehabilitation Continuum: From Hospital to Home, Lexington, KY
INVITED LECTURES (Continued)
Sep 1994
-
“The use of unconventional medication during geriatric rehabilitation."  
The Ohio State University Seventh Annual Update in Internal Medicine, 
Columbus, OH
-
"The electromyographic and kinematic analysis of climbing activities in
amputee farmers." Television Interview with Jerry Sanders, Channel 27, 
Lexington, KY
-
"The use of ankle strengthening exercises to prevent falling in the elderly." 
Television Interview with Jerry Sanders, Channel 27, Lexington, KY
Oct 1994
-
“Preventing falls in farmers with disabilities."  External Advisory 
Committee of Southeast Center for Agricultural Health and Injury Prevention, Lexington, KY
IRB #: STU00080585 Approved by NU IRB for use on or after 3/29/2018 through 3/25/2019.

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-
"Medical rehabilitation issues following stroke."  East Cumberland 
Hospital Medical Staff Meeting, Columbia, KY
-
"Stroke update: new developments in the acute management and 
rehabilitation of persons following stroke."  Cardinal Hill Rehabilitation Hospital 
Stroke Update 1994, Lexington, KY
Dec 1994
-
"Discussion of the AHCPR Guidelines on the Management of Acute Low 
Back Problems."  Television Interview with Jerry Sanders, Channel 27, Lexington, 
KY
Feb 1995
-
"Enabling the elderly."  University of Kentucky 25th Annual Family 
Medicine and Primary Care Review, Lexington, KY
-
"Muscle energy manipulation."   Cardinal Hill Rehabilitation 
Hospital 
Dept of Physical Therapy Grand Rounds, Lexington, KY
Mar 1995
-
"The aging athlete."  University of Kentucky Dept of Orthopedics, Sports 
Medicine Grand Rounds, Lexington, KY
-
“Structural diagnostic exam.”  University of Kentucky Dept of 
PM&R Course – Clinical Osteopathic Manual Medicine: Introductory Hands-On 
Course for Physicians and Therapists, Lexington, KY
-
“Principles of vertebral motion.”  University of Kentucky Dept of PM&R
Course: Clinical Osteopathic Manual Medicine: Introductory Hands-On Course for Physicians and 
Therapists, Lexington, KY
-
“Layer palpation.”  University of Kentucky, Dept of PM&R, Clinical 
Osteopathic Manual Medicine: Introductory Hands-On Course for Physicians and 
Therapists, Lexington, KY
-
“Segmental motion testing.”  University of Kentucky, Dept of 
PM&R, Clinical Osteopathic Manual Medicine: Introductory Hands-On Course for 
Physicians and Therapists, Lexington, KY
-
“Functional indirect technique.”  University of Kentucky, Dept of 
PM&R, Clinical Osteopathic Manual Medicine: Introductory Hands-On Course for 
Physicians and Therapists, Lexington, KY.
-
"Incorporating manual medicine into daily practice."  University of 
Kentucky, Dept of PM&R, Clinical Osteopathic Manual Medicine: Introductory 
Hands-On Course for Physicians and Therapists, Lexington, KY
Apr 1995
-
“Falls assessment.”  University of Kentucky, Division of Geriatrics and 
Sanders-Brown Center on Aging , Updates in Geriatrics, Lexington, KY
May 1995
-
“Enabling the elderly.”  University of Kentucky 25th Annual Family 
Medicine and Primary Care Review, Lexington, KY
INVITED LECTURES (Continued)
-
"A review of the AHCPR Guidelines for Acute Low Back Problems."  
University of Florida, Departments of Neurosurgery and Orthopedic Surgery 
Grand Rounds, Gainesville, FL
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Jun 1995
-
"A review of the AHCPR Guidelines for Acute Low Back Problems."  
Kentucky Osteopathic Medical Association Annual Meetings, Ft. Mitchell, KY
-
"How to use the AMA Guides for Disability and Impairment Ratings."  
Kentucky Osteopathic Medical Association Annual Meetings, Ft. Mitchell, KY
Jul 1995
-
"Pathophysiology and medical management of stroke."  Appalachian
Regional Hospitals Home Health Nursing Conference, Paintsville, KY
Aug 1995
-
“A review of the AHCPR Guidelines for Acute Low Back Problems."  
University of Kentucky Department of Physical Medicine and Rehabilitation 
Eighth Annual Rehabilitation Conference, Lexington, KY
Sep 1995
-
"Use of exercise in the elderly."  The Ohio State University Dept of 
Physical Medicine and Rehabilitation, EWJ Society Reunion, Columbus, OH
-
"EMG/kinematic analysis of the hemiplegic shoulder."  The Ohio State
University Department of Physical Medicine and Rehabilitation, EWJ Society
Reunion, Columbus, OH
-
"Enabling the elderly."  University of Kentucky, 25th Annual Family
Medicine and Primary Care Review, Lexington, KY
Nov 1995
-
"Nonoperative care: early physical therapy, injections, etc.; late pain and 
low back pain management; interventional blocks."  The Center for Advanced 
Medical Education Spine Review Course, Chicago, IL
-
"Postoperative care: acute and long-term rehabilitation; spinal cord
injury/bracing; postoperative bracing."  The Center for Advanced Medical 
Education Spine Review Course, Chicago, IL
Dec 1995
-
“A review of the AHCPR Guidelines for Acute Low Back Problems."  
University of Kentucky, Department of Physical Medicine and Rehabilitation 
Grand Rounds, Lexington, KY
Feb 1996
-
"A review of the AHCPR Guidelines for Acute Low Back Problems." 
Shands Hospital Rehabilitation Services Grand Rounds, Gainesville, FL
Mar 1996
-
“Diagnosis, treatment and care of patients with acute low back pain.”
University of Kentucky Offices of Continuing Pharmacy, Medical and Nursing 
Education, Bowling Green, KY
-
“Diagnosis, treatment and care of patients with acute low back pain.” 
University of Kentucky Offices of Continuing Pharmacy, Medical and Nursing 
Education, Owensboro, KY
-
“Diagnosis, treatment and care of patients with acute low back pain.”
University of Kentucky Offices of Continuing Pharmacy, Medical and Nursing 
Education, Corbin, KY
-
“Rehab of the acute CVA patient.”  University of Kentucky 
Department of Continuing Education, course on Topics in Geriatric Medicine, 
Lexington, KY
Apr 1996
-
“Agency for Health Care Policy and Research Guidelines for the Treatment 
of Acute Low Back Problems in Adults: a review.”  American College of 
Occupational and Environmental Medicine Seminar, The Physiatric Approach to 
Low Back Pain:  Aggressive Nonsurgical Approach, San Antonio, TX.
INVITED LECTURES (Continued)
IRB #: STU00080585 Approved by NU IRB for use on or after 3/29/2018 through 3/25/2019.

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-
Return to work issues in occupational low back injuries.” American
College of Occupational and Environmental Medicine Seminar, The Physiatric 
Approach to Low Back Pain: Aggressive Nonsurgical Approach, San Antonio, TX
-
“Return to work issues in occupational neck injuries.”American College 
of Occupational and Environmental Medicine Seminar, The Physiatric Approach 
to Neck Pain, San Antonio, TX
May 1996
-
“University of Florida SpineCare Program.”  Radio Call in Program, Rock 
104, Gainesville, FL
-
“University of Florida SpineCare Program.”  Noon News, Channel 20,
Gainesville, FL
Jun 1996
-
“Sacroiliac joint dysfunction: diagnostic evaluation and treatment.”  
Shands Hospital Physical Therapy Staff, Gainesville, FL
Aug 1996
-
“University of Florida SpineCare Program.” Interview with Myro Munroe
Noon News, Channel 20,Gainesville, FL
Jan 1997
-
“Enabling the elderly.”  Department of Veteran Affairs, Geriatric 
Conference, Gainesville, FL
-
“Appropriate referrals to the SpineCare Clinic.”University of Florida, 
Department of Community Health & Family Medicine, Gainesville, FL
Feb 1997
-
“Evaluation and treatment of acute spinal problems.” University of 
Florida, College of Medicine, Department of Rheumatology Grand Rounds, 
Gainesville, FL
May 1997
-
“Occupational low back pain.”  American College of Occupational and 
Environmental Medicine Conference, Safety Harbor, FL
-
“Assessment and treatment of occupational neck pain.”  American College
of Occupational and Environmental Medicine Conference, Safety Harbor, FL
Jul 1997
-
“Algorithmic approach to spinal interventions.” University of Florida,
College of Medicine, Health and Human Performances, Gainesville, FL 
Rehabilitation of the Spine Update ‘97. Orlando, FL
-
“Use of manual medicine in a comprehensive rehabilitation program.” 
University of Florida, College of Medicine, Health and Human Performances, 
Gainesville, FL Rehabilitation of the Spine Update ‘97.  Orlando, FL
-
“Medical interventions in rehabilitation.” Shands Rehab Hospital Staff, 
Gainesville, FL
Aug 1997
-
“Manual medicine.”  Kessler Institute for Rehabilitation, West Orange, 
NJ
Sep 1997
-
“Non-surgical care (part 1).”  Weekly Spine Conference, Departments of
Neurosurgery and Orthopaedic Surgery, College of Medicine, University of 
Florida, Gainesville, Fl
Oct 1997
-
“Evaluation and treatment of low back pain.”Orthopaedic Grand Rounds,                         
DepartmenT of Orthopaedic Surgery, College of Medicine, University of Florida,                                                      
Gainesville, FL
-
“Evaluation and treatment of low back pain” and “Evaluation and treatment of 
neck pain.”  Lecture to PA Students, College of Medicine, University of Florida, 
Gainesville, FL
-
“What’s on your mind?”  TV 20 panel, Gainesville, FL
IRB #: STU00080585 Approved by NU IRB for use on or after 3/29/2018 through 3/25/2019.

