Combined Meditation and Exercise as a Treatment for Patients With Chronic Back Pain
Phase: NA
Conditions: Chronic Low Back Pain
Sponsor: Duquesne University

Title Page: 
Study Protocol 
Combined exercise and meditation as a treatment for patients with chronic back pain 
NCT number not available 
10/24/17 

Protocol Summary Form 
Combined exercise and meditation as a treatment for patients with chronic back pain 
 
1. 
Statement of the research question 
Determine the feasibility of a combined exercise and guided meditation practice on reducing pain in individuals 
with lower back pain. 
We will investigate an experimental condition: guided meditation with subsequent treadmill walking, and three 
control conditions (negative control, meditation only, exercise only) in participants with clinically diagnosed 
lumbar spinal back pain without neuropathy or radiculopathy. Participants will receive meditation training then 
complete a guided meditation, using standard pre-recorded guided meditation audio, prior to a 5x per week 
treadmill walking experience for 4 weeks. Our goals are to: 
We hypothesize that back pain will show greater improvement following completion of a combined 
treatment protocol of both exercise and meditation. 
 
2. 
Purpose and significance of the study 
Chronic pain is a serious problem in the US that affects 116 million adults1. A number of chronic pain conditions 
can be linked both epidemiologically and biologically with various anxiety disorders2,3. It is well known that anxiety 
can increase pain and that many patients with pain exhibit increased anxiety. Standard treatment options for 
chronic pain include prescribed pharmaceuticals and physical therapy. Anxiety is most commonly treated with 
prescribed pharmaceuticals and psychotherapy. A major gap in the development of effective therapies has been 
the lack of focus on the interaction between pain and anxiety disorders. That is, treatment of pain but not anxiety, 
or vice versa, is likely not as effective as treatment of both disorders or sets of symptoms at the same time. 
Fortunately, a number of integrative therapies, such as exercise and meditation, have been shown to be effective 
in separate studies for both pain and anxiety. Exercise is analgesic, is anxiolytic, low cost, and has many positive 
side-effects. Similarly, meditation has demonstrated efficacy in the context of chronic pain and anxiety. A therapy 
regimen consisting of both exercise with mindfulness meditation in these patient populations may produce 
greater benefits but it is currently unknown whether this combination of treatment is feasible. Issues of interest 
in developing a combined treatment regimen that is feasible to implement include: patient adherence and 
acceptance and the use of appropriate measures to assess symptoms following intervention. Before exploring 
this combined treatment approach in a full clinical trial, we will first determine the feasibility of this intervention in 
persons with spinal low back pain.  
Our overall objective is to investigate the feasibility of an intervention that combines exercise and guided 
meditation in individuals with back pain. We will also investigate the feasibility of using a standard set of non-
invasive human pain tests for predicting change in symptoms following intervention. These objectives are 
necessary in order to achieve our long-term goal of determining prescribed exercise/meditation protocols with 
the best cost-to-risk ratio as a therapy for improving symptoms in patients with chronic pain and comorbid anxiety. 
Our central hypothesis is that a combined exercise and meditation protocol will be feasible in this clinical 
population as indicated by high recruitment rates, subject retention, and treatment acceptance.  
3. 
Research design and procedures 
This study is designed as a randomized single-blinded (for QST testing) trial with repeated measures.  
The participants will primarily be recruited through a University of Pittsburgh approved IRB patient registry (Pitt 
IRB protocol #REN16070141/PRO12030122 “Department of Physical Medicine and Rehabilitation Research 
Registry (PMR3) see “participant” recruitment below for additional details). Registry use is managed with co-PI 
Dr. Eric Helm (MD, University of Pittsburgh Department of Physical Medicine and Rehabilitation). Secondarily, 
we will recruit from the Clinical and Translational Science Institute’s Pitt + Me registry. 

