Study Protocol
Date:

March 2014

Version:13

Project Title:

Assessment of Chiropractic Treatment for Low Back
Pain and Smoking Cessation in Military Active Duty
Personnel

Grant Title:

Defense Health Program (DHP) Chiropractic Clinical Trial
Award (W81XWH-11-2-0107)

Co-Principal Investigators:

Ian D Coulter, PhD
RAND Corp/Samueli Chair in Integrative Medicine
Christine Goertz, DC, PhD
Palmer College of Chiropractic/Vice Chancellor for
Research and Health Policy
Joan Walter, JD, PA
Samueli Institute/Vice President, Military Medical
Research Programs

CONFIDENTIALITY STATEMENT
The information contained in this document, especially unpublished data, is the property of Palmer
College of Chiropractic and is therefore provided to you in confidence as an investigator, potential
investigator, or consultant, for review by you, your staff, and an applicable Institutional Review
Board/Independent Ethics Committee. It is understood that this information will not be disclosed toothers without written authorization from a Co-Principal Investigator listed above.

Revisions:
4/14/2011

Corrected the grant contract number.

06/02/2011Version 4.1

Updated the Tobacco (Smoking) Cessation protocol.

06/14/2011Version 4.2

Updated 5.6 Reporting of Adverse Events with more exact details of the reporting
process.

08/05/2011Version 5

Added the reference list.
Updated the Data Collection (added PROMIS-29; removed SF(RAND)-36).
Removed minimization on tobacco use.
Added outline for tobacco cessation training webinar.
Updated the Timeline (Table 2).

08/30/2011Version 6

Updated the Qualitative Analysis and Quality Assurance section.

012/01/2011Version 7

Added e-mail and text language (pg 20).
Added more specific on back-up network storage (pg 30).

03/08/2012
Version 8

Editorial changes (i.e. abbreviations spelled out; spelling errors corrected;
Ensured consistent use of CMT (Chiropractic Manipulative Therapy) and CMC(Conventional Medical Care)
Enlisted military personnel was changed to active duty military personnel in Specific
Aim #1 (page 12)
National Navy Medical Center was changed to Walter Reed National Military Medical
Center (WRNMMC)
Tobacco Cessation- Flow chart was added (Figure 11); description of studyndchiropractor’s tobacco education survey is now described at the bottom of the 2paragraph.
Data Storage now states that the ICD/HIPAA documents will be kept in a locked filingcabinet.
Timeline (Table 2) has been updated.
Added:
Appendix B- Tobacco Cessation course handouts
Appendix B- Tobacco Cessation study chiropractor’s survey
Appendix C- Blackboard Connect Protocol, including e-mail, voicemail, and text
script reminders for assessments and appointments.

4/18/2012
Version 9

Added Appendix D- Data Collection Forms (Exam and DC Treatment)

7/23/2012
Version 10

Removed Communication Plan
Updated Section 5.2 Participant Visit Protocols, Section 5.5.2 Data Storage & Table 2
Added Appendix E- Participant Certification

8/29/2012
Version 11

Removed Phase II from the protocol
Qualified “altered mental capacity” exclusion criterion
Changed PCP to stand for primary care provider versus primary contact provider
Removed “Unable to speak English” as an exclusion criterion since all active duty
personnel are required to speak English
Updated Exam form. Qualified the mental health question (#5) and updated thereferral/further testing question for clarity (#6)
Updated Treatment form. Added relevant ICD codes were added and added anothertobacco cessation option.
Updated Blackboard Connect Protocol (Appendix C): “Modifications to this protocol
may occur based on individual participants needs or request.” Page 67
Updated Data Storage: “Treatment and Exam forms will be kept in the locked cabinet
for a maximum of 7 days after all information has been entered into the CTCC
database.” Page 32
Removed Rock Island Arsenal as a recruitment site. Page 18
Reduced the sample size to 750, since we are no longer recruiting the 100 participantsfor Rock Island.

6/26/2013
Version 12

Section 2.1- Updated document to reflect the removal of Rock Island (changed 4 sites to 3 sites);
Removed RI from Figure 2 and Figure 4.
- Changed ‘smoker’ to ‘tobacco-user’Section 4.1. Added ‘Site PIs and PMs will have one-on-one monthly meetings with the
PI and lead PM at Palmer.”
Section 5.1.1.1 – clarified low back pain episode
Section 5.1.2 – Eligibility criteria- Added time frame for spinal fracture- Added exclusion criterion of ‘spinal surgery within 12 weeks)- Clarified exclusion of pregnancy by adding ‘planning to become pregnant within 8
weeks’
Section 5.2.1 – removed information sheet and changed photocopy of ICD to just a
copy of the ICD will be given to the participant.
Section 5.2.2 Added in recruitment from an acute care provider; removed “It is at thispoint that patients complaining of LBP are typically either prescribed medication orreferred to the base chiropractor.”; added independent duty corpsman as eligible tocomplete the baseline exam and give conventional medical care; and added that theexam form and baseline interview needs to be completed within 2 weeks of eachother.
Section 5.2.3 Treatment Visits- Clarified frequency/duration of chiropractic treatment based on what we haveobserved to date
- Clarified methods that Samueli/RAND will use when evaluating differences inparticipant treatment schedules- Under “Tobacco Cessation’ section – changed method of re-training to allow forother training methods- Changed frequency that chiropractor will complete a baseline tobacco cessation
survery from ‘3 months after recruitment begins’ to ‘1 year after recruitment begins’.
Section 5.3 – clarified that NRS is on a 0-10 rating scale versus 0-11 which was
inadvertent error
Section 5.3.2 – removed sentence pertaining to SF-36 as SF-36 was previously removed

March 2013
Version 13

and replaced with PROMIS-29.
Section 5.4 – added clarification of reporting procedures for protocol deviations
Section 5.5.1 and Appendix D- Removed use of Blackboard connect as method of reminding participants tocomplete study assessments; added new protocol for reminding participants of theirassessments, as well as method for obtaining outcomes not collected at week 6 andmonth 3
Section 5.5.3 Compliance and Co-Interventions – Clarified participant follow-up andcompliance plan.
Section 5.5.2 Data Storage – removed ‘for a maximum of 7 days after all information
has been entered into CTCC database’ and replaced ‘As soon as it ci completely
entered in the CTCC system, the forms will be shredded’ with ‘After information has
been entered into the database, it will be stored in the locked cabinet for up to 7
years after the study has been completed.’
Section 5.6- Revised and clarified process for collecting, reporting, and reviewing adverse events(see Reactions and Discomforts section in Week 2/4 or Week 6 Assessment inAppendix A)- Clarified reporting procedures for protocol violations- Under ‘Quality Analysis and Quality Assurance’ section – revised frequency ofSamueli/RAND site visits
Section 6.0: Timeline - Updated
Appendix A: added screenshots of all web-based assessments
Appendix D: removed Blackboard connect communication table; removed data planpertaining to use of Blackboard connect; removed Blackboard connect scripts nolonger being utilized
Appendix E: Data collection forms- Added revised physician exam form
- Added revised treatment form
Section 5.6
Added procedures for ‘Qualitative analysis and quality assurance’ section

Table of Contents
Table of Contents .......................................................................................................................................... 5
BACKGROUND ............................................................................................................................................... 8
1.1

Introduction .................................................................................................................................. 8

1.2

Summary of Significance ............................................................................................................. 14

2.0

STUDY DESIGN................................................................................................................................. 15

2.1

Specific Aims ............................................................................................................................... 15

2.2

Sample and Methodology ........................................................................................................... 16

3.0

OVERVIEW OF TRIAL ORGANIZATION ............................................................................................. 16

4.0

MAJOR STUDY COMMITTEES .......................................................................................................... 17

4.1

Internal Steering Committee ...................................................................................................... 17

4.2

External Advisory Committee ..................................................................................................... 17

4.3

Data and Safety Monitoring Committee ..................................................................................... 17

4.4

Institutional Collaboration and Support ..................................................................................... 18

4.5

Publication Committee ............................................................................................................... 18

5.0

RESEARCH DESIGN & METHODS ..................................................................................................... 19

5.1

Study Population ......................................................................................................................... 19

5.1.1

Participant Recruitment ...................................................................................................... 20

5.1.2

Eligibility Criteria ................................................................................................................. 20

5.1.3

Randomization .................................................................................................................... 21

5.1.4

Overview of Data Collection ............................................................................................... 21

5.2

Participant Visit Protocols ........................................................................................................... 22

5.2.1

Baseline Visit (BL) ................................................................................................................ 22

5.2.2

Exam .................................................................................................................................... 23

5.2.3

Treatment Visits .................................................................................................................. 24

5.3

Primary Outcomes ...................................................................................................................... 27

5.3.1

Data Analysis ....................................................................................................................... 29

5.3.2

Sample Size ......................................................................................................................... 30

5.4

Reporting of Protocol Deviations ................................................................................................ 31

5.5

Data Monitoring .......................................................................................................................... 31

5.5.1

Data Management .............................................................................................................. 31

5.5.2

Data and Safety Monitoring Plan. ....................................................................................... 32

5.5.3

Compliance and Co-Interventions ...................................................................................... 34

5.6
6.0

Reporting of Adverse Events ....................................................................................................... 34
TIMELINE ......................................................................................................................................... 38

References .................................................................................................................................................. 39
Appendix A: Participant Web-based Study Assessments .............................. Error! Bookmark not defined.
Baseline Interview ...................................................................................... Error! Bookmark not defined.
Baseline Exam ............................................................................................ Error! Bookmark not defined.
Baseline Assessment .................................................................................. Error! Bookmark not defined.
Week 2 and Week 4 Assessments.............................................................. Error! Bookmark not defined.
Week 6 Assessment (Primary Endpoint) .................................................... Error! Bookmark not defined.
Month 3 Assessment.................................................................................. Error! Bookmark not defined.
Appendix B: Tobacco Course Handouts ......................................................... Error! Bookmark not defined.
Presentation: Helping your Patients Quit- Guide ...................................... Error! Bookmark not defined.
Activity 1 - Invent your tobacco user ......................................................... Error! Bookmark not defined.
Activity 2 – Motivation and Opportunity ................................................... Error! Bookmark not defined.
Activity 3 - Role-play using scenario cards ................................................. Error! Bookmark not defined.
HELPING YOUR PATIENTS........................................................................... Error! Bookmark not defined.
QUIT TOBACCO .......................................................................................... Error! Bookmark not defined.
Provider Instructions for Using the Personal Quit Plan ............................. Error! Bookmark not defined.
The Personal Quit Plan ............................................................................... Error! Bookmark not defined.
The Personal Quit Plan Follow-Up ............................................................. Error! Bookmark not defined.

Patient Materials........................................................................................ Error! Bookmark not defined.
Appendix C: Tobacco Cessation DC questionnaire ........................................ Error! Bookmark not defined.
Appendix D: Assessment Reminder and Follow-Up Protocol ........................ Error! Bookmark not defined.
Appendix E: Paper-Based Data Collection Forms .......................................... Error! Bookmark not defined.
Appendix F: Participant Certification ............................................................. Error! Bookmark not defined.

BACKGROUND
1.1 Introduction
The focus of this study is on low back pain (LBP) for several critical reasons. First, LBP is well-recognized
as a public health problem in both military and civilian populations. Second, ninety percent of LBP inclinical practice is diagnosed as “idiopathic,” because its pathophysiology, diagnosis and treatment are
not well understood.1,2 This pervasiveness, as well as the lack of understanding of the condition, have
led to a consensus among experts on the importance of an extensive research agenda focusing on
clinically relevant scientific questions about the problem.3,4 Third, LBP has no cure, or even a “silver
bullet” medical approach. Carey et al. (2009) recently conducted a survey to determine health careutilization patterns in patients with chronic LBP.1 They found high health care utilization in this group,with an average of 21 visits to an average of 2.7 provider types annually. Many of the tests andtreatments used did not conform to evidence-based practice. The authors conclude that 1) careutilization for chronic LBP is very high, including high rates of use of advanced imaging, narcotics, andphysical treatments; 2) use of evidence-based treatments is low when compared with current best
evidence; and 3) many treatments appear to be over-utilized. Fourth, the most recent comprehensive
survey of complementary and alternative medicine (CAM) use in the US showed that 17% of those who
use CAM treatments, including chiropractic, do so for back pain or problems, making it the mostcommon and costly condition for which chiropractic treatment is sought.5 Fifth, a cadre of randomized
clinical trials (reviewed below) generally shows a positive benefit from chiropractic manipulative therapy(CMT), the cornerstone of chiropractic practice, for LBP. Finally, investigators for this study are able topresent pilot data demonstrating the effectiveness of CMT in active duty military personnel for LBP(reviewed below).
Overview of Low Back Pain and the Use of Chiropractic Manipulative Therapy: LBP is a well-recognizedpublic health problem in the US with estimates of overall prevalence ranging from 12-33% and one year
prevalence ranging from 22-65%.6 Back pain is the 2nd most frequent reason for physician visits, the 5thfor hospitalizations, and 3rd for surgery. There is no question it is debilitating to society: in the civilian
sector, work-related cases result in over one million lost work days per year and nearly 15 times thatmany visits to medical doctors. Care and productivity cost estimates in the US are at least $26 billion ormore annually.7,8
Low Back Pain in the Military
Low back pain (LBP) is the most common cause of disability worldwide, but it is even more prevalent in
active duty military personnel. A recent study published in Archives of Internal Medicine reported thatback pain is most prevalent in soldiers in combat deployments, and it is among the most likely
conditions to interrupt combat duty.9
In fact, more than 50% of all diagnoses resulting in disability discharges from the military across all
branches are due to musculoskeletal conditions.10. A study by Jones and Hanson (2010) found that

payments to veterans amounted to $485 million to newly disabled Army personnel in 1993.11 Lincoln
and colleagues examined the natural history and risk factors that led to disability among US Army
personnel.12 Their study was a retrospective cohort that followed active-duty Army personnel frominitial hospitalization for a musculoskeletal-related condition for years 1989-1996 through thedevelopment of physical disability up to 1997. To be included in the study, subjects had to have been on
active duty at the time of hospitalization, been hospitalized for a musculoskeletal disorder or severe
sprain/strain during 1989-1996, and have completed a health risk appraisal during that period. Data
were derived from the Total Army Injury and Health Outcomes Database. The outcome of interest,
disability, was defined as having been assigned the following status at a medical evaluation board during
the study period and up to 1997:•••

Permanent disability/retirement (disability rating of at least 30% or having 20 years of service)
Severance without benefits (disability rating of less than 30% and having less than 20 years ofservice)
Temporary disability (similar to permanent disability except for the possibility that the condition
will change within the next five years and enable the subject to return fit for duty)

The data from this project demonstrated that intervertebral disc degeneration had the highest
cumulative disability at 6 and 12 months, and that the five-year cumulative risk of disability was highest
for intervertebral disc degeneration, intervertebral disc derangement and non-specific back pain. One
surprising finding was that personnel at highest risk included those with 1-4 years of service, similar to
the group under study in this project, compared to those with more than 10 years of service. Backconditions were associated with the highest 5-year cumulative risk of disability discharge, making thema critical issue with regard to troop and personnel readiness.
Back pain has been characterized as “The Silent Military Threat,” because of its negative impact on
mission readiness, and the degree to which it compromises a fit fighting force. For these reasons,military personnel with LBP need a practical and effective treatment that relieves their pain and allows
them to return to duty quickly, but also one that preserves function and military readiness, addresses
the underlying causes of the episode and protects against re-injury. The DoD/VA clinical practiceguidelines (CPG’s) for the treatment of LBP offer wide options for care. These include screening for “redflag” indicators of potential surgical or medical urgencies, and first-line treatments including NSAID’sand acetaminophen; patient education on the importance of exercise; and monitoring anddocumentation of clinical course. However, they are generally focused on standardizing minimum careand documentation that can be applied in all practice settings where service members are treated, andless focused on long-term strategies for the minimization of lost duty time and for secondary
prevention. The program of research proposed herein is aimed at meeting the needs to establish
evidence-based standards of care for acute, sub-acute and chronic LBP, which can be integrated in to
the healthcare systems for all active-duty personnel, including combat-deployed troops and Special
Operation Forces.

Definition of Chiropractic Manipulative Therapy
Chiropractic manipulative therapy (CMT) is a manual therapy commonly used to treat low back pain andis the cornerstone of chiropractic practice. The procedure in its broadest definition describes thetherapeutic application of a load (force) to specific body tissues (usually vertebral joints). CMT can varyin terms of its velocity, amplitude and frequency, as well as anatomical location, choice of levers, anddirection of force application.13,14 In a course of care, the dosage of CMT (e.g. in terms of treatment
frequency) can also vary significantly. Numerous procedures are used in practice, but a more detailed
and quantitative biomechanical picture of CMT is emerging from studies on the forces applied and theresultant kinetics and kinematics.14-16 CMT can be divided into two broad categories by their force/time
profiles: those maneuvers that deliver a high-velocity low amplitude load or impulse “thrust” to bodytissues (HVLA- CMT) and those that deliver a low-velocity variable amplitude load (LVVA- CMT).17-19
Velocity refers to the speed with which a load is applied, while amplitude refers to the depth of thethrust into body tissues. HVLA manipulations are called “adjustments” by chiropractors, or“manipulation” by other professionals. Both terms distinguish it from LVVA maneuvers, which mostexperts label as “mobilization”.14,20 HVLA- CMT procedures are often associated with a cavitation soundor “crack,” as synovial joint linings are quickly separated. In contrast, in low-velocity maneuvers, theloads are applied slowly, and the amplitude (depth) of each load may vary depending on the clinicalsituation. Both forms of CMT are typically used by most doctors of chiropractic and both will be used inthis study.
Figure 1. Proposed Mechanisms of Action for CMT

M
A
S N
P I
I P
N U
A L
L A
T
I
O
N

BIOMECHANICALSTRUCTURAL DYSRELATIONSHIPMECHANICAL OVERLOAD

NEURAL
EFFECTS

PARASPINALSENSORY RECEPTORSNERVE ROOTS IN
INTERVERTEBRAL FORAMENCENTRAL NEURALSTIMULATED BY, INHIBITED BY, AND/OR SENSITIZED TO
VERTEBRAL MOTION, COMPRESSION AND ENDOGENOUS METABOLITESCENTRAL
FACILITATIONCLIINICAL OUTCOMES
ALTERED MUSCLE TONE
ALTERED MECHANICAL MOVEMENT

Figure 1 presents a flow diagram depicting one of the predominant theoretical paradigms used tounderstand the physiological basis for CMT 21, developed by Dr. Joel Pickar at the Palmer Center for
Chiropractic Research. It shows the potential mechanistic relationships between segmental

biomechanics, the nervous system, chiropractic manipulation therapy and end-organ physiology. The
figure is not all inclusive; circulatory and immunological changes in response to CMT have also beensuggested.22,23 The dark black line represents a “black box” of mechanisms by which a disordered motion
segment is thought to contribute to a patient’s symptomatology in general. The facet joints are thought
to become restricted, disturbed or functionally asymmetric due to paraspinal muscle dysfunction,
synovial meniscoids or inclusions trapped between articular surfaces of the facet joints, intra-articular or
myofascial adhesions and/or distortion of the annulus fibrosus.24-29 Any of these vertebral
dysrelationships may produce a biomechanical overload with effects on nerve roots or spinal cord
directly or via meningeal traction, or on surrounding paraspinal tissues that secondarily alter their
physiology including the signaling properties of mechanically- or chemically-sensitive neurons in theparaspinal tissues.30 The changes in neural activity are thought to modify neural integration, either bydirectly affecting reflex activity and/or by affecting central neural integration within motor, nociceptive
and autonomic neuronal pools. Pain, discomfort, altered muscle function or autonomic function
comprises the signs or symptoms that might cause patients to seek CMT. Mechanical treatment using
manipulation, then, theoretically alters the inflow of sensory signals from paraspinal tissues or activity ofcentral neurons either by direct effects on the nervous system or via indirect effects on tissue
biomechanics. A goal of CMT is to remove joint restrictions and “restore maximal, pain-free movementof the musculoskeletal system”.22,27,31,32
Randomized Controlled Trials (RCTs) of chiropractic manipulation therapy
The 1975 NINCDS conference on the “Research Status of Spinal Manipulative Therapy” pointed out thelack of any significant research to justify claims made by chiropractors or any other practitioner of
CMT.33 By 1992, at least 45 RCTs of all forms of CMT for the treatment of acute, sub-acute and chronic
LBP have been published.8 Thirty-one favored CMT over the comparison treatments in at least a
subgroup of patients, and the rest found no significant differences8.
The majority of systematic reviews are in agreement that CMT appears to reduce pain and disability atleast some of the time to some degree for a significant proportion of LBP patients.34-37 They also agree
on the highly variable quality of extant trials and reviews 38,39, on the inconsistent results, small effectsizes, and large variation in outcomes.40,41 Part of the problem is attributable to poor trial
methodologies, part to poor execution and reporting, and part is probably due to the large variation in
CMT treatments that have been studied. Finally, it is suspected that there is large and as yet unidentified
heterogeneity in LBP patients.42
The unexplained inconsistency in RCT results currently obscures the true utility of CMT for LBP patientsand contributes to ongoing debate. Current RCT evidence has not ruled out CMT’s potential
effectiveness for LBP, but the appropriate role of CMT in treating LBP has not been confirmed; thus
additional high quality RCTs are required.11,37,43,44 Successful completion of the study aims outlined inthis proposal will not only provide critical information regarding the impact of CMT in military
populations; it will also represent the largest multi-site randomized clinical trial conducted to evaluate
CMT to date.