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Nov 1997
-
“Evaluation and treatment of acute low back pain (part 1).”Family
Practice Noon Conference, Shands @ AGH, Gainesville, FL
INVITED LECTURES (Continued)
Dec 1997
-
“Evaluation and treatment of acute low back pain (part 2).”
Family Practice Noon Conference, Shands @ AGH, Gainesville, FL
Jan 1998
-
“A question of health.”  TV 20 Panel.  Gainesville, FL
-
“Non-surgical care (part 1).”  Weekly Spine Conference, Departments of 
Neurosurgery and Orthopaedic Surgery, College of Medicine, University of 
Florida, Gainesville, FL
-
“Evaluation and treatment of acute and chronic low back pain.”  PM&R 
Conference, Department of Orthopaedic Surgery, College of Medicine, University 
of Florida, Gainesville, FL
Mar 1998
-
“Evaluation and treatment of neck pain.”Family Practice Noon 
Conference, Shands @ AGH, Gainesville, FL
Apr 1998
-
“Back pain in the athlete.”  Gainesville Sports Organizing Committee, 
Gainesville, FL
May 1998
-
“Evaluation, classification, and rating of disability.”  PM&R Conference, 
Department of Orthopaedic Surgery, College of Medicine, University of Florida, 
Gainesville, FL
Jun 1998
-
“Case presentations.”  Weekly Spine Conference, Departments of 
Neurosurgery and    Orthopaedic Surgery, College of Medicine, University of 
Florida, Gainesville, FL
Aug 1998
-
“Non-surgical care (part 2).”  Weekly Spine Conference, Departments of 
Neurosurgery and Orthopaedic Surgery, College of Medicine, University of 
Florida, Gainesville, Fl
-
“Advances and research related to the hemiplegic shoulder.”  Shands Rehab 
Hospital, Grand Rounds, Gainesville, FL
Aug 1998
-
“Evaluation and maintenance of functional status in the elderly.”  
Department of Veterans Affairs; Gainesville, FL
Nov 1998
-
“Evaluation and treatment of low back pain” and “Evaluation and 
treatment of neck pain.”  Lecture to PA Students, College of Medicine, University 
of Florida, Gainesville, FL
Dec 1998
-
“Spine CAMP.”  Weekly Spine Conference, Departments of Neurosurgery 
and Orthopaedic Surgery, College of Medicine, University of Florida, Gainesville, 
FL
-
“Spine CAMP.” Rehabilitation Medicine Associates.  Gainesville, FL
Feb 1999
-
“My aching back.”  Health Discoveries Conference, University of Florida, 
Gainesville, FL
May 1999
-
“Learn how to stand up to back pain.”  With Eddy Duncan, M.D. and 
Patrick O’Connor, LPT.  Public Lecture/Q&A, Illuminations.  Gainesville, FL
Jun 1999
-
“A Question of Health.”  TV 20 Panel.  Gainesville, FL 
Aug 1999
-
“Initial visit and treatment – acute algorithm.”  Lecture to Family Practice 
Residents, College of Medicine, University of Florida, Gainesville, FL
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Sep 1999
-
“Evaluation and treatment of low back pain” and “Evaluation and 
treatment of neck pain.”  Lecture to PA Students, College of Medicine, University 
of Florida, Gainesville, FL
-
“Enabling the elderly.”  Lecture to Geriatric Psychiatry Residents.  
VA Medical Center, Gainesville, FL
Feb 2000
-
“Algorithmic approach to chronic spinal pain.”  Alachua County 
Pharmaceutical Association.  Gainesville, FL.
Aug 2000
-
“New strategies in the treatment of pain.”  Family Practice Noon 
Conference, 
College of Medicine, University of Florida, Gainesville, FL
Sep 2000
-
“Non-surgical management of back pain.”  Internal Medicine Grand 
Rounds.  
College of Medicine, University of Florida, Gainesville, FL
INVITED LECTURES (Continued)
-
“Occupational low back pain” and “Assessment and treatment of occupational 
neck pain.”  Lectures to PA Students, College of Medicine, University of Florida, 
Gainesville, FL
Jan 2001
-
“Management of low back pain in the athlete.”  With Ephraim 
Brenman,D.O.  
Sports Medicine Conference, College of Medicine, University of Florida, 
Gainesville, FL
May 2001
-
“Chronic low back pain.”  Medicine Noon Conference, College of 
Medicine, 
University of Florida, Gainesville, FL
-
“Exercise therapy for the spine.  Part 1.”  Anesthesia Pain Group, 
College of Medicine, University of Florida, Gainesville, FL
-
“Exercise therapy for the spine.  Part 2.”  Anesthesia Pain Group, 
College of Medicine, University of Florida, Gainesville, FL
May 2001
-
“Opioids for chronic pain: Outcomes and clinical dilemmas.”  With 
Michael Robinson, Ph.D.  Pain Interest Group.  College of Medicine, 
University of Florida, Gainesville, FL
-
“My aching back.”  National Association of Retired Federal Workers. Gainesville, 
FL
Sep 2001
-
“Non-surgical management of back pain.”  Internal Medicine Grand 
Rounds.  
College of Medicine, University of Florida, Gainesville, FL
-
“Occupational low back pain” and “Assessment and treatment of occupational 
neck pain.”  Lectures to PA Students, College of Medicine, University of Florida, 
Gainesville, FL
Oct 2001
-
“What is an osteopath?”  Introduction to Profession of Medicine Series. 
College of Medicine, University of Florida, Gainesville, FL
-
“Exercise therapy for the spine.”  Physical Therapy Inservice at Illuminations.  
Gainesville, FL.
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Dec 2001
-
“Exercise and manipulation” AND “Use of manual medicine in a 
comprehensive rehabilitation program.”   Department of Anesthesiology, College 
of Medicine, Gainesville, FL
Apr 2002
-
“EMG Case Studies.”  University of Florida, Department of Orthopaedics 
& Rehabilitation Spine Conference, College of Medicine, Gainesville, FL
38.1.1 May 2002
-
“Pain Management Strategies.”  ENT Department Morning 
Conference, 
38.1.2
University of Florida, College of Medicine, Gainesville, FL
-
“Pain Management Strategies.”  Neurosurgery Department Morning 
-
Conference, University of Florida, College of Medicine, Gainesville, FL
July 2002
-
“Other Uses of Zanaflex.”  Lakeside Occupational Medicine Group. 
38.1.3
Tampa, FL
July 2002
-
“Rehabilitation of the Stroke Patient.” Family Practice Residents,
University of Florida, College of Medicine, Gainesville, FL
Dec 2002
-
“Pain Assessment: A Review of Pain Algorithms.”  Shands Physical 
Therapists.  University of Florida, Gainesville, FL  
-
“Conservative Back Care.”  Department of Orthopaedics and Rehabilitation, 
-
Spine Conference.  University of Florida, College of Medicine, Gainesville, FL
Feb 2003
-
“Chronic Low Back Pain.”  Health Psychology Graduate Students.  
Department of Clinical Psychology, University of Florida, College of Health 
Professions, Gainesville, FL
INVITED LECTURES (Continued)
Mar 2003
-
“Implementing the Guidelines for Opioid Pharmacotherapy.” Jansen 
Pharmaceutical  
Roundtable, Gainesville, FL
38.1.4 Apr 2003
-
“Implementing the Guidelines for Opioid 
Pharmacotherapy.”  
38.1.5
Jansen Pharmaceutical Roundtable.  Gainesville, FL
38.1.6 Jul 2003
-
“Implementing the Guidelines for Opioid 
Pharmacotherapy.”  
38.1.7
Jansen Pharmaceutical Roundtable.  Gainesville, FL
Oct 2003
-
“Rehabilitation of the Stroke Patient” and “Occupational Low Back Pain.” 
(with Kalman, A.D.,  Rehab Psychology Class, University of Florida, College of 
Health Professions, Gainesville, FL
-
“Put That Back Pain Behind You!”  (with Kalman, A.D. and Shay, T.)  Public 
Lecture/ Q&A, Magnolia Park Rehab Center.  Gainesville, FL
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38.1.8 Nov 2003
-
“Rehabilitation Following Cervical Mylopathy.”  University 
of Florida, 
38.1.9 Department of Orthopaedics & Rehabilitation Spine Conference, College of 
Medicine, Gainesville, FL
Jan 2004
-
“Occupational Low Back Pain” AND “Assessment and Treatment of 
Occupational Neck Pain.”  Lectures to PA Students, College of Medicine, 
University of Florida, Gainesville, FL
Mar 2004
-
“Osteopathic Medicine.”  PM&R Interest Group.  University of Florida, 
College of Medicine, Gainesville, FL
Mar 2005
-
“Put That Back Pain Behind You!”  (with Kalman, A.D. and Shay. T.)
Public Lecture/Q&A, Orthopaedics & Sports Medicine Institute,
University of Florida, Gainesville, FL
-
“Common Neuropathic Pain Disease States in Primary Care.” Sponsored by
Embryon.  Presented to Research Triangle Primary Care Physicians, Raleigh, NC
Apr 2005
-
“Working With Your Patient in Managing Neuropathic Pain.”  Presented
to Cincinnati Area Primary Care Physicians.  Cincinnati, OH
May 2005
-
“Post-Op Pain Management.”  Grand Rounds, Department of 
Neurosurgery, University of Florida, Gainesville, FL
May 2005
-
Whole Patient Management in Neuropathic Pain: Evidence and 
Experience.  “Evidence-Based Treatment of Neuropathic Pain.  Pri-Med Update 
sponsored by Embryon.  Toledo, OH
June 2005
-
“Common Neuropathic Pain Disease States in Primary Care.”  Common 
Chronic Pain Conditions Confronting the Primary Care Provider.  Pennsylvania 
Convention Center.  Sponsored by Embryon.  Philadelphia, PA
Oct 2005
-
Improving Outcomes for Patients with Chronic Pain. “Chronic Pain: Its 
Causes and Clinical Manifestations.”  Presented to Pri-Med Regional Satellite 
Symposium. Sponsored by Embryon.  Baltimore, MD
Mar 2006
-
Whole Patient Management in Neuropathic Pain: Evidence and 
Experience.  “Management of Comorbidities: Evidence for Success.”  Pri-Med 
Update sponsored by Embryon.  Melville, NY
Apr 2006
-
Whole Patient Management in Neuropathic Pain: Evidence and 
Experience.  “Management of Comorbidities: Evidence for Success.”  Pri-Med 
Update sponsored by Embryon.  Charlotte, NC
May 2006
-
Modern Management of Spinal Disorders.  “Medical Management of 
Back Pain.”  Sponsored by Riverside Methodist Hospital.  Columbus, Ohio.
INVITED LECTURES (Continued)
Jun 2006
-
Whole Patient Management in Neuropathic Pain: Evidence and 
Experience.  “Evidence-Based Treatment of Neuropathic Pain.  Pri-Med Update 
sponsored by Embryon.  Jacksonville, FL
Sep 2006
-
Update in Management of Spinal Pain Problems.  Rochester Spine Study 
Group, University of Rochester, Rochester, NY
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Sep 2006
-
Management of Comorbitities: Evidence for Success.  (Clinical Experience 
in Managing Neuropathic Pain: Managing Comorbitities in Neuropathic Pain Case 
Study II) Pri-Med Update sponsored by Embryon.  Philadelphia, PA
Feb 2007
-
Indications and Outcomes of Rehabilitation Following Trauma.  
Multidisciplinary Trauma Conference, Shands Hospital.  Gainesville, FL
May 2007
Opiate Therapy, Narcotic Patient Contracts and Chronic Pain 
Management.  (Managing Chronic Pain: Clinical, Ethical & Lawful Solutions.)  The 
Medical Educational Council of Pensacola in joint sponsorship with Area One 
Florida Medicaid, Emerald Coast Health Alliance and Health First Network, Inc.  
Andrews Institute Conference Center, Gulf Breeze, FL
Sep 2007
Spine Course.  “Medical Management of Low Back Pain.”  Sponsored by 
the Department of Orthopaedics and Rehabilitation, University of Florida, 
Gainesville, FL
Sep 2007
Issues Related to Shands Rehab Hospital and Shands Healthcare.  
Presented at Florida Group Practice Board Meeting, Gainesville, FL
Apr 2008
Update on Electromyography.  Orthopaedics and Physical Medicine and 
Rehabilitation Spine Conference
Mar 2010
Neck and Cervical Spine. 
Physician Assistant Program, University of Florida, Gainesville, FL
Mar 2010
Rehabilitation Following Trauma – Indications and Outcomes.  
Multidisciplinary Trauma Conference, University of Florida, Gainesville, FL
Jun 2010
Management of Spinal Pain and Injury – Case Studies.  2010 PM&R 
Residents Graduating Class, Ohio State University, Columbus, OH
Opioid Analgesics.  2010 PM&R Residents Graduation Class, Ohio 
State University, Columbus, OH
So You’re Ready to Be a Physiatrist?  2010 PM&R Residents 
Graduating Class, Ohio State University, Columbus, OH
Mar 2011
Atchison, JW.  “Low Back and SI Pain in Runners.”  Running Medicine 
2011, Innovation & Practice Through Science.”  University of South Florida and 
University of Florida.  Gainesville, FL.
Sep 2011
Hamilton S, Nguyen W, Kennedy DJ, Atchison JW. Four Case 
Presentations.  Pain Connections Journal Club, Gainesville, FL.
Jan 2012
Atchison, JW.  “Pain Management.”  Grand Rounds.  Northwestern 
University -  Feinberg School of Medicine, Department of Physical Medicine and 
Rehabilitation, 
The Rehabilitation Institute of Chicago.  Chicago, IL.
Mar 2012
AHMA “Back Pain” Seminar to medical students. 
University of Florida, College of Medicine, Gainesville, FL
“Principles of Pain Management” Geriatric Fellowship Noon Conference. 
University of Florida/North Florida/South Georgia Veterans Health System, 
Geriatric Research Education & Clinical Centers, Gainesville, FL
INVITED LECTURES (Continued)
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September 2014
67th Annual Ward E. Perrin Clinical Refresher Course, “ER/ LA Opioid 
REMS: Achieving 
use while improving patient care”. Lombard, IL 
Feb 2015
CRPS  Grand Rounds. Anesthesia Pain Center, Stanford University, Palo 
Alto, CA.
Rational Pharmacology. Division of PM&R, Stanford University, Palo Alto, 
CA.
38.1.10 PRESENTATIONS AT PROFESSIONAL MEETINGS
Nov 1989
-
Atchison JW, Pelligrino M, Herbers, P, and Matkovic V.  “Hepatic
Encephalopathy mimicking stroke." APM&R National Convention, San Antonio, 
TX; Poster; Nov 1989.
Oct 1990 
-
Atchison JW, Rindler J, Haddock D, Saneda D, and Pease W.  
"Rehabilitation following arsenic toxicity." AAPM&R National Convention,
Phoenix, AZ. Platform
-
Atchison JW and Waylonis G.  "Manipulative medicine."  AAPM&R National 
Convention, Phoenix, AZ. Video
-
Atchison JW, Wachendorf J, Gribble M, Corrigan J., and Mysiw J.  Hyponatremia 
associated cognitive deficits in a traumatic brain injured
-
population."  AAPM&R National Convention, Phoenix, AZ.  Poster
Feb 1991
-
Atchison JW, McDonough N, Shamir D, Powers J, Waylonis G, and
Pease W.  "Electrodiagnostic medicine during PM&R residency training."  AP 
National Convention, San Diego, CA.  Poster
Nov 1992
-
Atchison JW, Salcido R, Noble L, Marshall R, and Walker M.  "Use of 
exercise in the elderly to enhance mobility."  AAPM&R National Convention, San 
Francisco, CA. Platform
Nov 1992
-
Salcido, R, Schleenboker RE, Atchison JW, and Gershkoff, AM.  
"Controversies in geriatric rehabilitation case management."  AAPM&R National 
Convention, San Francisco, CA. Breakfast Focus  Session;  Sponsored by Geriatrics 
SIG
-
Salcido R, Farrage JR, Lindsey R, and Atchison JW.  Painful 
compression of the lateral antebrachial cutaneous nerve in C5-C6 quadriplegia.” 
AAPM&R National Convention, San Francisco, CA. Platform (presented by 
Farrage JR).
Nov 1993
-
Farrage JR, Salcido R, Atchison JW, and Haglund B.  “Compression 
syndrome involving lateral antebrachial cutaneous nerve in high level of 
quadriplegia.” AAPM&R National Convention, Miami Beach, FL. Platform 
(presented by Farrage JR).
-
Mein EA, Gilliar W, and Atchison JW (faculty).  "The sacroiliac joint 
and its relationship to low back pain." AAPM&R National Convention, Miami 
Beach, FL. Breakfast Focus Session;  Sponsored by Manual Medicine SIG
-
Atchison JW , Mein EA, Gillar W, and Gershkoff A (faculty).  "Manual 
medicine techniques in the elderly."  AAPM&R National 
Convention, Miami Beach, FL. Workshop Leader; Sponsored by Geriatrics and 
Manual Medicine SIGs
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Farrage J, Salcido R, Atchison JW, Stanos SP, and Stracener WA.  “The 
efficacy of impedance plethysmography for detecting deep venous 
thrombosis in patients following stroke at a free-standing rehabilitation 
hospital.” AAPM&R National Convention, Miami Beach, FL. Poster
Atchison JW, Ikai T, Kraft GH, Lan N, and Salcido R.  "Kinematic 
and EMG firing patterns regarding normal and hemiparetic shoulder function."  
Course on Futuristic Models for 
38.1.11 PRESENTATIONS AT PROFESSIONAL MEETINGS (Continued)
Rehabilitation of the Hemiparetic Arm. AAPM&R National 
Convention, Miami Beach, FL
Jan 1994
-
Newman RL, Atchison JW, and Klim GV.  "The perceived need for
increased training in manual medicine by residents in PM&R." AAP National
Convention, Naples, FL. Poster
Oct 1994
-
Holmes T, Atchison JW, Gilliar WG, and Gershkoff A (faculty).  
"Manual medicine approach to shoulder pain:  adhesive capsulitis, neck, and 
scapula or rib dysfunction."  AAPM&R National Convention, Anaheim, CA. 
Workshop; Sponsored by Manual Medicine SIG and Geriatrics SIG
-
Atchison JW , Glassman J, and Holmes T.  "Exercise prescription as a
continuum of manual medicine"  AAPM&R National Convention, Anaheim, CA. 
Workshop Leader; Sponsored by Manual Medicine SIG
Oct 1994
-
Gilliar WG, Atchison JW, and Mein EA (faculty).  "The use of manual
medicine in performing artists."  AAPM&R National Convention, Anaheim, CA. 
Workshop; Sponsored by Manual Medicine SIG and 
Performing Arts SIG
-
Atchison JW, Hecht JS, and Biundo, JJ.  "Shoulder pain and 
dysfunction in the disabled person: the hemiplegic shoulder -- anatomy and 
kinesiology."  AAPM&R National Convention, Anaheim, CA.  Course; Sponsored 
by Geriatrics SIG, Arthritis SIG, Stroke SIG
-
Atchison JW, Nickerson RB, McDowell SM, and Turner HS. "The use 
of a university-based  student health clinic to promote and educate PM&R 
residents."  AAPM&R National Convention, Anaheim, CA. Platform
Mar 1995
-
Nickerson RB, VanHoose J, Hayes D, and Atchison JW.  "Hiccups 
associated with lateral medullary syndrome."  AAP National Convention, 
Phoenix, AZ.  Poster
Apr 1995
-
Atchison JW, Stine R, Sampson J, Oeffinger D, Shapiro R, and Salcido 
R.  Electromyographic and kinematic analysis of the hemiplegic shoulder in 
comparison to healthy elderly males."  Seventh World Congress of the 
International Rehabilitation  Medicine Association, Washington, DC. Platform 
May 1995
-
Atchison JW.  “Unique uses of manual medicine: a series of case 
reviews.” American Osteopathic College of Rehabilitation Medicine National 
Meetings, Chicago, IL. Platform
Nov 1995
-
Atchison JW, Belfie AH, Robbins HJ, and Alfaro A.  "Neck pain: 
prevalence, etiology, and pathological changes associated with acute and chronic 
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neck pain."  AAPM&R National Convention, Orlando, FL.  Course on Neck Pain 
and Cervical Manipulation.  Sponsored by Manual Medicine SIG
-
Atchison JW, Noble LE, Salcido RM, Herrel P, and Donofrio JC.  
"Maintenance of Improved strength and functional mobility 18 months following 
an isotonic quadriceps exercise program."  AAPM&R National Convention, 
Orlando, FL. Platform
Nov 1995
-
Atchison JW, Simpson L, Knapp L, Oeffinger D, and Mainous III A.  
"Increased isotonic quadriceps strength following stroke with a six week exercise 
program."  AAPM&R National Convention,  Orlando, FL. Platform 
-
Atchison JW, Oeffinger D, Johnson D, Simpson C, and Salcido, RM. 
"Increased isotonic ankle dorsiflexor strength in a healthy elderly population 
with an eight week exercise program."  AAPM&R National Convention, Orlando, 
FL. Platform
-
Kuhlman KA, Atchison JW, Gay RE, Hennessey WJ, and Robbins HF (faculty).  
"Application of manual medicine for the young physiatrist."AAPM&R National 
38.1.12 PRESENTATIONS AT PROFESSIONAL MEETINGS (Continued)
Convention, Orlando, FL. Resident Physician Council Workshop; Sponsored by 
Manual Medicine SIG.
-
Kirsteins A, Atchison JW and Hecht JS (faculty).  “Shoulder pain following stroke.”  
AAPM&R National Convention, Orlando, FL.  Stroke and Neurologic Diseases 
Rehabilitation SIG
-
Stoll ST and Atchison JW.  “Comparison of primary care physicians 
and patient’s attitudes toward manual medicine.”  AAPM&R National 
Convention, Orlando, FL. Platform; (presented by Stoll ST)
Oct 1996
-
Bilkey W, Holmes T, Atchison JW, Stoll ST, and Belfie A (faculty). 
“Foolproof techniques for the manual medicine beginner.”  AAPM&R  National 
Convention, Chicago, IL.Workshop; Sponsored by Manual Medicine SIG
-
Glassman J, Holmes T, Atchison JW, and Belfie A (faculty).  
“Manual medicine approach to headaches which originate in the cervical 
spine.”AAPM&R National Convention, Chicago, IL. Workshop; Sponsored by 
Manual Medicine SIG
-
Tolchin R, Mein, E, Stoll S, Atchison JW, Dreyfuss, PH Magaziner E, 
Guisto J, and Tomski M.  “Combination techniques in manual medicine.”  
AAPM&R National Convention, Chicago, IL. Course on Facet Joint Injections and 
Manual Medicine.  Manual Medicine SIG Forum 
-
Atchison JW, Nickerson R, and Tharp D.  “Innovations in exercise prescriptions: 
videotaping manual medicine treatment programs to be used at home or with a 
therapist.”  AAPM&R National Convention, Chicago, IL.  Poster
-
Atchison JW, Stoll ST, and McDowell S.  “Manipulation under local 
anesthesia:  lumbar sympathetic blocks followed by high-velocity, low-amplitude 
treatment.” AAPM&R National Convention, Chicago, IL. Poster
-
Atchison JW, Knapp L, Oeffinger D, Mainous III A, and Salcido RM. 
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“The risk of post-stroke falls based on timed ‘up & go’ testing and isotonic 
quadriceps weight lifting.”  AAPM&R National Convention, Chicago, IL. Platform
-
Knapp L, Atchison JW, Shapiro R, Salcido RM, and Abbas J.
“Electromyographic and kinematic analysis of the painful hemiplegic shoulder 
before and after subscapularis motor point block”AAPM&R National 
Convention, Chicago, IL. Platform
Feb 1997
-
Knapp L, Atchison JW, Oeffinger P, Bay S, Lang R, and Salcido R.  “The 
Effects of an isotonic ankle dorsiflexor strengthening program on falling in a 
healthy elderly population.” AAP National Convention, Colorado Springs, CO.  
Platform 
Nov 1997
-
Atchison JW, Tran AH, and Nickerson RB.  "The availability of 
manual medicine instruction in PM&R training programs."  AAP National 
Convention, Las Vegas, NV. Poster
-
Bilkey W, Holmes T, Atchison JW, Stoll ST, Belfie A, and Tomski M
(faculty).  “Foolproof techniques for the manual medicine beginner.”   AAPM&R 
Annual Assembly, Atlanta, GA. Workshop; Sponsored by Manual Medicine SIG
-