The co-primary investigators (co-PIs) will be involved in the procedures listed below. Graduate research students 
(e.g. Anna Polaski, Biological Sciences) and technicians will assist with recruitment, data collection, and data 
processing. These additional technicians have yet to be identified but will be added to the protocol with 
subsequent amendments. The graduate student and technicians will be trained on all procedures involved in this 
study by the co-PIs. Prior to data 
collection, the prospective subjects 
will complete a full screening, using 
a checklist of the inclusion/exclusion 
criteria 
and 
the 
AHA 
health 
questionnaire (see “Instruments”) to 
determine eligibility. The purpose of 
the study, the methods of data 
collection and all potential risks will 
be 
verbally 
communicated 
to 
prospective subjects at the initiation 
of the first data collection session 
(Day 1) (Figure 1). Prospective 
subjects will be given an approved 
informed consent form to read and 
sign. Subjects will then complete 
additional questionnaires to assess 
baseline activity level and state 
anxiety (see “Instruments” below). 
The researcher will explain the 
questionnaires to subjects and will 
be available to answer any questions 
while the subjects complete these forms. Basic health information obtained from the subject will assess whether 
the subject has been diagnosed with any cardiac, respiratory, neurological or musculoskeletal disorder, chronic 
pain or currently has acute pain (AHA health questionnaire).  Subjects who report any of the above medical 
diagnoses or pain (with the exception of chronic low back pain) during screening will be excused from 
participation in the study. Subjects who cannot walk independently without a device will be excused from 
participation as well. Any identifying information used to determine eligibility, including the checklist of 
inclusion/exclusion criteria and the health questionnaires, will be destroyed.  
Each trial is designed to last 29 days including an intake session and a post-meditation/exercise pain testing 
session. Pain testing is performed during the intake session (baseline) and on day 29 (48 hours after the last 
intervention). See Figure 1 for illustrative time-line of individual trials for individuals assigned to the meditation 
then exercise group. Analogous time-lines will be used for exercise only subjects (30 minutes of exercise each 
day and 15 minutes of audiobook), meditation only subjects (15 minutes of meditation each day and 30 minutes 
of audiobook) or negative control subjects (15 minutes of audio book followed by 30 minutes of rest each day). 
During the enrollment period, subjects will also be given a full description of all sensory and pain measures that 
will be taken.  With initial consent, all subjects will be allowed to experience all sensory/pain measures before 
baseline pain testing is completed. All sensory and pain assays are based on well-established assays used in 
both healthy human participants and patients with chronic pain4,5.  All assays involve either innocuous (non-
painful stimuli) or acute noxious stimuli (painful stimuli) that do not damage tissue. Sensory testing will be 
completed on both the non-dominant forearm and low back. For testing completed on the forearm, subjects will 
be seated in a chair with their arm supported. For testing completed on the low back, subjects will be positioned 
in prone on a plinth table with a head rest. Time between different tests will be >5 min to allow the subject to 
rest. Order of the three stimuli (e.g. mechanical, thermal, pressure) will be randomized during each day 1 versus 
day 29 testing. Training and description of each measure is as follows: 
Cutaneous mechanical sensitivity assay4: Assay involves determining the sensitivity threshold for 
innocuous cutaneous stimulation and noxious cutaneous stimulation.  Stimulation is provided with standard 
sensory evaluator filaments.  These small nylon filaments each apply a single force (ranging from 0.008g to 4g).  
Before the start of the first experimental trial (baseline testing), subjects will be allowed to feel and manipulate 
the filaments. Starting with the smallest filament (0.008g; typically below the sensory threshold for human 
detection), 5 trials will be directed at the subject’s forearm and low back. Experimenter will ask “Can you feel 
Figure 1 – Time-line of four week trial for participants in combined 
intervention group. 