Chiropractic manipulation therapy and Chiropractic
CMT delivered by doctors of chiropractic is commonly used by LBP patients. Although CMT is atreatment procedure used by both conventional and CAM professions, chiropractors provide over 90%
of CMT in the US.4 Chiropractors report using some form of CMT on at least 80% of their patients.45,46 At
least 7.5% of the US population seeks care from chiropractors annually, representing approximately 190
million patient visits.5,47 A national survey of patterns and perceptions of care found that 20% of thosereporting back or neck pain sought chiropractic care, while 37% sought conventional care.48 Surveys
suggest that patients are highly satisfied with chiropractic care.49,50 More than 60% of chiropractic
patients report their care as being “very helpful,” while 27% report the same for conventional medicalcare.48
Comparative Effectiveness ResearchThis protocol describes a comparative effectiveness trial (CER). The Institute of Medicine definition 51 forComparative Effectiveness Research (CER) is:“CER is the generation and synthesis of evidence that compares the benefits and harms of alternative
methods to prevent, diagnose, treat and monitor a clinical condition, or to improve the delivery of care.
The purpose of CER is to assist consumers, clinicians, purchasers, and policy makers to make informed
decisions that will improve health care at both individual and population levels.”
The Agency for Healthcare Research and Quality (AHRQ) states that their Effective Health Care Program
purpose is to fund research that provides reliable and practical data that can inform decisions in clinicalpractice.52 CER has been identified by several names in the past: pragmatic trials, head-to-head trials
and practical clinical trials.
Some writers have contrasted CER (or Practical Clinical Trials – PCTs) trials to explanatory trials 53, which
are hypothesis driven and usually done with the hope of revealing the biological effect of a treatment. In
contrast CER or pragmatic trials are done to assist decision makers. Zwarenstein and Treweek (2009)
note that there is often a mismatch between the clinical setting in which decisions must be made andthe RCTs (explanatory trials to test hypotheses).54 They note “evidence from an explanatory trial isunlikely to inform a pragmatic question, nor vice versa…”.51
One key feature of CER is a focus on effectiveness rather than efficacy.55 Efficacy establishes a causal
connection between an intervention and a specific outcome. To do this it is necessary to control allbiases so that the only thing contributing to the outcome is the specific intervention. This requires thatthe enrollments in the trial are controlled and random, that the intervention is standardized andcontrolled (it must be constant and identical across all subjects), that the populations are homogeneousand that the outcome measures are standardized and objective. These trials will have at least two arms,
one where the intervention is given and one where a sham treatment or a placebo is given. Individual
subjects are randomly allocated to one of the arms. Neither the provider of the therapy nor the patient
should know which arm of the trial the patient is in (double blinding).

The problem is that to achieve the kind of controls you need for an efficacy RCT, you end up creating asituation that is very different from the normal way in which the therapy will ultimately be practiced in
the real world. The exclusion criteria for the subjects in the trial may be so restrictive that the very subpopulations the provider wants to treat were not even included in the trial. In summary, the evidence
from efficacy RCTs may be rigorous but not relevant to the real world of practice. Most methodologists
describe pragmatic trials as enrolling all patients to whom health care providers might offer theintervention, allowing clinicians to administer the intervention and co-interventions without restrictions
and measuring patient-important outcomes.56 Maclure (2009) in discussing how to describe pragmatic
trials to policy makers, states “pragmatic trials are real-world studies for decision whereas explanatory
trials are specialized studies for information.”57 The investigative team has chosen a modified
comparative effectiveness approach for the proposed study that combines elements of both efficacy
trials and pragmatic trials. We believe that this is the best way to answer questions that will bemeaningful to policy makers as they consider the appropriate role for CMT in active duty military
populations. Further, our experience in the conduct of clinical trials in military treatment facilities (akasite) has shown us that this type of trial is feasible to conduct in busy clinical practice settings.
Smoking in the Military
Smoking is a known major public health concern in the United States. Recent statistics indicate that
20.6% of American adults, or 46 million people, smoke.58 Smoking is a proven risk factor for major
illnesses, such as lung cancer, chronic obstructive pulmonary disease (COPD), heart attacks, stroke and ahost of other related cancers and vascular syndromes.59 The individual lifelong impacts of smoking
include decreased overall quality of life, significant disability that affects work life and productivity, as
well as decreased life expectancy. The societal impact in the United States has been estimated as:
number of smoking-related deaths per year (450,000); productivity loss due solely to smoking-relatedpremature deaths of workers ($97 billion); and medical costs for smoking-related illness ($96 billion).58
Smoking in the military is associated with even more disturbing statistics. A 2009 report by the Instituteof Medicine reported an overall smoking rate of more than 30% in active duty (AD) personnel.
Additional data suggest that as many as two thirds of military personnel deployed use tobacco. The
report recommended that the DoD close “the pipeline of new tobacco users entering the military andpromote cessation programs to ensure abstinence.” Furthermore, it urged the military to “treat tobacco
use in the same way as other health-related behaviors, such as alcohol abuse and poor physical fitness.”
The 2005 DoD Survey of Health-Related Behaviors reported that smoking rates were highest among
members of the Army and Marine Corps (38.2% and 36.3%, respectively); smoking was more prevalent
among men than women (37.8% v. 35.5% overall, respectively); and that the 18-25 year old segment of
the military has higher smoking rates (38.7%) than the 26-55 year-olds (35.7%).60
The high costs of smoking in the military, reportedly $564 million 61, are driven higher still when one
considers literature indicating that smokers are more likely to fail trainings and PT tests;62-64 indulge inother substance abuse behaviors; and to sustain injuries, particularly musculoskeletal injuries.65,66 Since
the heaviest tobacco use occurs in the same populations that characterize young combat soldiers andMarines, who are more prone to injury, and given the high overall rates of tobacco use in the military, it
is appropriate that programs targeting smoking cessation be evaluated in military patients seeking carefor LBP.
Research has linked smoking with back pain, identifying it as a risk factor for back pain severity andduration.67-69 Smoking has also been implicated as self-medication for back pain.70 It therefore comes as
no surprise that chiropractors have taken increasing interest in promoting cessation of tobacco use by
their patients.71,72 Gordon et al found that chiropractors in Oregon advise their patients to quit smoking
and were interested in learning more about helping their patients quit smoking.73 The authors
subsequently developed and pilot tested a tobacco cessation program tailored for use in private
chiropractic practice. Cessation outcomes were positive and the program was found to be promising.74
It should be noted that no randomized trials have assessed the effect of CMT for smoking cessation.36
There is no current reason to suspect a direct effect on tobacco cessation. However, CMT might help
relieve back pain, which in turn might reduce patients’ need to self-medicate with tobacco. A recent
study by Gordon et al provides both preliminary data and a smoking cessation program for delivery bydoctors of chiropractic, which form the model for the proposed nested study of tobacco cessation.74 We
will attempt to replicate these findings in active duty smokers with LBP.

1.2 Summary of SignificanceThe significance of this study is high. Low back pain (LBP) is a prevalent public health problem in boththe military and civilian populations. Currently a clear “gold standard” medical treatment for low backpain does not exist and studies show that evidence-based guidelines are rarely used in general practice.
Thus, there is a need to consider innovative treatment options for chronic diseases such as LBP. Our
preliminary data suggest that chiropractic manipulative therapy (CMT) in addition to standard medicalcare may be superior to standard medical care alone in active duty service members. In addition,
doctors of chiropractic are well positioned to provide information to support tobacco cessation. The
results from this randomized clinical trial, with a nested tobacco (smokers and smokeless tobacco users)
cessation intervention will provide critical information regarding the health and mission-support
benefits of chiropractic health care delivery for active duty service members in the military.

2.0 STUDY DESIGN
2.1

Specific Aims

The primary objectives of the proposed study described in this clinical protocol are to: 1) assess theeffectiveness of chiropractic manipulative therapy (CMT) for pain management and improved functionin active duty service members with low back pain that do not require surgery; and 2) to assess theimpact of a chiropractic intervention on smoking cessation. This study will focus on active duty service
members who are not deployed in theater.
The primary hypothesis is that CMT, in
addition to conventional medical care, will
provide significantly better pain relief andimproved functional status in volunteers
with LBP than conventional medical carealone. A secondary hypothesis is that
education and monitoring of tobacco
habits provided during routine chiropractic
care visits for LBP will result in a significant
decrease in the average number of tobacco
use per week among those who selfidentify as a tobacco user at baseline.
Please refer to Figure 2 ‘Chiropractic Trials
Figure 2. Chiropractic Trials Logic Model.
SPECIFIC AIMS
A multi-site RCT will be conducted at 3 militarysites [Walter Reed National Military Medical
Center in Bethesda, MD (n = 250); Naval
Hospital in Pensacola, FL (n = 250); Naval
Medical Center in San Diego, CA (n = 250)] to
accomplish the following two Specific Aims.
Specific Aim #1: To evaluate the pain andfunctional outcomes of CMT plus conventional
medical care to those of conventional medicalcare alone in a total of 750 active duty military
personnel ages 18-50 with non-surgical acute,sub-acute or chronic LBP.
Specific Aim #2: To measure the impact of atobacco cessation program delivered by doctorsof chiropractic in active duty volunteers
receiving CMT for LBP.

Logic Model’ for a snapshot of the program
design.
Department of Defense Low Back Pain Study
Baseline Visit
Study Registration
Consent to Participate
Interview/Questionnaires
Exam
X-ray, if necessary
Assign to Treatment Group50%
Conventional Medical Care50%
Conventional Medical Care
& Chiropractic Care+
Smoking Cessation, optional

Week 2 Assessment (Web)
Week 4 Assessment (Web)

Week 6 Assessment (Web)
Release from study care

Month 3 Assessment (Web)Figure 3. Study Flow Chart.

2.2 Sample and Methodology
To accomplish the specific aims, a multi-site Clinical Comparative Effectiveness Trial designed torigorously compare the outcomes of CMT and conventional medical care (CMC) to CMC alone.
Chiropractic treatment will include chiropractic manipulative therapy (CMT) plus ancillary
physiotherapeutic interventions. CMC will be delivered following current standards of medical practiceat each site. At each of the three participating sites, active duty military personnel, ages 18-50, who
present with acute, sub-acute or chronic low back pain that does not require surgery will be randomized
to one of the two treatment groups. Outcome measures include the Numerical Rating Scale for pain, theRoland-Morris Low Back Pain and Disability questionnaire, the Back Pain Functional Scale for assessing
function, and the Global Improvement questionnaire for patient perception regarding improvement infunction. Patient Expectation and Patient Satisfaction questionnaires will be used to examine volunteer
expectations toward care and perceptions of that care. Pharmaceutical use and duty status data will also
be collected. The PROMIS-29 will be used to compare the general health component and quality of lifeof our sample at baseline. As a secondary aim, this clinical trial will include a nested study designed tomeasure the impact of a tobacco cessation program delivered by a doctor of chiropractic.

3.0 OVERVIEW OF TRIAL
ORGANIZATION
Responsibility for the conduct of theclinical trial described in this protocol isplaced on the Palmer College of
Chiropractic, in collaboration with RAND
Corporation, the parent institution, andthe Samueli Institute (SIIB). Please see
the organizational chart in Figure 4.
Dr. Christine Goertz is Co-PI of the grant,with the overall administrative andscientific responsibility for the success ofthe clinical trial described in thisprotocol. As Vice Chancellor for Researchand Health Policy at Palmer College of
Chiropractic Research, reporting directly
to the Chancellor, she is in an excellent position to
Figure 4. Organizational Plan
ensure the availability of institutional resources. She
will work closely and continuously with the Internal Steering Committee (ISC) and Expert Advisory
Committee (EAC) to assure progress, focus, coordination and synergy.

4.0 MAJOR STUDY COMMITTEES
4.1 Internal Steering Committee
Dr. Coulter will establish and chair an Internal Steering Committee (ISC) composed of the lead
investigators and project managers from RAND, Palmer and Samueli Institute, as well as the site PIs. This
committee will provide a wide range of input to manage the multi-centered trial. The primary purposeof the ISC is to share information, monitor progress, raise issues and solve problems and plan for future
research. The ISC will make recommendations for policy or protocol additions or changes whennecessary. In keeping with a governance structure most conducive to productive research, the ISC will
be advised when major decisions regarding the study must be taken. ISC members have theresponsibility to communicate and share appropriate decisions with their project staff.
Regular telephone meetings of the ISC will take place on a weekly basis, with RAND, Palmer and Samueli
personnel required to attend by teleconference. Agendas will be prepared in advance of each meetingand minutes will be recorded, circulated and kept. These meetings will also be used to confirm thesuccess or make recommendations regarding the more regular communication expected between CoPIs. Site PIs and PMs will have one-on-one monthly meetings with the PI and lead PM at Palmer.

4.2 External Advisory Committee
The External Advisory Committee (EAC) will be the primary advisory body for the clinical trial and willassist the Co-PIs to meet its goals. The EAC will provide written annual reports to the project
investigators focused on the following issues: 1) progress of research projects; 2) effectiveness ofcommunication and collaboration between co-investigators; 3) use of resources; 4) changes to theoriginal research plan; 5) the Co-PI’s effectiveness; and 6) identified challenges, problems and proposedsolutions. The EAC will first meet 3 months after the award date and then will meet yearly after that.
The EAC is comprised of six individuals who have all agreed to sit on the Board. These individuals
represent leaders in either the research community in LBP, the chiropractic research community or in
the military. They include the following individuals: Anthony J Lisi, DC, National Director Chiropractic
Services, Department of Veteran Affairs; Valerie Johnson, DC, Staff Chiropractor, VAGLA, Department of
Veteran Affairs; Dan Cherkin, PhD, Senior Scientific Investigator, Group Health Research Institute;
Marion McGregor, DC, FCCS(C), PhD, Canadian Memorial Chiropractic College; Scott Haldeman, DC, MD,
PhD, Clinical Professor Neurology, UC Irvine; Reed Phillips, DC, PhD, NCMIC Foundation.

4.3 Data and Safety Monitoring Committee
The Data and Safety Monitoring Committee (DSMC) is a standing independent committee at the PCCR toprovide an independent means of examining objectively accruing controlled trial data for indications ofharm (from adverse events from the interventions applied or tested) as well as benefit.
The DSMC will monitor the overall conduct of the RCT described in this protocol. Responsibilities of the
DSMC are: 1) to ensure the overall safety of participants in clinical trials conducted by PCCR investigatorsby protecting participants from avoidable harm and declaring clear benefit when there is proof beyond areasonable doubt; and 2) to provide DoD and the EAC with advice about the scientific and ethicalconduct of clinical trials.
The DSMC will meet at least twice per year either in person or by teleconference. The DSMC will
evaluate the adverse event data to protect the safety of study participants. If necessary, DSMC members
will make recommendations to the Co-PIs and DoD regarding continuation, termination or othermodifications of the trial based on observed adverse events of the treatments under study.
The DSMC is comprised of a biostatistician, medical physician, doctor of chiropractic andepidemiologists/clinical trialists, none of whom are affiliated with Palmer. The team biostatistician will
prepare a study report for the DSMC including accrual plots and other enrollment data, data collection
forms processing status, baseline characteristics of enrolled participants, follow-up and treatmentcompliance, protocol violations and all web-based reportable adverse events (see Reporting of Adverse
Events) every 6 months.

4.4 Institutional Collaboration and Support
Scientific and institutional collaboration and commitment are key attributes to the success of the
proposed project. During the planning process of the grant writing, the Co-PIs identified key
investigators, core resources and institutions that demonstrated a high level of enthusiasm fordeveloping this application. An ad hoc planning team was composed to consider and reach out topotential DoD partners based on common and complementary scientific interests, expertise, pastexperience and productivity. Enthusiastic letters of support were included in the original grantapplication from each Institution and Military site involved in the project. Before the grant was received,
each of the partner institutions had already contributed considerable resources to the development of
this joint project and each had committed the institution and its resources to successfully carrying out
the project.

4.5 Publication Committee
The publication committee consists of all investigators and other invited individuals that havecontributed scientifically to this study. This committee will meet six months after the onset of primarydata collection and will continue meeting once a quarter with potential to bi-weekly toward the end of
implementation. They will discuss potential papers, necessary data, projected journal submissions,conference presentations and timelines for each publication project.