Atchison JW, Holmes T, Belfie A, Stoll S, and Tomski M (faculty).   
“Diagnosis of low back pain secondary to SI joint or piriformis dysfunction.”  
AAPM&R Annual Assembly, Atlanta, GA.  Workshop; Sponsored by Manual 
Medicine SIG
-
Glassman J, Holmes T, Atchison JW, Belfie A, and Tomski M 
(faculty).  “Manual medicine approach to headaches which originate in the 
cervical 
38.1.13 PRESENTATIONS AT PROFESSIONAL MEETINGS (Continued)
spine.”  AAPM&R National Convention, Atlanta, GA. Workshop; Sponsored by 
Manual Medicine SIG.  
-
Atchison JW, Holsbeke M, and Jacob RP.  “An unusual case 
demonstrating the use of L1 and L2 selective nerve root blocks.” AAPM&R 
National Convention, Atlanta, GA. Poster
Nov 1998
-
Atchison JW.  “Advantages of oral narcotics in chronic spine pain.”  
AAPM&R National Convention, Seattle, WA
Feb 1999
-
Otis J, Robinson, ME, and Atchison JW.  “Long term narcotics for 
chronic pain: cognitive, neuromotor, and pain response.”  University of Florida, 
College of Health Profession’ Research Fair.  Gainesville, FL. Poster
-
Atchison JW.  “Efficacy of manipulative treatment.”  Association of 
Academic Physiatrists Annual Meeting.  San Antonio, TX  
Mar 2000
-
Robinson MJ and Atchison JW.  “Recent reports about using opiates to 
treat chronic pain.”  Association of Academic Physiatrists 36th Annual Meeting. 
San Diego, CA  (Presented by Michael J. Robinson, Ph.D.)
Nov 2000
-
Robinson M, Waxenberg L, Otis J, Atchison J, Radson E, and Lafayette-
Lucey A.  Effectiveness of oral opioids for chronic non-malignant pain.  American 
Pain Society 19th Annual Scientific Meeting.  Atlanta, GA.
Apr 2001
-
Atchison JW.  “Pain management: Everybody’s business.”  Rehab 2001:  
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From discovery to recovery.  Gainesville, FL
Nov 2001
-
Otis JD, Robinson ME, and Atchison JW.  “The comparison of
multidimensional pain measures: Use of a multitrait multimethod matrix 
technique.”  35th Annual Meeting of the Association for the Advancement of 
Behavior Therapy. Poster Session.  Philadelphia, PA
Mar 2002
-
Atchison JW.  “Teaching manual medicine techniques to residents.” 
Association of Academic Physiatrists Annual Meeting.  Las Vegas, NV
Jul 2002
-
Atchison JW.  “The treatment of acute musculoskeletal injury.”  Annual
Meeting of the Florida Society of the American College of Osteopathic Family 
Physicians.  Orlando, FL
Nov 2002
-
Atchsion JW.  “Cervical spine manipulation.”  American Academy of 
Physical Medicine and Rehabilitation Annual Assembly.  Orlando, FL
Mar 2003
-
Robinson ME, Atchison J W, Bulcourf BB, Lafayette-Lucey A, and
Berger J.  “Predicting adherence to pain rehabilitation: Patient and provider 
predictors.”  39th Annual Meeting Association of Academic Physiatrists.  Ft. 
Lauderdale, FL
Jan 2004
-
Atchison JW.  “What’s up with PM&R?”  Annual Disorders of the Spine.  
Sponsored by University of South Florida, Vancouver, BC, 
Canada
-
Atchison JW.  “Post-Op Pain Management.”  Annual Disorders of the Spine.  
Sponsored by University of South Florida, Vancouver, BC, Canada
Apr 2004
-
Atchison JW.  “Geriatric issues.”  Session A.  Emerging Concepts in the 
Diagnosis and Treatment of Pain: An Intensive and Comprehensive Review.  
American Academy of Physical Medicine and Rehabilitation.  New Orleans, LA
Apr 2004
-
Atchison JW.  “Pain issues of pregnancy.”  Session B.  Emerging                                           
Concepts in the Diagnosis and Treatment of Pain: An Intensive and 
Comprehensive Review.  American Academy of Physical Medicine and 
Rehabilitation.  New Orleans, LA
38.1.14 PRESENTATIONS AT PROFESSIONAL MEETINGS (Continued)
-
Atchison JW.  “Modalities - traditional.”  Session 4.  Emerging Concepts in the 
Diagnosis and Treatment of Pain: An Intensive and Comprehensive Review.  
American Academy of Physical Medicine and Rehabilitation.  New Orleans, LA
-
Atchison JW.  “Complementary and alternative medicine (CAM) – Manual TX.”  
Session 6.  Emerging Concepts in the Diagnosis and Treatment of Pain: An 
Intensive and Comprehensive Review.  American Academy of Physical Medicine 
and Rehabilitation.  New Orleans, LA
-
Atchison JW.  “Acute, trauma-related issues.”  Session 18  Emerging
Concepts in the Diagnosis and Treatment of Pain: An Intensive and 
Comprehensive Review.  American Academy of Physical Medicine and 
Rehabilitation.  New Orleans, LA
May 2004
-
Hirsh AT, Chung SK, O’Brien EM, George SZ, Cianfrini L, Atchison 
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JW, Gremillion H, Waxenberg LB, and Robinson ME.  “Does the catastrophizing 
subscale of the coping strategies questionnaire provide unique information 
regarding the pain experience?”   2nd Joint Scientific Meeting of the American 
Pain Society and Canadian Pain Society (poster session).  Vancouver, BC, Canada
May 2004
-
Edwards PS, Riley JL, Brown JL, George SZ, Fillingim RB, Waxenberg
LB, Atchison JW, Wittmer V, and Robinson MF.  Patients success criteria 
predicted by distress and expectation for treatment.”  2nd Joint Scientific 
Meeting of the American Pain Society and Canadian pain Society (poster 
session).  Vancouver, BC, Canada
May 2004 
-
Brown JL, Edwards PS, George SZ, Fillingim RB, Waxenberg LB, 
Atchison JW, Gremillion HA, and Robinson ME.  “Patient centered success 
criteria and expectations for treatment: A comparison of spine pain and facial 
pain patients.” 2nd Joint Scientific Meeting of the American Pain Society and
Canadian Pain Society (poster session).  Vancouver, BC, Canada
Jun 2004
-
Dannecker EA, Robinson ME, and Atchison JW.  “Sex differences in 
RPE and pain during eccentric contractions.  “ American College of Sports 
Medicine.  51st Annual Meeting.  Indianapolis, IN
-
Atchison JW.  “Manual medicine:  Is there a role in acute and chronic 
low back pain?”  Controversies in Pain Management Course.  Rehab Institute of 
Chicago, Chicago, IL
Jul 2004
-
Atchison JW.  “Sacroiliac and piriformis dysfunction.”  Charlotte 
Institute of Rehabilitation.  Carolinas Medical Center.  Charlotte, NC
Sep 2004
-
Thomas P and Atchison JW.  “Coming to terms with the concept of
“medical necessity” in medical rehabilitation.”  American Congress of 
Rehabilitation and American Society of Neurorehabiltation Joint Conference.  
Ponte Verda Beach, FL
Oct 2004
-
Atchison JW.  “The Burden of Neuropathic Pain: A Multidisciplinary 
Approach Yields a Successful Outcome.” American Academy of Physical Medicine 
and Rehabilitation Annual Meeting.  Sponsored by the Dannemiller Memorial 
Foundation and Embryon, and is supported by an unrestricted educational grant 
from Pfizer Inc.  Phoenix, AZ
Nov 2004
-
Atchison JW.  “Manual medicine: An evidence based medicine review.”  
American Association of Electrodiagnostic Medicine 51st Annual Scientific 
Meeting. Savannah, GA
Jan 2005
-
“Discogenic Pain: Initial Treatment and When to Refer to a Surgeon.”  
Annual Disorder of the Spine.  Sponsored by University of South Florida, 
Vancouver, BC, Canada
38.1.15 PRESENTATIONS AT PROFESSIONAL MEETINGS (Continued)
-
“Discogenic Pain: Post-op and Chronic Pain Management.”  
Annual Disorder of the Spine.  Sponsored by University of South Florida, 
Vancouver, BC, Canada
May 2005
-
Atchison JW.   “Modalities – traditional and non-traditional, acupuncture 
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and manipulation.”  Session 9.  Emerging Concepts in the Diagnosis and 
Treatment of Pain: An Intensive and Comprehensive Review.  American Academy 
of Physical Medicine and Rehabilitation.  New Orleans, LA
-
Atchison JW.  “Opioid pharmacology II.”  Session 21.  Emerging Concepts in the 
Diagnosis and Treatment of Pain: An Intensive and Comprehensive Review.  
American Academy of Physical Medicine and Rehabilitation.  New Orleans, LA 
-
Atchison JW.  “Diagnosis of neck pain.”  Session 30.  Emerging Concepts in the 
Diagnosis and Treatment of Pain: An Intensive and Comprehensive Review.  
American Academy of Physical Medicine and Rehabilitation.  New Orleans, LA
-
Atchison JW.  “Treatment of low back pain.”  Session 37.  Emerging Concepts in 
the Diagnosis and Treatment of Pain: An Intensive and Comprehensive Review.  
American Academy of Physical Medicine and Rehabilitation.  New Orleans, LA
-
Atchison JW. “Pain in medical diseases.” Session P1. Emerging Concepts in the
Diagnosis and Treatment of Pain: An Intensive and Comprehensive Review.  
American Academy of Physical Medicine and Rehabilitation.  New Orleans, LA
May 2005
-
Atchison JW.  “Acute, trauma-related issues.”  Session P2.  Emerging
Concepts in the Diagnosis and Treatment of Pain: An Intensive and 
Comprehensive Review.  American Academy of Physical Medicine and 
Rehabilitation.  New Orleans, LA
-
Atchison JW.  “Post-op pain management.”  Session P3.  Emerging
Concepts in the Diagnosis and Treatment of Pain: An Intensive and 
Comprehensive Review.  American Academy of Physical Medicine and 
Rehabilitation.  New Orleans, LA
-
Atchison JW.  “Geriatric issues.”  Session P7.   Emerging Concepts in the 
Diagnosis and Treatment of Pain: An Intensive and Comprehensive Review.  
American Academy of Physical Medicine and Rehabilitation.  New Orleans, LA
Jun 2005
-
Atchison JW.  “Modalities – traditional and non-traditional, acupuncture 
and manipulation.”  Session 7.  Emerging Concepts in the Diagnosis and
Treatment of Pain: An Intensive and Comprehensive Review.  American Academy 
of Physical Medicine and Rehabilitation.  San Francisco, CA
-
Atchison JW. “Non-opioid analgesics: NSAIDs, and COX-2 inhibitors, 
corticosteroids, antispasmodics.” Session 14. Emerging Concepts in the Diagnosis 
and Treatment of Pain: 
An Intensive and Comprehensive Review.  American Academy of Physical 
Medicine and Rehabilitation.  San Francisco, CA
-
Atchison JW.  “Opioid pharmacology II.”  Session 19.  Emerging Concepts in the 
Diagnosis and Treatment of Pain: An Intensive and Comprehensive Review.  
American Academy of Physical Medicine and Rehabilitation.  San Francisco, CA
-
Atchison JW.  “Treatment of low back pain.”  Session 33.  Emerging 
Concepts in the Diagnosis and Treatment of Pain: An Intensive and
Comprehensive Review.  American Academy of Physical Medicine and 
Rehabilitation.  San Francisco, CA
-
Atchison JW. “Diagnosis of neck pain.”  Session 30.  Emerging
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Concepts in the Diagnosis and Treatment of Pain: An Intensive and 
Comprehensive Review.  American Academy of Physical Medicine and 
Rehabilitation. San Fransisco, CA
38.1.16 PRESENTATIONS AT PROFESSIONAL MEETINGS (Continued)
Oct 2005
-
Atchison JW. “Improving Outcomes for Patients with Chronic Pain.”  
Chronic Pain: Its Causes and Clinical Manifestations.  Pri-Med Regional Satellite
Symposium.  Baltimore, MD
-
Atchison JW. “Thoracic Spine – Role of Manual Therapy.”  American Academy of 
Physical Medicine and Rehabilitation 66th Annual Assembly.  Philadelphia, PA.
Jan 2006 
-
Atchison JW. “Sacroiliac and Piriformis Dysfunction.”  18th Annual 
Disorders of the Spine.  Sponsored by University of South Florida, Vancouver, BC, 
Canada
Jan 2006
-
Atchison JW. “Update on Electromyography.”  18th Annual Disorders of 
the Spine.  Sponsored by University of South Florida.  Vancouver BC, Canada
Nov 2006
-
Glassman JH, Holmes TG, Atchison JW, Garrison SJ. “Principles of Manual 
Medicine and Rehabilitation.”  American Academy of Physical Medicine and 
Rehabilitation.  Honolulu, Hawaii
Jan 2007
-
Atchison JW. “Physiatrists: Cervical Session.”  19th Annual Disorders of 
the Spine.  Sponsored by University of South Florida, Vancouver, BC, Canada.
-
Atchison JW. “Physiatrists: Pharmacologic Management.”  
Sponsored by University of South Florida, Vancouver, BC, Canada
-
Atchison JW. “Physiatrists: Thoraco-Lumbar Session.”  Sponsored 
by University of South Florida, Vancouver, BC, Canada
-
Atchison JW. “Pain Issues in the Elderly.”  Sponsored by University 
of South Forida, Vancouver, BC, Canada
Mar 2007
-
Atchison, JW. “Opiate Therapy, Narcotic Patient Contracts and Chronic 
Pain Management.”  American College of Osteopathic Family Physicians 44th 
Annual Convention, Kissimmee, Florida
Sep 2007
-
Atchison JW. “Topical Analgesics in the Management of Neuropathic 
Pain.”  Principles of Effective Pain Management: Focus on Topical Analgesia.  A 
CME Symposium, AAPM&R 68th Annual Assembly.  Sponsored by ENDO 
Pharmaceuticals.  Boston, MA.
Atchison JW. “Course 514, PASSOR: Therapeutic Exercise for 
Lumbar Spine Disorders. AAPM&R 68th Annual Assembly, Boston, MA
Jan 2008
-
Atchison JW. “New Post-Op Pain Management.”  20th Annual Disorders 
of the Spine.  Sponsored by the University of South Florida. Vancouver, BC, 
Canada
-
Atchison JW. “Evidence Based Evaluation and Treatment of Back 
Pain.”  Sponsored by the University of South Florida.  Vancouver, BC, Canada
Nov 2010
-
Glassman J, Holmes T, Atchison JW, Gay R, Schlinger M, Silverman J. 
“Principles of 
Manual Medicine.”  American Academy of Physical Medicine and Rehabilitation.  
Seattle, WA
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Nov 2010
-
Atchison, JW.  “Cervical Spine Mechanics – Muscle Energy Techniques.”  
Principles of Manual Medicine.  Seattle, WA
Nov 2010
-
Atchison, JW. “Principles of Mobilization with Impulse: High Velocity/Low 
Amplitude Thrust Technique.”  Principles of Manual Medicine.  Seattle, WA
Nov 2010
-
Atchison, JW.  “Spine Care for the Obese Patient.”  American Academy of 
Physical Medicine and Rehabilitation. Seattle, WA
Nov 2011
-
Atchison, JW.  “Best Papers”.  American Academy of Physical Medicine 
and Rehabilitation. 72nd Annual Assembly of AAPM&R.  Orlando, FL 
-
Atchison, JW.  “Manual Treatment of SI.” Principles of Manual Medicine.  72nd 
Annual Assembly of AAPM&R.  Orlando, FL
38.1.17 PRESENTATIONS AT PROFESSIONAL MEETINGS (Continued)
-
Atchison, JW. “Cervical Manipulation.” Principles of Manual Medicine. 72nd
Annual Assembly of AAPM&R.  Orlando, FL
April 2013
-
Atchison, JW. “New Sacroiliac Joint Interventional Procedure: A shot in 
the Dark or New                                         Techniques that work? AAPM’s 29th Annual Meeting. 
Fort Lauderdale, FL
-
Atchison, JW. “Structural and Functional Examination of the Cervical and 
Thoracic Spine”. AAPM’s 29th Annual Meeting. Fort Lauderdale, FL
-
Atchison, JW. “Epidemiology and Pathway to develop Lumbar Spinal Stenosis”. 
AAPM’s 29th Annual Meeting. Fort Lauderdale, FL
May 2013
-
Gagnon C, Atchison JW, Stanos SP. “Patients’ Perception of Change 
Following an                                                     Interdisciplinary Pain Management Program. 
American Pain Society Annual Meeting.                                             New Orleans, LA
October 2013 -
Atchison, JW. “ New Approaches and Treatment Consideration in Mild 
Moderate 
Musculoskeletal Pain”. AMCP Symposium, San Antonio, TX. 
March 2014
-
Atchison, JW. “Applying Interdisciplinary Principles of Pain Management 
to Persons  
With knee OA”. Management of Knee Osteoarthritis: What is Missing 
from the 
Treatment Guidelines.  AAPM 30th Annual Meeting, Phoenix, AZ.
-
Atchison, JW. “What not to Miss When the Young Patient Presents with Low 
Back Pain”. Updates in Chronic Pain Management in the Adolescent Population. 
AAPM 30Th Annual Meeting, Phoenix, AZ.
-
Atchison, JW. : “Osteopathic Manipulation (Muscle Energy) Techniques for 
Lumbar, Sacral and Pelvis Dysfunction: Demonstration”. Physical Examination 
and Differentiation of Lumbar Spine, SI Joint and Hip Joint Problems. AAPM 30th 
Annual Meeting, Phoenix, AZ.
November 2014-
Atchison, JW. “Manual Medicine for Low Back Pain”. AAPM&R 2014
Annual Assembly, San Diego, CA.
-
Atchison, JW. “Interdisciplinary Functional Restoration Pain Programs”. AAPM&R 
2014 Annual Assembly, San Diego, CA.
-
Atchison, JW. “How Much is Enough…Interdisciplinary Treatment 
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Time?”AAPM&R 2014 Annual Assembly, San Diego, CA.
-
Atchison, JW. “Manual Treatment for Cervical Pain and Headache”. AAPM&R 
2014 Annual Assembly, San Diego, CA.
March 2015
-
Atchison, JW. “ Structural and Functional Examination of the Cervical and 
Thoracic                       Spine”. AAPM 31st Annual Meeting, Washington, DC 2015.
-
Atchison, JW. “The Most Common Complaints of Knee Pain that Present in the 
office”. AAPM 31st Annual Meeting, Washington, DC 2015.
PEER-REVIEWED PUBLICATIONS 
Atchison J, Pelligrino M, Herbers P, and Matkovic V, "Hepatic encephalopathy mimicking stroke.  
A case Report."  Am J Phys Med Rehab 1992;71(2):114-118.
Atchison J, Wachendorf J, Haddock D, Mysiw J, Gribble M, and Corrigan J. "Hyponatremia
associated cognitive impairment in traumatic brain injury."  Brain Inj 1993;7(4):347-352.
Farrage JR, Salcido R, Atchison J, and Haglund B. "Compression syndrome involving lateral 
antebrachial cutaneous nerve in high level of quadriplegia."  J Am Paraplegia Soc 1994; 17:12-
14.
PEER-REVIEWED PUBLICATIONS (Continued)
Noble LJ, Salcido R, Atchison J, Walker MK, and Marshall R. "Improving functional mobility 
through exercise." Rehabil Nurs 1994; 3:23-29.
Atchison JW. "The use of exercise in the elderly to enhance functional mobility and prevent 
falls."  J Back Musculoskel Med 1994; 4:97-104.
Atchison JW, Bryan D, Lumm S, Morgan M, Nickerson N, Niehaus A, Stratton T, and Salcido R. 
"Dysphagia: diagnosis and treatment in Kentucky."  J Kentucky Med Assoc 1995; 93:203-210.
Atchison JW, Newman RL, and Klim GV. "Interest in manual medicine among residents in 
physical medicine and rehabilitation.  The need for increased instruction."  Am J Phy Med Rehab 
1995; 74(6):439-443.
Atchison JW and English WR. “Manipulative techniques for geriatric patients” Phy Med Rehab 
Clinics N Am 1996; 7(4):825-843.
Nickerson RB, Atchison JW, Van Hoose JD, and Hayes D: “Hiccups associated with lateral 
medullary syndrome.”  Am J Phy Med Rehab 1997; 76(2):144-146.
Atchison JW and Lafayette-Lucey, A.  “How to diagnose and manage neck pain.”  Int Med 1998; 
19(2):10-22. (Cover Story).
Brown SE, Atchison JW, Gnatz SM, and Cifu DX.  “Pain rehabilitation. 2. Documentation of 
acute, subacute, and chronic pain.”  In 1998 Study Guide.  Arch Phys Med Rehab 1998; 79:S54-
S59.
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Atchison JW, Taub NS, and Cifu DX.  “Pain rehabilitation.  4. New frontiers in the rehabilitative 
management of pain.”  In 1998 Study Guide.  Arch Phys Med Rehab 1998; 79:S65-S73.
Gnatz SM, Brown SE, Atchison JW, and Worsowicz GM.  “Pain rehabilitation.  5.  Pain 
assessment and management of common disorders.”   In 1998 Study Guide.  Arch Phys Med 
Rehab 1998; 79:S74-S76.
Robinson ME, Wise EA, Riley JL, and Atchison JW.  “Sex differences in clinical pain: a multi-
sample study.” J Clin Psych in Clin Settings 1998; 5(4):413-424. 
Atchison JW, “Manipulation for the treatment of occupational low back pain.”  Occup Med 
State of Art Rev 1998; 13(1):185-197.
Atchison JW, Taub, NS, Cotter, AC, and Tellis, A.  “Complementary and alternative medicine 
treatments for low back pain.”  In Low Back Pain, Lox, DM (ed), PM&R State of the Art Reviews; 
1999; 13(3):561-586.
Holmes T and Atchison JW.  “Manual medicine applied to the extremities.”  IN Manual 
Medicine, Tomski MA (ed), PM&R State of the Art Reviews; 2000 14(1):65-72.
Atchison JW.  “Manipulation efficacy: upper body.”  J. Back Musculo Rehab; 2000 15(1):3-15.
Ogle AA, Garrison SJ, Kaelin DL, Atchison JW, Park YI, and Currie DM.  “Roadmap to physical 
medicine and 
PEER-REVIEWED PUBLICATIONS (Continued)
rehabilitation: answers to medical students’ questions about the field. Am J Phys Med Rehabil 
2001; 80(3):218-224.
Currie, DM, Atchison JW, Fiedler IG. “The challenge of teaching rehabilitative care in medical 
school.  Acad Med; 2002  77(7):701-708.
Stoll ST, Russo DP and Atchison JW. “Physicians’ and patients’ attitudes toward manual 
medicine: implications for continuing medical education.” J Cont Educ Health Prof 2003 
23(1):13-20.
Robinson ME, Bulcourf B, Atchison JW, Berger JJ, Lafayette-Lucey A, Hirsh AT, Riley JL.  
Compliance in pain rehabilitation: patient and provider perspectives.  Pain Medicine 2004; 
5(1):66-80.
Hirsh A, Atchison JW, Berger JJ, Waxenberg LB, Lafayette-Lucey A, Bulcourf BB, and Robinson 
ME.  Patient satisfaction with treatment for chronic pain: predictors and relationship to 
compliance.  Clin J Pain 2005; 21(4):302-310.
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Dannecker EA, O’Connor PD, Atchison JW, Robinson ME.  The effect of eccentric strength 
testing on delayed-onset muscle pain.  J Strength Conditioning Res 2005; 19(4):888-892.
Robinson ME, Dannecker EA, George SZ, Otis J, Atchison JW, Fillingim RBl  “Sex differences in 
the associations among psychological factors and pain report: a novel psychophysical study of 
patients with chronic low back pain.  J Pain (July) 2005; 6(7):463-470.
Robinson ME, Brown JL, George SZ, Edwards PS, Atchison JW, Hirsh AT, Waxenberg LB, Wittmer 
V, Fillingim RB, (2005).  Multidimensional success criteria and expectations for treatment of 
chronic pain: the patient perspective.  Pain Medicine, 6(5), 336-345.
Hirsh AT, Waxenberg LB, Atchison JW, Gremillion HA, Robinson ME Evidence for sex differences 
in the relationships of pain, mood and disability. J Pain (August), 2006;7(8):592-601.
O’Brien EM, Atchison JW, Gremillion HA, Waxenberg LB, Robinson, ME.  Somatic 
focus/awareness: Relationship to negative affect and pain in chronic pain patients.  European 
Journal of Pain 2008;12:104-115.
Brown JL, Edwards PS, Atchison JW, Lafayette-Lucey A, Wittmer V, Robinson ME.  Defining 
patient-centered, multidimensional success criteria for treatment of chronic spine pain.  Pain 
Medicine 2008;9(7):851-62.
O’Brien EM, Waxenberg LB, Atchison JW, Gremillion HA, Staud RM, McCrae CS.  Negative Mood 