this” while the experimenter applies the filament to the subject’s forearm and lower back.  With each filament, 
the experimenter will apply the filament 3 times in the “positive” trials.  For the other 2 trials, the experimenter 
will not apply the filament but ask the subject, “Can you feel this?”  These 2 “negative” trials will be randomly 
inserted with the 3 “positive” trials and are designed to test for false responses.  If a subject detects >2 of the 
positive trials and 0 negative trials for a filament, that force will be the subject’s “mechanical sensory threshold.”  
For a single filament, if the subject detects <2 of the real trials and/or >0 of the false trials, the experiment will 
start another round of 5 trials with the next biggest filament until the sensory threshold is reached.  Typical testing 
time is about 5 min per body part. After the sensory threshold is reached, testing will continue until the “pain 
threshold” is reached. Pain experienced from these filaments is transient and is roughly equivalent to firmly 
pushing the end of a paper clip into one’s skin. As soon as the patient says that an individual filament feels 
painful, the trials will stop. This is the cutaneous pain threshold. Typical testing time is about 5 min per body part. 
Heat sensitivity assay4:  Assay involves determining the sensitivity threshold for painful thermal 
stimulation.  Stimulation is provided with a small thermal device, which will be strapped to the subject’s forearm 
then lower back at the site of back pain (Medoc Instruments).  Before the start of the training/ experimental trials, 
subjects will be shown the device and allowed to feel the stimulus with their hand.  Subjects are told to press the 
‘stop’ button on a remote and/or verbally tell the experimenter to stop testing when they feel the stimulus 
transition from “innocuous warmth or heat” to “painful heat.”  Each trial lasts for a maximum of 20 sec.  The 
device is set so that typical withdrawal thresholds occur at approximately 10 seconds into the trial.  The 
temperature on the probe tip at this point is ~47oC (116oF).  The maximum temperature of the trial at the 20 
second cutoff time point is 50oC (120oF). Temperatures in US desert areas often reach this temperature and 
research has shown that testing of the skin at this temperature for this length of time does not produce skin 
damage6. Additionally, this testing modality has been safely used a part of a standard pain/sensory testing 
protocol5. Total testing time is <5 min. 
A second assay will be used to evaluate the quality and unpleasantness of thermal pain.  Each subject will 
receive a constant 45oC stimulus.  45oC is a standard temperature that is the typical minimal stimulus necessary 
to feel thermal pain.  Stimulus (3cm x5cm heating block) will be applied for 3 seconds.  Immediately following 
stimulus, the subject will be asked to evaluate the quality and unpleasantness of the pain. This is done with a 
standard 0-10 visual analog scale (VAS).  On the “quality scale”, “0” is represented as “no pain” and “10” is 
represented as “the worst pain imaginable.”  On the “unpleasantness scale”, “0” is represented as “not 
unpleasant” and “10” is represented as “the most unpleasant sensation imaginable.”  
Example instructions for quality VAS – “Please use the scale below to tell us how intense your pain is.  Place an 
“X” on the scale that best describes the intensity of your pain.”  
Example instructions for unpleasantness VAS – “Now that you have told us about the physical quality of the pain, 
we want you to tell us overall how unpleasant your pain is to you.  Words used to describe very unpleasant pain 
include “miserable” and “intolerable.”  Remember, pain can have a low intensity, but still feel extremely 
unpleasant, and some kinds of pain can have a high intensity but be very tolerable.  With this scale, please tell 
us how unpleasant your pain feels.” 
Mechanical pressure sensitivity assays7:   Assay involves determining the sensitivity threshold for painful 
pressure stimulation and then determining the quality and unpleasantness of that same pressure in a separate 
trial.  Stimulation is provided with a standard clinical pressure algometer (see below “instrument” section).  This 
device consists of a probe connected to a pressure meter.  The probe is placed on the subject’s forearm and low 
back at the site of back pain and pressure is gradually applied.  Before the first training/experimental trial subjects 
will be allowed to apply the stimulus to themselves.  During a trial, pressure will gradually be applied until the 
stimulus transitions from “innocuous pressure” to “painful pressure.”  At this point, subject will say “stop” and the 
stimulus will be removed from the subject’s lower back.  When algometer is removed from the subject, the 
greatest pressure applied is automatically recorded in the device.  This is the “pressure pain threshold” for the 
trial.  2 trials will be applied to each the forearm and low back in two distinct sites at least 1 inch from each other 
to avoid damage or sensitization to a single area. After the pressure threshold has been determined for a subject, 
1 additional trial will be applied (in a third testing site).  In this trial, the subject will be asked to evaluate the 
quality and unpleasantness of a pressure stimulus given for 3 seconds.  This is done with a standard 0-10 visual 
analog scale (VAS).  On the “quality scale”, “0” is represented as “no pain” and “10” is represented as “the worst 
pain imaginable.”  On the “unpleasantness scale”, “0” is represented as “not unpleasant” and “10” is represented 
as “the most unpleasant sensation imaginable.”  During this trial, the experimenter will tell the subject that they 
are going to apply a painful stimulus to the subject and then ask the subject to evaluate that pain (on the two 
VASs).  The exact stimulus will be matched to the subject’s pain threshold determined during the baseline trials 

(e.g if baseline trials indicated a pressure threshold of 50 N then subject will be asked to evaluate the pain of 
that stimulus).  During final testing trial (day 29), the pressure pain threshold will be re-measured to determine if 
there is a change from baseline.  For the quality/unpleasantness testing, subjects will be tested on day 29 at 
their original baseline pressure threshold (from day 1) AND the new threshold determined day 29.  This will allow 
an analysis of change from baseline and pain at threshold across the experiment. 
Following baseline pain testing, subjects (in the exercise only and meditation then exercise groups) will be set-
up for training on the exercise protocol. Subjects will become familiarized with the exercise protocol, including 
the physiological measures to be assessed [heart rate (HR)], the Borg Rate of Perceived Exertion (RPE) Scale, 
and the treadmill speed at which they will be walking. Subjects will be instructed to step up onto the treadmill 
and stand on the sides not the belt or belt deck. The researcher will slowly raise the speed to 2 mph. The subject 
will be instructed to step on the treadmill at this time. After 30 seconds, the speed will be ramped up to 2.5 mph 
and after another 30 seconds, the speed will be ramped up to their prescribed session speed (±3.5 mph). They 
will also be instructed to walk with a natural gait pattern, allowing bilateral arm swing. To allow a natural arm 
swing, subjects are unable to hold onto the treadmill arm rails.  Subjects will be introduced to the Borg RPE scale 
and asked to provide subjective feedback on their level of exertion at the initiation of and during the final minute 
of this 5 minute training period (Borg).  
Intervention Sessions  
Subjects will be scheduled for 20 intervention sessions during their time in the study – that is five sessions per 
week over four weeks. Subjects are only required to return to campus for the first session of each week. The 
remaining four weekly sessions can be completed at home on a personal treadmill or in the community, such as 
a local gym. Subjects are able to complete all sessions at Duquesne University if that is their preference. 
Sessions will be scheduled/encouraged to occur at the same approximate time each day to control for factors 
that may influence exercise performance and assessments.  
This clinical trial will test the methodology and trial retention of one version of a combined therapy (along with 
comparison control groups). The combination of meditation and exercise will be done sequentially. This 
methodology is termed (1) Meditation first & then Exercise (Med&Exer). All participants in this exploratory trial 
will receive the therapeutic intervention, or one of three control options (negative control, meditation only, 
exercise only) (Table I). We describe below the details of the interventions. 
 