5.0 RESEARCH DESIGN & METHODS
5.1 Study Population
Naval Air Station (Pensacola, FL) n = 250
The Naval Air Station (NAS) Pensacola has approximately 11,200 active duty personnel and is theprimary training base for all Navy, Marine and Coast Guard aviators and Naval Flight officers. It is also
home to the Navy Flight Demonstration Team (Blue Angels), Naval Air Technical Training Center andTraining Air Wing 6. Health care is provided at the Naval Hospital Pensacola (NHP), a 108-bed hospital,
as well as at the Naval Branch Health Clinic which supports approximately 12,000 active duty personnel
ranging in age from 18 to 55 years old. Chiropractic services were established in September 2003 andare offered at the Chiropractic Clinic, which is part of the Sports Medicine and Reconditioning Team
(SMART) clinic. The clinic sees approximately 600 new patients, and 3,500 to 4,000 total patient visits ayear, all of whom are active duty personnel. Seventy percent of the patients are treated for low backpain. Of these, 30% are treated for acute pain, 50% for sub-acute and 20% for chronic pain. Dr. Greg
Lillie is the treating chiropractor at this site.
Walter Reed National Military Medical Center (Bethesda, MD) n = 250
The 500-bed Walter Reed National Military Medical Center (WRNMMC) is the Navy’s third largest healthcare delivery system, providing more than 12,500 ambulatory surgeries and almost 8,000 inpatientadmissions each year. It is the designated hospital for Navy and Marine casualties returning to thecontinental United States from Operation Enduring Freedom (OEF) and Operation Iraqi Freedom (OIF).
In 2006, there were approximately 7,960 hospital admissions, 455,503 visits to hospital clinics and an
average daily patient load of 128. Since 2003, WRNMMC has treated more than 1,600 war wounded
service members. The chiropractic clinic there is staffed by two chiropractors and additional supportive
staff, who provide care for Army (33%), Navy (40%), Marine Corps (11%) and Air Force (15%) personnel
based in the Washington, DC area. Navy personnel stationed at Washington Navy Yard, Naval Surface
Weapons Centers in Indian Head, and Carderock, MD, the US Naval Academy and Naval Air Station
Patuxent River are among the patients served, as are Marines stationed at Quantico and Marine Corps
barracks in Washington, DC. Low back pain is the most common condition treated. The doctors ofchiropractic at this site are William E. Morgan and Terence Kearney.
Naval Medical Center (San Diego,CA) n = 250
NMCSD sees about 3, 600 to 4,000 active duty patients per year, 20 to 25% of which are new patient
exams. Chiropractic services are part of the Physical Therapy Department and are located in the acutecare area at both the Naval Air Station and BUDS Medical (SEALs). Patients seeking services come fromdiffuse locations including medical sick call, acute care area, flight medicine, BUDS medical primary
providers, physical therapy and other specialty providers. The chief complaint of chiropractic patients is
spinal pain, most often LBP (40%). Approximately 20% of the patient population is special operation
forces including Explosive Ordinance Demolition (EOD), Special Boats Units and SEALs, who often suffer
LBP, premature disc degeneration, disc herniations and facet arthritis. The treating doctor ofchiropractic is David W. Ward and Bart Green.

5.1.1 Participant Recruitment
5.1.1.1

Recruitment Strategies

The volunteers required for this clinical trial will be recruited primarily through the existing primary caretriage system established at each site. Initial recruitment efforts will include efforts by primary contact
providers with patients who present with an episode of acute, sub-acute or chronic LBP during routine
patient care visits. Other recruitment efforts may include signs and brochures describing the study
posted and distributed in the patient care clinic lobbies and review of existing patient records to identify
patients with a previous diagnosis of low back pain.
Volunteers will not be compensated for participation in the study. Any recruitment materials will
accurately reflect the study and will not advertise “free treatment” or promise a cure or benefit beyond
that mentioned in the consent form protocols. In addition, all materials will be approved by local andcentral DoD/Palmer/RAND IRBs. Materials will not be coercive or offer undue inducements. We do not
anticipate recruitment of vulnerable populations for this study.

5.1.1.2

Enrollment of Women and Ethnic as well as Racial Minorities

The inclusion of women and minorities will be proportional to that found in the active duty military
population. General demographics on military populations indicate a 14.8% female distribution.
Ethnic/minority distribution is as follows: 17.6% African American, 8.8% Hispanic and 9.2% other (Bray,
Olmsted, et al, 2006). All reasonable attempts will be made to include representation from women andethnic and racial minorities proportional to that found in active duty service members across the US.

5.1.2 Eligibility Criteria
All participants must meet the following inclusion and exclusion criteria.
Inclusion Criteria
Age > 18 and < 50
Diagnosis of acute, subacute or chronic low back pain
Ability to provide voluntary written informed consent
Active duty at one of the three participating military sites
Exclusion Criteria
LBP from other than somatic tissues as determined by history, examination and course (i.e., pain referred fromvisceral conditions)Co-morbid pathology or poor health conditions that may directly impact spinal pain. Volunteers who have casehistories and physical examination findings indicating other than average good health.
Bone and joint pathology contraindicating CMT. Volunteers with recent spinal fracture (within the last 8 weeks),
recent spinal surgery (within the last 12 weeks), concurrent spinal or paraspinal tumor(s), spinal or paraspinal
infection(s), inflammatory arthropathies and significant / severe osteoporosis will be referred for appropriate
care.
Other contraindications for CMT of the lumbar spine and pelvis (i.e., unstable spinal segments, cauda equine
syndrome)
Pregnancy or planning to become pregnant within 8 weeks

Exclusion Criteria Cont’d
Altered mental capacity as determined by the clinician (e.g. nonsensical statements, not oriented to time andplace)
Use of manipulative care for any reason within the past month
Unwilling to provide phone and electronic contact information
Unable to confirm that they will not be transferred during the active phase of the study: i.e., deployment, receive
orders for a distant duty assignment or training site or otherwise be absent from the current military site over the
next 8 weeks (active study participation period).
Does not agree to be enrolled regardless of group assignment
PTSD Classification

5.1.3 Randomization
A total of 750 active duty (AD) personnel ages 18-50 with acute, sub-acute or chronic LBP will berandomized to one of the two treatment groups. Randomization will be done by using an adaptive
computer-generated minimization treatment allocation to balance volunteer characteristics between
groups on the baseline factors of sex, age, LBP duration and baseline Numeric Rating Scale (NRS)
measurement. The site project manager will access the Treatment Assignment Module in the passwordprotected web database system on a secured computer network and pull down the volunteer ID. The
minimization algorithm will run and produce the coded treatment assignment. The treatment groupassignment and date, time and study personnel ID will be stored in the SQL database. All study
personnel are blinded to the next treatment assignment. The back-up treatment assignment protocol isby predetermined sequentially numbered, opaque envelopes and to be used when the web-based
system for randomization is unavailable.

5.1.4 Overview of Data Collection
The Manual of Operating Procedures (MOOP) will be created in Year One and posted on a passwordprotected secure server with a user friendly web interface. The MOOP will include current versions ofconsent and HIPAA forms, paper back-up of all web data collection forms, and all protocols andprocedures that are standardized across and within sites.
Using the model that was successful in conducting our pilot study at Ft Bliss, Palmer will hire site project
managers for each data collection site. The site project managers will be trained and supervised by anexperienced project manager at the Palmer Center for Chiropractic Research. Site project managers will
have the overall day-to-day responsibility for ensuring the completion and accuracy of data collection.
The data collection instruments and timing for data collection efforts are indicated in Table 1.

Table 1. Data Collection Schedule
BaselineInterview

BaselineQuestionnaire

Week2
Questionnaire

Week4
Questionnaire

Week6
Questionnaire

Month3
Questionnaire

NRS
RMDQ
BPFS
Bothersomeness
PROMIS - 29
Healthcare Utilization &Medication Use

X
X
X
X
X

X
X
X
X

X
X
X
X

X
X
X
X
X

X
X
X
X
X

X

X

X

X

X

Tobacco Use/Dependence
Patient Satisfaction/
Global Improvement(modified VAS)

X

X

X

Patient Expectation
Self-report type of carereceived

X

Item

AE
Duty Status
LBP history, clinical findings
and prior care
Sociodemographic
characteristics

X
X

X

X

X

X

X

X

X

X

X

X
X

X
X

X
X

X

Data will be collected from participants at baseline, Week 2, Week 4 , Week 6 (at the end of active care),and Month 3. The primary endpoint is at Week 6. The baseline assessment will be scheduled as inperson visits with the site project manager. All other follow-up assessments will be collected via a webbased data collection system.
We will attempt to obtain outcomes data from all participants in the trial, including those who neverattend, who drop out of care, or who move away. It is required for all participants to have cell phones
and an active email address. Therefore, follow-up reminders will be sent via telephone calls, text
messages and emails.

5.2 Participant Visit Protocols
5.2.1 Baseline Visit (BL)At this baseline visit, the site project manager will explain the handling of data and personal healthinformation as dictated by HIPAA and guide potential participants through the informed consent
process. This interview will be held in a room with a closed door to insure volunteer privacy. During theinformed consent process, the site project manager will explain the study requirements and provide a
study flow chart (Figure 3) to the potential participant. This discussion will include an explanation of theinterview time commitments, examination procedures (which may or may not have already occurred),follow-up assessments, intervention commitments, potential risks of participation, potential benefits ofparticipation, what to do in case of an adverse experience, and the option for discontinuing study

participation. In addition, the site project manager will answer any questions the participant may haveabout chiropractic care and the research study requirements and commitment. The study staff will
ensure that volunteers understand and agree to all aspects of participation before proceeding.
Volunteers will have the opportunity to discuss the implications of participating in the study at thebaseline visit or at any time thereafter if questions arise. These points include the following:
1. Volunteers who qualify for the study will be randomly assigned to one of two treatment groups. One
involves conventional medical care only and the other involves chiropractic care in combination withconventional medical care.
2. All exams (including screening x-rays) and treatments will be provided at no charge to the volunteer.
3. Investigators cannot predict whether the treatments will be effective for each volunteer. However,based on previous evidence and clinical experience, there is a likelihood that volunteers will
experience improvement in their LBP condition.
4. Potential study participants must be screened for eligibility, and if they are not eligible for the study
they will be told so at that point, and will continue to receive care at the site.
5. Volunteers are expected to meet all scheduled appointments and complete all study questionnaires,interviews and tests.
6. Volunteers are expected not to initiate other types of manual or medical care for their LBP during
their involvement in the study and to inform their study clinician if such treatment, or treatment for
any other health problem, becomes necessary.
Once informed consent has been obtained, both the participant and site project manager will sign anddate the consent form. The participant will receive a copy of the informed consent document. If theparticipant requests documentation about their participation in the study that does not containprotected health information, they will be given a participant certificate (Appendix F).

5.2.2 Exam
As discussed in recruitment strategies (section 5.1.1.1) there are 2 ways in which a potential participant
enters into the study. They can either be recruited directly from their acute or primary care provider
within the site clinic system or through recruitment efforts such as signs and brochures.
When military personnel present in the site clinic system, they meet initially with an independent duty
corpsman (IDC) (corpsmen with specialized medical training) or other primary care provider (PCP) prior
to having care rendered. The PCP or a IDC will be informed in advance that patients seeking care forback pain may be eligible for the trial and will be trained to complete an exam form which assesses
study eligibility (Appendix E). When the medical examination is complete and the provider has given the
military personnel their recommended conventional medical care treatments, the exam form will begiven to the site project manager. S/He will key enter items from the study eligibility form into thesecure module during the baseline interview after the informed consent document (ICD) has beensigned. If a potential participant does not have their baseline interview completed within 2 weeks of theexam, then a new exam form and interview will need to be completed.

If study participant is recruited through other recruitment efforts, they will first go through the baseline
visit and then be given the exam form. The site project manager will assist the potential participant in
obtaining an appointment with a primary care provider or an independent duty corpsman who will beable to complete the exam form and provide them with conventional medical care as required in thisstudy. The form will be returned to the site project manager, who will enter the information into thesecure web module. After the form has been entered into the system, the participant will know if theymeet all eligibility criteria. If so, they will be randomized to a treatment group (per section 5.1.3).

5.2.3 Treatment Visits
Conventional Medical Care
Conventional medical care may include the following: a focused history and physical examination;
limited diagnostic imaging restricted to select volunteers (i.e., for example, those with radiculopathy);education about self-management, including maintaining activity levels as tolerated and local ice/heatapplication; pharmacologic management with the use of analgesics and anti-inflammatory agents; andadditional therapies that may be applied for volunteers not responding to the initial interventions,
including physical therapy and referral to a pain clinic.
Chiropractic Care & Conventional Medical Care
Volunteers in the chiropractic care groups will receive the same care listed above in the conventional
medical care group, as well as chiropractic manipulative therapy (CMT). CMT will occur from a doctor ofchiropractic over a six week period of time. We will set an a priori treatment schedule of up to 2 times
per week for six weeks for this study; for a total of up to 12 total visits. It is conceivable that a
participant may not medically need this number of visits. Therefore, as with conventional medical care,
the treatment plan will be based on the patient’s baseline evaluation by the chiropractor, the severity ofthe patient’s condition, and how they respond to treatment. Two times a week was chosen as thisfrequency is a common treatment schedule seen in general clinical practice and was used in our pilot
work at Ft Bliss. A duration of six weeks was chosen over the four weeks used in our pilot because in thisstudy we will be including volunteers with sub-acute and chronic low back pain, which generally requires
a longer treatment period. Following numerous discussions with the chiropractic clinicians at the threesites participating in this trial, the investigators have concluded that at some sites it may not be feasible
to follow a tightly prescribed treatment schedule. Many of the DoD doctors of chiropractic frequently
have waiting times of up to two weeks for a new patient, with a similar wait for additional patient visits.
To address potential differences among sites on this issue, we will take the following steps: 1) each site
will have a large enough sample size to detect significant differences between groups; 2) we will
carefully track the number of visits each volunteer received and the timing of those visits; 3)investigators at RAND and SIIB will use both quantitative and qualitative methods to evaluate thepotential impact that varying treatment schedules has on patient care outcomes. At each treatment
visit, the study clinician will determine which of the two most common therapeutic approach(s) toconsider with each participant: high-velocity, low-amplitude (HVLA) or low-velocity, variable-amplitude

(LVVA). An informal survey of the doctors of chiropractic participating in this study confirmed that these
two treatments are most commonly used in active duty service members. Thus, treatment will belimited to these two techniques for the purposes of this study.
The clinician will decide which form of CMT to use based primarily upon the diagnosis and combinationof co-morbid or complicating diagnoses. The volunteer’s previous response to care (if known), flexibility
and mobility, and general condition are also considered. Clinicians then make a second decision
regarding the application (location and direction) of CMT. This decision is most often based upon the
diagnosis; however, other items are considered such as tenderness, hypertonicity, hypomobility,
positions of relief and provocation, imaging findings (e.g., spinal curvatures, degeneration,
spondylolisthesis) and other factors individual to the case.
Lastly, the clinician considers what other forms of treatment would benefit the volunteer. Rehabilitation
exercises (attended or at-home), passive stretching, neuromobilization techniques, manual musculartherapies (e.g., ischemic compression, friction massage), counseling (proper movement,
activities and nutrition), or other modalities such as ultrasound, electricalneuromuscular stimulation (e.g. interferential current), heat, ice, taping and bracing
may also be used as adjunctive therapies.75 The type of CMT and adjunctive therapies
used in the study will be carefully tracked throughout the study.
At each chiropractic visit, a treatment form will be completed (Appendix E) by thechiropractor. All forms will follow the data storage collection procedure described in
Section 5.2.
Tobacco Cessation
Investigation of a tobacco cessation program delivered by doctors of chiropractic will be
imbedded in the LBP trial. Volunteers randomized to the CMT who self-identify as
tobacco users (i.e. smokers or smokeless tobacco users) at baseline andagree to participate by signing theinformed consent document will
receive the program. The tobacco
cessation program to be used is basedon the “Clinical Practice Guidelines for Treatment of Tobacco Use and
Dependence” of Fiore et al.76,77 These guidelines promote theuse of the “5As” of a tobacco cessation intervention to bedelivered by health care practitioners. It has been refined for
dental and chiropractic practice by Gordon et al (R21
DA021349) and adapted for a large RCT in public dental
Figure 5. Tobacco Cessation Study Flow Chart.
clinics.74,78 Volunteers for the LBP trial will be screened to
identify tobacco users and level of interest in quitting as
74,78
in Gordon et al.
Smokers will be defined as persons who have smoked at least one cigarette, cigar, or
pipe in the last 7 days. Smokeless tobacco users will be defined as anyone taking at least one dip orchew in the last 7 days. Willingness to participate in the tobacco cessation component of the study will
be documented through written informed consent. Those who wish to participate in the LBP study but
not the tobacco cessation program will still be allowed into the LBP study as participation in the nested
tobacco cessation study is optional.
Prior to initiation of data collection, study chiropractors will attend a 3-hour webinar training session ondelivering the intervention.74,78 (Handouts and lecture items are in Appendix B.) The webinar will include
a PowerPoint presentation to present the tobacco cessation program. Refinements may be made toaddress study clinic operating procedures. Brief follow-up training sessions will be required every six
months The outline for the webinar is: 1) Tobacco Cessation in Chiropractic Setting; 2) Tobacco-Related
Health Problems; 2a) Chronic Pain/Musculoskeletal Problems; 2b) Decreased Healing; 2c) Respiratory
Problems; 2d) Heart Diseases; 2e) Allergies; 2f) Diabetes; 2g) Macular Degeneration; 3) Helping yourPatients Quit Tobacco; 3a) Patient Flow; 3b) Ask about Tobacco Use; 3c) Ask Assessment Questions; 3d)
Advise-Relate Findings & Give Direct Advice to Quit; 3e) Arrange Help for Quitting; 4) Assess Readinessto Quit; 5) What about “Hard Core” Users?; 5a) Motivational Interviewing; 5b) Express Empathy; 5c)
Promote Patient Autonomy; 5d) Avoid Argumentation; 5e) Roll with Resistance; 5f) Develop
Discrepancy; 5g) Support Self-Efficacy; 6) Complete Personal Quit Plan; 6a) Reasons for Quitting; 6b) 5
Step for Quitting: Get Ready, Get Support, Learn New Skills & Behaviors; Get Cessation Treatment; Be
Prepared; 7) Quitting Resources; and 8) Follow-Up.
Prior to recruitment at each site, the study chiropractor will complete a baseline tobacco cessation
survey and then again 1 year after recruitment has started at their site. (Survey is in Appendix C.)
Tobacco Cessation Intervention
Volunteers in the chiropractic treatment group will receive the “5As” tobacco cessation program as
adapted for chiropractic clinics.74 It is designed to be brief and fit into clinic patient flow. The program
will be modified slightly to fit into this randomized trial.
Ask: The volunteers will be asked about their tobacco use status at each visit by the treatingchiropractor. The questions will include the baseline questions from the baseline instrument.
Advise: The chiropractor will discuss health risks of using tobacco. S/he will emphasize how tobacco
affects the volunteers’ low back condition and other health problems they may have such as chronic
pain, decreased healing, respiratory conditions, and allergies. The chiropractor will then advise thevolunteer to quit, and will be direct and non-judgmental, as well as acknowledging the difficulty ofquitting.
Assess: The chiropractor will ask a series of questions about the readiness to quit. These questions will
include the “5 Rs” of motivational interviewing: relevance, risks, rewards, roadblocks, and repetition.
Reasons for quitting must be made personally relevant. The volunteers must identify risks and rewards
for themselves. Personal obstacles will be identified. The chiropractor will express empathy, promotepatient autonomy, and support self-efficacy.