Medicate the Effect of Poor Sleep on Pain Among Chronic Pain Patients.  Clin J Pain (May) 
2010;26(4):310-9.
Atchison JW, Indelicato P, George S, Lentz T, Vincent K, Moser M, Day T, McDonald K, Tillman S. 
Preliminary Results of Patient-Defined Success Criteria for Individuals with Musculoskeletal Pain 
in Outpatient Physical Therapy Settings.  Arch PMR. October 2010 Accepted for publication.
Atchison, JW, Vincent HK.  Obesity and low back pain: relationships and treatment.  Pain 
Management.  (Jan) 2012;2(1):79-86.
PEER-REVIEWED PUBLICATIONS (Continued)
Sanderson KB, Roditi D, George SZ, Atchison JW, Banou E, Robinson ME.  Investigating patient 
expectations and treatment outcome in a chronic low back pain population.  J Pain Research. 
January 2012 Accepted for publication.
Sanderson KB, Roditi D, George SZ, Atchison JW, Banou E, Robinson ME. Investigating patient 
expectations and treatment outcome in a chronic low back pain population. J Pain Res. 
2012;5:15-22.doi:10.2147/JPR.S28636.Epub 2012 Jan 31. 
Wandner LD, Heft MW, Lok BC, Hirsh AT, George SZ, Horgas AL, Atchison JW, Torres CA, 
Robinson ME. The impact of patients’ gender, race, and age on health care professionals’ pain 
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management decisions: An online survey using virtual human technology. Int J. Nurs Stud. 2013 
Sep 29. Pii:S0020-7489(13)00272-1.doi:10.1016/j.ijnurstu.2013.09.011.[Epub ahead of print]
39.0
BOOK CHAPTERS
Atchison JW, Stoll S, and Gilliar WG. "Manipulation, traction and massage.” Chapter 21 In 
Physical Medicine and Rehabilitation, Braddom RL (ed), WB Saunders, Philadelphia.  1995; 421-
448.
Atchison JW.  “Manipulation.”  In The Nonsurgical Management of Acute Low Back Pain.  
Cutting Through the AHCRP Guidelines, Gonzalez, E and Matterson, R (ed), Demos Vermande, 
New York.  1997; 187-198.
Atchison JW, Newman RL, and Klim GV.  “Interest in manual medicine among residents in 
physical medicine and rehabilitation:  the need for increased instruction.”  In The Year Book of 
Chiropractic, Mosby Press, St. Louis, MO; 1998; 3-4.
Atchison JW.  “Manual Medicine.”  Chapter 9 In Occupational Low Back Pain: Aggressive 
Nonsurgical Care, Kaplansky, BD (ed).  CRC Press/Lewis Publishers, Boca Raton, FL. Pp 171-200; 
2000. 
Atchison JW, Stoll S, and Cotter, AC. "Manipulation, traction and massage.” Chapter 20 In 
Physical Medicine and Rehabilitation, 2nd Edition, Braddom RL (ed), WB Saunders, PA. Pp 392-
412; 2000.
40.0
Atchison JW.  “The efficacy of manipulative therapy” Chapter 2 in Alternative Medicine and 
Rehabilitation:  A Guide for Practitioners, Wainapel SF and Fast A (eds). Demos Vermande, NY. 
Pp 31-58; 2003.
PUBLICATIONS - NATIONAL MEETINGS: COURSE LITERATURE
Atchison JW.  “Geriatric, rheumatologic, and stroke and neurologic diseases rehabilitation 
SIGs:  shoulder pain and dysfunction in the disabled person. The hemiplegic shoulder: anatomy
and kinesiology.”  56th Annual Assembly Am Acad Phys Med Rehab, 1994; 200-207.
Atchison JW. “Manual medicine SIG: neck pain and cervical manipulation. Neck pain: 
relevance, etiology, and pathological changes associated with acute and chronic neck pain.”  57th
Annual Assembly Am Acad Phys Med Rehab, 1995; 1058-1062.
PUBLICATIONS IN PREPARATION
ABSTRACTS
Atchison J, Pelligrino M, Herbers P, and Matkovic V.  "Hepatic encephalopathy mimicking 
stroke." Arch Phys Med Rehab, 1989; 70(11): A-73.
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Atchison J, Rindler J, Haddock D, and Saneda D, Pease W.  "Rehabilitation  following arsenic 
poisoning." Arch P Med Rehab; 1990; 71(10):792.
Atchison J, Wachendorf J, Gribble M, Corrigan J, and  Mysiw J.  "Hyponatremia associated 
cognitive impairment in traumatic brain injury." Arch Phys Med Rehab, 1990; 71(10):816.
Atchison J and Waylonis G.  "Manipulative medicine."   Arch Phys Med Rehab, 1990; 
71(10):836.
Atchison J, McDonough N, Shamir D, Powers J, Waylonis G, and Pease W.  "Electrodiagnostic 
exposure during physical medicine and rehabilitation residency training."  Am J Phys Med 
Rehab; 1991; 70(4):228.
Salcido R, Atchison J, and Costich J.  "PM&R in a required geriatrics rotation for third-year 
medical students." Am J Phys Med Rehab, 1992; 71(4):248.
Salcido R, Farrage J, Lindsey R, and Atchison J. "Painful compression of the lateral antebrachial 
cutaneous nerve in C5-C6 quadriplegia."   Arch Phys Med Rehab, 1992; 73(10):960.
Atchison J, Salcido R, Noble L, Marshall R, and Walker M.  "Improved functional mobility 
through quadriceps strengthening in an elderly population." Arch Phys Med Rehab, 1992; 
73(10):972.
Farrage JR, Salcido R, Atchison JW, Stanos SP, and Stracener WA. "The efficacy of impedance 
plethysmography for detecting deep venous thrombosis in patients following stroke at a free-
standing rehabilitation hospital."  Arch Phys Med Rehab, 1993; 74(11):1277.
Farrage JR, Salcido R, Atchison J, and Haglund B. "Compression syndrome involving lateral 
antebrachial cutaneous nerve in high level of quadriplegia."   J Am Paraplegia Soc, 1993; 
16(4):249.
Atchison JW, Nickerson RB, McDowell SM, and Turner HS.  "Use of a university-based student 
health clinic to promote and educate PM&R residents."  Arch Phys Med Rehab, 1994; 
75(9):1037-1038.
Newman RL, Atchison JW, and Klim GV. "The perceived need for increased training in Manual 
medicine by residents in PM&R."  Am J Phys Med Rehab, 1994; 73:143. 
Atchison JW, Stine R, Sampson J, Oeffinger D, Shapiro R, and Salcido R. "Electromyographic and 
kinematic analysis of the hemiplegic shoulder in comparison to healthy elderly males." 
Seventh World Congress of The International Rehabilitation Medicine Association.  Final 
Program and Book of Abstracts. 1994, Pg. A68.
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Nickerson RB, Van Hoose J, Hayes D, and Atchison JW.  "Hiccups associated with lateral 
medullary syndrome." Am J Phys Med Rehab, 1995; 74(2):176.
Stoll ST and Atchison JW. "Comparison of primary care physicians' and patients' attitudes 
toward manual medicine." Arch Phys Med Rehab, 1995; 76(11):1027.
ABSTRACTS (Continued)
Atchison JW, Noble LE, Salcido RM, Herrel P, and Donofrio JC.  "Maintenance of improved 
strength and functional mobility 18 months following an isotonic quadriceps exercise program."  
Arch Phys Med Rehab, 1995; (11):1034.
Atchison JW, Oeffinger D, Johnson D, Simpson C, and Salcido RM. "Increased isotonic ankle
dorsiflexor strength in a healthy elderly population with an eight-week exercise program." Arch 
Phys Med Rehab, 1995; 76(11):1034.
Atchison JW, Simpson L, Knapp L, Oeffinger D, and Mainous III A.  "Increased isotonic 
quadriceps strength following stroke with a six-week exercise program." Arch Phys Med Rehab, 
1995; 76(11):1041.
Atchison JW, Tran AH, and Nickerson RB.  “The availability of manual medicine instruction in 
PM&R training programs.”  Am J Phys Med Rehab, 1996; 75(2):155.
Atchison JW, Knapp L, Oeffinger D,  Mainous III A, and Salcido RM.  "The risk of post-stroke falls 
based on timed up & go testing and isotonic quadriceps weight lifting." Arch Phys Med 
Rehab, 1996; 77(9):932.
Knapp L, Atchison JW, Shapiro R, Salcido RM, and Abbas J.  “Electromyographic and  kinematic 
analysis of the 
painful hemiplegic shoulder before and after subscapularis motor point block." Arch Phys Med 
Rehab, 1996; 77(9):925.
Currie, DM, Atchison JW, Fiedler IG. “The challenge of teaching rehabilitative care in medical 
school.  Acad Med; 2002  77(7):701-708.
Atchison JW, Nickerson R, and Tharp D.  "Innovations in exercise prescriptions: videotaping 
manual medicine treatment programs to be used at home or with a therapist." Arch Phys Med 
Rehab, 1996; 77(9):956.
Atchison JW, Stoll ST, and McDowell S.  "Manipulation under local anesthesia: Lumbar 
sympathetic blocks followed by high-velocity, low-amplitude treatment." Arch Phys Med Rehab, 
1996; 77( 9):956.
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Atchison JW, Knapp, L, Oeffinger P, Bay S, Lang R, and Salcido R.   “The effect of an isotonic 
ankle dorsiflexion strengthening program on falling in a healthy elderly population.”  Am J Phys 
Med Rehab, 1997; 76(2):174.
Atchison JW, Holsbeke M, and Jacob, RP.  “An unusual case demonstrating the use of L1 and L2 
selective nerve root blocks.”  Arch Phys Med Rehab, 1997; 78(9):1040.
Garrison SJ, Fuoco GS, and Atchison JW.  “Interest in manual medicine among residents in 
physical medicine and rehabilitation: comparisons of residents surveyed in 1999 versus 1993.”  
Am J Phys Med Rehab, 2000, 79:217-218.
Robinson ME, Atchison JW, Gagnon C, Waxenberg L, and Lafayette-Lucey A.  “Opioids for 
treatment of chronic pain: Who says they work?” Arch Phy Med Rehab, 2002, 83:1668.
ABSTRACTS (Continued)
Robinson ME, Atchison JW, Gagnon C, and Lafayette-Lucey A.  Patient-centered outcomes in 
chronic pain:  How much pain relief is enough?”  Arch Phy Med Rehab, 2002, 83:1668
Robinson ME, Bulcourf B, Atchison J, Berger J, and Lafayette-Lucey A.  “Predicting adherence to 
pain rehabilitation: Patient and provider predictors.”  Am J Phys Med Rehab, 2003 , 82(3):249
Dannecker EA, Robinson ME, and Atchison JW.  Sex differences in PRE and pain during eccentric 
contractions. Med & Sci in Sports & Exer 2004 36(5):S223
Hirsh AT, Chung SK, O’Brien EM, George SZ, Cianfrini L, Atchison JW, Gremillion H, Waxenberg 
LB, and Robinson ME.  Does the Catastrophizing subscale of the coping strategies 
questionnaire provide unique information regarding the pain experience?  J Pain, 2004, 
5(3):S127
Edwards PS, Riley JL, Brown JL, George SZ, Fillingim RB, Waxenberg LB, Atchison JW, Wittmer V, 
Robinson ME. Patient’s success criteria predicted by distress and expectation for treatment.  J 
Pain, 2004, 5(3):S111
Brown JL, Edwards PS, George SZ, Fillingim RB, Waxenberg LB, Atchison JW, Gremillion HA, and 
Robinson ME. Patient centered success criteria and expectations for treatment:  A comparison 
of spine pain and facial pain patients.  J Pain, 2004, 5(3):S115
Zeppieri G, Lentz T, Atchison J, Indelicato P, Moser M, Vincent K, and George S.  Patient Defined 
Success Criteria in Outpatient Physical Therapy Settings.
Atchison JW, Vincent HK.  Obesity and low back pain: relationships and treatment. Pain 
Manage. 2012, 2(1), 1-xxx
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41.0
BOOK REVIEWS
Disorders of Peripheral Nerves 2nd Edition by H. Schaumburg, A. Berger and P. Thomas.  F.A. 
Davis Co., Philadelphia, PA.  Am J Phys med Rehab 1992;71(4):242
Principles of Manual Medicine: Muscle Energy and High Velocity Thrust Techniques by P.H. 
Greenman.  Williams & Wilkins, Baltimore, MD.  Am J Phys med Rehab 1992;71(6):358.
GRANT PROPOSALS:   PRINCIPAL INVESTIGATOR
Apr 1992
-
University of Kentucky, College of Medicine Research Fund.  “Improved 
functional mobility through exercise following stroke.”
Jul 1992
-
Retirement Research Foundation, Chicago, IL.  “Improved functional 
mobility through exercise following stroke.”  Funded for $35,848 (1/93-1/94).  
No cost extension to 1/96.
Mar 1993
-
University of Kentucky, College of Medicine Research Fund.  “Isotonic 
ankle dorsiflexor strengthening to improve functional mobility and decrease falls 
in an elderly population with borderline-safe ambulation skills”  Funded for 
$7,200.
-
Kentucky NIH/EPSCOR.  “Isotonic ankle dorsiflexor strengthening to
improve functional mobility and decrease falls in an elderly population with 
borderline-safe ambulation skills.”
GRANT PROPOSALS:  CO-INVESTIGATOR
Apr 1993
-
University of Kentucky, Medical Center Research Fund.  “Isotonic ankle
dorsiflexor strengthening to improve functional mobility and decrease falls in an 
elderly population with borderline-safe ambulation skills.”  Funded for $8,000.
Feb 1992
-
Sanders-Brown Center on Aging, Lexington, KY.  “Electromyographic 
and kinematic activity of  the normal and hemiparetic shoulder after stroke.”  
Funded                              for $10,000.
May 1992
-
National Institute for Occupational Safety and Health, Centers for Disease 
Control.   In association with the University of Kentucky Department of 
Preventive Medicine and Environmental Health.   “Cooperative Agreement 
Program for Centers for  Agricultural Research, Education and Disease and Injury 
Prevention - kinematic motion analysis of climbing by amputee farmers.”  
Funded for $33,677.  
Jan 1993
-
Retirement Research Foundation, Chicago, IL.  In association with 
Randall  Schleenbaker, M.D., University of Kentucky, Dept of Rehabilitation 
Medicine.  “Muscle strengthening as an intervention to improve recovery from 
near falls in the elderly.”  
Mar 1993
-
Whitaker Foundation, Mechanicsburg, PA.  “Effects of continuous Passive 
motion and neuromuscular electrical stimulation in the prevention of shoulder 
sequela of stroke.”  Initial Submission: Oct 1992.  Revision.
Oct 1994
-
National Institute of Health, Department of Health and Human Services, 
Washington, DC.  In association with Nancy Stiles, M.D., University of Kentucky, 
Dept of Internal Medicine and Geriatrics.  “Trial of occupational therapy for 
elders in primary care.”  Initial submission Resubmitted Oct 31, 1994.
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Feb 1996
-
Department of Health and Human Services, Public Health Service, 
Washington, DC. In association with Dr. Alexander Hadjipavlou, Department of 
Orthopaedics, University of Texas at Galveston Medical Branch.  “Port 2: chronic 
low back pain.”   
Oct 1997
-
National Institute of Mental Health, Washington, DC.  In association with 
Michael Robinson, Ph.D., University of Florida, Dept of Clinical Psychology.  
“Depression and clinical pain perception.”  Funded
-
National Institute of Health, Washington, DC.  In association with Michael 
Robinson, Ph.D., University of Florida, Dept of Clinical Psychology.  “Sex and 
gender role influences in pain and analgesia.”  Funded
-
National Institute of Health, Washington, DC.  With MichaelRobinson, PhD. “Pain 
and Depression.”  $103,000.
Jun 2001
-
National Institute of Health, Washington, DC. With Michael Robinson,
PhD.  “Effect of Long Term Opioid Use for Chronic Pain.” 
Feb 2002
-
National Institute of Health, Washington, DC.  With Michael Robinson, 
PhD. “Effect of Long Term Opioid Use for Chronic Pain.”  
Jan 2003
-
National Institute of Health, Washington, DC.  With Michael Robinson, 
PhD. “Patient Centered Outcomes.”
Jan 2004
-
National Institute of Health, Washington, DC.  “Locomotor experience 
applied post-stroke (LEAPS).  With Pamela W. Duncan, PhD, et al.  (SRH is a 
proposed study site.)
Feb 2004
-
National Institute of Health, Washington, D.C (R01).  With 
MichaelRobinson, PhD and Steve George, PhD.  “Pain treatment decisions:  
Influence of sex, race, and age.”
Aug 2004
-
Foundation for Physical Therapy.  With Steve George, PhD.  “Efficacy of 
slump stretch treatment:  A pilot randomized trial.”
Sep 2006
-
National Institute of Health/NINR, Washington, D.C.  With Michael 
Robinson, PhD.  “Pain Rehabilitation: Patient Centered Outcomes.”
2006
-
National Institute of Health.  Robinson ME, Atchison JW, et al.  
“Mechanisms of Neural                                           Mobilization for Chronic Pain.” 
Sep 2008 
-
National Institute of Health/NINR, Washington, D.C.  With Michael 
Robinson, PhD.  “Pain Treatment Decisions: Influence of Sex, Race and Age.” 
(9/1/2008 – 6/31/2012)
IRB PROPOSALS:  PRINCIPAL INVESTIGATOR
May 1992
-
University of Kentucky   IRB# 92-00090.  “Improved functional mobility 
through exercise in a stroke survivor population.” 
Mar 1992
-
University of Kentucky IRB# 93-00086.  “Isotonic ankle dorsiflexor 
strengthening to improve functional mobility and decrease falls in an elderly 
population with borderline-safe ambulation skills.”  
Mar 1993
-
University of Kentucky IRB# 93-00049.  “Improved physical mobility 
through exercise.”  
May 1993
-
University of Kentucky IRB# 93-00139.  “Electrodiagnostic evaluation of 
the lateral antebrachial cutaneous nerve following spinal cord injury.”  
Oct 1994
-
University of Kentucky IRB# 94-22056.  “Weight bearing status at the 
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time of admission to a rehabilitation hospital following orthopedic procedure.”
Feb 1995
-
University of Kentucky IRB# 95-22008.  “A survey of physical medicine 
and rehabilitation faculty in academic training programs to determine needs and 
interest in manual medicine.”  
Mar 1995
-
University of Kentucky IRB.  “Electromyographic and kinematic activity of 
the hemiplegic shoulder before and after subscapularis motor point block.”
May 2002
-
University of Florida IRB# 336-02 (now IRB 1-2004).  “Efficacy of 
supported standing in spinal cord injury during acute inpatient rehabilitation – A 
pilot study.”  
Sep 2003
-
University of Florida IRB# 2348-2003. “Progress in rehabilitation following 
orthopaedic injury correlated to analgesic medications prescribed: A comparison 
of patients in 1996 to 2001.”  
IRB PROPOSALS: CO-INVESTIGATOR
Feb 1993
-
University of Kentucky IRB# 93-22010.  “Manual medicine questionnaire
for rehabilitation medicine residents.”  
Jun 1993
-
University of Kentucky IRB# 93-30092.  “Electromyographic and 
kinematic activity of the normal and hemiparetic shoulder after stroke.”  . 
Jul 1998
-
University of Florida IRB# 233-94.  “Depression and clinical pain 
perception.  With Michael Robinson, PhD and Patrick O’Connor PT. 
May 1998
-
University of Florida IRB# 122-1998.  “Sex differences in emotional
response to pain.”   With Michael Robinson, PhD.
Aug 2002
-
University of Florida IRB# 421-2002.  “Pain rehabilitation:  patient 
centered outcomes.”  Michael Robinson, PhD, Fillingim, Roger B.; Waxenberg, 
Lori B. PhD.
42.0
Jun 2003
-
University of Florida IRB# 83-2003.  “Chronic analgesic 
medication for the treatment of chronic pain.”  With Michael 
Robinson, PhD.
-
University of Florida IRB# 116-2003.  “Behavioral interventions for 
chronic low back pain.”  With Steve George, PhD and Michael Robinson, PhD.
Jul 2003
-
University of Florida IRB# 350-2003.  ‘Pain rehabilitation: reliability
testing of the patient centered outcomes questionnaire.”  With Michael 
Robinson, PhD
IRB PROPOSALS:  CO-INVESTIGATOR (Continued)
-
University of Florida IRB# 327-2003.   “Fear of movement/anxiety disorder 
related to knee osteoarthritis.”  With Steve George, PhD and Michael Robinson, 
PhD
2007
- 
University of Florida IRB# 595-2007. “Rehabilitation and Therapy Outcomes in 
Patients with Lumbar Disorders.” (Co-I)
2008
-
University of Florida WIRB 2008.  “A Multi-center, Double-blind, Randomized 
Parallel-Group, Placebo Controlled Phase 2 Study of Once-Daily Subcutaneous 
Methylnaltrexone (MNTX) in the Treatment of Opioid-Induced Constipation 
During Rehabilitation After Orthopedic Procedures.” (Sub-I)
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-
National Institute of Health RO3 (collaborator) HK Vincent, PI.  
“Resistance exercise effects on fear avoidance beliefs and physical function in 
obese, older adults with chronic low back pain (in second review, NIAMS NIH 
subsection)
CONTINUING MEDICAL EDUCATION
Feb 1992
-
Association of Academic Physiatrists National Meeting, Orlando, FL
Aug 1992
-
“9th Annual Summer Aging Series.”  Saunders-Brown Center on Aging,
Lexington, KY
Sep 1992
-
“Geriatric rehabilitation issues.”  University of Kentucky Office of
Continuing Medical Education, Lexington, KY
-
Kentucky Medical Association/Kentucky Academy of PM&R Meetings,
Louisville, KY
Oct 1992
-
American Association of Electrodiagnostic Medicine National Meetings,
Charleston, SC
Nov 1992
-
American Association of Physical Medicine & Rehabilitation National
Meetings, San Francisco, CA
Feb 1993
-
“Bloodborne Pathogens.”  University of Kentucky. Lexington, KY
Mar 1993
-
“Updates in geriatrics.”  University of Kentucky Office of Continuing
Medical education and Sanders-Brown Center on Aging, Lexington, KY
May 1993
-
PM&R in the 21st century.”  Bruce Gans.  Kentucky Academy of PM&R 
Spring Meetings, Midway, KY
May 1993
-
Kentucky Osteopathic Medical Association Meetings, Louisville, KY
-
“Use of new generation calcium channel blockers.”  Barry McLain, 
MD, UAB.  Kentucky Horse Park, Lexington, KY
Jun 1993
-
“Stepwise use of anticonvulsant medications.”  J. John Dotson, MD, St.
Louis University.  Bravo Pitinos.  Lexington, KY
Jul 1993
-
“Surveyor Training.”  Commission on Accreditation of Rehabilitation 
Facilities, Tucson, AZ
Jul 1993
-
“Alzheimer’s disease:  theory, treatment and research.”  Bill Pert, MD, 
Vanderbilt University, Nashville, TN, New Orleans House
Sep 1993
-
Kentucky Medical Association/Kentucky Academy of PM&R Meetings, 
Louisville, KY
Oct 1993
-
“Stroke and related disorders – new approaches and practical solutions.” 
National Stroke Association ‘93 Symposium, Lexington, KY
Nov 1993
-
American Association of Physical Medicine and Rehabilitation National
Meetings, Miami Beach, FL
CONTINUING MEDICAL EDUCATION (Continued)
-
“Principles of manual medicine in physical medicine and rehabilitation.” 
Michigan State University, College of Osteopathic Medicine Course. 
Miami Beach, FL
Jan 1994
-
Association of Academic Physiatrists National Meetings, Naples, FL
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Apr 1994
-
Seventh World Congress of The International Rehabilitation Medicine
Association, Washington, DC
-
“Introduction to problem based learning for geriatrics preceptors.” 
University of Kentucky, Lexington, KY
May 1994
-
Kentucky Osteopathic Medical Association Annual Meetings.  
Louisville, KY
Sep 1994
-
Kentucky Medical Association/Kentucky Academy of PM&R Meetings.
Louisville, KY
Oct 1994
-
American Academy of Physical Medicine and Rehabilitation National 
Meeting.  Anaheim, CA
Dec 1994
-