Table 1 – Experimental Conditions 
Experimental Condition 
Description 
Negative control 
In clinic or at home, listen to an audiobook for 
~15 minutes followed by 30 minutes of rest 
(including survey assessments) 
Meditation only control 
In clinic or at home, 15 minutes of meditation 
and listen to an audiobook for ~30 minutes 
(including survey assessments) 
Exercise only control  
In clinic or at home, listen to an audiobook for 
~15 minutes (including survey assessments) 
then exercise (treadmill) for ~30 minutes 
Meditation & then exercise (Med&Exer) 
In clinic or at home, 15 min of meditation 
followed by 30 min of exercise (treadmill) plus 
survey assessments 
 
Exercise in this exploratory study will consist of 30 minutes of moderate-intensity treadmill walking (starting at 
3.5 mph and adjusted up or down to reflect moderate intensity for each individual participant) in the Rangos 
Human Testing Facility (Fisher Hall) on a treadmill with auto-shut off and integrated heart rate monitor (Polar H1 
Heart Rate Sensor) on day 2 (first day of intervention), day 9, day 16, and day 23.  During the other intervention 
days (day 3-6, 10-13, 23-27) participants will have the option of completing trials at Duquesne or “at home.” At 
home is defined as a participant using a personal treadmill or going to a community fitness center (e.g. YMCA). 
This “at home” component is designed to reduce the extra burden for patients who would otherwise have to 
travel to Duquesne for 22 total sessions (20 days of intervention plus intake and outtake sessions).  Exercise will 

be performed 5x per week (1x per day) for a total of four weeks with two days of rest between the four exercise 
runs. Participants in the exercise-only group and Med&Exer will be encouraged to exercise when the gym is less 
busy. Any trials done in the Rangos Human Testing Facility will be donewith the researcher in the room, 
monitoring the participant. . Walking speed has been prescribed based on a standard equation incorporating 
metabolic equivalent of the task (METs). METs are a measure of an individual’s energy exertion during a physical 
activity. The speed of treadmill walking was set to ensure energy expenditure falls within the moderate-intensity 
range (3.00-5.99 METs). Heart rate is monitored continuously before, during, and after exercise.  
To evaluate the effect of the meditation on the participants, they will complete the Freiburg Mindfulness inventory 
(FMI) meditation survey immediately prior to their first meditation before exercise. The FMI will be used again on 
day 27. 
All participants will receive a 45 min meditation and stress training session following baseline pain testing (see 
Assessment section below) on the intake day (Day 1). These training sessions, done by clinical Psychologist Dr. 
Ian Edwards (Counseling and Wellbeing Center), discuss the potential of and use of mindfulness and meditation 
(in the meditation groups only) or about stress management for chronic pain (in the exercise only and negative 
control group). On subsequent “intervention” days, guided meditation recordings will be used for the two relevant 
meditation participant groups. Participants will listen to a 15 min guided meditation with mindfulness recording. 
We have 5 recordings, which will be pre-loaded on a MP3 player (see URLs for Recordings at the end of this 
Protocol). The participants will be allowed to take this MP3 player home with them if they choose to perform “at-
home” trials.  
Subjects will perform their exercise session with the researcher in the room, monitoring their heart rate and level 
of exertion. For subjects exercising “at home,” we will instruct the subjects on warning signs to indicate that they 
should stop exercising. Subjects will be advised to place a chair near the treadmill to sit and rest if they become 
over-exerted. 
4. 
Instruments 
 Assessments in this exploratory trial are designed to evaluate four elements of the trial: (1) Pain and Disability, 
(2) Meditation, (3) Anxiety and Stress, and (4) Fitness and General Health and. Although these elements are not 
mutually exclusive and multiple survey tools overlap, we describe these elements as individual groups of 
assessments below for ease of interpretation. General assessment includes demographic information (gender, 
age, race/ethnicity, and education level) and handedness. The primary outcome of this trial is a reduction in 
disability as measured by the RMDQ (see below).  See Appendix 1 – Instruments for all surveys and 
questionnaires. 
 