Assist: The chiropractor will assist the volunteer in completing a personal quit plan with quit date. The
chiropractor will work with the volunteer on a five-step plan for quitting (get ready, get support andencouragement, learn new skills and behaviors, get cessation treatment, and be prepared fordifficulties), disseminate tobacco cessation resources, and make necessary referrals. This discussion will
include pharmacotherapy options (prescription and nicotine patches, natural methods (e.g., exercise
and relaxation), and web-based quitting programs. All volunteers in the program will be given a
volunteer packet with motivational cessation information.
Arrange: Study investigators will arrange follow-up to determine adherence to the program, level ofmotivation to quit and program success. This information will be gathered at each follow up visit.
Ending Care
Volunteers in either care group may at some time during the six-week period have severe exacerbations
that may require referral for surgery or other specialty care. Criteria for ending care may include thepresence of any exclusion criteria, worsening pain, or loss of function. The chiropractor will have theresponsibility to end care for participants in the CMT plus conventional medical care (CMC) group, while
the primary care provider will provide this service to the CMC group. Any volunteer who must change
care due to referral will remain in the study and for statistical purposes will be included in his/her
original group for analysis. All attempts will be made to obtain outcome measures at all collection points
regardless of whether participants change care (intention-to-treat
Figure 6. Follow-up reminders (Seeanalysis).

5.3 Primary Outcomes
Demographics
The following information will be collected at baseline after receipt
of written informed consent: Date of birth, gender, ethnicity, race,
marital status.
Low Back Pain Variables (Appendix A)
Numerical Rating Scale (NRS) (primary endpoint)
Volunteers will be asked to rate their level of pain on that day onan ordinal 11-box scale (0=no LBP; 10=worst LBP possible) atbaseline and at all of the follow-up assessments. The NRS has
excellent metric properties, is easy to administer and score, andhas received much use in LBP research.79,80 Pain data will becollected at baseline and at all endpoint visits. The question willcapture information pertaining to pain over the last 24 hours.
Roland Morris Disability Questionnaire (RMDQ) (primary endpoint)

Appendix D)
E-mail follow-up reminder:
Thank you for your continued
participation in the ACT low back pain
study. As a reminder we ask that you fillout assessments at week 2, 4, 6, andmonth 3. It is time for your week xx
assessment. Please complete this by XX
at https://backtoaction. If you have any
questions, please contact me at XX (sitemanager’s contact information).
Thank you,
Site PM (to be determined)
Reminder: Your login is your email
address.
Text follow-up reminder:Your ACT assessment for week XX isready to be completed. Please go towww.backtoaction.com and complete byXX. (provide date of one week later)
Thank you, Site PM

As in previous LPB studies, the volunteer self-report81 modified 24-item version of the RMDQ will be
used to assess LBP-related disability. The RMDQ may be the most common and respected LBP
assessment instrument in LBP outcomes research.82 It is a one-page questionnaire related to LBP
disability with documented reliability and validity.83 It can discriminate between different forms oftreatment for back pain, and it is sensitive to clinical change.81,84,85 The RMDQ has been chosen for anumber of clinical trials of LBP treatments for its excellent metric properties, ease of use, patient
acceptance, and high face validity. This questionnaire will be administered at baseline and at all
endpoint visits.
Bothersomeness of Symptoms
The bothersomeness of symptoms commonly associated with LBP will be measured using an existingmeasure from the LBP literature. Volunteers will be asked to rate how bothersome various aspects of
their LBP have been during the past week, each symptom measured on a 1 to 5 scale (where 1=not at all
bothersome and 5=extremely bothersome). A LBP bothersomeness index will be calculated by summing
the four symptom ratings (1-20). Bothersomeness questions are practical and have demonstrated goodinternal consistency, construct validity, and responsiveness to change with time in patients with LBP and
sciatica.86 Bothersomeness will be measured at baseline and at all endpoint visits.
Back Pain Functional Scale (BPFS)
The Back Pain Functional Scale is a 12-question functional status survey designed for use as an individual
patient decision-making tool. Each of the 12 questions is answered using a 5-point Likert-type scale andtherefore scores for this scale will range from 0-60.85 In recent studies, the BPFS is showing more
improved sensitivity to change than the RMDQ. This scale will be administered at baseline and all
endpoint visits.
Patient Expectation
Previous work has shown that patient expectation regarding benefit of care can be a significant nonspecific effect.87 Two questions regarding patient expectation of benefit from CMT and their general
expectation of improvement in 1 month were modified for this study. Patient expectation will beassessed at the baseline visit only.
Patient Satisfaction
A one item patient satisfaction questionnaire was developed based on the work of Cherkin et al.50 This
will be administered at week 2, week 4 and week 6 of care.
Global Improvement Scale
This is a modification of the Visual Analog Scale (VAS) developed to assess degree of improvement overa specified period of time. It will be administered at week 6 and month 3.

Medication Use
Based upon the pilot study conducted at Ft Bliss, volunteers will most likely have been prescribed pain
medication by a primary care provider prior to being enrolled in the study. At baseline and at all
endpoint visits, we will collect data on the types of medication used and frequency of use.
Duty Status
Volunteers will be asked about their duty status (full, light, limited) at their baseline interview. Change
to that status will be questioned at each assessment.
Tobacco Cessation Variables
Tobacco Use
Volunteers will be asked about their tobacco use with the questionnaire by Gordon et al.74,78 The 7-day
abstinence will be determined from the point-prevalence of tobacco use: “Have you smoked, even apuff, in the last 7 days?” Prolonged abstinence will be defined as no tobacco use in the prior 6 months.
Other variables will include annual quit attempts, number of cigarettes smoked per day, extent of
current tobacco use, and current readiness to quit.
Tobacco Dependence
The level of tobacco dependence will be evaluated as in Fagerstrom & Schneider.88 We will ask how longthe volunteer has smoked, how soon after waking the first cigarette is smoked, and if there are strong
cravings when going two hours without a cigarette.

5.3.1 Data Analysis
The analysis team will conduct the data analyses using SAS System for Windows (Release 9.2). They will
collaborate with the investigators in presenting and interpreting the results. Descriptive statistics ofparticipant baseline characteristics will be presented for each treatment group to assess theircomparability as well as the generalizability of the sample. Descriptive statistics of the primary andsecondary outcome variables will be presented for each treatment group at baseline, weeks 2, 4, 6 andmonth 3.
The primary outcome analysis will focus on the changes from baseline to week 6 since this is the lengthof the chiropractic care group. Similar analyses will be conducted including the 2 week, 4 week and 3
month waves. Outcome measures will be compared between the chiropractic and medical care only
groups at baseline to check for imbalances in the randomization.
A difference-of-differences approach will be used to compare changes over time in the chiropractic arm
to changes over time in the conventional medical care only arm. This will be implemented as aregression model rather than by literally modeling change scores. Each study participant will contributean observation for each wave of data collection. The regression models can be ordinary, logistic, orderedlogistic or Poisson depending on the distribution of the outcome measure. As an example we presentthe logistic version of the model that might be used for a simple satisfied vs. not satisfied survey
response.
Model 1. Pre-Post Comparison of Satisfaction between Chiropractic and Medical Care

 p 

ln ijt  = β 0 + β1τ 1 + β 2 xijt
1− p ijt 
Where pijt is the probability participant i responds as satisfied in treatment arm j in time period t. t
takes on 2 values, 0 or 1, for the baseline and 6 week study periods in the basic model. The τ 1 takes on
the value 1 in the chiropractic treatment arm at week 6 and takes on the value zero in the medical carearm. τ 1 takes on the value of zero in both treatment arms in the baseline wave. β1 is an estimate of thechiropractic treatment effect. This model can be easily modified to reflect multiple post time periods(e.g., weeks 2, 4, and month 3). Participant level random effects can be included to control for clustering
within participant over time. X can include other patient level covariates to control for imbalance inrandomization and differential attrition. It may also be fit for a single outcome type or simultaneously fit
across several outcomes to accommodate the correlations between outcomes within participant.
Adjusted mean differences and 95% confidence intervals between conventional medical care alone andconventional medical care plus CMT at week 6 will be based on the final models. An intention-to-treat
analysis will be used.

5.3.2 Sample SizePain Sample Size
The study power is primarily driven by the requirement to detect a practically important average
difference between treatment and control groups of 2.0 in the RMDQ. A sample size of 250 (100treatment and 100 medical care after 20% attrition) will produce a power of 80% at the 5% level for a 2sided test for this difference. At this sample size the power to detect a practically important differenceof 1.0 for the NRS is 92%. This sample size will also have 80% power for a difference of 4.4 (less than half
a population standard deviation) in the BPF scale. For a dichotomous self-reported satisfaction measure
the power will be 80% to detect a difference of 20% (e.g. 40% for chiropractic participants vs. 20% for
medical care.)Tobacco Cessation Sample Size
A conservative estimate of the subset of the study population that smokes is 30%. Two measures oftobacco use reduction will be considered, 7 day abstinence and prolonged abstinence. With a sample
size of 75 (30 treatment and 30 medical care after 20% attrition), we will have 80% power at the 5%
level for a difference in 7 day abstinence of 35% (e.g., 9% vs. 44%). We will have 80% power at the 5%
level for a difference in prolonged abstinence of 37% (e.g., 13% vs. 50%). We will have more power for
similar comparisons when combining sites. After adjusting for clustering within sites a combined multisite estimate would have 80% power to detect differences of 14% for 7 day abstinence and 16% forprolonged abstinence.

5.4 Reporting of Protocol Deviations
All protocol deviations will be tracked and submitted to the Palmer DSMC and reported to study IRBs
per respective reporting requirements. It is important to note that any deviation to the protocol that
may have an effect on the safety or rights of the volunteer, or the integrity of the study will be promptly
reported to the Palmer College of Chiropractic Human Protections Officer within 24 hours of becoming
aware of the deviation.
In this study, protocol deviations will be tracked on the web system by all personnel. Necessary
information needed to complete the form includes: date of occurrence, participants involved (options
include: all, several, one, none), and a notes field for specific details. After submission an automatic
email notification will be sent to the lead and site project manager. The site project manager will haveprimary responsibility for accessing the protocol deviation report and updating the submission with theappropriate category and notes.

5.5 Data Monitoring
5.5.1 Data Management
The Clinical Trial Coordinating Center (CTCC) within the Palmer Center for Chiropractic Research has:1)developed web-based data collection forms; 2) program web applications to support data and project
management; 3)will continue to provide technical support; and 4) execute procedures for data security
and data quality control, storage and back-up. The programmer has designed the web applications anddatabase structures based on Palmer Center for Chiropractic Research standards. He has programed the
ASP.NET web application elements in C# and Structured Query Language (SQL) using Microsoft Visual
Studio 2010 and Microsoft SQL Server Enterprise Manager. Web application modules include patient
baseline screening questionnaires and follow-up data collection, patient eligibility checks, random
treatment assignment, participant tracking, report generation and follow-up scheduling. Data entry
interfaces are programmed with appropriate participant flow restrictions, validation schemes and skip
patterns. The CTCC uses a Project/Users Permissions System (PUPS) to control project personnel accessto web modules. All data are stored on a secure internal Microsoft SQL Server. The system wasdeveloped and tested by data-related CTCC personnel on a development server and then published tothe training site for further testing and training by other CTCC personnel. After testing was complete thesite was published to the official project site that resides on a production web server secured with
Secure Socket Layers (SSL) certified by Thawte Server CA. The servers are all maintained by Information
Services, Palmer College of Chiropractic. All project systems are integrated with the Central Patient
Database (CPD) and use a PUPS to control project personnel access to web modules. All data are stored
on an internal Microsoft SQL Server to which only the Data Core Manager, Data Manager, Web
Application Architect and Web Programmer have access via a Microsoft SQL Server Enterprise Manager
interface. The CTCC manager will monitor the quality of the web applications and related databases,
manage change requests and create documentation, and assisted by the Web Programmer.
All participant questionnaires will be administered via the web. Baseline screening will be performed on
the site PM’s computer. Follow-up questionnaires can be completed at any computer available to theparticipant. During the baseline screening, the participant will be asked to create a username/email andpassword that can be used to provide secure access on follow-up questionnaires. Forgotten passwords
will be emailed to their personal email account. In the event of a forgotten username, the participant
will be asked to contact their site project manager. During baseline screening, the participant will also be
required to provide email and cell phone information. Follow-up contact will be made using email, cell
phone voicemail, and/or text messaging.
Web reports detailing when follow-up contacts need to be made with each participant will be madeavailable to the lead and site project managers. The web system is also programmed to send out areminder email to each participant when study assessment becomes available (date that data collection
window opens for that study assessment) as well as when the online assessment is actually due if theparticipant has not completed the assessment by the due date. Site PMs may also contact study
participants by email, text message, and/or phone call for additional reminders if needed. (SeeAppendix D for details)
Data management and quality control of web forms are performed using SQL views, stored procedures
and real-time, web-based reports. Automated reports are viewed by the Data Manager and ProjectManagers to determine if quality improvement actions such as improved documentation, protocol
revisions or personnel retraining.
Final project datasets are assembled by transferring data from Microsoft SQL Server to SAS System for
Windows (Release 9.1). The Data Core Manager writes and tests SAS programs to create datasets asrequested by the investigators and creates the data dictionaries. Database management system copy isused to move data across software applications.

5.5.2 Data and Safety Monitoring Plan.
Participant Safety Monitoring Plan: See Reporting of Adverse Events.
Data Monitoring Plan: Data Collection and Management
Information is collected at every stage of recruitment, treatment allocation, and throughout treatment,so that patient flow can be reported according to the CONsolidated Standards of Reporting Trials(CONSORT) guidelines.89 Specifically, we collect recruitment source, total number of responses per
recruitment source, potential participants’ resolution (i.e., ineligible, do not wish to participate,allocated), the number allocated to each treatment group, participant compliance to treatment
protocol, the number lost to follow-up, and the number of participants completing the trial. All selfreport questionnaires are web based and password protected. They are stored in a secure database at
the CTCC. Site PMs have oversight for all data collection.
The project’s web system is password-protected and uses a Microsoft SQL Server database platform tostore all data. Study personnel have unique user IDs and passwords restricting access from a Main
Menu. All data collected by study personnel are recorded in user-friendly data-entry interfaces. The
CTCC data manager creates the data dictionaries and datasets for analysis.

Quality control procedures are utilized to ensure that recruitment is on schedule, treatment allocation is
occurring as planned, data collection protocols are being used accurately, data collected through theComputer Assisted Telephone Interview (CATI) and other web interfaces are being stored correctly in
the SQL databases, and that the data are being transferred and retrieved properly.
Data Storage
All Informed Consent Documents/HIPAA and all paper data collection forms used will only include
unique study ID numbers or participant name, be accessible only by study personnel, and kept in locked
filing cabinets. Treatment and Exam forms will be kept in the locked cabinet. After information has beenentered into the database, it will be stored in the locked cabinet for up to 7 years after the study has
been completed. Computer files with volunteer names will be password protected with restricted
access to project staff who will only use this information to recruit volunteers and obtain follow-up data.
All analytic data files and tracking databases will be maintained on a secure, password-protected serverat the Clinical Trial Coordinating Center (CTCC).
Data Transfer
Electronic data are collected via web forms on a web server secured with Secure Socket Layers (SSL)
certified by ipsCS CLASEA1 Certification Authority, www.ipsCS.com. All data are stored on an internal
Microsoft SQL Server to which only the CTCC Data Manager and Database Programmer have directaccess. All web forms and reports have limited accessibility based on individual project role.
Once data have been verified, cleaned, and de-identified by the Data Core Manager, these data will be apassed for analysis to RAND Corporation via encrypted password-protected file transfer (secured FTP).
All RAND research that involves acquisition of private, individual-level data is required to follow thecommon federal rule for the protection of human subjects of research. These guidelines are spelled out
in 45 CFR 46 and in RAND's Multiple Project Assurance of Compliance with the regulations. The
Assurance of Compliance is on file with the Department of Health and Human Services and also serves
as our assurance of compliance with the regulations of other federal departments and agencies.
It is not possible for all study data to remain anonymous. However, to protect confidentiality, paper data
will be kept in locked filing cabinets and will be identifiable only by unique study ID numbers. Computer
files will be password protected with access restricted to staff who will use this information only torecruit volunteers or obtain follow-up data. All web based questionnaires and data files are password
protected and stored in a secure database at the CTCC.
CTCC Data Security and Confidentiality
The CTCC computer servers are stored in locked, temperature-controlled rooms with the otherinstitutional servers at Palmer College. Back-up tapes of the network drive are produced nightly. Palmer
College uses Symantec Backup Exec and FalconStor for server backups. Tapes are handled solely by
network staff, primarily by one person. Backup tapes are transported daily to a storage vault in abuilding designated for this purpose. The vault is used exclusively for backup tape storage and the door
requires both a key and combination for access.

5.5.3 Compliance and Co-Interventions
Non-compliance with treatment protocols is a potential confounder of outcomes in clinical trials.
Participants are asked on each questionnaire about any co-interventions, including care from providers
outside the study and the use of medications or other self-administered treatments. Individual site
tracking logs were created to monitor participant’s compliance with respect to completing assessments
within the allotted time period (see Appendix D). In addition, another log is utilized to ensure data iscollected at all study chiropractic treatment visits.