“The use of oral medications in pain Management.”  Douglas Kennedy, 
MD, Private Practice Anesthesia Pain Management, Lexington, KY
Mar 1995
-
Association of Academic Physiatrists National Meetings. Phoenix, AZ
Apr 1995
-
“Updates in geriatrics.”  University of Kentucky Office of Continuing 
Medical Education and Sanders-Brown Center on Aging.  Lexington,
KY
Jun 1995
-
“PM&R in the 21st Century.”  Kentucky Academy of PM&R Spring 
Meetings.  Shelbyville, KY
-
Kentucky Osteopathic Medical Association Annual Meetings, Ft.
Mitchell, KY
Sep 1995
-
EWJ Society Reunion, The Ohio State University, Columbus, OH
Nov 1995
-
American Association of Physical Medicine and Rehabilitation National
Meetings, Orlando, FL
-
Comprehensive Spine Review Course, Chicago, IL
Jan 1996
-
Seventh Annual Osteopathic Winter Conference, Clearwater Beach, FL
Feb 1996
-
Association of Academic Physiatrist National Meetings, Las Vegas, NV
-
“Diagnosis and treatment of osteoporosis.”  University of Florida, Gainesville, FL
Apr 1996
-
“The physiatric approach to neck pain.”  American College of 
Occupational and Environmental Medicine Meetings, San Antonio, TX
Oct 1996
-
American Association of Physical Medicine and Rehabilitation National 
Meetings, Chicago, IL
Nov 1996
-
“New treatments in acute ischemic stroke.”  University of Florida, 
Gainesville, FL
Apr 1997
-
“Managing rehabilitation care by using critical pathways.”
Rehabilitation Foundation, Inc., Chicago, IL
May 1997
-
“Assessment and treatment of neuromuscular conditions in the work 
place.”  
American College of Occupational and Environmental Medicine, Orlando, FL
Jun 1997
-
“Accreditation standards for medical staff.”  Joint Commission on 
Accreditation of healthcare Organizations.  Falmouth, MS
Aug 1997
-
“Manual medicine.”  Kessler Institute for Rehabilitation, West Orange,NJ
CONTINUING MEDICAL EDUCATION (Continued)
Oct 1997
-
“Orthopaedic Grand Rounds.”  
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University of Florida, Department of Orthopaedic Survey, Gainesville, FL
Nov 1997
-
“Domestic violence education update.” University of Florida,
Department of  Orthopaedic Survey, Gainesville, FL
-
Annual Scientific Assembly of the American Association of Physical
Medicine and Rehabilitation, Atlanta, GA
Jan 1998
-
“9th Annual Osteopathic Winter Seminar.”  St. Petersburg, FL
Feb 1998
-
Association of Academic Physiatrists Annual Meeting, San Antonio, TX
Apr 1998
-
“3-D CT of congenital scoliosis.”  Dr. Charles H. Bush, Orthopaedic Grand 
Rounds.  University of Florida, Department of Orthopaedic Surgery, Gainesville, 
FL
May 1998
-
“Current advances in spinal cord injury rehabilitation.”  
American Osteopathic College of Rehabilitation Medicine.  Lake Buena Vista, FL
Sep 1998
-
“Avascular necrosis of the hip.” Orthopaedic Grand Rounds.
University of Florida, Department of Orthopaedics and Rehabilitation, 
Gainesville, FL
Oct 1998
-
American Association of Electrodiagnostic Medicine Annual Meeting.  
Orlando, FL
Nov 1998
-
Annual Scientific Assembly of the American Association of 
PhysicalMedicine and Rehabilitation, Seattle, WA
-
“Proximal humerus fractures treated with arthroplasty.”  Orthopaedic 
Grand Rounds.  University of Florida, Department of Orthopaedics and 
Rehabilitation, Gainesville, FL
Jan 1999
-
“The historical developments in total knee arthroplasty.”  Orthopaedic
Grand Rounds.  University of Florida, Department of Orthopaedics and 
Rehabilitation, Gainesville, FL
Feb 1999
-
Association of Academic Physiatrists 1999 Annual Meeting.  Orlando, FL
May 1999
-
“Kinematics of the knee and its implication for total knee prosthesis 
design.”  Orthopaedics Grand Rounds.  
University of Florida, Department of Orthopaedics and Rehabilitation, 
Gainesville, FL
Jul 1999
-
“19th Annual Convention and National Family Practice Update.” 
Florida Society American College of Osteopathic Family Physicians.  Orlando, FL
Nov 1999
-
“14th Annual Meeting.”  North American Spine Society.  Chicago, IL
-
“Treatment of open tibia fracture.”  Orthopaedic Grand Rounds. 
University of Florida, Department of Orthopaedics and Rehabilitation, 
Gainesville, FL
Jan 2000
-
“Synthetic calcium phosphates in orthopaedic surgery: HA-coated 
implants and skeletal                                          substitute materials.”  Orthopaedic Grand Rounds.  
University of Florida, Department                                            of Orthopaedics and Rehabilitation, 
Gainesville, FL
Oct 2000
-
“Motion Analysis.” Orthopaedic Grand Rounds.  
University of Florida, Department of Orthopaedics and Rehabilitation, 
Gainesville, FL
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Nov 2000
-
“Failed back surgery and adjacent segment disease.” Orthopaedic Grand 
Rounds.  University of Florida, Department of Orthopaedics and Rehabilitation, 
Gainesville, FL
-
“Annual Meeting.”  American Academy of Physical Medicine and 
Rehabilitation.  
San Francisco, CA.
Mar 2001
-
Orthopaedic Grand Rounds.  University of Florida, Department of 
Orthopaedics and Rehabilitation.  Gainesville, FL
Apr 2001
-
Orthopaedic Grand Rounds.  University of Florida, Department of
Orthopaedics and Rehabilitation.  Gainesville, FL
CONTINUING MEDICAL EDUCATION (Continued)
May 2001
-
Orthopaedic Grand Rounds. University of Florida, Department of
Orthopaedics and Rehabilitation.  Gainesville, FL
-
“Annual Meeting.”  American Spinal Injury Association.  Long Beach, CA.
Jun 2001
-
“CARF 101: Blueprint for success.  Building a strong foundation in medical 
rehabilitation.”  June 13-15, 2001.  Dallas, TX 
-
“33rd Annual Meeting.”  Southern Society of Physical Medicine and 
Rehabilitation.  
New Orleans, LA
Nov 2001
-
“Medical Directors Training Academy.”  National Association of   
Managed Care Physicians.  Charlotte, NC.
43.0
Jan 2002
-
“13th Annual Osteopathic Winter Seminar.”  
44.0
Pinellas County Osteopathic Medical Society.  
-
Orthopaedic Grand Rounds.  
-
University of Florida, Department of Orthopaedics and Rehabilitation.  
Gainesville, FL
May 2002
-
“Microsurgery.” Orthopaedic Grand Rounds.  
University of Florida, Department of Orthopaedics and Rehabilitation.  
Gainesville, FL
45.0
Sep 2002
-
“Thrombosis prophylaxis: new strategies for an old problem.”  
46.0
Orthopaedics & Rehabilitation Grand Rounds, University of Florida, 
47.0
Department of Orthopaedics and Rehabilitation.  Gainesville, FL
Nov 2002
-
American Academy of Physical Medicine and Rehabilitation Annual 
Assembly.  
Orlando, FL
Mar 2003
-
“39th Annual Meeting Association of Academic Physiatrist, Ft. Lauderdale, 
FL
May 2003
-
“Appropriate opioid pharmacotherapy for chronic pain management.” 
Discovery International.  Gainesville, FL
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Jul 2003
-
“Comprehensive pain board symposium.”  University of Wisconsin 
Medical School, Madison, WI
Sep 2003
-
“Interventional pain management symposium.”  American Society of 
Interventional Pain Physicians.  Washington, DC
Nov 2003
-
American Academy of Physical Medicine and Rehabilitation Annual 
Assembly.  Chicago, IL
Feb 2004
-
Florida Osteopathic Medical Association 101st Annual Meeting, Ft. 
Lauderdale, FL
Apr 2004
Emerging concepts in the diagnosis and treatment of pain: An intensive 
and comprehensive review.  American Academy of PM&R.  New Orleans, LA
May 2004
-
30th Annual Scientific Meeting of the American Spinal Injury Association. 
Denver, CO
Oct 2004
-
American Academy of Physical Medicine and Rehabilitation Annual
Assembly.  
Phoenix, AZ
Nov 2004
-
American Association of Electrodiagnostic Medicine.  51st Annual 
Scientific Meeting, Savannah, GA
Jan 2005
-
University of South Florida 17th Annual Disorders of the Spine Course.
Whistler, Canada
Mar 2005
-
Alachua County Medical Society Foundation.  We Care Program (patient 
care).  Gainesville, FL
Apr 2005
University of Florida, Department of Orthopaedics and Rehabilitation.  
Medical Grand Rounds.  Gainesville, FL
CONTINUING MEDICAL EDUCATION (Continued)
May 2005
Emerging concepts in the diagnosis and treatment of pain: An intensive 
and comprehensive review.  American Academy of PM&R.  New Orleans, LA
Jun 2005
Emerging concepts in the diagnosis and treatment of pain: An intensive 
and comprehensive review.  American Academy of PM&R.  San Francisco, CA
Sep 2005
University of Florida, Department of Orthopaedics and Rehabilitation.  
Medical Grand Rounds.  Gainesville, FL
2005 Florida Osteopathic Medical Association Mid-Year Seminar.  
Tampa, FL
Oct 2005
American Academy of Physical Medicine and Rehabilitation Annual 
Assembly.  Philadelphia, PA
Jan 2006
University of South Florida 18th Annual Disorders of the Spine Course.  
Whistler, Canada
Mar 2006
University of Florida, Department of Orthopaedics and Rehabilitation.  
Medical Grand Rounds.  Gainesville, FL
May 2006
University of Florida, Department of Orthopaedics and Rehabilitation.  
Medical Grand Rounds.  Gainesville, FL
Jun 2006
American Spinal Cord Injury Association/ISCoS Global Spinal Cord Injury 
Conference. Boston, MA
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Nov 2006
American Academy of Physical Medicine and Rehabilitation Annual 
Assembly.  Honolulu, HI
Nov 2006
Orthopaedics & Rehabilitation Medical Grand Rounds.  University of 
Florida.  Gainesville, FL.
Jan 2007
19th Annual Disorders of the Spine Disorder of the Spine Course.  
Whistler, Canada.
Jan 2007
Multidisciplinary Trauma Conference.  University of Florida College of 
Medicine.  Gainesville, FL.
May 2007
Managing Chronic Pain: Clinical, Ethical & Lawful Solutions.  The Medical 
Educational Council of Pensacola.  Gulf Breeze, FL.
May 2007
33rd Annual Scientific Meeting, American Spinal Injury Association, 
Tampa, FL.
Sep 2007
Florida Osteopathic Medical Association Mid-Year Seminar, Tampa, FL.
Sep 2007
American Academy of Physical Medicine and Rehabilitation 2007 Annual 
Assembly.  Boston, MA.
Jan 2008
20th Annual Disorders of the Spine Disorder of the Spine Course.  
Whistler, Canada
Feb 2008
University of Florida, Department of Orthopaedics And Rehabilitation 
Medical Grand Rounds, Medical Errors from a Spinal Perspective. Gainesville, FL.
Mar 2008
University of Florida, Department of Orthopaedics and Rehabilitation.  
Medical Grand Rounds.  Gainesville, FL
Jun 2008
American Spinal Injury Association 2008 Annual Meeting.  San Diego, CA
Jan 2009
University of Florida, Department of Orthopaedics and Rehabilitation.  
Medical Grand Rounds.  Gainesville, FL
Sep 2009
Florida Osteopathic Mid-year Seminar. Tampa, FL.
Oct 2009
American Academy of Physical Medicine and Rehabilitation 2009 Annual 
Assembly.  Austin, TX
Nov 2010
American Academy of Physical Medicine and Rehabilitation 2010 Annual 
Conference.  Seattle, WA
Nov 2010
American Academy of Physical Medicine and Rehabilitation – Manual 
Medicine (Faculty) Seattle, WA
CONTINUING MEDICAL EDUCATION (Continued)
Jul 2011
American College of Osteopathic Family Physicians 31st Annual 
Convention.
Sep 2011
9th Annual Medical Rehabilitation Conference/American Medical 
Rehabilitation Providers Association. South Beach, FL
Nov 2011
American Academy of Physical Medicine and Rehabilitation 2011 Annual 
Conference.  Orlando, FL
Feb 2012
Florida Osteopathic Medical Association 109th Annual Convention
Jan 2014
25th Annual Osteopathic Winter Seminar, Pinellas County Osteopathic 
Medical Society (PCOMS). Florida
April-May 2014
The 33rd Annual Scientific Meeting of the American Pain Society.
Tampa, FL
March 2015
31st AAPM Annual Meeting. Washington, DC
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CONTINUING MEDICAL EDUCATION – WRITTEN MATERIAL
Jan 1992
-
The Medical Letter and the Yale School of Medicine, Continuing Medical 
Education Program.  Exam #25
Jun 1992
-
American Association of Electrodiagnostic Medicine Training Program
Self-Assessment Examination
Jan 1993
-
The Medical Letter and the Yale School of Medicine, Continuing Medical 
Education Program.  Exam #27
Jul 1993
-
The Medical Letter and the Yale School of Medicine, Continuing Medical 
Education Program.  Exam #28
Jul 1994
-
The Medical Letter and the Yale School of Medicine, Continuing Medical 
Education Program.  Exam #30
Sep 1994
-
“HIV and the health care worker.” University of Washington, School of
Medicine, Office of Continuing Medical Education.  
Dec 1994
-
“Amyotrophic lateral sclerosis.”  American Association Electrodiagnostic
Medicine Case Report #5
Jan 1995
-
The Medical Letter and the Yale School of Medicine, Continuing Medical 
Education Program.  Exam #31
Feb 1995
-
“Diseases associated with excess motor unit activity.”  American 
Association of Electrodiagnostic Medicine Mimimonograph #44
-
“Monomelic amyotrophy.”  American Association of 
Electrodiagnostic Medicine Case Report #28
Dec 1995
-
“Intraoperative monitoring of peripheral and cranial nerves.”  American 
Association of Electrodiagnostic Medicine Minimonograph #42
-
“Neuromuscular problems in the performing arts.” American 
Association of Electrodiagnostic Medicine Minimonograph #43
Jun 1996
-
“Instrumentation and measurement in electrodiagnostic medicine.”
American Association of Electrodiagnostic Medicine Minimonograph 
#16
Jul 1996
-
“Prolonged paralysis after neuromuscular blockade.”  American 
Association of Electrodiagnostic Medicine Case Report #29
-
“The early development of electromyography.” American 
Association of Electrodiagnostic Medicine Minimonograph #45
CONTINUING MEDICAL EDUCATION – WRITTEN MATERIAL (Continued)
Oct 1996
-
The Medical letter and the Yale School of Medicine Continuing Medical 
Education Program Exam #33
-
“Multifocal motor neuropathy.” American Association of Electro-
diagnostic Medicine Case Report #30
Mar 1997
-
Neurogenic muscle hypertrophy.” American Association of Electro-
diagnostic Medicine Minimonograph #46
Mar 1997
-
“Single-fiber electromyography.” American Association of Electro-
diagnostic Medicine Case Report #25
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-
“Diabetic amyotrophy.” American Association of Electrodiagnostic 
Medicine Case Report #13
Sep 1997
-
“Normative data in electrodiagnostic medicine.” American Association 
of Electrodiagnostic Medicine Minimonograph #47
Nov 1997
-
The Medical Letter and the Yale School of Medicine, Continuing 
Medical Education Program.  Exam #35
Jan 1998
-
“HIV/AIDS update: a self-study course for primary health care
professionals.”  University of Florida, Office of Continuing Medical
Education, Gainesville.
-
“Autonomic nervous system testing.” American Association of Electro-                              
diagnostic Medicine Minimonograph #48
May 1998
-
“The electrodiagnosis of carpal tunnel syndrome.” American
Association of Electrodiagnostic Medicine Minimonograph #26
Oct 1998
-
“Somatosensory evoked potential.”  American Association of
Electrodiagnostic Medicine Minimonograph #19
Oct 1999
-
“Nerve injury associated with hip arthroplasty.”  American Association 
of Electrodiagnostic Medicine Case Report #32
-
“1998 AAEM Training Program Self-Assessment Examination.“ 
Jan 1999
-
The Medical Letter and the Yale School of Medicine continuing medical 
education program.  Exam No. 37.
Aug 1999
-
The Medical Letter and the Yale School of Medicine continuing medical
education program.  Exam No. 38.
Feb 2000
-
The Medical Letter and the Yale School of Medicine continuing medical
education program.  Exam No. 39.
Mar 2000
-
“New pharmacologic options for the management of neuropathic pain: a
practical treatment guide.  Dannemiller Memorial Educational Foundation.
Apr 2000
-
“Gullian-Barre Syndrome.”  American Association of Electrodiagnostic
Medicine.  Case Report #4.
Jun 2000
-
“Costoclavicular Mass Syndrome.”  American Association of
Electrodiagnostic Medicine.  Case Report # 33.
Jan 2001
-
“Electrodiagnostic Studies in Amyothrophic Lateral Sclerosis and Other
Motor Neuron Disorders.”  American Association of Electrodiagnostic Medicine.  
Mimimonograph #18.
-
“Botulism.”  American Association of Electrodiagnostic Medicine.  
Case Report #16.
May 2001
-
“Assessment test.”  Rehab in Review.
CONTINUING MEDICAL EDUCATION – WRITTEN MATERIAL (Continued)
Oct 2001
-
“Rehab in review assessment test.”  Spaulding Rehabilitation Hospital.  
Nov 2001
-
“Lawful prescribing and prevention of diversion.”  CME/CE 
Teleconference Series.
-
“Rehab in review assessment test.”  Spaulding Rehabilitation Hospital.
Dec 2001
-
“Rehab in review assessment test.”  Spaulding Rehabilitation Hospital.
Jan 2002
-
The Medical Letter and the Yale School of Medicine continuing medical
education program.  Exam No. 43.
-
“Advances in migraine prophylaxis program: Current state of the art and
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future prospects.”  Finch University of Health Sciences/The Chicago Medical 
School
Jun 2002
-
“Rehab in review assessment test.”  Spaulding Rehabilitation Hospital.
Oct 2002
-
“Rehab in review assessment test.”  Spaulding Rehabilitation Hospital.
Dec 2002
-
Contemporary Spine Surgery Volume 3 Issue 4.  Lippincott Williams & 
Wilkins.
-
The Medical Letter and the Yale School of Medicine Continuing Medical
Education Program.  Exam No. 45.
Feb 2003
-
Contemporary Spine Surgery Volume 3 Issue 3.  Lippincott Williams 
&Wilkins.
Mar 2003
-
“Urine Drug Testing in Primary Care.”  2002-2003 Monograph.  
California Academy of Family Physicians.
-
”2001 AAEM Training Program Self-Assessment Examination Review Session.”
American Association of Electrodiagnostic Medicine
-
“2001 AAEM Training Program Self-Assessment Examination.”  
American Association of Electrodiagnostic Medicine.
Apr 2003
-
“New analgesic options: Overcoming obstacles to pain relief.”  
University of Wisconsin, Continuing Medical Education.
Feb 2005
-
The Medical Letter and the Yale School of Medicine Continuing Medical
Education Program.  Exam No. 49.
Jan 2008
-
“Neuroimaging: Interpreting Addiction.”  Emerging Solutions in Pain.  
David Schyler, PhD. Medicom.
VI.
Study Roster  
This is a list of additional personnel (IRB-approved) who will be involved in the study (and who 
are not listed on the title page).  
Location 1:
Feinberg School of Medicine
Northwestern University
Dept of Physiology
Tarry Bldg 7th floor, 310 E Superior St.
Chicago, IL 60611
Etienne Vachon-Presseau, PhD
Postdoc – Data Analysis and Study Support
etienne.vachon.presseau@gmail.com
312-503-3039
Office 7-701
***works remotely most of time (email is best source of contact)
Melissa Farmer, PhD
Research Associate – Administrative Support
melissa-farmer@northwestern.edu
312-503-2562
Office 7-707
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Alexis (Alex) Baria, PhD
Lab Manager – Scanning and Analytical Support
axlebaria@gmail.com
Office 7-665 (Morton corridor)
312-503-3971
Mariam Ghantous, MD
Postdoc – Scanning and Study Support
Office 7-751
312-503-1319
Rami Jabakhanji, PhD
Research Associate – Scanning and Study Support
Office 7-701
312-503-3039
Maria Virginia (Marivi) Centeno, MS
Technician – Technical Support and Database Quality Control
marivicenteno@gmail.com
312-503-1703
Office 7-767
Lejian Huang, PhD
Research Associate – Data Quality Control and Preprocessing
lejian@gmail.com
312-503-3195
Office 7-763
Beth Hunt, MA
Research Coordinator and Recruiter (also aids in administrative duties)
beth.hunt@northwestern.edu
312-503-6475
Office 7-701
Taha Abdullah, MS
Research Coordinator/Study Leader
taha.b.abdullah@gmail.com 
312-503-0413
Office 7-731
Binbin Wu, MD
Visiting Scholar – Study support
Office 7-731
312-503-0413
Diane Reckziegel, PhD
Postdoc – Scanning and Study Support
312-503-3971
Office 7-705
Location 2:
Northwestern University Clinical and Translational Sciences Institute
(NUCATS)
750 North Lake Shore Drive
Floor 11
Chicago, IL 60611
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Priya Rakesh Tripathi
Regulatory Coordinator – Regulatory support and recruitment
priya.tripathi@northwestern.edu
312-503-4122
Ashley Sipocz
Research Project Coordinator – Regulatory support and recruitment
ashley.sipocz@northwestern.edu
312-503-2289 (desk #)
312-503-1709 (recruitment hotline #)
Annette Kinsella, RN, CCR
Clinical Research Nurse/Staff Educator/Trainer – bottling and blinding study agent
a-kinsella@northwestern.edu
312-503-2317
Location 3
Northwestern Memorial Hospital – Feinberg Pavilion
Research Pharmacy
251 E. Huron St.
LC-700
Chicago, IL 60611
Jane Regalado, Pharm D
Investigational Pharmacist – orders and encapsulates study agent
jregalad@nmh.org
312-926-7470
Location 4
Northwestern Memorial Hospital - Arkes Family Pavilion
676 North St. Clair St.
Diagnostic Testing Center (DTC)
Suite 280
Chicago, IL 60611
This center provides labs and phlebotomy services on an out-patient basis.  This location is listed 
as a back-up in case the study staff is unable to draw blood at the first visit. Staff will fill out 
necessary form prior to escorting participant to this location and wait with them until their labs are 
taken.
Location 5
Northwestern University, Feinberg School of Medicine
Department of Physical Medicine & Rehabilitation,
10th floor Abbot Hall, 710 N Lake Shore Dr
Chicago, IL 60611
Julia Marks,
Clinical Research Manager, Study Support and Phlebotomy 
julia.marks@northwestern.edu
312-503-1215
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Narina Simonian, BS, CCRC – Study Support and Phlebotomy 
Clinical Research Project Manager
n-simonian@northwestern.edu
312-503-5780
Amy Lange, R.N. – Study Support and Phlebotomy 
Research Coordinator
amy.lange@northwestern.edu 
312-503-9915
Katie Rankin, B.S. – Study Support and Phlebotomy 
Project Coordinator 
katie.rankin@northwestern.edu
312-503-4043
VII.
Schedule of Evaluations and Assessments
Before Study Begins (visit/week not applicable):
Purpose: Set up all parameters necessary for the study to run smoothly
List of Items to be Completed:

After approval from study sponsor, submit updated protocol and documentation to the 
Northwestern IRB for approval

Order encapsulated study drugs (placebo, naproxen, and omeprazole)

Order, bottle, and label rescue medication (acetaminophen)

Pharmacy will randomize drugs according to our block design (sect 4.3)

Create and organize participant folders

Begin recruitment and pre-screen interested for initial eligibility (sects 2.1 and 2.2)
Visit 1: Consent and Baseline Pain Monitoring (week -3): 
Purpose: Determine initial eligibility and collect the first of a subset of pre-treatment 
measurements; monitor baseline pain ratings without study interference
List of Items to be Completed:

Informed consent – read and discuss, signature obtained

Medical/pain history recorded 

Patient demographics recorded

Physical exam and Vitals: temperature, pulse, respiration, blood pressure, weight, 
height

Blood and urine collection: complete blood count, comprehensive chemistry panel 
including liver functions, pregnancy test (if applicable)

Review eligibility criteria

Review previous and current concomitant medications and side effects, if any, 
associated with them

Assess initial pain intensity 

Begin washout of current pain medications

Complete questionnaires***
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
Dispense rescue medication
Interim 1: Monitor App Use
Collect daily pain and mood ratings on the electronic phone/computer app; monitor for 
eligible pain range (see Visit 2, bullet point 1)
Visit 2: Baseline Pre-Treatment Scan 1 (week -1):
Purpose:  Collect the screening and safety measurements, complete the first scanning 
session, and continue to monitor pain ratings 
List of Items to be Completed:

Review interim VAS ratings for eligibility (≥ 5/10 pain on average over the 2 week period 
in Interim 1)

Collect current VAS pain intensity

Ask about any changes in clinical status since last visit

Complete scanning session: T1, Resting, DTI

Complete questionnaires***

Dispense rescue medication
Interim 2: Stratification
Purpose:  Use predictive model to stratify into placebo responders versus non-
responders
List of Items to be Completed:

Pre-process imaging data

Send data through the model and based on results, stratify into responders versus non-
responders

Send stratification result to the pharmacy so that they can randomize participant 
accordingly

Continue to monitor daily pain and mood app ratings
Visit 3: Randomization and Treatment starts (week 0):
Purpose:  Collect measurements and randomize; begin treatment (if applicable)
List of Items to be Completed:

Collect current VAS pain intensity

Collect adverse events/changes in health, if any

Document use of rescue medication 

Dispense additional rescue medication if needed

Vitals

Complete questionnaires***

If in treatment group, pharmacy will give participants their already randomized and 
blinded study medication and specific instructions for taking it; provide with additional 
rescue medication; if in no-treatment group, independent assessor will notify participant 
of this assignment 
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Interim 3: Monitor App Use and Agent Compliance
Purpose: Collect daily pain and mood ratings on the electronic phone/computer app; 
monitor study agent compliance and/or rescue medication use
Visit 4: Interim Monitoring Visit (week 3): 
Purpose: Collect measurements and continue treatment, if applicable
List of Items to be Completed:

This list is identical to that in Visit 3
Interim 4: Same as Interim 3
Visit 5: Post Treatment Scan (week 6)
Purpose: Collect measurements; complete second/last scanning protocol; begin study 
medication washout

Collect current VAS pain intensity

Collect adverse events, if any

Collect rescue medication

Complete T1, resting state, DTI, and pain rating scans

Questionnaires ***

Begin washout period and provide additional rescue medication
Interim 5: Same as Interim 1 
Visit 6: Final Visit (week 9)
Purpose: Collect measurements; end washout; complete study

Collect current VAS pain intensity

Collect adverse events, if any

Vitals

Questionnaires ***

Return of phone, if applicable
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VIII.
Biostatistician CV
Curriculum Vitae
Name                                James William Griffith
E-mail                                j-griffith@northwestern.edu jameswgriffith@gmail.com
License                             Clinical Psychology, State of Illinois, U.S.A. #071.007223
Citizenship                        United States of America

New Orleans VA Medical Center
EDUCATION

American Psychological Association (APA) accredited psychology Internship

Research areas: Cognition and emotional, longitudinal assessment of PTSD symptoms in Operation Desert 
Storm Veterans

The State University of New York at Binghamton

Doctor of Philosophy in Clinical Psychology, January 2004, Minor in Statistics (APA Accredited)

Master of Arts, Clinical Psychology, August 2001

Research areas: Depression and memory processes, life-events and mental health, comorbidity, 
psychological assessment

Temple University

Bachelor of Arts, Psychology, Magna Cum Laude, January 1998

HONORS AND AWARDS RECEIVED

Graduate student award for excellence in teaching

Tuition Scholarship at State University of New York (4 years)

Travel expense award for AABT awarded by the psychology department (3, approximately $125 each)

Temple University’s College of Arts and Sciences Dean’s Scholar (Spring 1997)

Dean’s List (Spring 1995, Fall 1995, Spring 1996, Spring 1997)

Member of Psi Chi (National Honors Society in Psychology)

Member of Golden Key Honor’s Society

RESEARCH EXPERIENCE

K.U.Leuven, Centre for Experimental Psychopathology, 25 October 2011-present

Senior visiting fellow
Conducted analyses of overgeneral memory, rumination and treatment outcome data

Northwestern University, Department of Medical Social Sciences, April 27th, 2009-
present

Research Assistant Professor

Oversaw taste, audition, and somatosensation teams for ~$25 million NIH Toolbox contract

Assisted with consulting to the pharmaceutical industry
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
Center on Outcomes Research and Education, July 15th, 2008-April 24th, 2009

Research Scientist

Oversaw taste, audition, and somatosensation teams for ~$25 million NIH Toolbox contract

Provided statistical consultation at internal medicine club

Northwestern University, Department of Psychology, August 2003-July 2008

Postdoctoral Fellow/Project Director

Oversaw a NIMH-funded, longitudinal multi-site study of risk for emotional disorders

Trained and supervised interviewers on the Structured Clinical Interviewer for DSM-IV and Hammen’s Life 
Stress Interview

Oversaw staff of project coordinators, graduate students, independent-study students, work-study
students, and volunteers

Coordinated screening of 200-300 adolescents per year and subsequent recruitment into longitudinal phase 
(cross-site N = 627)