Protocol Pain and Disability 
There are multiple assessments for experimental measurement of pain. First, we will use the Roland-Morris 
Disability Questionnaire, which provide a qualitative analysis of the disability that is associated with an 
individual’s chronic low back pain. This is our primary outcome for the trial. We hypothesize that exercise, 
meditation, and combined exercise/meditation will decrease disability in patients. Second, we will use standard 
visual analog scoring of instantaneous back pain for participants before and after exercise (or meditation in the 
“meditation only” control group or audio book in the negative control group) during each day of the trial.  These 
scales will be included in the subject online diary (Qualtrics Survey Platform) for participants completing “at 
home” trials.  
Finally, we employ quantitative sensory testing (QST) to quantitatively measure participants sensory and pain 
thresholds for mechanical stimulation, thermal stimulation, and pressure stimulation as described in detail above. 
All QST will be performed by a clinician/researcher blinded to meditation and exercise intervention. These well-
validated measures provide a quantitative assessment of pain during the meditation and exercise intervention. 
QST pain assessment will occur at baseline (intake day) and day 29 (48 hours after the last intervention). All 
QST measures will occur on the forearm and in the lumbosacral area identified by the individual participant as 
being painful. Briefly, mechanical testing is accomplished using von Frey filaments and assesses general 
mechanical sensitivity and mechanical allodynia in cases of cutaneous hypersensitivity. Filaments are similar to 
fishing line thread and stimulus ranges from undetectable to detectable to painful. Any pain is similar to “pin 
prick” pain. Thermal pain is assessed using a Peltier-type device (Medoc Pathway) to measure thermal pain 
threshold. Similarly, we assess the qualitative nature of thermal pain by applying a 45oC constant heat stimulus 
to the participant’s back. 45oC is the molecular activation threshold for pain receptors and allows for an analysis 

of thermal allodynia using VAS scales for the sensory and emotional component of pain. Finally, we will use a 
manual pressure algometer (0.2-2cm diameter, Wagner Instruments) to first measure pressure pain thresholds. 
Threshold detection is then followed by a constant pressure stimulus at an individual participant’s pain threshold 
to determine the sensory and emotional VAS properties of the stimulus. All of these quantitative sensory 
techniques are safe and carry only minor risk for participants. 
Assessment - Meditation and Mindfulness 
All participants in the meditation groups will complete the Freiburg Mindfulness Inventory (FMI) at the beginning 
of their first day of exercise/meditation and on the last day of the trial. The FMI is a 30-item tool that assesses 
an individual’s experience with meditation and mindfulness. For this feasibility study, data from the FMI will be 
particularly useful in evaluating whether there were any changes in mindfulness that developed during the trial. 
Failure to increase mindfulness during the trial might be a sign that a patient failed to “buy in” to the meditation 
intervention. We will also evaluate the likelihood of a patient to continue to meditate (or exercise) using a 
qualitative exit survey given on day 29. There are no safety concerns associated with the FMI or custom exit 
survey. 
Assessment – Anxiety 
To account for changes in anxiety during the current exploratory trial, we will use the State-Trait-Anxiety Inventory 
(STAI) form Y to evaluate state anxiety and the Fear-Avoidance Beliefs Questionnaire (FABQ) to evaluate fear 
avoidance behavior. Subjects will report their state anxiety (using a survey) before and after each trial. FABQ 
will be evaluated on day 1 and day 29. There are no serious safety concerns associated with this survey.   
Assessment - Exercise 
As described above, we will be using multiple assessment tools to evaluate physical fitness and exercise in this 
trial. General fitness will be determined by the International Physical Activity Questionnaire – Short Form (IPAQ-
short) and a clearance of physical readiness for exercise will be determined by the AHA/ACSM Health/Fitness 
Facility Pre-participation Screening Questionnaire. Exercise exertion will be measured daily through active heart 
rate monitoring during exercise and the Borg Rate of Perceived Exertion (Borg RPE)8. Finally, throughout the 4 
week trial, participants will be asked to wear wrist-based health activity monitors. These watches monitor and 
record activity and other factors.  There are no serious safety concerns associated with these surveys or 
monitoring methods.  
 
5. 
Sample selection 
Adults with chronic low back pain who are otherwise healthy will be recruited for participation in this study. The 
AHA screening questionnaire will be administered during the screening process to determine whether potential 
subjects meet the inclusion/exclusion criteria. 
 
Eligibility Criteria: 
Inclusion criteria 
1. Presence of clinically diagnosed nonspecific low back pain for at least 6 months (see below for additional 
detail) 
2. Between age 18-60  
3. Body mass index within the normal to overweight range (18.5-29.9)   
4. Resting heart rate 60 to 100 beats per minute 
5. Resting blood pressure less than or equal to 140/90 
6. Able to independently ambulate community distances without external support (e.g., walker, cane) 
Exclusion criteria 
7. Age less than 18 or greater than 60 years 
8. BMI ≥ 30 or ≤ 18.4 
9. Cardiovascular or respiratory disease  
10. Neurological disease, unrelated to low back pain 
11. Radicular low back pain 

12. Back pain associated with neuropathy 
13. Diabetes mellitus, Types 1 and 2 
14. Diagnosed with a chronic pain condition, unrelated to low back pain 
15. Acute pain 
16. Regular participation in high intensity athletic/sporting activities 
17. Sedentary lifestyle 
18. Currently pregnant 
19. Current cigarette smoker 
20. On-going litigation associated with back pain 
21. Inability to walk independently without external support (e.g. walker). 
22. No regular participation in meditation techniques or training in Mindfulness-based stress reduction 
None of the above exclusion criteria are based on gender, race, or ethnicity. 
 