5.6 Reporting of Adverse Events
AE Collection
For this study an Adverse Event (AE) will be defined as any untoward medical occurrence that may
present itself during the conduct of the study and that may or may not have a causal relationship withthe study procedures. AEs will be monitored at three levels: 1) self-report AE collected at Week 2, Week
4, and Week 6 assessments or via self-report to the study physician or site PM directly; 2) serious
adverse events (SAE) regardless of their attribution reported via Week 2, Week 4, Week 6 or Month 3
assessments or via self-report to the study physician or site PM directly; and 3) Unanticipated Problems
Involving Risks to Subjects or Others (UPIRTSOs) that are unanticipated, serious, and at least possibly
related to the research procedures that do not meet the SAE definition also reported directly to the site
PM. Each allocated participant will be given a business card with the PMs’ contact information as well as
instructions for when it is important to contact the PM. Additionally, contact information for the site PM
as well as the PI are listed in the informed consent document.
AE Reporting
Since the majority of AEs will be reported via the participant at the online assessments, a protocol wasdeveloped to ensure oversight of this data is being maintained and that AEs meeting site IRB reporting
requirements are conveyed to the site PM/PI contemporaneously. A designated study clinician will beassigned to review a live report of AEs reported from the ‘Reactions and discomforts’ section of theparticipant online assessment. This portion of the assessment is designed to illicit adverse events during
the time period from the last online assessment (see Appendix A). These questions have been added to
study assessments at week 2, week 4, and week 6. Additionally, participants are told during theinformed consent process about the importance of reporting adverse experiences and instructions for
how to report these experiences.
The designated study clinician will convey these events to the site PM for appropriate reporting to IRB.
The study clinician may also ask that the site PM contact the participant if more information is needed
regarding a reported adverse experience that could be potentially serious, appear to have no resolution
date, or appear to require additional medical follow-up for safety purposes. Our goal is to ensure that

we are following up with any event that could appear to affect participant safety and report adverse
events per all study IRB reporting guidelines.
We will use the FDA definition of SAE, which is any adverse experience occurring during treatment that
results in any of the following outcomes: death, a life-threatening adverse experience, in patient
hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity,
or a congenital anomaly/birth defect.
All SAEs and UPIRTSOs will be reported to the IRBs (Palmer and RAND), Palmer DSMC, and the UnitedStates Army Medical Research and Material Command, Office of Research Protections (USAMRMC ORP)
within 5 business days. The site PM will be responsible for reporting all AEs to the lead PM at Palmer.
The lead PM will report to Palmer IRB, Palmer DSMC and to RAND PM. The RAND PM will report toRAND IRB and USAMRMC ORP.
UPIRTSOs, SAEs related to participation in the study, and all volunteer deaths related to participation in
the study will be promptly reported by phone (301-619-2165), by email (hsrrb@amedd.army.mil), or byfacsimile (301-619-7803) to the USAMRMC ORP, Human Research Protections Office (HRPO). A
complete written report should follow the initial notification. In addition to the methods above, thecomplete report can be sent to the US Army Medical Research and Materiel Command, ATTN: MCMRZB-P, 504 Scott Street, Fort Detrick, Maryland 21702-5012.
The medical monitor is required to review all UPRIRTSOs involving risk to volunteers or others, SAEs, andall volunteer deaths associated with the protocol, and provide an unbiased written report of the eventto the USAMRMC Office of Research Protections (ORP), HRPO. At a minimum, the medical monitor willcomment on the outcomes of the event or problem, and in the case of a SAE or death, comment on therelationship 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 byeither the investigator or medical monitor to be possibly or definitely related to participation, andreports of events resulting in death will be promptly forwarded to the HRPO.
All study protocol violations will be reported to the Palmer DSMC. Protocol violations meeting
respective study site’s IRB criteria for reporting will also be reported per IRB guidelines.
Qualitative Analysis and Quality Assurance
Site visits will be conducted to ensure the rigor and robustness of the trials. This oversight will provide
quality control and feedback to the Palmer Center for Chiropractic Research and to DoD for
implementation of future research programs. In addition, because it is a multi- site study in which theintervention will vary from context to context, by using both quantitative and qualitative data, we cansystematically describe each context to determine how they are similar and different from each otherand to determine to what degree (if any) these similarities and differences might affect the effectivenessof the intervention being studied. Robustness is the confidence that an intervention will perform (withina given range) similarly across different contexts. In this study, programs must be successfully
implemented across widely varying military contexts.

The approach to be used is akin to fidelity evaluation and is a practice- level method that serves
purposes similar to treatment adherence in clinical studies. Fidelity measurement assesses integrity of
initial and on- going implementation (i.e., is the practice model being delivered according to design).
How faithfully an intervention is implemented as it was planned affects how well it succeeds and how
reliably it can be adapted to other settings.
Fidelity is assessed by a process evaluation tailored to the practice and can involve multiple data sources
including questionnaires, administrative records, and qualitative observations. The method to be usedwill be to interview key informants who have been involved at the site (in this instance WRNMMC) withthe chiropractic trials either in the implementation, administration or in the running of the trials. We
have identified 7 key informants (potential participants) to be interviewed such as local leadership,providers, and study staff.
Potential participants will be invited to take part in this qualitative portion of the ACT 1 study. Researchstaff will review the informed consent document with each partipant emphasizing the purpose of thequalitative piece, and potential information to be gained by participating in this study. Research staff
will also emphasize that participation in this piece is voluntary and that refusal to participate will nothave any implications. The interview will begin after the informed consent document is signed and allparticipant questions are answered to satisfaction.
Standard probes, such as verification and compare and contrast questions will be used. These questions
provide more details about the topic being discussed and usually generate lists of items, shortqualitative answers, and close-ended, quantitative data. We will follow well-established procedures for
conducting semi-structured interviews.
Quality Assurance
The Clinical Trial Coordinating Center will use their standard Quality Assurance / Quality Control(QA/QC) processes. Their focus will be on the recruitment process and treatment protocols, looking at
the application of both the eligibility and exclusion criteria. Initial questions during the site visits will
glean information as to whether randomization occurred and was followed. We will also examine theadministration of the trials including the management of Informed Consent Documents, HIPAA forms,
adverse events and data transfer. Overall we are interested in fidelity to the treatment protocol andidentifying challenges to maintaining standardized practice and evaluation methods.
These indicators will be part of the chart review:
•
•
•
•
•
•
•

Informed consent forms and processes
Eligibility criteria
Missed visits
Concomitant therapies
SAE identification and reporting
Treatment and procedure protocols
Protocol endpoint identification

Additional QA for the trial includes:••••

Monitoring all clinical research training certifications and healthcare licensures of all study
personnel
Protocol audits
Data Management QC procedures
Tracking & Monitoring protocol deviations

6.0 TIMELINE
Table 2. Timeline for Study I (ACT1) Controlled Trial for Low Back Pain and Tobacco Cessation
2011
TASK

TIMELINE

Finalize protocols
Hiring/training site
personnel
Multi-site IRB review
Develop web-based datacollection systems
Conduct controlled trial
Walter Reed National
Military Medical Center
Bethesda, MD
Naval Hospital,
Pensacola, FL
Naval Medical Center,
San Diego, CA
Quality Assurance
Data Analysis
Report Writing
Annual Reporting

Feb

May

Aug

2012
Nov

Feb

May

Aug

2013
Nov

Feb

May

Aug

2014
Nov

Feb

May

Aug

Nov

References
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39. Furlan AD, Clarke J, Esmail R, Sinclair S, Irvin E, Bombardier C. A critical review of reviews on thetreatment of chronic low back pain. Spine (Phila Pa 1976 ). 2001;26:E155-E162.
40. Walker BF, French SD, Grant W, Green S. Combined chiropractic interventions for low-back pain.
Cochrane Database Syst Rev. 2010;4:CD005427.
41. Ferreira ML, Ferreira PH, Latimer J, Herbert R, Maher CG. Does spinal manipulative therapy help
people with chronic low back pain? Aust J Physiother. 2002;48:277-284.
42. Haigh R, Clarke AK. Effectiveness of rehabilitation for spinal pain. Clin Rehabil. 1999;13 Suppl
1:63-81.:63-81.
43. Shekelle PG, Adams AH, Chassin MR, Hurwitz EL, Brook RH. Spinal manipulation for low-backpain. Ann Intern Med. 1992;117:590-598.
44. Cooper RA, McKee HJ. Chiropractic in the United States: trends and issues. Milbank Q.
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45. Hawk C, Long CR, Boulanger K, Morschhauser E, Fuhr A. Chiropractic care for patients aged 55
years and older: report from a practice-based research program. J Am Geriatr Soc. 2000;48:534545.
46. Christensen M.G., Kerkhoff D, Kollasch M.W., Cohn L. Job analysis of chiropractic. Greeley, CO:
National Board of Chiropractic Examiners; 2000.
47. Barnes PM, Powell-Griner E, McFann K, Nahin RL. Complementary and alternative medicine use
among adults: United States, 2002. Adv Data. 2004;1-19.
48. Wolsko PM, Eisenberg DM, Davis RB, Kessler R, Phillips RS. Patterns and perceptions of care fortreatment of back and neck pain: results of a national survey. Spine (Phila Pa 1976 ).
2003;28:292-297.
49. Carey TS, Garrett J, Jackman A, McLaughlin C, Fryer J, Smucker DR. The outcomes and costs ofcare for acute low back pain among patients seen by primary care practitioners, chiropractors,
and orthopedic surgeons. The North Carolina Back Pain Project. N Engl J Med. 1995;333:913917.
50. Cherkin DC, MacCornack FA. Patient evaluations of low back pain care from family physicians
and chiropractors. West J Med. 1989;150:351-355.
51. Sox HC, Greenfield S. Comparative effectiveness research: a report from the Institute ofMedicine. Ann Intern Med. 2009;151:203-205.
52. Conway PH, Clancy C. Comparative-effectiveness research--implications of the Federal
Coordinating Council's report. N Engl J Med. 2009;361:328-330.
53. Schwartz D, Lellouch J. Explanatory and pragmatic attitudes in therapeutical trials. J Chronic Dis.
1967;20:637-648.
54. Zwarenstein M, Treweek S. What kind of randomized trials do we need? CMAJ. 2009;180:9981000.
55. Luce BR, Kramer JM, Goodman SN, Connor JT, Tunis S, Whicher D, et al. Rethinking randomized
clinical trials for comparative effectiveness research: the need for transformational change. Ann
Intern Med. 2009;151:206-209.
56. Karanicolas PJ, Montori VM, Devereaux PJ, Schunemann H, Guyatt GH. A new 'mechanisticpractical" framework for designing and interpreting randomized trials. J Clin Epidemiol.
2009;62:479-484.
57. Maclure M. Explaining pragmatic trials to pragmatic policymakers. J Clin Epidemiol. 2009;62:476478.
58. CDC. Annual Smoking-Attributable Mortality, Years of Potential Life Lost, and Productivity
Losses-United States 2000-2004. MMWR. 2008;57.

59. National Cancer Institute. Changes in Cigarette-Related Disease Risks and Their Implications forPrevention and Control. Bethesda, MD; 1997. Report No.: Vol. 8.
60. Bray RM, Hourani LL, Rae Olmsted KL, et al. 2005 Department of Defense Survey of Health
Related Behavious Among Active Duty Military Personnel, A Component of the Defense Lifestyle
Assessment Program (DLAP). RTI International; 2006. Report No.: Prepared for the Assistant
Secretary of Defense (Health Affairs), U.S. Department of Defense, Cooperative Agreement No.
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61. Dall TM, Zhang Y, Chen YJ, Wagner RC, Hogan PF, Fagan NK, et al. Cost associated with being
overweight and with obesity, high alcohol consumption, and tobacco use within the military
health system's TRICARE prime-enrolled population. Am J Health Promot. 2007;22:120-139.
62. Klesges RC, Haddock CK, Chang CF, Talcott GW, Lando HA. The association of smoking and thecost of military training. Tob Control. 2001;10:43-47.
63. Jensen RG. The effect of cigarette smoking on Army Physical Readiness Test performance ofenlisted Army medical department personnel. Mil Med. 1986;151:83-85.
64. Kao TC, Schneider SJ, Hoffman KJ. Co-occurrence of alcohol, smokeless tobacco, cigarette, andillicit drug use by lower ranking military personnel. Addict Behav. 2000;25:253-262.
65. Knapik JJ, Sharp MA, Canham-Chervak M, Hauret K, Patton JF, Jones BH. Risk factors for trainingrelated injuries among men and women in basic combat training. Med Sci Sports Exerc.
2001;33:946-954.
66. Altarac M, Gardner JW, Popovich RM, Potter R, Knapik JJ, Jones BH. Cigarette smoking andexercise-related injuries among young men and women. Am J Prev Med. 2000;18:96-102.
67. Deyo RA, Bass JE. Lifestyle and low-back pain. The influence of smoking and obesity. Spine (Phila
Pa 1976 ). 1989;14:501-506.
68. Goldberg MS, Scott SC, Mayo NE. A review of the association between cigarette smoking and thedevelopment of nonspecific back pain and related outcomes. Spine (Phila Pa 1976 ).
2000;25:995-1014.
69. Vogt MT, Hanscom B, Lauerman WC, Kang JD. Influence of smoking on the health status ofspinal patients: the National Spine Network database. Spine (Phila Pa 1976 ). 2002;27:313-319.
70. Jamison RN, Stetson BA, Parris WC. The relationship between cigarette smoking and chronic low
back pain. Addict Behav. 1991;16:103-110.
71. Hawk C, Long CR, Perillo M, Boulanger KT. A survey of US chiropractors on clinical preventive
services. J Manipulative Physiol Ther. 2004;27:287-298.
72. Rupert RL. A survey of practice patterns and the health promotion and prevention attitudes of
US chiropractors. Maintenance care: part I. J Manipulative Physiol Ther. 2000;23:1-9.

73. Gordon JS, Istvan J, Haas M. Tobacco Cessation: Attitudes and Behaviors of Oregon
Chiropractors. J Amer Chiro Assoc. 2005;42:8-14.
74. Gordon JS, Istvan J, Haas M. Tobacco cessation via doctors of chiropractic: results of a feasibility
study. Nicotine Tob Res. 2010;12:305-308.
75. Liebenson C. Active rehabilitation protocols. In: Liebenson C, editor. Rehabilitation of the spine:a practitioner's manual.Baltimore, MD: Williams and Wilkins; 1996. 355-390.
76. Fiore MC, Bailey WC, Cohen SJ, Dorfman SF, Goldstein MG, Gritz ER, et al. Treating Tobacco Useand Dependence. Clinical Practice Guidelines. Rockville, MD: U.S.Department of Health andHuman Services,Public Health Services; 2000.
77. Fiore MC, Jaen CR, Baker TB, Bailey WC, Benowitz NL, Curry SJ, et al. Treating Tobacco Use and
Dependence: 2008 Update. Clinical Practice Guideline. Rockville, MD: U.S. Department of Healthand Human Services. Public Health Services.; 2008.
78. Gordon JS, Andrews JA, Albert DA, Crews KM, Payne TJ, Severson HH. Tobacco cessation via
public dental clinics: results of a randomized trial. Am J Public Health. 2010;100:1307-1312.
79. Childs JD, Piva SR, Fritz JM. Responsiveness of the Numeric Pain Rating Scale in Patients with
Low Back Pain. Spine. 2005;30:1331-1334.
80. van der Roer N, Ostelo RWJG, Bekkering GE, van Tulder MW, de Vet HCW. Minimal Clinically
Important Change for Pain Intensity, Functional Status, and General Health Status in Patientswith Nonspecific Low Back Pain. Spine. 2006;31:578-582.
81. Deyo RA, Cherkin D, Conrad D. The Back Pain Outcome Assessment Team. Health Serv Res.
1990;25:733-737.
82. Deyo R. Chiropractic care for back pain. Health News. 1998;4:1-2.
83. Roland M, Fairbank J. The Roland-Morris Disability Questionnaire and the Oswestry Disability
Questionnaire. Spine. 2000;25:3115-3124.
84. Riddle DL. Classification and low back pain: a review of the literature and critical analysis of
selected systems. Phys Ther. 1998;78:708-737.
85. Stratford PW, Binkley JM, Riddle DL. Development and initial validation of the back pain
functional scale. Spine. 2000;25:2095-2102.
86. Patrick DL, Deyo RA, Atlas SJ, Singer DE, Chapin A, Keller RB. Assessing health-related quality oflife in patients with sciatica. Spine. 1995;20:1899-1908.
87. Kalauokalani D, Cherkin DC, Sherman KJ, Koepsell TD, Deyo RA. Lessons from a trial ofacupuncture and massage for low back pain: patient expectations and treatment effects. Spine(Phila Pa 1976 ). 2001;26:1418-1424.

88. Fagerstrom KO, Schneider NG. Measuring nicotine dependence: a review of the Fagerstrom
Tolerance Questionnaire. J Behav Med. 1989;12:159-182.
89. Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, et al. CONSORT 2010
Explanation and Elaboration: Updated guidelines for reporting parallel group randomised trials. J
Clin Epidemiol. 2010;63:e1-37.

Baseline 1 Visit

Page 1 of 1

Appendix A. Participant Web-based Study Assessment

Baseline 1 Visit Interview
Select Site: SelectInformed Has the participant signed the informed consent document?
Consent:
Yes
No
If no, specify reason:

Tobacco Did the participant consent to be in the tobacco cessation study?
Cessation
Consent:No
Yes
Not Administered
Not a tobacco user

Next >>

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6/25/2013Baseline 1 Visit

Page 1 of 1

Baseline 1 Visit
First name:Last name:Middle initial:
Rank:

Cell phone*:
Home phone:Work phone:ext.

Are you able to receive text messages, in addition to voicemail and email
messages?
No

Yes

Main email*:
Personal email:

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6/25/2013Baseline 1 Visit

Page 1 of 1

Baseline 1 Visit
1.

Duty status:
Full Duty - no restrictions
Profiled - limited duty
Not on Active Duty

2.

Sex:
Female3.

MaleEthnicity:
Hispanic or Latino
Not Hispanic or Latino
Unspecified

4.

Race (mark all that apply):
American Indian or Alaska Native
Asian
Native Hawaiian or Other Pacific IslanderBlack or African American
White
Unspecified<< Previous

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6/25/2013Baseline 1 Visit

Page 1 of 1

Baseline 1 Visit
1.

How did you hear about this research study?
Acute Care Provider
Primary Care Provider
Internal Medicine Provider
Physical Therapist
Chiropractor
PosterWord of Mouth
Other
Specify Other:<< Previous

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Next >>

6/25/2013Baseline 1 Visit

Page 1 of 2

Baseline 1 Visit
Interview Questions
1.

How long ago did your current episode of low back pain begin? Was it...
An episode of pain is defined as at least some low back pain requiring you to seek
treatment or modify your activity during consecutive weeks (a week or more with no pain
separates episodes).

Less than 7 days ago
7 days to less than 16 days ago
16 days to less than 1 month ago
1-3 months ago
More than 3 months and less than 6 months ago
6 months to less than 1 year ago
1 year or more ago
You are not experiencing a current episode of low back pain
2.

Where is your pain currently located? (Mark all that apply)
Low Back
Buttocks
Thigh
Lower Leg

3.

Have you received manipulative care from any healthcare provider in thepast month?
No

4.

Are you likely to be deployed or receive a distant duty assignment in thenext 8 weeks?
No

5.

Yes

Yes

Do you agree to be enrolled in this clinical trial regardless which treatmentgroup you are assigned to?
No

Yes

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6/25/2013Baseline 1 Visit

6.

Page 2 of 2

During this study, you will be asked to read a consent form and complete
internet/web-based questionnaires. Do you need assistance from anotherperson to complete these activities?
No

7.

Yes

Are you pregnant or planning to become pregnant in the next 8 weeks?
No

Yes<< Previous

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Submit6/25/2013Baseline 1 Exam

Page 1 of 4

Baseline 1 Exam
Exam Questions
1.

Do you suspect the low back pain is caused primarily by a visceral source orsystemic condition (e.g., renal disease, endometriosis, MS, malignancy, GI
disease)?
No

2.

Is there a condition requiring priority care such that treatment for low backpain should be delayed?
No

3.

Suspected

Yes

Does this participant need a referral or further testing to rule out pathologythat would exclude his/her participation in this study?
No

7.

Yes

Does the participant exhibit signs of cognitive or memory impairment thatcompromises your ability to accurately assess health status (e.g.
nonsensical statements, not oriented to time and place)?
No

6.

Yes

Do you suspect the presence of a spinal or paraspinal infection,
inflammatory arthropathy of the spine (i.e. rheumatoid arthritis, ankylosing
spondylitis) or severe osteoporosis?
No

5.

Yes

Has the participant suffered a spinal fracture within the past 8 weeks?
No

4.

Yes

Yes

Does the participant carry a PTSD classification?
No

Yes

https://w5.palmer.edu/dod_act1-train/clinicForms/frmBL1Exam.aspx?ptid=120904

6/25/2013Baseline 1 Exam

Page 2 of 48.

Notes:

9.