Oversaw data processing and data analysis

Programmed computerized cognitive experiments in MediaLab and DirectRT

New Orleans VA Medical Center, July 2002-July 2003

Psychology Intern

Analysis of archival data of post-deployment psychopathology in ODS veterans

Designing computerized Stroop experiments (using E-Prime) for use with veterans

Attend research meetings and didactic seminars

Reviewed manuscripts and grant applications for various faculty members interested in PTSD and 
information processing

Pepper Research Lab, September 1998-July 2002

Graduate Student Staff Member

Designed and conducted experiments with human participants

Supervised undergraduate research assistants

Set up and maintained five-terminal local area network

Conducted diagnostic interviews as part of NIMH B-Start grant awarded to Dr. Carolyn Pepper (advisor)

Worked as paid research assistant on life events and mood disorder research (Summer 1998)

Temple University Social Phobia Program (the clinic is now called “Adult Anxiety 
Clinics at Temple”), February 1996-June 1998

Research Assistant

Made conceptual contributions to several research studies on the treatment outcome and etiology of social 
phobia

Interacted with research participants including college students and persons with psychiatric 
disabilities

Created Microsoft Access databases for several NIMH-funded research studies

Acted as liaison between lab and major computer vendor

Upgraded and maintained computer hardware and software

Maintained file backup system for lab computers

TEACHING EXPERIENCE

Center on Outcomes Research and Education, July 2008-April 2009

Developed logistic regression seminar for department of surgery

The State University of New York at Binghamton, September 1998-July 2002

Course Instructor

Instructor of record for undergraduate Statistics and Design course

Teaching assistant for graduate Statistics and Design I and II

Instructor for General Psychology Laboratory

Teaching assistant for undergraduate Statistics and Design
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
CLINICAL AND COMMUNITY 
EXPERIENCE

The Family Institute, August 2003-present

Affiliate Therapist

Conduct individual therapy with adults

New Orleans VA Medical Center, July 2002-July 2003

Psychology Intern

Conducted individual and group therapy for women who report past sexual trauma

Taught smoking cessation classes

Conducted individual and group psychotherapy for veterans with PTSD

Conducted compensation and pension evaluations

Syracuse VA Medical Center, September 2001-May 2002

Psychology Trainee

Administered neuropsychological and psychological testing and psychotherapy in behavioral health and 
primary care settings

Attended grand rounds and training seminars in topics such as PTSD and veteran culture

Consulted with supervising psychologists about data analysis for staff morale project 
Broome County Community Mental Health, September 1999-June 2000 
Administrative Trainee

Conducted and presented research on the functioning of Broome County’s mental health system

Provided consultation to Mental Health Commissioner regarding community research projects and 
interpretation of state, county, and agency mental health data

Interviewed local mental health professionals and consumers pursuant to gathering data to inform county 
mental health expenditures, program planning, and program development

Presented findings to Mental Health Commissioner’s advisory subcommittee

The Psychological Clinic (Student Clinic at SUNY), 1999-May 2002

Administered neuropsychological and psychological testing and psychotherapy

Cases included clients with major depressive disorder, generalized anxiety disorder, panic disorder, memory 
problems, and learning disabilities


TRAINING WORKSHOPS ATTENDED

22 May 2008: Mixed Models for Longitudinal Data Analysis. Facilitated by Donald Hedeker.

DEPARTMENTAL SERVICE

2010-2011: Search Committee for junior developmental neuroscientist

PUBLICATIONS
Griffith, J. W., Kleim, B., Sumner, J. A., & Ehlers, A. (in press). The factor structure of the Autobiographical 
Memory Test in recent trauma survivors. Psychological Assessment.
Griffith, J. W. (in press). Exploratory Factor Analysis. Encyclopedia entry to be published in the
Encyclopedia of Quality of Life Research.
Uliaszek, A. A., Zinbarg, R. E., Mineka, S., Craske, M. G., Griffith, J. W., Sutton, J. M., Epstein, A., & Hammen,
C. (in press). A longitudinal examination of stress generation in depressive and anxiety Disorders.
Journal of Abnormal Psychology.
Barnhofer, T., Duggan, D., & Griffith, J. W. (in press). Dispositional mindfulness moderates the relation 
between neuroticism and depressive symptoms. Submitted to Personality and Individual Differences.
Hahn, E. A., Choi, S. W., Griffith, J. W., Yost, K. J., & Baker, D. B. (2011). Health Literacy Assessment Using 
Talking Touchscreen Technology (Health LiTT): A New Item Response Theory-based Measure of Health 
Literacy. Journal of Health Communication, 16, 150-162. doi: 10.1080/10810730.2011.605434
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Prenoveau, J. M., Craske, M. G., Zinbarg, R. E., Mineka, S., Rose, R. D., & Griffith, J. W. (in press). Are anxiety 
and depression just as stable as personality during late adolescence? Results from a three-year longitudinal 
latent variable study. Journal of Abnormal Psychology.
Griffith, J. W., Sumner, J. A., Raes, F., Barnhofer, T., Debeer, E., & Hermans, D. (in press). Current psychometric 
and methodological issues in the measurement of overgeneral autobiographical memory. Journal of 
Behavior Therapy and Experimental Psychiatry.
Sumner, J. A., Griffith, J. W., & Mineka, S. (2011). Examining mechanisms of overgeneral autobiographical 
memory: Capture and rumination, and impaired executive control. Memory, 19, 169-183. 
doi:10.1080/09658211.2010.541467
Desai, H., Smutzer, G., Coldwell, S., & Griffith, J. W. (in press). Validation of edible taste strips for identifying 
PROP taste-recognition thresholds. The Laryngoscope.
Lewis, A. R., Zinbarg, R. E., Mineka, S., Craske, M. G., Epstein, A., & Griffith, J. W. (2010). The relationship
between anxiety sensitivity and latent symptoms of emotional problems: A structural equation modeling 
approach. Behaviour Research and Therapy, 48, 761-769. doi:10.1016/j.brat.2010.05.001
Sutton, J. M., Mineka, S., Zinbarg, R. E., Craske, M. G., Griffith, J. W., Rose, R. D., Waters, A. M., Nazarian, M.
& Mor, N. (2010). The relationships of personality and cognitive styles with self-reported symptoms of 
depression and anxiety. Cognitive Therapy and Research. doi: 10.1007/s10608-010-9336-9
Mennella, J. A., Lukasewycz, L. D., Griffith, J. W., & Beauchamp, G. K. (2011). Evaluation of the Monell
Forced-Choice, Paired-Comparison Tracking Procedure for Determining Sweet Taste Preferences across 
the Lifespan. Chemical Senses. doi:10.1093/chemse/bjq134
Sumner, J. A., Griffith, J. W., Mineka, S., Rekart, K. N., Zinbarg, R. E., & Craske, M. G. (2011). Overgeneral 
autobiographical memory and chronic interpersonal stress as predictors of the course of depression in 
adolescents. Cognition and Emotion, 25, 183-192. doi:10.1080/02699931003741566
Sumner, J. A., Griffith, J. W., & Mineka, S. (2010). Overgeneral autobiographical memory as a predictor of the 
course of depression: A meta-analysis. Behaviour Research and Therapy, 48, 614-625. PMCID: 
PMC2878838
Prenoveau, J. M., Zinbarg, R. E., Craske, M. G., Mineka, S. M., Griffith, J. W., Epstein, A. M. (2010). Testing a 
hierarchical model of anxiety and depression in adolescents: A tri-level model. Journal of Anxiety Disorders, 
24, 234-244.
Mor, N., Doane, L. D., Adam, E. K., Mineka, S., Zinbarg, R. E., Griffith, J. W., Craske, M. G., Waters, A., & 
Nazarian, M. (2010). Within-person variations in self-focused attention and negative affect in 
depression and anxiety: A Diary Study. Cognition and Emotion, 24, 48-62.
Adam, E. K., Doane, L. D., Zinbarg, R. E., Mineka, S., Craske, M. G., & Griffith, J. W. (2010) Prospective prediction 
of major depressive disorder from cortisol awakening responses in adolescence. 
Psychoneuroendocrinology, 35, 921-931. doi: 10.1016/j.psyneuen.2009.12.007
Zinbarg, R. E., Mineka, S., Craske, M. G., Griffith, J. W., Sutton, J., Rose, R. D., Nazarian, M., Mor, N., & Waters, 
A. (2010). The Northwestern-UCLA Youth Emotion Project: Associations of cognitive vulnerabilities, 
neuroticism and gender with past diagnoses of emotional disorders in adolescents. Behaviour Research 
and Therapy, 48, 347-358.
Griffith, J. W., Zinbarg, R. E., Craske, M. G., Mineka, S, Rose, R. D., Waters, A. M. & Sutton, J. M. (2010).
Neuroticism as a common dimension in the internalizing disorders. Psychological Medicine, 40,
1125-1136.
Griffith, J. W., Sumner, J. A., Debeer, E., Raes, F., Hermans, D., Mineka, S., Zinbarg, R. E., & Craske, M. G. 
(2009). An Item Response Theory/Confirmatory Factor Analysis of the Autobiographical Memory Test. 
Memory, 17, 609-623.
Uliaszek, A. A., Zinbarg, R. E., Mineka, S., Craske, M. G., Sutton, J. M., Griffith, J. W., Rose, R., Waters, A., &
Hammen, C. (2009). The Role of Neuroticism and Extraversion in the Stress-Anxiety and Stress-
Depression Relationships. Anxiety, Stress & Coping: An International Journal.
doi:10.1080/10615800903377264
Uliaszek, A. A., Hauner, K. K. Y., Zinbarg, R. E., Craske, M. G., Mineka, S., Griffith, J. W., & Rose, R. D. (2009).
An Examination of Content Overlap and Disorder-Specific Predictions in the Associations of Neuroticism 
with Anxiety and Depression. Journal of Research in Personality, 43, 785-794.
Craske, M. G., Waters, A. M., Nazarian, M., Mineka, S., Zinbarg, R. E., Griffith, J. W., Naliboff, B., & Ornitz, E.
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M. (2009). Does neuroticism in adolescents moderate contextual and explicit cue modulation of the startle 
reflex? Biological Psychiatry, 65, 220-226.
Prenoveau, J. M., Zinbarg, R. E., Craske, M. G., Mineka, S., Griffith, J. W., & Rose, R. D. (2009). Evaluating the
Invariance and Validity of the Structure of Dysfunctional Attitudes in an Adolescent Population.
Assessment, 16, 258-273.
Hauner, K. K. Y., Adam, E. K., Mineka, S., Doane, L. D., DeSantis, A. S., Zinbarg, R. E., Craske, M. E. & Griffith,
J. W. (2008). Neuroticism and introversion are associated with salivary cortisol patterns in 
adolescents. Psychoneuroendocrinology, 33, 1344–1356.
Mor, N., Zinbarg, R. E., Craske, M. G., Mineka, S., Uliaszek, A., Rose, R., Griffith, J. W., & Waters, A. (2008).
Evaluating the invariance of the factor structure of the EPQ-R-N among adolescents. Journal of 
Research in Personality, 90, 66-75.
Zinbarg, R. E., & Griffith, J. W. (2008). Behavior therapy. In J. L. Lebow (Ed.). Twenty First Century 
Psychotherapies. Hoboken, NJ: John Wiley & Sons.
Newcomb-Rekart, K., Mineka, S., Zinbarg, R. E., & Griffith, J. W. (2007). Perceived family environment and 
symptoms of emotional disorders: The role of perceived control, attributional style, and
attachment. Cognitive Therapy and Research, 31, 419-436.
Jeglic, E. L., Pepper, C. M., Ryabchenko, R. A., Griffith, J. W., Milller, A. B. & Johnson, M. (2005). Coping with a 
partner’s depression: A caregiving model. Family Relations, 54, 37-45.
Ryabchenko, K. A., Pepper, C. M., Jeglic E. L., Griffith, J. W., & Miller, A. B. (2004). Differences in course and 
comorbidity of recurrent depression in primary care and psychiatric populations. Depression and Anxiety, 
20, 153-154.
Griffith, J. W. (2003) The Cochran’s Q. In M. Lewis-Beck, A. E. Bryman, & T. F. Liao (Eds.). Sage Encyclopedia of 
Social Science Research Methods. Sage Publications: Thousand Oaks, CA.
Griffith, J. W. (2001). Professionals’ beliefs regarding child sexual abuse: Assessment and treatment 
implications. The Journal of Threat Assessment, 1, 35-61.

MANUSCRIPTS SUBMITTED FOR 
PUBLICATION
Uliaszek, A. A., Zinbarg, R. E., Mineka, S., Craske, M. G., Sutton, J. M., Griffith, J. W., Rose, R., Waters, A., & 
Hammen, C. The Role of Personality in the Stress-Depression and Stress-Anxiety Relationships. 
Submitted to Personality and Individual Differences.
Schoofs, H., Raes, F., Griffith, J. W., & Hermans, D. (2011). Rumination Relates to Reduced
Autobiographical Memory Specificity in Formerly Depressed Patients Following a Self-Discrepancy 
Challenge: The Case of Autobiographical Memory Specificity Reactivity. Submitted to Behavior Research and 
Therapy.

MANUSCRIPTS UNDER 
REVISION
Griffith, J. W., Zinbarg, R. E., Mineka, S., Sutton, J. & Craske, M. G. Association of neuroticism and cognitive 
vulnerability for depression.
Griffith, J. W. Warrier, C., Zecker, S. Siegle, J. H, & Dhar, S. An item response theory analysis of the Hearing 
Handicap Inventory.
Griffith, J. W., Constans, J. I., Brailey, K., & Vasterling, J. J. Cognitive bias in posttraumatic stress disorder
(PTSD): Impact of a trauma-related stressor on the emotional Stroop task.

MANUSCRIPTS IN PREPARATION
Salsman, J. M., Butt, Z., Pilkonis, P. A., Cyranowski, J. M., Zill, N., Hendrie, H. C., Kupst, M. J., Kelly, M. A. R., 
Bode, R. K., Choi, S. W., Lai, J-S., Griffith, J. W., & Cella, D. Emotional Health and its Assessment 
within the NIH Toolbox. To be submitted to Neurology for inclusion in a special issue.
Coldwell, S. E., Mennella, J. A., Duffy, V. B., Pelchat, M. L., Griffith, J. W., Smutzer, G., Cowart, B. J., Breslin, P.
A. S., Bartoshuk, L. M., Hastings, L., Beauchamp, G. K., O’Mahony, M. A., Victorson, D., & Hoffman,
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H. (2010). NIH Toolbox for Neurological and Behavioral Function: Assessments for gustation. To be 
submitted to Neurology for inclusion in a special issue.
Griffith, J. W., Pepper, C. M., Ryabchencko, K. & Calabrese V. Reality monitoring and depressive disorders.
Doane, L.D., Adam, E.K., Mineka, S., Zinbarg, R., Griffith, J. W., & Craske, M. Flattened diurnal cortisol 
rhythms as a scar marker of past depressive episodes and a state marker of current negative
emotion in a community sample of adolescents.

GRANTS FUNDED

NorthShore University HealthSystem CCRP Grant

Topic: Development and IRT analysis of a dysmenorrhea self-report instrument

Total grant = $60,000, direct salary support = $5,000

Role: Co-principal investigator

GRANT APPLICATIONS

NorthShore pilot grant (2008, Not Funded)

CORE Davis Award (2008, Not Funded)

NIH Extramural Loan Repayment Program (2004, Not Funded)

Individual National Research Service Award #1-F31-MH65753-01. Reality Monitoring and Major 
Depression (2001, Not Funded)

Society for a Science of Clinical Psychology Dissertation Grant. Reality Monitoring and Major
Depression (2001 & 2002, Not Funded)

EDITORIAL EXPERIENCE

Ad-hoc reviewer for Clinical Psychology Review (1)

Ad-hoc reviewer for Journal of Psychopathology and Behavioral Assessment (1)

Reviewer for Behaviour Research & Therapy (31)

Reviewer for Journal of Abnormal Psychology (10)

Reviewer for Emotion (1)

Reviewer for International Journal of Methods in Psychiatric Research (1)

Reviewer for Journal of Affective Disorders (1)

Reviewer for British Journal of Clinical Psychology (2)

Reviewer for Cognition and Emotion (1)

Reviewer for Journal of Behaviour Therapy and Experimental Psychiatry (1)

Reviewer for Brain, Behavior, and Immunity (2)

Reviewer for Biomed Central Psychiatry (1)

Reviewer for Journal of Traumatic Stress (1)

Reviewer for American Journal of Psychology (1)

Reviewer for Neuropsychologia (1)

Reviewer for Social Science Research (1)

Reviewer for Cognitive Therapy and Research (1)

British Psychology Society

PROFESSIONAL MEMBERSHIPS

American Psychological Association

American Psychological Association Practice Organization

Association for the Advancement of Behavior and Cognitive Therapies

COLLOQUIA and INVITED 
PRESENTATIONS

NorthShore University HealthSystem psychiatry grand rounds. The Youth Emotion Project: Assessing risk for 
anxiety and depression (January, 20th, 2009).
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
Katholieke Universiteit Leuven (in English – The University of Leuven, Belgium). The Youth Emotion 
Project: Assessing risk for anxiety and depression (February 2008)

University of Zürich The Youth Emotion Project: Associations among Neuroticism, Psychopathology, and 
Cognitive Vulnerability for Depression. (11 November 2010)

Annual Meeting of the International Pelvic Pain Society. MAPP – Project II, Northwestern University: Self-
report assessment of UCPPS. (22 October 2011, Las Vegas, Nevada)

OTHER PRESENTATIONS

Future Directions in Cognition and Emotion Research (CORE Internal Seminar, October 2008)

The Youth Emotion Project: Assessing Autobiographical Memory (Job talk to CORE, June 2008)

All Good Things Must End… (Case conference given to VAMC MH and PTSD staff, May 2003)

Why Worry? The case of “Fred” (Assessment case conference given to VAMC MH and PTSD staff, 
December 2002)

Cleaning Up Your Data with SPSS(given to VAMC research staff, October 2002)

Case Conference: Sixty years of PTSD (February 2002)

Case Conference: Community Mental Health Services: A Needs Assessment (with R. Russell & A. 
Johnson)

Evaluating Mental Health Services in Broome County (given to Broome County MH subcommittee)

Evaluating Case Management and Residential Services In Broome County (given to Broome County MH 
subcommittee)

Computerized data analysis with SPSS (given to first-year graduate statistics class)