Back pain definition for inclusion:   
The target population for this exploratory trial and the subsequent full clinical trial are patients with chronic back 
(>6 months) pain with no evidence of neuropathic pain, radicular (i.e. sciatica) pain, or referred somatic pain.  
These diagnoses will be made prior to entry in the study. Diagnostic inclusion criteria for patients is back pain 
identified as either lumbar spinal pain (localized between the last thoracic spinous process and the first sacral 
spinous process; e.g. lumbar discogenic pain, internal disc disruption, lumbar zygapophysial joint pain, lumbar 
muscle sprain and muscle spasm, spondylolysis) and/or sacral spinal pain (localized between the first sacral 
spinous process and the posterior sacrococcygeal joints; e.g. sacroiliac joint pain). These two types of pain will 
be grouped together as lumbosacral spinal back pain. Laterally, these pain syndromes are localized between 
the lateral borders of the erector spinae. Patients with chronic back pain fall roughly into five categories: (1) 
internal disc disruption (39%), (2) zygapophysial joint pain (15%), and (3) sacroiliac joint pain (15%), with the 
remaining patients falling into either (4) failed back surgery syndrome, or (5) idiopathic pain.  
In our three main clinics, about 45% of patients display idiopathic and failed surgery back pain, 25% of patients 
demonstrating marked pain in their peripheral limbs indicative of radiculopathy or referred somatic pain, and 30% 
of patients with neck pain. Our exploratory and clinical trial will be marketed towards a strict definition of 
lumbosacral low back pain without radiculopathy. The majority of these individuals have spontaneous chronic 
back pain with or without movement-induced low back pain. QST provides for additional measurements in these 
populations to characterize on-going pain and changes in pain thresholds (with pain condition and with 
experimental treatment condition).   
6. 
Recruitment of subjects 
Participants will be primarily recruited using in-clinic recruitment to the University of Pittsburgh Department of 
Physical Meditation and Rehabilitation Research Registry (PMR3) (Pitt IRB # PRO12030122; renewed 
7/20/2016). All registry participants have provided informed consent to be contacted for future research studies. 
The IRB approved advertisement for our study (see Appendix 2 – Advertisements) will be provided to the registry 
investigators to distribute to potential subjects according to the procedures established in the approved registry 
protocols. In response to the advertisement, potential subjects will directly contact the research team, if they are 
interested in participating, or Dr. Szucs will contact patients after consent into the PMR3 database. co-PI Dr. Eric 
Helm and staff Mr. Ian Smith will be our primary liaisons to identify patients in the registry and hand them our 
research study flyer. 
We will also recruit from the University of Pittsburgh Clinical and Translational Science Institute CTSI patient 
registry (Pitt + Me), which includes over 100,000 persons, and is a free resource for researchers. Finally, we will 
also utilize the free recruitment services offered by the CTSI. These services include help using bus advertising, 
community advertising, websites, and social media options for recruitment. 
The research flyer contains basic details on eligibility for the study along with contact information for Dr. Szucs. 
When prospective subjects contact Dr. Szucs (or Dr. Szucs contacts patients who have consented for 
recruitment), a thorough description of the study and its requirements will be provided. The PI will then conduct 
a brief eligibility screening to determine general health and fitness level before inviting eligible subjects to enroll. 