Treatment Recommendations: (mark all that apply)
Prescription Medications
Muscle relaxants
Narcotics
AntidepressantsAnesthetic/Steroid
NSAIDsReferral To
Physical Therapy
Chiropractic
Neurology
Orthopedic
Self-CareOTC Medications
Exercises
Behavior Modification
Other
Other
Specify:

ICD Codes
719.45 - Sacroiliac arthralgia / SI joint arthralgia
721.3 - Lumbosacral spondylosis without myelopathy (facet arthrosis) (facet
hypertrophy)
722.93 - Disc disorder of lumbar region, other, unspecified, NOS
722.2 - Discogenic Pain
722.73 - Intervertebral disc disorder with myelopathy lumbar724.2 - Lumbalgia
724.3 - Sciatica
724.4 - Lumbosacral neuritis or radiculitis

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6/25/2013Baseline 1 Exam

Page 3 of 4

724.8 - Lumbar Facet Syndrome (Other symptoms refer to back)729.1 - Myalgia / myofascial pain
737.2 - Lordosis (acquired) (postural) (hyperlordosis)739.3 - Nonallopathic lesions of lumbar region NOS
739.4 - Nonallopathic lesions of sacral region NOS
846.1 - Sacroiliac (ligament) sprain
847.2 - Lumbar sprain / strain
847.3 - Sprain of sacrum
847.4 - Sprain of coccyx
CPT Codes
99201 - Problem Focused New Patient Eval.
99202 - Expanded New Patient Eval.
99203 - Detailed New Patient Eval.
99204 - Comprehensive New Patient Eval.
99211 - Est. Patient Eval. – Minimal
99212 - Est. Patient Eval. – Problem Focused99213 - Est. Patient Eval. – Expanded
99214 - Ext. Patient Eval. - Detailed
20550 - Drain/inject, ligament/cyst
20610 - Drain/inject joint/bursa
96372 - Intramuscular Injection (Dr. supervised)
97010 - Hot/Cold Packs
97014 - Electrical Muscle Stimulation
97035 - Ultrasound97039 - Mechanical Massage
97110 - Therapeutic Exercise
97112 - Neuromuscular Re-Ed
97124 - Massage
97116 - Gait training therapy
97139 - Physical (unlisted) medicine procedure
97140 - Manual Therapy Technique
97140 - Trigger Point
97530 - Therapeutic Activities
97535 - Self management training
97750 - Physical performance test

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6/25/2013Baseline Assessment
SECTION
Pain Rating Scales
Select the number that best describes your low back pain at its worst during thepast 24 hours?
No
Pain
0

Worst
Possible
Pain

1

2

3

4

5

6

7

8

9

10

Select the number that best describes your average low back pain during thepast week?
No
Pain
0

Worst
Possible
Pain

1

2

3

4

5

6

7

8

9

10

Next >>

8/30/201112:03:38 PM

Roland Morris Disability Questionnaire
When your back hurts, you may find it difficult to do some of the things you
normally do.
This list contains sentences that people have used to describe themselves when
they have back pain. When you read them, you may find that some stand out
because they describe you today. As you read the list, thing of yourself today.
When you read a sentence that describes how you feel today, choose YES. If thesentence does not describe you, then choose NO.
Remember, only choose YES if you are sure that the sentence describes
you today.
No

Yes

I stay home most of the time because of my back.
I change position frequently to try and get my backcomfortable.
I walk more slowly than usual because of my back.
Because of my back, I am not doing any jobs that I
usually do around the house.
Because of my back, I use a handrail to get upstairs.
Because of my back, I lie down to rest more often.
Because of my back, I have to hold on to something to
get out of an easy chair.
Because of my back, I try to get other people to do things
for me.

Next >>

8/30/201112:05:35 PM

Roland Morris Disability Questionnaire
Remember, only choose YES if you are sure that the sentence describes you
today.
NoYes

I get dressed more slowly than usual because of my back.
I only stand up for short periods of time because of myback.
Because of my back, I try not to bend or kneel down.
I find it difficult to get out of a chair because of my back.
My back is painful almost all of the time.
I find it difficult to turn over in bed because of my back.
My appetite is not very good because of my back.
I have trouble putting on my socks (stockings) beause of
the pain in my back.

Go To Next Question >Skip To Next Section >>8/30/201112:09:01 PM

Roland Morris Disability

Page 1 of 1

SECTION
Roland Morris Disability Questionnaire
Remember, only choose YES if you are sure that the sentence describes you
today.
No

Yes

I only walk short distances because of my back pain.
I sleep less well because of my back pain.
Because of my back pain, I get dressed with help fromsomeone else.
I sit down for most of the day because of my back.
I avoid heavy jobs around the house because of my back.
Because of my back pain, I am more irritable and badtempered with people than usual.
Because of my back, I go upstairs more slowly than usual.
I stay in bed most of the time because of my back.

<< Previous

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6/25/2013

Back Pain Function Scale
On the questions listed below, we are interested in knowing whether you arehaving ANY DIFFICULTY at all with the activities because of your backproblem for which you are currently seeking attention. Please porvide an answer
for each activity.
Today, do you or would you have any DIFFICULTY at all with thefollowing activities BECAUSE OF YOUR BACK PROBLEM?

(choose one response on each line)

Unableto
Quite aA little
perform Extreme
bit ofbit ofModerateNo
activity difficulty difficulty difficulty difficulty difficulty

Any of your usual work,
housework, or school
activities
Your usual hobbies,
recreational, or sporting
activities
Performing heavy activities
around your home
Bending or stooping
Putting on your shoes orsocks (pantyhose)
Lifting a box of groceries
from the floor

Next >>

8/30/201112:09:35 PM

Back Pain Function Scale
Today, do you or would you have any DIFFICULTY at all with thefollowing activities BECAUSE OF YOUR BACK PROBLEM?

(choose one response on each line)

Unableto
Quite aA little
perform Extreme
bit ofbit ofModerateNo
activity difficulty difficulty difficulty difficulty difficulty

Sleeping
Standing for 1 hour
Walking a mile
Going up or down 2 flightsof stairs (about 20 stairs)
Sitting for 1 hour
Driving for 1 hour<< Previous

8/30/2011

Next >>

12:09:46 PM

Bothersomeness
During the past week, how bothersome have each of the following symptoms
been? (choose one response for each symptom)
Not at all
bothersome

Slightly
bothersome

Moderately
bothersomeVerybothersome

Extremely
bothersome

Low back pain
Leg pain (sciatica)
Neck pain

During the past week, how much did pain interfere with your normal work
(including both work outside the home and housework)?
Not at all
A little bitModerately
Quite a bit
Extremely

Next >>

8/30/201112:10:08 PM

BothersomenessIf you had to spend the rest of your life with the symptoms you have right now,
how would you feel about it?
Very dissatisfied
Somewhat dissatisfied
Neither satisfied nor dissatisfied
Somewhat satisfied
Very satisfied

During the past 4 weeks, about how many days did you cut down on the things
you usually do for more than half the day because of your low back pain?
# of days

During the past 4 weeks, how many days did low back pain keep you from going
to work or school?
# of days<< Previous

8/30/2011

Next >>

12:10:21 PM

Health Survey - PROMIS-29
In the past 7 days...
WithoutanydifficultyWith alittledifficulty

With
some
difficulty

With
much
difficulty

Unableto do

Are you able to do chores
such as vacuuming or yard
work?
Are you able to go up anddown stairs at a normalpace?
Are you able to go for awalk of at least 15
minutes?
Are you able to run
errands and shop?

Next >>

8/30/201112:10:34 PM

Health Survey - PROMIS-29
In the past 7 days...
Never

RarelySometimes

Often

AlwaysI felt fearful.
I found it hard to focus
on anything other than
my anxiety.
My worries
overwhelmed me.
I felt uneasy.

Next >>

8/30/201112:10:49 PM

Health Survey - PROMIS-29
In the past 7 days...
Never

RarelySometimes

Often

AlwaysI felt worthless.
I felt helpless.
I felt depressed.
I felt hopeless.

<< Previous

8/30/2011

Next >>

12:11:10 PM

Health Survey - PROMIS-29
During the past 7 days...
Not
at allA
little bit

Somewhat

Quite
a bit

Very
much

Not
at allA
little bit

Somewhat

Quite
a bit

Very
much

I feeel fatigued.
I have trouble starting
things because I am
tired.
In the past 7 days...

How run-down did you
feel on average?
How fatigued were you
on average?

<< Previous

8/30/2011

Next >>

12:11:21 PM

Health Survey - PROMIS-29
In the past 7 days...
Very poor

Poor

Fair

Good

Very goodNot
at allA
little bit

Somewhat

Quite
a bit

Very
much

My sleep quality was...

In the past 7 days...

My sleep wasrefreshing.
I had a problem withmy sleep.
I had difficulty falling
asleep.

<< Previous

8/30/2011

Next >>

12:11:37 PM

Health Survey - PROMIS-29
In the past 7 days...
Not
at allA
little bit

Somewhat

Quite
a bit

Very
much

I am satisfied with howmuch work I can do(include work at home).
I am satisfied with myability to work (include
work at home).
I am satisfied with myability to do regularpersonal and household
responsibilities.
I am satisfied with myability to perform mydaily routines.

<< Previous

8/30/2011

Next >>

12:11:50 PM

Health Survey - PROMIS-29
In the past 7 days...
Not
at allA
little bit

Somewhat

Quite
a bit

Very
much

How much did paininterfere with your day
to day activities?
How much did paininterfere with workaround the home?
How much did paininterfere with yourability to participate insocial activities?
How much did paininterfere with yourhousehold chores?

<< Previous

8/30/2011

Next >>

12:12:00 PM

Health Survey - PROMIS-29
In the past 7 days...
How would you rate your pain on average?
No
Pain
0

Worst
Imaginable
Pain

1

2

3

4

5

6

7

8

9

10

Next >>

8/30/201112:12:14 PM

Health Care and Medication Use
Since the beginning of your current episode of pain, from which of thefollowing providers have you sought treatment for your low back pain?
(Choose all that apply)

Primary care doctor
Medical specialist (specify type below)
Doctor of Osteopathy
Doctor of Chiropractic
Acupuncturist
Massage therapist
Physical therapist
Pain clinic or pain specialist
Counselor or mental health specialist
N/A
Other (specify type below)
Specify:During the past week, how often have you taken pain relieving medication(including prescription and over-the-counter medications or supplements)?
0 days
1-2 days
3-4 days
5-6 days
7 daysNext >>

8/30/201112:12:25 PM

Health Care and Medication Use
During the past week, have you taken non-narcotic analgesics?
Examples: Acetaminophen, Tylenol, Tylenol Extra Strength, Ultram, etc.
No
Yes, for back pain ONLY
Yes, for other reasons ONLY
Yes, for back pain AND other reasons
During the past week, have you taken non-steroidal anti-inflammatory
drugs (NSAIDS)?
Examples: Advil, Aleve, Aspirin, Bextra, Celebrex, Disalcid, Excedrin, Excedrin
PM, Feldene, Ibuprofen, Indomethacin, Meclomen, Motrin, Maproxen/Naprosyn,
Relefen, Sulindac, Trilisate, Tolectic, etc.
No
Yes, for back pain ONLY
Yes, for other reasons ONLY
Yes, for back pain AND other reasons<< Previous

8/30/2011

Next >>

12:12:35 PM

Health Care and Medication Use
During the past week, have you taken sedatives or muscles relaxants?
Examples: Alprazolam, Ambien, Baclofen, Diazepam, Donnatal, Flexeril,
Lorazepam, Meprobamate, Methocarbamol/Robaxin, Norflex, Phenergan,
Phenobarbital, Skelaxin, Soma, Temazepam, tizanidine, Tranxene, Tylenol PM,
Valium, Xanax, Zanaflex, etc.
No
Yes, for back pain ONLY
Yes, for other reasons ONLY
Yes, for back pain AND other reasons
During the past week, have you taken narcotic analgesics?
Examples: ASA w/ Codeine, Darvocet, Darvon, Demerol, Dilaudid, Fentanyl,
Meperidine, Morphine, Oxycodone, Percodan, Talwin, Tylenol-3, Tylenol w/
Codeine, Tylox, Vicodin, etc.
No
Yes, for back pain ONLY
Yes, for other reasons ONLY
Yes, for back pain AND other reasons<< Previous

8/30/2011

Next >>

12:12:50 PM

Health Care and Medication Use
During the past week, have you taken anti-depressants?
Examples: Amitriptyline, Celexa, Desipramine, Doxepin, Effexor, Imipramine,
Lexapro, Nortriptyline, Paxil, Prozac/Fluoxetine, Trazodone, Wellbutrin, Zoloft,etc.
No
Yes, for back pain ONLY
Yes, for other reasons ONLY
Yes, for back pain AND other reasons
During the past week, have you taken supplements?
Examples: Chondroitin Sulfate, fish oils, flax seeds/oils, Glucosamine, willow
bark, etc.
No
Yes, for back pain ONLY
Yes, for other reasons ONLY
Yes, for back pain AND other reasons<< Previous

8/30/2011

Next >>

12:13:02 PM

Tobacco Use
Do you currently smoke cigarettes (smoked even 1 puff in the last 7 days)? (Thisincludes name brand, generic, all natural and roll-your-own cigarettes) .
No
Yes
Do you currently use chewing tobacco or snuff (took even 1 dip in the last 7days)?
No
Yes

Next >>

8/30/201112:13:19 PM

Tobacco Use
During the past 7 days, how many cigarettes did you smoke on a
typical day?
(# of cigarettes)

How soon after you wake up do you usually smoke your first cigarette?
Less than 5 minutes
5-30 minutes
31-60 minutes
More than 60 minutes
How many years have you smoked?
(# of years)<< Previous

8/30/2011

Next >>

12:15:08 PM

Tobacco Use
Do you experience strong cravings to smoke when you have to go without acigarette for more than an hour or two?
Never
SeldomSometimes
Often
AlwaysHave you been advised to quit smoking by your: (check all that apply)
Doctor of Chiropractic
Medical Doctor
DentistNurse/Physician Assistant
Dental Hygientist
Other Health Professional
None
In the past year, how many times have you made a serious attempt to quit
smoking (A serious attempt is 24 hours or more without smoking)?
None
1 time2 times
3 timesMore than 3 times<< Previous

8/30/2011

Next >>

12:15:17 PM

Tobacco Use
If you made a serious attempt to quit, which of the following methods did you
use? (check all that apply)
Went cold turkey (quit with no help)
Made a quit plan
Set a specific date to quit
Nicotine patches, nicotine gum or nicotine lozenges
Prescription medication (Zyban, Wellbutrin, Chantix)
Telephone tobacco quit line
Self-help guide
Chiropractic adjustment/careAcupuncture/acupressure
MassageHypnosis
Biofeedback
Meditation/yoga/relaxation/imagery
Herbal or botanical supplements
Homeopathy
Other
If Other, please specify:<< Previous

8/30/2011

Next >>

12:15:28 PM

Tobacco Use
Are you seriously thinking about quiting smoking in the next 30 days?
No
YesMark the number that shows how you feel about quitting.
0 No thought of quitting
1
2 Should consider quitting some day
3
4 Should quit but not quite ready5
6 Thinking about cutting down or quitting
7
8 Have cut down and seriously considering quitting
9
10 Ready to quit now<< Previous

8/30/2011

Next >>

12:16:21 PM

Tobacco Use
Do you currently use the following brands of chewing tobacco/snuff?
Loose moist snuff (Copenhagen, Cougar, Kodiak, Skoal, etc.)

No

Yes

Snuff pouches (Skoal bandits, etc.)

No

Yes

Snus (Camel, etc.)

No

Yes

Chew (Beech-Nut, Red Man, Granger, etc.)

No

Yes

In a typical week, how many days do you use chewing tobacco or snuff?
(# of days / week)

How many days does a can/tin/pouch last you?
(# of days)<< Previous

8/30/2011

Next >>

12:16:36 PM

Tobacco Use

Page 1 of 1

SECTION
Tobacco Use
How soon after you wake up do you use chewing tobacco or snuff?
Less than 5 minutes
5-30 minutes
31-60 minutes
More than 60 minutes
Do you swallow the tobacco juice from chewing tobacco?
Never
Sometimes
Frequently
How many years have you chewed tobacco or dipped snuff?
(# of years)<< Previous

https://w5.palmer.edu/dod_act1-train/ptforms/frmTobaccoBL.aspx?v=6

Next >>

6/25/2013

Tobacco Use
Do you experience strong cravings for a dip/chew when you go more than one
hour or two without one?
Never
SeldomSometimes
Often
AlwaysHave you been advised to quit chewing tobacco by your: (check all that apply)
Doctor of Chiropractic
Medical Doctor
DentistNurse/Physician Assistant
Dental Hygientist
Other Health Professional
None
In the past year, how many times have you made a serious attempt to quitchewing tobacco or snuff? (A serious quit attempt is 24 hours or more withoutchewing).
None
1 time2 times
3 timesMore than 3 times<< Previous

8/30/2011

Next >>

12:16:54 PM

Tobacco Use
If you made a serious attempt to quit, which of the following methods did you
use? (check all that apply)
Went cold turkey (quit with no help)
Made a quit plan
Set a specific date to quit
Nicotine patches, nicotine gum or nicotine lozenges
Prescription medication (Zyban, Wellbutrin, Chantix)
Telephone tobacco quit line
Self-help guide
Chiropractic adjustment/careAcupuncture/acupressure
MassageHypnosis
Biofeedback
Meditation/yoga/relaxation/imagery
Herbal or botanical supplements
Homeopathy
Other
If Other, please specify:<< Previous

8/30/2011

Next >>

12:17:07 PM

Tobacco Use
Are you seriously thinking about quiting chewing tobacco/snuff in the next 30
days?
No
Yes
Mark the number that shows how you feel about quitting.
0 No thought of quitting
1
2 Should consider quitting some day
3
4 Should quit but not quite ready5
6 Thinking about cutting down or quitting
7
8 Have cut down and seriously considering quitting
9
10 Ready to quit now<< Previous

8/30/2011

Next >>

12:17:19 PM

Expectations

SECTION
Expectations
How helpful do you believe medical care plus chiropractic care will be for your current
low back pain?
Not
helpfulat all0

Extremely
helpful

1

2

3

4

5

6

7

8

9

10

How helpful do you believe medical care alone will be for your current low back pain?
Not
helpfulat all0

Extremely
helpful

1

2

3

4

5

6

7

8

9

One month from now, do you expect your low back pain to be:Completely gone
Much better
Moderately better
A little better
About the same
A little worse
Much worse

http://localhost:2911/ptforms/frmExpect.aspx?v=0 (1 of 2)11/29/2012 1:46:23 PM

10Episodes of Pain
An episode of pain is defined as at least some low back pain requiring you toseek treatment or modify your activity during consecutive weeks (a week ormore with no pain separates episodes).
Have you had more than one episode of low back pain?
No
Yes
If Yes,Date of first episode of low back pain:/(month / year)
How many episodes have you had?
Month...