CONFERENCE PRESENTATIONS
Barkema, D., Linn, S. Ruppert, L., Wysocki1, N. Streff, L., Bhuva, S. Welbel, R. Gordon, K., Griffith, J. Samuels,
D. & Schnitzer, T. (2011). Heel Ultrasound compared to DXA in Spinal Cord Injury. Poster to be 
presented at the American Society for Bone and Mineral Research. San Diego, CA, U.S.A.
Desai, H., Coldwell, S. E., Griffith, J. W., Hastings, L., & Smutzer, G. S. (2011). Validation of commercial PROP taste 
strips for the NIH Toolbox. Poster presented at the annual meeting of the Association for
Chemoreception Sciences.
Polster, R., Griffith, J. W., Calhoun, E. A., Tu, F. F., Cella, D., & Gershon, R. (2010). Patient-Reported 
Measurement Aspects of Chronic Pelvic Pain: MAPP Northwestern University Project II Preliminary Results 
from Qualitative Interviews with Pelvic Pain Patients. Poster presented at the annual meeting of the 
International Pelvic Pain Society.
Hahn, E. A., Choi, S. W., Griffith, J. W., Yost, K. J., & Baker, D. W. (2010). A New Multimedia Health Literacy Item 
Bank Developed Using Item Response Theory. Poster to be presented at the 2nd annual meeting of the 
Health Literacy Annual Research Conference, Boston, MA, U.S.A.
Coldwell, S., Griffith, J. W., & Victorson, D. (2009). Initial selection of taste perception assessment measures for 
NIH Toolbox, Poster to be presented at the 21st annual meeting of the Association for Psychological 
Science, San Francisco, U.S.A.
Sumner, J.A., Mineka, S., Griffith, J. W., Zinbarg, R., & Craske, M. (2008, May). Overgeneral autobiographical 
memory predicts unipolar mood disorders in adolescents. Poster presentation at the 20th annual meeting of 
the Association for Psychological Science, Chicago, IL.
Bostick, S., Epstein, A., Dickson, D., Craske, M. G., Mineka, S., Zinbarg, R. E., & Griffith, J. W. (2008). Anxiety and 
depression: Potential mediators between stressful life events and alcohol use disorders at one year follow up. 
Abstract submitted to the 42nd meeting of the Association for Behavioral and
Cognitive Therapies, Orlando, FL.
Sumner, J., Mineka, S., Griffith, J. W., Zinbarg, R., & Craske, M. (2007, October). Autobiographical memory 
specificity as a predictor of unipolar mood disorders in adolescents. Poster presentation at the 21st annual 
meeting of the Society for Research in Psychopathology, Iowa City, IA.
Yeh, M. V., Griffith, J. W., Mineka, S., & Zinbarg, R. E. (2007). Neuroticism and anxiety sensitivity: Predicting 
anxious and depressive symptoms. Poster presented at the 41st meeting of the Association for Behavioral 
and Cognitive Therapies, Philadelphia, PA.
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Zinbarg, R. E., Craske, M. G., Mineka, S., & Griffith, J. W. & Rose, R. D. (2007). Personality, Cognitive Style and 
Diagnoses in Adolescents: Cross-sectional and Prospective Prediction of Emotional Disorders. Symposium 
talk presented at the 41st meeting of the Association for Behavioral and Cognitive Therapies, Philadelphia, 
PA.
Griffith, J. W., Mineka, S. Craske, M. G., Zinbarg, R. E., Sumner, J. A. Lewis, A. R., Rekart, K. (2007). Cognitive 
Predictors of Depression. Symposium talk presented at the 41st meeting of the Association for
Behavioral and Cognitive Therapies, Philadelphia, PA.
Epstein, A. Craske, M G., Shoptaw, S., Stein, J. Mineka, S., Zinbarg, R. E., Griffith, J. W., & Rose, R. D. (2007).
A Prospective Examination of Risk Factors for Alcohol Use Disorders in Adolescents. Symposium talk 
presented at the 41st meeting of the Association for Behavioral and Cognitive Therapies, Philadelphia, PA.
Epstein, A. M., Dickson, D., Castriotta, N., Craske, M.G., Mineka, S., Zinbarg, R. E., & Griffith, J. W. (2007).
Risk Factors Predicting Lifetime and Future Alcohol Use Disorders in Male and Female Adolescents. Poster 
presented at the 30th annual meeting of the Research Society on Alcoholism, Chicago, IL.
Adam, E. K., Doane, L. D., Medelsohn, K., Griffith, J. W., Mineka, S., Zinbarg, R. E., & Craske, M. G. (2007).
Diurnal cortisol patterns, stressful life events, momentary negative emotion and mood and anxiety disorders 
in late adolescence. Paper to be presented at the Society for Research in Child Development.
Sutton J, Mineka S, Griffith J. W., Zinbarg R, & Craske M. (2006). Prospective relationships between neuroticism, 
cognitive styles, and life stress with depressive and anxious symptoms. Poster presented at the Association 
for Psychological Science, 18th Annual Meeting, New York, NY.
Sutton J, Mineka S, Griffith J. W., Zinbarg R, Craske M, & Rose, R. Neuroticism, cognitive vulnerabilities, and life 
stress: Concurrent relationships with depressive and anxious symptoms. (2006). Poster presented at the 
Society for Research in Psychopathology, 20th Annual Meeting, San Diego, CA.
Haller, M., Sutton, J., Mineka, S., Zinbarg, R., Craske, M., & Griffith, J. W. (2006). The impact of chronic and 
episodic stress on personality and attributional style. Poster presented at the Associations for Behavioral 
and Cognitive Therapies, 40th Annual meeting, Chicago, IL.
Oehlberg, K., Mineka, S., Griffith, J. W., Zinbarg, R. E., & Craske, M. G. (2006). Social Phobia and Emotional 
Stroop Bias: Predictive Value of Attentional Interference. Poster presented at the Society for
Research in Psychopathology.
Hauner, K. K. Y., Adam, E. K., Mineka, S., Doane, L. D., Zinbarg, R. E., Craske, M. G., & Griffith, J. W. (2006, 
May). Personality as a predictor of salivary cortisol patterns in adolescents. Poster presented at the 18th 
Annual Convention for the Association of Psychological Science, New York, NY.
Callahan, C., Rose, R. D., Nazarian, M., Griffith, J. W., Zinbarg, R. E., Mineka, S., & Craske, M. G. (2005).
Ethnic and gender differences among adolescents’ cognitive styles. Poster presented at the 39th annual 
meeting of The Association for the Advancement of Behavior Therapy, Washington, D.C.
Spies, L. A., Griffith, J. W., Mineka, S., Zinbarg, R. E., & Craske, M. (2005). Sociotropy, Autonomy, and their
Relationship to Emotional Disorders in Adolescence. Poster presented at the 39th annual meeting of The 
Association for the Advancement of Behavior Therapy, Washington, D.C.
Doane, L., Adam, E., Mineka, S., Zinbarg, R. E., Craske, M., Griffith, J.W., & Rose, R. (2005). Longitudinal 
associations among emotion, stress, and cortisol on the emergence of depressive and anxious
disorders. Symposium talk presented at the Society for Research in Adolescence.
Griffith, J. W., & Constans, J. I. (2004). Suppression of the Subliminal Stroop Effect in Vietnam Veterans with PTSD. 
Poster presented at the 38th annual meeting of The Association for the Advancement of Behavior Therapy, 
New Orleans, LA.
Chiong, A., Griffith, J. W., Mineka, S., Zinbarg, R. E., & Craske, M. G. (2004). Differences Between Subliminal and 
Supraliminal Stroop in Adolescents at High Risk for Emotional Disorders. Poster presented at
the 38th annual meeting of The Association for the Advancement of Behavior Therapy, New Orleans, LA.
Zinbarg, R. E., Craske, M. G., Rose, R., Griffith, J. W., Waters, A., Mineka, S., & Mor, N. (2004). Lifetime and 
Current Diagnoses and Validity of Peer Reports of Personality and Attributional Style in Adolescents. 
Symposium talk presented at the 38th annual meeting of The Association for the
Advancement of Behavior Therapy, New Orleans, LA.
Mineka, S., Craske, M. G., Zinbarg, R. E., Mor, N., Rose, R., & Griffith, J. W. (2004). Comorbidity of Anxiety and 
Mood Disorder in a High Risk Sample of Adolescents. Symposium talk presented at the 38th annual 
meeting of The Association for the Advancement of Behavior Therapy, New Orleans, LA.
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Version 8.0 (Phase 2), Date: 03/28/2018 
Griffith, J. W., Mineka, S., Newcomb-Rekart, K., Zinbarg, R. E., & Craske, M. G. (2004). Information- processing 
Biases and Neuroticism as Predictors of Anxiety and Depression in Adolescents. Symposium talk presented 
at the 38th annual meeting of The Association for the Advancement of Behavior Therapy, New Orleans, LA.
Griffith, J. W., Pepper, C. M., Ryabchenko, K., A., Calabrese, V., Miller, A. B., & Jeglic, E. L. (2004). Reality 
Monitoring and Major Depression. Poster presented at the 19th annual meeting of the Society for
Research in Psychopathology, St. Louis, MO.
Mineka, S. Craske, M., Zinbarg, R. E., Griffith, J. W., & Rose, R. (2004). Neuroticism, extraversion and the 
lifetime prevalence of emotional disorders in adolescents. Poster presented at the 19th annual meeting 
of the Society for Research in Psychopathology, St. Louis, MO.
Sutton, J. M., Mineka, S., Mor, N., Griffith, J. W., & Zinbarg, R. E. (2004) The Specificity of Cognitive, Personality, 
and Life Stress Variables to Depressive and Anxious Symptoms. Poster presented at the
19th annual meeting of the Society for Research in Psychopathology, St. Louis, MO.
Sutton, J. M., Mineka, S., Mor, N., Griffith, J. W., Jaeger, J., & Zinbarg, R. E. (2004). The Relationship of 
Cognitive Styles, Personality, and Life Stress to Depressive Symptoms. Poster presented at the 16th 
meeting of the American Psychological Society, Chicago, IL.
Griffith, J. W., Vasterling, J., Brailey, K., Constans, J. I., & Sutker, P. B. (2003). Depression and PTSD over time in 
1991 Gulf War veterans: The effect of stress and coping. Symposium presentation at the
meeting of the International Society for Traumatic Stress Studies, Chicago, IL.
Griffith, J.W., Fassler, O., Sonin, K., Dudas, M., & Pepper, C.M. (2002). Can retrieval cues decrease the 
depressive memory bias? Poster presented at the meeting of the Eastern Psychological Association, 
Boston, MA.
Griffith, J.W., Jeglic, E., Miller, A., Ryabchenko, K.A., & Pepper, C.M. (2001). Symptom Reduction Following The 
SCID-IV In A Primary Care Sample. Poster presented at the 35th annual convention of the
Association for the Advancement of Behavior Therapy, Philadelphia, PA.
Griffith, J.W., Miller, A., & Pepper, C.M. (2001). A Comparative Examination of the Validity of Mailback Follow-Up 
Assessments. Poster presented at the 35th annual convention of the Association for the Advancement of 
Behavior Therapy, Philadelphia, PA.
Griffith, J.W., Dudas, M., Fassler, O., Flora, R., & Pepper, C.M. (2001). Depressive Memory Bias: Verbatim Or
Gist Based? Poster presented at the 35th annual convention of the Association for the 
Advancement of Behavior Therapy, Philadelphia, PA.
Jeglic, E.L., Ryabchenko, K.A., Miller, A.B., Vanderhoff, H.A., Griffith, J.W., & Pepper, C.M. (2001). Spousal 
perceptions of depressive symptomatology. Poster presented at the 35th annual convention of the 
Association for the Advancement of Behavior Therapy, Philadelphia, PA.
Jeglic, E.L., Ryabchenko, K.A., Miller, A.B., Vanderhoff, H.A., Griffith, J.W., & Pepper, C.M. (2001). A
caregiving model of depression. Poster presented at the 35th annual convention of the 
Association for the Advancement of Behavior Therapy, Philadelphia, PA.
Ryabchenko, K.A., Jeglic, E., Griffith, J.W., Miller, A., Axelrad M., & Pepper, C.M. (2001). Recurrence of Major 
Depression In A Primary Medical Care And An Outpatient Psychiatry Sample. Poster presented at the 
35th annual convention of the Association for the Advancement of Behavior Therapy, Philadelphia, PA.
Pepper, C. M., Ryabchenko, K. A., Jeglic, E. L., Griffith, J. W. and Miller, A. B. (2001, November). Course  and 
comorbidity of recurrent depression in two treatment settings. Poster presented at the annual meeting of the 
Society for Research in Psychopathology, Madison, WI.
Griffith, J.W., Jeglic, E., Ryabchenko, K.A., Lam, C.Y., & Pepper, C. (2000). Comorbid Alcohol-Related Disorders 
And Major Depression In A Primary Care Sample. Poster to be presented at the 34th annual convention of 
the Association for the Advancement of Behavior Therapy, New Orleans,
Louisiana.
Griffith, J.W., Ryabchenko, K.A., Lam, C., Jeglic, E., & Pepper, C. (2000) Psychiatric Comorbidity in a College 
Sample. Poster to be presented at the 34th annual convention of the Association for the Advancement of 
Behavior Therapy, New Orleans, Louisiana.
Miller, A., Williams, K., Pepper, C., Vetrano, M., Idoniboye, L., Dossa, F., Jeglic, E., Ryabchenko, K., Griffith,
J.W., & Axelrad, M. (2000). Rates of depression and head injury in patients with chronic hepatitis 
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Poster to be presented to the 34th annual convention of the Association for the Advancement of 
Behavior Therapy, New Orleans, Louisiana.
Ryabchenko, K.A., Jeglic, E., Griffith, J.W., Lam, C., Pepper, C.M. (November 1999). Identifying 
Predictors
of Major Depression in a Primary Care Population (II). Poster presented at the 2000 annual 
meeting of the American Psychosomatic Society. Savannah, Georgia.
Griffith, J.W., Ryabchenko, K.A., Lam, C., Jeglic, E., & Pepper, C.M. (November 1999). A Two-stage 
Screening for Major Depression in a College Sample. Poster presented at the 33rd annual 
convention of the Association for the Advancement of Behavior Therapy, Toronto, Canada.
Ryabchenko, K.A., Jeglic, E., Griffith, J.W., Lam, C., Pepper, C.M. (November 1999). Identifying 
Predictors
of Major Depression in a Primary Care Population (I). Poster presented at the 33rd annual 
convention of the Association for the Advancement of Behavior Therapy, Toronto, Canada.
VIII. Laboratory Procedures/Evaluations
Clinical Laboratory Evaluations
Baseline laboratory values will be collected for determination of inclusion/exclusion 
criteria and to assess safety and also will be entered into the study database. Repeat 
laboratory testing will only be done if there is a clinical basis for further testing. Blood 
and urine samples will be collected at the MRI scanning facility by a RN or trained 
member of the research personnel. If for some reason a blood pregnancy test cannot be 
obtained, urine pregnancy tests will be processed at the MRI scanning facility before 
starting any procedures, including scanning. Blood samples will be processed through 
Pathology Laboratory at NMH, 251 E. Huron St. LC700, Chicago, IL 60611. All results 
will be faxed to the study doctor for review before subjects begin study medications. 
Samples will not be frozen nor stored for long-term or future use. All results will be 
entered into REDcap after the study physician has looked over them and noted out of 
range results and plan of action, if necessary.
Screening Laboratory Evaluations

The normal ranges for each test is listed within the brackets below.  
Hematology - Complete Blood Count (CBC)
9 tests will be performed. Normal results will be required before starting all study 
medications.

White cell count [3.5-10.5 K/UL, normal reference range]

Red cell count [3.80-5.20 M/UL]

Hemoglobin [11.6-15.4 g/dL]
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
Hematocrit HCT [34.0-45.0%]

MCV [80-99 FL]

MCH [27.0-34.0 pg]

MCHC [32.0-35.5%]

RDW [11.0-15.0%]

Platelet count [140-390 K/UL]
Hematology - Differential
10 tests will be performed. Normal results will be required before starting all study 
medications.

Neutrophils [34-73%]

Lymphocytes [15-50%]

Monocytes [5-15%]

Eosinophils [0-8%]

Basophils [0-2%]

Absolute neutrophils [1.5-8.0 K/UL]

Absolute lymphocytes [1.0-4.0 K/UL]

Absolute monocytes [0.2-1.0 K/UL]

Absolute eosinophils [0.0-0.6 K/UL]

Absolute basophils [0.0-0.3 K/UL]
Comprehensive Chemistry Panel
16 tests will be performed. Normal results will be required before starting all study 
medications.

Sodium [134-142 mEq/L]

Potassium [3.5-5.1 mEq/L]

Chloride [98-109 mEq/L]

Bicarbonate [21-31 mEq/L]
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
Blood urea nitrogen [2-25 mg/dL]

Creatinine [0.00-1.30 mg/dL]

eGFR – African Am [>=60 mL/min/1.73m2]

eGFR – Non African Am [>=60 mL/min/1.73m2]

Glucose level [65-100 mg/dL]

Calcium [8.3-10.5 mg/dL]

Albumin [3.5-5.7 g/dL]

Total protein [6.4-8.9 g/dL]

ALT [0-52 Unit/L]

AST [0-39 Unit/L]

Total bilirubin [0.0-1.0 mg/dL]

Alkaline phosphatase [34-104 Unit/L]

BAC [negative result needed]; looks for levels of ethyl glucuronide and ethyl 
sulfate
Vital signs

Blood Pressure – diastolic [60-90 mm Hg]

Blood Pressure – systolic [100-130 mm Hg]

Pulse [60-100 beats/minute]

Respirations  [10-16 breaths/minute]

Temperature [36-37.5oC]
Urine Tests
A pregnancy test will be performed on all WOCBP prior to starting treatment, via either 
blood or urine. A negative test result will be required before receiving study medication 
and before starting scanning procedures.
Special Assays or Procedures
N/A
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Specimen Preparation, Handling, and Storage
N/A
Specimen Shipment
N/A
Clinical Laboratory Evaluations
Baseline laboratory values will be collected for determination of inclusion/exclusion criteria 
and to assess safety and also will be entered into the study database. Repeat laboratory testing 
will only be done if there is a clinical basis for further testing. Blood and urine samples will be 
collected at the MRI scanning facility by a RN or trained staff member. Urine pregnancy tests 
will be processed before starting any study medication and before any scan is done. Blood and 
urine samples will be processed through Pathology Laboratory at NMH, 251 E. Huron St. (7th 
floor), Chicago, IL 60611; samples will be taken immediately to laboratory window after 
collection. All results will be faxed to the study doctor for review before participants begin 
study medications. Samples will not be frozen nor stored for long-term or future use.
In the rare cases that a participant cannot a provide blood or urine sample at the time of the visit 
OR if the RN or staff member cannot draw blood due to difficult veins, the following will be 
done.  For individuals who cannot provide a sample the same day as visit 1, they will be 
rescheduled within 5 days for a blood draw/urine collection with the hospital diagnostic testing 
center (DTC, listed in the appendix locations); a member of the study staff will escort them to 
the center and wait with them until the samples have been collected. Participants will be 
reimbursed for travel up to $20 for this extra visit if needed. For individuals with difficult veins, 
study staff will escort them to the DTC at the end of the visit and wait with them until the 
samples have been collected. 
IRB #: STU00080585 Approved by NU IRB for use on or after 3/29/2018 through 3/25/2019.