No private identifiable information will be recorded during this screening. Recruitment and enrollment will be 
conducted without regard for gender, race or ethnic background.  
Compensation for participation in this study is based on the number of sessions completed. Compensation for 
the intake session and each completed intervention session is $4.50 and compensation for the Exit Session is 
$100. Therefore, if a participant completes this project in its entirety (intake session, 20 intervention sessions, 
and the Exit session), they will receive $200. Only participants who complete at least 80% of all intervention 
sessions (greater than 16 of 20 sessions) and the intake session, will be invited to complete the Exit Session. If 
the subject chooses to withdraw before completing at least 80% of the intervention sessions, they will receive 
partial compensation for the sessions that they have completed. 
As part of this study, we are also interested in identifying barriers to participant interest and persistent. To identify 
these barriers, we will utilize an anonymous online survey of participants who drop out of the study. If a participant 
consents to the Duquesne study but later drops out of the study, they will be directly given a URL for a survey.   
7. 
Informed consent procedures for exercise/meditation study 
As noted above, initial consent is obtained through the University of Pittsburgh Department of Physical Meditation 
and Rehabilitation Research Registry (PMR3) (Pitt IRB # PRO12030122). This consent is obtained by UPMC/Pitt 
Physician Dr. Eric Helm (co-I), and his partners, Drs. Suehun G Ho, MD, Alan Chu, MD, and Gwen Sowa, MD 
(see Support Letter) along with Physical Medicine and Rehabilitation Clinical Research Coordinator Mr. Ian J. 
Smith, MS. Backup recruitment efforts will occur in collaboration with the CTSI (see Support Letter) using the 
Pitt + Me registry. IRB approved consent is provided when patients are entered into the Pitt + Me registry.  
Subsequent consent for the exercise/meditation study here at Duquesne occurs as follows: 
At the initiation of the intake day, Dr. Szucs will explain the purpose of the study, the methods of data collection 
and all potential risks associated with participation to prospective participants. Prospective participants will then 
be given an approved informed consent form to read, following the guidelines determined by the Duquesne 
University IRB.  If they agree to participate, they will be asked to sign two copies of the form; one copy to be 
retained by the PI and the second copy for the subject’s records. Hard copies retained by the PI will be stored in 
a locked cabinet in a locked room. Participants will be made aware during the consent process that they may 
withdraw from participation at any time during their enrollment. 
8. 
Collection of data and method of data analysis 
Qualitative analysis of the online questionnaire will identify main reasons why patients may withdraw from the 
study. Percentages of eligible participants who withdraw will be carefully monitored and reported providing more 
accurate estimates of recruitment rates and target population numbers.  Proportion estimates will be reported to 
assess percentages who actually complete the intake questionnaires as well as adherence to the four-week 
intervention and all daily measurements. 
To address the evaluation of the four key elements; meditation, anxiety and stress, fitness and general health, 
and pain, a variety of analyses and descriptive statistics are necessary to calculate key estimates needed to 
inform the design and power of a large-scale trial given the different variable types and repeated measures 
embedded in the methodology. The primary assessment for this study will be a reduction in disability. Means 
and standard deviations will be reported for all quantitative measures for all groups, effect sizes for comparisons 
of means and repeated measures, and proportion estimates will be reported for qualitative variables. Where 
appropriate, correlations between various assessments of mindfulness, pain and disability (self-reported and 
quantitative measures), anxiety/fear, and activity (i.e. IPAQ-short and exercise performance) will be analyzed. 
9. 
Emphasize issues relating to interactions with subjects and subjects' rights 
Subjects will be notified of their rights, all risks and benefits of participation in this study during the informed 
consent procedure.  Subjects will be informed that they may withdraw from participation at any time.  Data 
collection sessions will be scheduled at times that are mutually convenient for the subject and the researchers 
and all efforts will be made to work with the subject’s schedule.   
Subjects will be instructed that they are able to stop intervention and pain measurements at any time if they 
experience excessive discomfort/pain. Treadmill exercise occurring at Duquesne will be monitored visually by a 
researcher in the adjacent room using a wireless camera system. Physiological measures, including heart rate, 
will also be monitored in real-time to ensure no issues during exercise. Subjects will be encouraged to stop 
exercise if they experience any discomfort or symptoms of over-exertion (≥ 17 on the Borg RPE scale). These 
symptoms will be explained during the informed consent process. There is a risk of falling off the treadmill. 
Subjects will be instructed to hold onto the rails if they feel like they are losing their balance or are going to fall. 

The safety key will be on the waist of their pants to turn off the treadmill if they move too far back on the belt. 
Specific instructions will be given to patients who exercise or participate “at home.” 
Though the likelihood is minimal, there is also a risk of a serious cardiac event, including loss of consciousness, 
chest pain, shortness of breath, and myocardial infarction, associated with performing moderate intensity 
exercise. To minimize this risk, eligibility criteria have been set to ensure healthy adults with low risk are enrolled 
in this study.  
During exercise at Duquesne, participants will be monitored for signs associated with a cardiac event based on 
the American College of Sports Medicine (ACSM) Indications for Terminating Exercise Testing protocol. These 
indications include: onset of angina, signs of poor perfusion (dizziness, confusion, light-headedness, ataxia), 
failure of heart rate to rise with exercise, severe fatigue, or subject request to stop. To determine if any of these 
indications occur, participants will be visually monitored and heart rate will displayed in real-time at Duquesne 
trials. All participants will be notified that they may stop exercising if they feel short of breath, chest pain, abnormal 
back pain, or extremely fatigued. Also, patients are instructed that if they feel that their exertion reaches a 17 on 
the Borg Scale, they can stop walking. All research staff will be trained on this protocol and medical emergency 
management associated with a medical event. An emergency action plan will be stored in the laboratory and will 
be reviewed quarterly. Dr. Helm, MD will serve as our medical PI on this study. Any adverse reaction will be 
evaluated by Dr. Helm within 1 week of the event. “At home” trials will be additionally monitored through an online 
diary using Qualtrics Survey Platform, which allows the patient to record adverse events for the PIs. Qualtrics is 
supported by both Duquesne University and the University of Pittsburgh for research using surveys. Qualtrics 
servers are protected by high-end firewall systems and use Transport Layer Security encryption for all 
transmitted data. For ‘at home’ trials, subjects cannot be monitored for signs associated with a cardiac event, 
however, subjects will be made fully aware of these signs and told to stop exercising if they experience any of 
these symptoms. Subjects will be instructed to contact Dr. Szucs or Dr. Kostek via a Google Voice number 
immediately when these symptoms occur. If these symptoms do not resolve within 15 minutes of resting, subjects 
will be instructed to seek medical help.  Any adverse events will be discussed immediately (subjects will have 
Dr. Helm’s, Dr. Szucs’ and Dr. Kostek’s contact information) and during the single trial that occurs each week at 
Duquesne. To ensure Dr. Szucs or Dr. Kostek is available to take these phone calls, a Google Voice number will 
be set up. This is the phone number subjects will be given. Calling this number will route the call to any of Dr. 
Szucs’ or Dr. Kostek’s existing phone numbers while maintaining privacy of personal contact information. 
Risk of injury related to cutaneous mechanical testing is extremely rare and unlikely4.  Mechanical testing is 
widely used and safe.  Risks to the individual are minimal, because 1) subjects are instructed that they may stop 
any procedure at any time with no adverse consequences; and 2) the level of sensation experienced by subjects 
is at or below their tolerance level and threshold for pain.  
Risk of injury related to thermal pain testing is minimal4.  Thermal testing is widely used and safe.  While thermal 
testing does produce pain, risks to the individual are minimal, because 1) the pain is transient in nature and 
generally subsides immediately after the procedure; 2) subjects are instructed that they may stop any procedure 
at any time with no adverse consequences; and 3) the level of pain experienced by subjects is below their 
tolerance level.  With thermal stimulation there is a very slight risk of a burn, but this is minimized by the following: 
1) positive lockout of stimulus parameters above 50°C; 2) the stimulator has built in a shut-down system to 
prevent the delivery of prolonged or high intensity stimuli (20 sec); 3) and before each use, temperature at probe 
will be verified with an electronic thermometer.  Trials will proceed only if temperature detected at 20 sec cutoff 
is < 50oC. Colleagues who have used this pain paradigm inform us that they have completed thermal testing with 
this stimulator on over 1000 subjects without producing a single burn. However, skin will be monitored for 
changes consistent with burns, such as redness that persists greater than one day and blistering. If a burn 
occurs, standard medical treatment will be recommended. 
Risk of injury related to pressure pain testing is minimal4,7.  Pressure testing is widely used and safe.  While 
pressure testing does produce pain, risks to the individual are minimal, because 1) the pain is transient in nature 
and generally subsides immediately after the procedure; 2) subjects are instructed that they may stop any 
procedure at any time with no adverse consequences; 3) the level of pain experienced by subjects is below their 
tolerance level; and 4) the pain applied is never more than that subjects pain threshold, which is well below any 
pressure that could cause damage.      
Participants will be made aware during the consent process that they may withdraw from participation at any 
time during their enrollment. 
 