(# of episodes)

Is the rate of frequency of your low back pain episodes:
Increasing in frequency
Decreasing in frequency
Unchanged in frequency

Next >>

8/30/201112:17:47 PM

Demographic Information

Page 1 of 2

SECTION
Demographic Information
What is your marital status?
Married or living with significant other
Divorced or separated
WidowedNever been married
What is the highest grade or level of school you have completed or the highest
degree you have received?
Some grade school or high school
High school graduate
GED or equivalentSome college or other program, no degree
Associate degree: occupational, technical, or vocational
Associate degree: academic program
Bachelor's degree (for example: BA, AB, BS, BBA)
Master's degree (for example: MA, MS, MEng, MEd, MBA)
Professional school degree (for example: MD, DC, DDS, DO)
Doctoral degree (for example: PhD, EdD)
Which armed forces are you a member of?
Navy
Army
Marines
Air Force
Coast Guard
Air National Guard
Army National Guard
Special Operations
ROTC
USPHS
NOAA
Next >>

https://w5.palmer.edu/dod_act1-train/ptforms/frmDemographics.aspx

6/25/2013

Demographic Information
Have you ever been to a Doctor of Chiropractic?
No
Yes
If yes, do you consider yourself someone who receives regularchiropractic care?
NoYes
If yes, how often would you say you receive chiropractic
care?
Annually
Semi-annually
Monthly
Bi-weekly
Weekly<< Previous

8/30/2011

Next >>

12:18:10 PM

Demographic Information

Page 1 of 1

SECTION
Demographic Information
What is your household income?
Less than $20,000$20,000 - $39,999$40,000 - $59,000$60,000 - $79,000$80,000 or more
How would you describe the amount of physical activity in your daily routine?
No physical activity
Very light physical activity
Light physical activity
Moderate physical activity
Heavy physical activity
Very heavy physical activity

What is your height?
(feet)(inches: up to 1 decimal place)

What is your weight?
(lbs)<< Previous

https://w5.palmer.edu/dod_act1-train/ptforms/frmDemographics.aspx

Next >>

6/25/2013

Friday, February 08, 2013
4:25 PM

Week 2 and Week 4 Assessments

New Section 1 Page 1

New Section 1 Page 2

New Section 1 Page 3

Roland Morris Disability

Page 1 of 1

SECTION
Roland Morris Disability Questionnaire
Remember, only choose YES if you are sure that the sentence describes you
today.
No

Yes

I only walk short distances because of my back pain.
I sleep less well because of my back pain.
Because of my back pain, I get dressed with help fromsomeone else.
I sit down for most of the day because of my back.
I avoid heavy jobs around the house because of my back.
Because of my back pain, I am more irritable and badtempered with people than usual.
Because of my back, I go upstairs more slowly than usual.
I stay in bed most of the time because of my back.

<< Previous

https://w5.palmer.edu/dod_act1-train/ptforms/frmRM.aspx

Next >>

6/25/2013

New Section 1 Page 5

New Section 1 Page 6

New Section 1 Page 7

New Section 1 Page 8

New Section 1 Page 9

New Section 1 Page 10

New Section 1 Page 11

New Section 1 Page 12

New Section 1 Page 13

New Section 1 Page 14

New Section 1 Page 15

New Section 1 Page 16

New Section 1 Page 17

Reactions and Discomforts

Page 1 of 1

SECTION
Reactions and Discomforts
During the past 2 weeks, have you seen a healthcare provider for any reason
besides routine care*?
No
Yes*Any planned visit to the physician such as preventive care, routine
physical exams, or maintenance exams. Please be sure to tell us of any
unplanned visit to the doctor or hospital.

If yes, please describe the reason for the visit and any treatment that wasprovided.



Next >>

http://w5.palmer.edu/dod_act1-train/ptforms/frmAE.aspx?v=0

6/25/2013

Reactions and Discomforts

Page 1 of 1

SECTION
Reactions and Discomforts
Were you hospitalized during the course of treatment?
No
Yes

If yes, please describe*:*Please be sure to include whether it was an ER visit only or not (andlength of visit), hospital admission and discharge dates.

<< Previous

http://w5.palmer.edu/dod_act1-train/ptforms/frmAE.aspx?v=0

Next >>

6/25/2013

Reactions and Discomforts

Page 1 of 1

SECTION
Reactions and Discomforts
During the past 2 weeks, have you experienced any discomfort and/or an
unpleasant reaction that you think could be connected to the treatment you
received in this study?
No
Yes

If yes, indicate what discomforts or reactions you experienced.
(check all that apply)

Reaction to medication(s)Muscle and/or joint sorenessNeck pain
Headache
Pain or tingling down the arm/hand or leg/footMid and upper backDizziness
Broken rib
Broken hip
Other<< Previous

http://w5.palmer.edu/dod_act1-train/ptforms/frmAE.aspx?v=0

Next >>

6/25/2013

Reactions and Discomforts

Page 1 of 1

SECTION
Reactions and Discomforts
Reaction to medication(s)Please describe the study treatment that you believe is connected to this
discomfort/reaction:

Were you hospitalized because of this reaction/discomfort?
No
Yes

If Yes, please describe*:*Please be sure to include admission and discharge dates.

<< Previous

http://w5.palmer.edu/dod_act1-train/ptforms/frmAE.aspx?v=0

Next >>

6/25/2013

Reactions and Discomforts

Page 1 of 1

SECTION
Reactions and Discomforts
Reaction to medication(s), continued
Name of medication:

Describe your reaction to the medicine:How would you rate the amount of discomfort?
No
Discomfort

0

1

Unbearable
Discomfort

2

3

4

5

6

7

8

9

10

<< Previous

http://w5.palmer.edu/dod_act1-train/ptforms/frmAE.aspx?v=0

Next >>

6/25/2013

Reactions and Discomforts

Page 1 of 2

SECTION
Reactions and Discomforts
Reaction to medication(s), continued
How long after the treatment did the discomfort/reaction begin?
Less than 30 minutes
30 minutes to 4 hours
4 hours to 24 hours
More than 24 hours

How long did the discomfort last?
Less than 1 day
1 day - 1 week
More than 1 week
Ongoing

Did you have to modify your normal daily activities at home and/or work?
Not at all
A little
Moderately
Could not perform daily activities

If you could not perform daily activities, please explain:<< Previous

http://w5.palmer.edu/dod_act1-train/ptforms/frmAE.aspx?v=0

Next >>

6/25/2013

Reactions and Discomforts

Page 1 of 1

SECTION
Reactions and Discomforts
Muscle and/or joint soreness
Please describe the study treatment that you believe is connected to this
discomfort/reaction:

Were you hospitalized because of this reaction/discomfort?
No
Yes

If Yes, please describe*:*Description should include date of admission and date of discharge.

<< Previous

http://w5.palmer.edu/dod_act1-train/ptforms/frmAE.aspx?v=0

Next >>

6/25/2013

Reactions and Discomforts

Page 1 of 1

SECTION
Reactions and Discomforts
Muscle and/or joint soreness, continued
Describe the discomfort from your muscle and/or joint soreness:

How would you rate the amount of discomfort?
No
Discomfort

0

1

Unbearable
Discomfort

2

3

4

5

6

7

8

9

10

<< Previous

http://w5.palmer.edu/dod_act1-train/ptforms/frmAE.aspx?v=0

Next >>

6/25/2013

Reactions and Discomforts

Page 1 of 2

SECTION
Reactions and Discomforts
Muscle and/or joint soreness, continued
How long after the treatment did the discomfort begin?
Less than 30 minutes
30 minutes to 4 hours
4 hours to 24 hours
More than 24 hours

How long did the discomfort last?
Less than 1 day
1 day - 1 week
More than 1 week
Ongoing

Did you have to modify your normal daily activities at home and/or work?
Not at all
A little
Moderately
Could not perform daily activities

If you could not perform daily activities, please explain:<< Previous

http://w5.palmer.edu/dod_act1-train/ptforms/frmAE.aspx?v=0

Next >>

6/25/2013

Reactions and Discomforts

Page 1 of 1

SECTION
Reactions and Discomforts
Neck Pain
Please describe the study treatment that you believe is connected to this
discomfort/reaction:

Were you hospitalized because of this reaction/discomfort?
No
Yes

If Yes, please describe*:*Description should include date of admission and date of discharge.

<< Previous

http://w5.palmer.edu/dod_act1-train/ptforms/frmAE.aspx?v=0

Next >>

6/25/2013

Reactions and Discomforts

Page 1 of 1

SECTION
Reactions and Discomforts
Neck pain, continued
Describe the discomfort from your neck pain:How would you rate the amount of discomfort?
No
Discomfort

0

1

Unbearable
Discomfort

2

3

4

5

6

7

8

9

10

<< Previous

http://w5.palmer.edu/dod_act1-train/ptforms/frmAE.aspx?v=0

Next >>

6/25/2013

Reactions and Discomforts

Page 1 of 2

SECTION
Reactions and Discomforts
Neck pain, continued
How long after the treatment did the discomfort begin?
Less than 30 minutes
30 minutes to 4 hours
4 hours to 24 hours
More than 24 hours

How long did the discomfort last?
Less than 1 day
1 day - 1 week
More than 1 week
Ongoing

Did you have to modify your normal daily activities at home and/or work?
Not at all
A little
Moderately
Could not perform daily activities

If you could not perform daily activities, please explain:<< Previous

http://w5.palmer.edu/dod_act1-train/ptforms/frmAE.aspx?v=0

Next >>

6/25/2013

Reactions and Discomforts

Page 1 of 1

SECTION
Reactions and Discomforts
Headache
Please describe the study treatment that you believe is connected to this
discomfort/reaction:

Were you hospitalized because of this reaction/discomfort?
No
Yes

If Yes, please describe*:*Description should include date of admission and date of discharge.

<< Previous

http://w5.palmer.edu/dod_act1-train/ptforms/frmAE.aspx?v=0

Next >>

6/25/2013

Reactions and Discomforts

Page 1 of 1

SECTION
Reactions and Discomforts
Headache, continued
Describe the discomfort from your headache:

How would you rate the amount of discomfort?
No
Discomfort

0

1

Unbearable
Discomfort

2

3

4

5

6

7

8

9

10

<< Previous

http://w5.palmer.edu/dod_act1-train/ptforms/frmAE.aspx?v=0

Next >>

6/25/2013

Reactions and Discomforts

Page 1 of 2

SECTION
Reactions and Discomforts
Headache, continued
How long after the treatment did the discomfort begin?
Less than 30 minutes
30 minutes to 4 hours
4 hours to 24 hours
More than 24 hours

How long did the discomfort last?
Less than 1 day
1 day - 1 week
More than 1 week
Ongoing

Did you have to modify your normal daily activities at home and/or work?
Not at all
A little
Moderately
Could not perform daily activities

If you could not perform daily activities, please explain:<< Previous

http://w5.palmer.edu/dod_act1-train/ptforms/frmAE.aspx?v=0

Next >>

6/25/2013

Reactions and Discomforts

Page 1 of 1

SECTION
Reactions and Discomforts
Pain or tingling down the arm/hand or leg/footPlease describe the study treatment that you believe is connected to this
discomfort/reaction:

Were you hospitalized because of this reaction/discomfort?
No
Yes

If Yes, please describe*:*Description should include date of admission and date of discharge.

<< Previous

http://w5.palmer.edu/dod_act1-train/ptforms/frmAE.aspx?v=0

Next >>

6/25/2013

Reactions and Discomforts

Page 1 of 1

SECTION
Reactions and Discomforts
Pain or tingling down the arm/hand or leg/foot, continued
Describe the discomfort:

How would you rate the amount of discomfort?
No
Discomfort

0

1

Unbearable
Discomfort

2

3

4

5

6

7

8

9

10

<< Previous

http://w5.palmer.edu/dod_act1-train/ptforms/frmAE.aspx?v=0

Next >>

6/25/2013

Reactions and Discomforts

Page 1 of 2

SECTION
Reactions and Discomforts
Pain or tingling down the arm/hand or leg/foot, continued
How long after the treatment did the discomfort begin?
Less than 30 minutes
30 minutes to 4 hours
4 hours to 24 hours
More than 24 hours

How long did the discomfort last?
Less than 1 day
1 day - 1 week
More than 1 week
Ongoing

Did you have to modify your normal daily activities at home and/or work?
Not at all
A little
Moderately
Could not perform daily activities

If you could not perform daily activities, please explain:<< Previous

http://w5.palmer.edu/dod_act1-train/ptforms/frmAE.aspx?v=0

Next >>

6/25/2013

Reactions and Discomforts

Page 1 of 1

SECTION
Reactions and Discomforts
Mid and upper backPlease describe the study treatment that you believe is connected to this
discomfort/reaction:

Were you hospitalized because of this reaction/discomfort?
No
Yes

If Yes, please describe*:*Description should include date of admission and date of discharge.

<< Previous

http://w5.palmer.edu/dod_act1-train/ptforms/frmAE.aspx?v=0

Next >>

6/25/2013

Reactions and Discomforts

Page 1 of 1

SECTION
Reactions and Discomforts
Mid and upper back, continued
Describe the discomfort:

How would you rate the amount of discomfort?
No
Discomfort

0

1

Unbearable
Discomfort

2

3

4

5

6

7

8

9

10

<< Previous

http://w5.palmer.edu/dod_act1-train/ptforms/frmAE.aspx?v=0

Next >>

6/25/2013

Reactions and Discomforts

Page 1 of 2

SECTION
Reactions and Discomforts
Mid and upper back, continued
How long after the treatment did the discomfort begin?
Less than 30 minutes
30 minutes to 4 hours
4 hours to 24 hours
More than 24 hours

How long did the discomfort last?
Less than 1 day
1 day - 1 week
More than 1 week
Ongoing

Did you have to modify your normal daily activities at home and/or work?
Not at all
A little
Moderately
Could not perform daily activities

If you could not perform daily activities, please explain:<< Previous

http://w5.palmer.edu/dod_act1-train/ptforms/frmAE.aspx?v=0

Next >>

6/25/2013

Reactions and Discomforts

Page 1 of 1

SECTION
Reactions and Discomforts
Dizziness
Please describe the study treatment that you believe is connected to this
discomfort/reaction:

Were you hospitalized because of this reaction/discomfort?
No
Yes

If Yes, please describe*:*Description should include date of admission and date of discharge.

<< Previous

http://w5.palmer.edu/dod_act1-train/ptforms/frmAE.aspx?v=0

Next >>

6/25/2013

Reactions and Discomforts

Page 1 of 1

SECTION
Reactions and Discomforts
Dizziness, continued
Describe the discomfort:

How would you rate the amount of discomfort?
No
Discomfort

0

1

Unbearable
Discomfort

2

3

4

5

6

7

8

9

10

<< Previous

http://w5.palmer.edu/dod_act1-train/ptforms/frmAE.aspx?v=0

Next >>

6/25/2013

Reactions and Discomforts

Page 1 of 2

SECTION
Reactions and Discomforts
Dizziness, continued
How long after the treatment did the discomfort begin?
Less than 30 minutes
30 minutes to 4 hours
4 hours to 24 hours
More than 24 hours

How long did the discomfort last?
Less than 1 day
1 day - 1 week
More than 1 week
Ongoing

Did you have to modify your normal daily activities at home and/or work?
Not at all
A little
Moderately
Could not perform daily activities

If you could not perform daily activities, please explain:<< Previous

http://w5.palmer.edu/dod_act1-train/ptforms/frmAE.aspx?v=0

Next >>

6/25/2013

Reactions and Discomforts

Page 1 of 1

SECTION
Reactions and Discomforts
Broken rib
Please describe the study treatment that you believe is connected to this
discomfort/reaction:

Were you hospitalized because of this reaction/discomfort?
No
Yes

If Yes, please describe*:*Description should include date of admission and date of discharge.

<< Previous

http://w5.palmer.edu/dod_act1-train/ptforms/frmAE.aspx?v=0

Next >>

6/25/2013

Reactions and Discomforts

Page 1 of 1

SECTION
Reactions and Discomforts
Broken rib, continued
Describe the fracture:How long after the treatment did you first suspect a fracture/injury?
Less than 30 minutes
30 minutes to 4 hours
4 hours to 24 hours
More than 24 hours

How long was it until you sought medical treatment for the fracture?
Less than 1 day
1 day - 1 week
More than 1 week
Ongoing<< Previous

http://w5.palmer.edu/dod_act1-train/ptforms/frmAE.aspx?v=0

Next >>

6/25/2013

Reactions and Discomforts

Page 1 of 1

SECTION
Reactions and Discomforts
Broken hip
Please describe the study treatment that you believe is connected to this
discomfort/reaction:

Were you hospitalized because of this reaction/discomfort?
No
Yes

If Yes, please describe*:*Description should include date of admission and date of discharge.

<< Previous

http://w5.palmer.edu/dod_act1-train/ptforms/frmAE.aspx?v=0

Next >>

6/25/2013

Reactions and Discomforts

Page 1 of 1

SECTION
Reactions and Discomforts
Broken hip, continued
Describe the fracture:How long after the treatment did you first suspect a fracture/injury?
Less than 30 minutes
30 minutes to 4 hours
4 hours to 24 hours
More than 24 hours

How long was it until you sought medical treatment for the fracture?
Less than 1 day
1 day - 1 week
More than 1 week
Ongoing<< Previous

http://w5.palmer.edu/dod_act1-train/ptforms/frmAE.aspx?v=0

Next >>

6/25/2013

Reactions and Discomforts

Page 1 of 1

SECTION
Reactions and Discomforts
Other reaction/discomfort
Please describe the study treatment that you believe is connected to this
discomfort/reaction:

Were you hospitalized because of this reaction/discomfort?
No
Yes

If Yes, please describe*:*Description should include date of admission and date of discharge.

<< Previous

http://w5.palmer.edu/dod_act1-train/ptforms/frmAE.aspx?v=0

Next >>

6/25/2013

Reactions and Discomforts

Page 1 of 1

SECTION
Reactions and Discomforts
Other reaction/discomfort, continued
Describe the reaction/discomfort:

How would you rate the amount of discomfort?
No
Discomfort

0

1

Unbearable
Discomfort

2

3

4

5

6

7

8

9

10

<< Previous

http://w5.palmer.edu/dod_act1-train/ptforms/frmAE.aspx?v=0

Next >>

6/25/2013

Reactions and Discomforts

Page 1 of 2

SECTION
Reactions and Discomforts
Other reaction/discomfort, continued
How long after the treatment did the reaction/discomfort begin?
Less than 30 minutes
30 minutes to 4 hours
4 hours to 24 hours
More than 24 hours

How long did the reaction/discomfort last?
Less than 1 day
1 day - 1 week
More than 1 week
Ongoing

How much did the reaction/discomfort affect your normal daily activities at home
and/or work?
Not at all
A little
Moderately
Could not perform daily activities

If you could not perform daily activities, please explain:<< Previous

http://w5.palmer.edu/dod_act1-train/ptforms/frmAE.aspx?v=0

Next >>

6/25/2013

New Section 1 Page 42

Week 6 Assessment
SECTION
Pain Rating Scales
Select the number that best describes your low back pain at its worst during thepast 24 hours?
No
Pain
0

Worst
Possible
Pain

1

2

3

4

5

6

7

8

9

10

Select the number that best describes your average low back pain during thepast week?
No
Pain
0

Worst
Possible
Pain

1

2

3

4

5

6

7

8

9

10

Next >>

8/30/201112:03:38 PM

Roland Morris Disability Questionnaire
When your back hurts, you may find it difficult to do some of the things you
normally do.
This list contains sentences that people have used to describe themselves when
they have back pain. When you read them, you may find that some stand out
because they describe you today. As you read the list, thing of yourself today.
When you read a sentence that describes how you feel today, choose YES. If thesentence does not describe you, then choose NO.
Remember, only choose YES if you are sure that the sentence describes
you today.
No

Yes

I stay home most of the time because of my back.
I change position frequently to try and get my backcomfortable.
I walk more slowly than usual because of my back.
Because of my back, I am not doing any jobs that I
usually do around the house.
Because of my back, I use a handrail to get upstairs.
Because of my back, I lie down to rest more often.
Because of my back, I have to hold on to something to
get out of an easy chair.
Because of my back, I try to get other people to do things
for me.