 

URLS TO GUIDED MEDITATION RECORDINGS 
We have carefully chosen the following guided meditation recordings based on the experience and practice 
with guided meditation in a counseling setting of our clinical psychologist (Dr. Ian Edwards). All recordings are 
from the world-renowned meditation teacher and psychologist Dr. Tara Branch (https://www.tarabrach.com). 
One of the aspects of Dr. Branch’s work that resonates and fits well with the current proposal is her interest in 
multiple types of guided meditation. This diverse approach recognizes that meditation is not a “one size fits all” 
intervention. Our hope is that by including a selection of five recordings that all have elements of mindfulness 
that we will help novice patients get used to meditative practice and prevent boredom during the 4-week trial 
(each recording will be listened to 1x per week).  
Recording 1 (16:58): https://www.tarabrach.com/meditation-vipassana-insight/  
Recording 2 (15:58): https://www.tarabrach.com/meditation-quieting-mind/ 
Recording 3 (12:36): https://www.tarabrach.com/meditation-relaxing-back-presence-2/ 
Recording 4 (17:08): https://www.tarabrach.com/meditation-living-presence-3/ 
Recording 5 (12:18): https://www.tarabrach.com/meditation-basic-body-scan/  
 
 
 

References: 
1. 
Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. 
In: Academies IoMotN, ed. Washington D.C.2011. 
2. 
Cornwall A, Donderi DC. The effect of experimentally induced anxiety on the experience of pressure 
pain. Pain. 1988;35(1):105-113. 
3. 
Wierwille L. Fibromyalgia: diagnosing and managing a complex syndrome. J Am Acad Nurse Pract. 
2012;24(4):184-192. 
4. 
Rolke R, Magerl W, Campbell KA, et al. Quantitative sensory testing: a comprehensive protocol for 
clinical trials. Eur J Pain. 2006;10(1):77-88. 
5. 
Kostek MC, Polaski AM, Kolber BJ, Ramsey A, Kranjec A, Szucs KA. A Protocol of Manual Tests to 
Measure Sensation and Pain in Humans. Journal of Visualized Experiments. 2016;118(e54130). 
6. 
Dewhirst MW, Viglianti BL, Lora-Michiels M, Hoopes PJ, Hanson M. Thermal Dose Requirement for 
Tissue Effect: Experimental and Clinical Findings. Proc SPIE Int Soc Opt Eng. 2003;4954:37. 
7. 
Kinser AM, Sands WA, Stone MH. Reliability and validity of a pressure algometer. J Strength Cond 
Res. 2009;23(1):312-314. 
8. 
Borg G. Psychophysical scaling with applications in physical work and the perception of exertion. Scand 
J Work Environ Health. 1990;16 Suppl 1:55-58.