Next >>

8/30/201112:05:35 PM

Roland Morris Disability Questionnaire
Remember, only choose YES if you are sure that the sentence describes you
today.
NoYes

I get dressed more slowly than usual because of my back.
I only stand up for short periods of time because of myback.
Because of my back, I try not to bend or kneel down.
I find it difficult to get out of a chair because of my back.
My back is painful almost all of the time.
I find it difficult to turn over in bed because of my back.
My appetite is not very good because of my back.
I have trouble putting on my socks (stockings) beause of
the pain in my back.

Go To Next Question >Skip To Next Section >>8/30/201112:09:01 PM

Roland Morris Disability

Page 1 of 1

SECTION
Roland Morris Disability Questionnaire
Remember, only choose YES if you are sure that the sentence describes you
today.
No

Yes

I only walk short distances because of my back pain.
I sleep less well because of my back pain.
Because of my back pain, I get dressed with help fromsomeone else.
I sit down for most of the day because of my back.
I avoid heavy jobs around the house because of my back.
Because of my back pain, I am more irritable and badtempered with people than usual.
Because of my back, I go upstairs more slowly than usual.
I stay in bed most of the time because of my back.

<< Previous

https://w5.palmer.edu/dod_act1-train/ptforms/frmRM.aspx

Next >>

6/25/2013

Back Pain Function Scale
On the questions listed below, we are interested in knowing whether you arehaving ANY DIFFICULTY at all with the activities because of your backproblem for which you are currently seeking attention. Please porvide an answer
for each activity.
Today, do you or would you have any DIFFICULTY at all with thefollowing activities BECAUSE OF YOUR BACK PROBLEM?

(choose one response on each line)

Unableto
Quite aA little
perform Extreme
bit ofbit ofModerateNo
activity difficulty difficulty difficulty difficulty difficulty

Any of your usual work,
housework, or school
activities
Your usual hobbies,
recreational, or sporting
activities
Performing heavy activities
around your home
Bending or stooping
Putting on your shoes orsocks (pantyhose)
Lifting a box of groceries
from the floor

Next >>

8/30/201112:09:35 PM

Back Pain Function Scale
Today, do you or would you have any DIFFICULTY at all with thefollowing activities BECAUSE OF YOUR BACK PROBLEM?

(choose one response on each line)

Unableto
Quite aA little
perform Extreme
bit ofbit ofModerateNo
activity difficulty difficulty difficulty difficulty difficulty

Sleeping
Standing for 1 hour
Walking a mile
Going up or down 2 flightsof stairs (about 20 stairs)
Sitting for 1 hour
Driving for 1 hour<< Previous

8/30/2011

Next >>

12:09:46 PM

Bothersomeness
During the past week, how bothersome have each of the following symptoms
been? (choose one response for each symptom)
Not at all
bothersome

Slightly
bothersome

Moderately
bothersomeVerybothersome

Extremely
bothersome

Low back pain
Leg pain (sciatica)
Neck pain

During the past week, how much did pain interfere with your normal work
(including both work outside the home and housework)?
Not at all
A little bitModerately
Quite a bit
Extremely

Next >>

8/30/201112:10:08 PM

BothersomenessIf you had to spend the rest of your life with the symptoms you have right now,
how would you feel about it?
Very dissatisfied
Somewhat dissatisfied
Neither satisfied nor dissatisfied
Somewhat satisfied
Very satisfied

During the past 4 weeks, about how many days did you cut down on the things
you usually do for more than half the day because of your low back pain?
# of days

During the past 4 weeks, how many days did low back pain keep you from going
to work or school?
# of days<< Previous

8/30/2011

Next >>

12:10:21 PM

Health Survey - PROMIS-29
In the past 7 days...
WithoutanydifficultyWith alittledifficulty

With
some
difficulty

With
much
difficulty

Unableto do

Are you able to do chores
such as vacuuming or yard
work?
Are you able to go up anddown stairs at a normalpace?
Are you able to go for awalk of at least 15
minutes?
Are you able to run
errands and shop?

Next >>

8/30/201112:10:34 PM

Health Survey - PROMIS-29
In the past 7 days...
Never

RarelySometimes

Often

AlwaysI felt fearful.
I found it hard to focus
on anything other than
my anxiety.
My worries
overwhelmed me.
I felt uneasy.

Next >>

8/30/201112:10:49 PM

Health Survey - PROMIS-29
In the past 7 days...
Never

RarelySometimes

Often

AlwaysI felt worthless.
I felt helpless.
I felt depressed.
I felt hopeless.

<< Previous

8/30/2011

Next >>

12:11:10 PM

Health Survey - PROMIS-29
During the past 7 days...
Not
at allA
little bit

Somewhat

Quite
a bit

Very
much

Not
at allA
little bit

Somewhat

Quite
a bit

Very
much

I feeel fatigued.
I have trouble starting
things because I am
tired.
In the past 7 days...

How run-down did you
feel on average?
How fatigued were you
on average?

<< Previous

8/30/2011

Next >>

12:11:21 PM

Health Survey - PROMIS-29
In the past 7 days...
Very poor

Poor

Fair

Good

Very goodNot
at allA
little bit

Somewhat

Quite
a bit

Very
much

My sleep quality was...

In the past 7 days...

My sleep wasrefreshing.
I had a problem withmy sleep.
I had difficulty falling
asleep.

<< Previous

8/30/2011

Next >>

12:11:37 PM

Health Survey - PROMIS-29
In the past 7 days...
Not
at allA
little bit

Somewhat

Quite
a bit

Very
much

I am satisfied with howmuch work I can do(include work at home).
I am satisfied with myability to work (include
work at home).
I am satisfied with myability to do regularpersonal and household
responsibilities.
I am satisfied with myability to perform mydaily routines.

<< Previous

8/30/2011

Next >>

12:11:50 PM

Health Survey - PROMIS-29
In the past 7 days...
Not
at allA
little bit

Somewhat

Quite
a bit

Very
much

How much did paininterfere with your day
to day activities?
How much did paininterfere with workaround the home?
How much did paininterfere with yourability to participate insocial activities?
How much did paininterfere with yourhousehold chores?

<< Previous

8/30/2011

Next >>

12:12:00 PM

Health Survey - PROMIS-29
In the past 7 days...
How would you rate your pain on average?
No
Pain
0

Worst
Imaginable
Pain

1

2

3

4

5

6

7

8

9

10

Next >>

8/30/201112:12:14 PM

Health Care and Medication Use
Since the beginning of your current episode of pain, from which of thefollowing providers have you sought treatment for your low back pain?
(Choose all that apply)

Primary care doctor
Medical specialist (specify type below)
Doctor of Osteopathy
Doctor of Chiropractic
Acupuncturist
Massage therapist
Physical therapist
Pain clinic or pain specialist
Counselor or mental health specialist
N/A
Other (specify type below)
Specify:During the past week, how often have you taken pain relieving medication(including prescription and over-the-counter medications or supplements)?
0 days
1-2 days
3-4 days
5-6 days
7 daysNext >>

8/30/201112:12:25 PM

Health Care and Medication Use
During the past week, have you taken non-narcotic analgesics?
Examples: Acetaminophen, Tylenol, Tylenol Extra Strength, Ultram, etc.
No
Yes, for back pain ONLY
Yes, for other reasons ONLY
Yes, for back pain AND other reasons
During the past week, have you taken non-steroidal anti-inflammatory
drugs (NSAIDS)?
Examples: Advil, Aleve, Aspirin, Bextra, Celebrex, Disalcid, Excedrin, Excedrin
PM, Feldene, Ibuprofen, Indomethacin, Meclomen, Motrin, Maproxen/Naprosyn,
Relefen, Sulindac, Trilisate, Tolectic, etc.
No
Yes, for back pain ONLY
Yes, for other reasons ONLY
Yes, for back pain AND other reasons<< Previous

8/30/2011

Next >>

12:12:35 PM

Health Care and Medication Use
During the past week, have you taken sedatives or muscles relaxants?
Examples: Alprazolam, Ambien, Baclofen, Diazepam, Donnatal, Flexeril,
Lorazepam, Meprobamate, Methocarbamol/Robaxin, Norflex, Phenergan,
Phenobarbital, Skelaxin, Soma, Temazepam, tizanidine, Tranxene, Tylenol PM,
Valium, Xanax, Zanaflex, etc.
No
Yes, for back pain ONLY
Yes, for other reasons ONLY
Yes, for back pain AND other reasons
During the past week, have you taken narcotic analgesics?
Examples: ASA w/ Codeine, Darvocet, Darvon, Demerol, Dilaudid, Fentanyl,
Meperidine, Morphine, Oxycodone, Percodan, Talwin, Tylenol-3, Tylenol w/
Codeine, Tylox, Vicodin, etc.
No
Yes, for back pain ONLY
Yes, for other reasons ONLY
Yes, for back pain AND other reasons<< Previous

8/30/2011

Next >>

12:12:50 PM

Health Care and Medication Use
During the past week, have you taken anti-depressants?
Examples: Amitriptyline, Celexa, Desipramine, Doxepin, Effexor, Imipramine,
Lexapro, Nortriptyline, Paxil, Prozac/Fluoxetine, Trazodone, Wellbutrin, Zoloft,etc.
No
Yes, for back pain ONLY
Yes, for other reasons ONLY
Yes, for back pain AND other reasons
During the past week, have you taken supplements?
Examples: Chondroitin Sulfate, fish oils, flax seeds/oils, Glucosamine, willow
bark, etc.
No
Yes, for back pain ONLY
Yes, for other reasons ONLY
Yes, for back pain AND other reasons<< Previous

8/30/2011

Next >>

12:13:02 PM

Tobacco UseThis section only appears if thept stated they were a tobaccouser and signed the consent.

Which of the following topics did your Doctor of Chiropractic talk to you about inthe last six weeks .
Tobacco-related health problems
Setting a date to quit all tobacco use
Tips to help you quit all tobacco use
Telephone tobacco quit lines
Tobacco cessation groups/classes
Nicotine patches, nicotine gum, or nicotine lozenges
Prescription medications (such as Chantix, Zyban, nicotine inhaler)
Natural ways to quit tobacco (such as acupunture, hypnosis, herbal
supplements)
None of the above
Did you expect to hear advice about quitting tobacco from your Doctor of
Chiropractic?
No
Yes
How helpful were the topics that you talked about with your Doctor of
Chiropractic?
1 Not at all helpful
2
3 Somewhat helpful
45 Very helpful

Next >>

8/30/2011

4:08:34 PM

Tobacco Use
Did your Doctor of Chiropractic give you written materials related to tobacco use?
No
Yes
If Yes,Did you read them?
Did not read them
Read all or parts of them
If you read them,
How helpful were the written materials?
1 Not at all helpful
2
3 Somewhat helpful
45 Very helpful
Which statement best describes your smoking during the past 7 days?
For both of these answers, go to 'During
I smoked regularly.
the past 7 days, how many cigarettes did
I smoked once in a while. you smoke on a typical day?'I have not smoked at all, not even a puff.
Go to Question 'When did you
last smoke a cigarette?'<< Previous

8/30/2011

Next >>

4:08:51 PM

Tobacco Use
When did you last smoke a cigarette?
Less than 1 week ago
1 - 4 weeks ago

Continue here when 'I havenot smoked at all, not even apuff.

1 - 2 months ago
2 - 3 months ago
How confident are you that you will remain a non-smoker?
1 Not at all confident
2
3 Somewhat confident
4
5 Very confident<< Previous

8/30/2011

Next >>

4:09:49 PM

Tobacco Use

Page 1 of 1

Tobacco Use
When you quit smoking, which methods or product did you use?
(check all that apply)

Did not make a serious attempt to quit
Went cold turkey (quit with no help)
Made a quit plan
Set a specific date to quit
Nicotine patches, nicotine gum or nicotine lozenges
Prescription medication (Zyban, Wellbutrin, Chantix)
Telephone tobacco quit line
Self-help guide
Chiropractic adjustment/careAcupuncture/acupressure
MassageHypnosis
Biofeedback
Meditation/yoga/relaxation/imagery
Herbal or botanical supplements
Homeopathy
Other
If Other, please specify:<< Previous

http://w5.palmer.edu/dod_act1-train/ptforms/frmTobaccoCig.aspx?v=2

Next >>

6/25/2013

Tobacco UseContinue here when 'I smokedregularly' or 'I smoked once in awhile' were marked.

During the past 7 days, how many cigarettes did you smoke on a
typical day?
(# of cigarettes)

How soon after you wake up do you usually smoke your first cigarette?
Less than 5 minutes
5-30 minutes
31-60 minutes
More than 60 minutes
Do you experience strong cravings to smoke when you have to go without acigarette for more than an hour or two?
Never
SeldomSometimes
Often
Always<< Previous

8/30/2011

Next >>

4:10:41 PM

Tobacco Use

Page 1 of 2

Tobacco Use
During the past 6 weeks, how many times have you made a serious attempt toquit smoking (gone at least 24 hours without smoking)?
None
1 time2 times
3 timesMore than 3 times

If you made an attempt to quit, which of the following methods or products did
you use? (check all that apply)
Did not make a serious attempt to quit
Went cold turkey (quit with no help)
Made a quit plan
Set a specific date to quit
Nicotine patches, nicotine gum or nicotine lozenges
Prescription medication (Zyban, Wellbutrin, Chantix)
Telephone tobacco quit line
Self-help guide
Chiropractic adjustment/careAcupuncture/acupressure
MassageHypnosis
Biofeedback
Meditation/yoga/relaxation/imagery
Herbal or botanical supplements
Homeopathy
Other
If Other, please specify:<< Previous

http://w5.palmer.edu/dod_act1-train/ptforms/frmTobaccoCig.aspx?v=0

Next >>

6/25/2013

Tobacco Use
Are you seriously thinking about quiting smoking in the next 30 days?
No
YesMark the number that shows how you feel about quitting.
0 No thought of quitting
1
2 Should consider quitting some day
3
4 Should quit but not quite ready5
6 Thinking about cutting down or quitting
7
8 Have cut down and seriously considering quitting
9
10 Ready to quit now<< Previous

8/30/2011

Next >>

4:11:13 PM

Tobacco Use
Do you also use chewing tobacco or snuff?
No
Yes
If Yes,What kind of tobacco is more important to you?
Chewing tobacco/snuff
Cigarettes<< Previous

8/30/2011

Next >>

4:11:33 PM

Tobacco Use

Appears if question above was'yes' or 'yes' on the chewing
tobacco/snuff question on
baseline.

Which statement best describes your use of chewing tobacco or snuff during thepast 7 days?
For both of these options, go to question 'In
a typical day, how often did you use chewing
I used chewing tobacco/snuff once in a while. tobacco/snuff, even once?'
I have not used chewing tobacco/snuff at all, not even one dip.
Go to question 'When did you last use chewing tobacco or
snuff?'
I used chewing tobacco/snuff regularly.

<< Previous

8/30/2011

Next >>

4:11:54 PM

Tobacco Use
When did you last use chewing tobacco or snuff?

Continue here when
'I have not usedchewing tobacco/snuff, not even on
dip.' was marked.

Less than 1 week ago
1 - 4 weeks ago
1 - 2 months ago
2 - 3 months ago
How confident are you that you will remain a non-chewer?
1 Not at all confident
2
3 Somewhat confident
4
5 Very confident<< Previous

8/30/2011

Next >>

4:12:09 PM

Tobacco Use

Page 1 of 1

Tobacco Use
When you quit smoking, which methods or product did you use?
(check all that apply)

Did not make a serious attempt to quit
Went cold turkey (quit with no help)
Made a quit plan
Set a specific date to quit
Nicotine patches, nicotine gum or nicotine lozenges
Prescription medication (Zyban, Wellbutrin, Chantix)
Telephone tobacco quit line
Self-help guide
Chiropractic adjustment/careAcupuncture/acupressure
MassageHypnosis
Biofeedback
Meditation/yoga/relaxation/imagery
Herbal or botanical supplements
Homeopathy
Other
If Other, please specify:<< Previous

http://w5.palmer.edu/dod_act1-train/ptforms/frmTobaccoCig.aspx?v=2

Next >>

6/25/2013

Continue here if either 'I use chewing
tobacco/snuff regularly' or 'I use
Tobacco Usechewing tobacco/snuff once in awhile' were marked.
In a typical week, how many days do you use chewing tobacco or snuff?
(# of days / week)

How many days does a can/tin/pouch last you?
(# of days)

How soon after you wake up do you use chewing tobacco or snuff?
Less than 5 minutes
5-30 minutes
31-60 minutes
More than 60 minutes
Do you experience strong cravings for a dip/chew when you go more than one
hour or two without one?
Never
SeldomSometimes
Often
Always<< Previous

8/30/2011

Next >>

4:15:47 PM

Tobacco Use

Page 1 of 2

Tobacco Use
During the past 6 weeks, how many times have you made a serious attempt toquit smoking (gone at least 24 hours without smoking)?
None
1 time2 times
3 timesMore than 3 times

If you made an attempt to quit, which of the following methods or products did
you use? (check all that apply)
Did not make a serious attempt to quit
Went cold turkey (quit with no help)
Made a quit plan
Set a specific date to quit
Nicotine patches, nicotine gum or nicotine lozenges
Prescription medication (Zyban, Wellbutrin, Chantix)
Telephone tobacco quit line
Self-help guide
Chiropractic adjustment/careAcupuncture/acupressure
MassageHypnosis
Biofeedback
Meditation/yoga/relaxation/imagery
Herbal or botanical supplements
Homeopathy
Other
If Other, please specify:<< Previous

http://w5.palmer.edu/dod_act1-train/ptforms/frmTobaccoCig.aspx?v=0

Next >>

6/25/2013

Tobacco Use
Are you seriously thinking about quiting chewing tobacco/snuff in the next 30
days?
No
Yes
Mark the number that shows how you feel about quitting.
0 No thought of quitting
1
2 Should consider quitting some day
3
4 Should quit but not quite ready5
6 Thinking about cutting down or quitting
7
8 Have cut down and seriously considering quitting
9
10 Ready to quit now<< Previous

8/30/2011

Next >>

4:16:38 PM

Satisfaction with CareHow satisfied are you with your care?
Not
at allsatisfied
0
1

Extremely
satisfied

2

3

4

5

6

7

8

9

10

Compared to your first visit, your low back pain is:Completely gone
Much better
Moderately better
A little better
About the same
A little worse
Much worse

Next >>

8/30/2011

12:40:23 PM

Self-Reported Care
During the past 2 weeks, what type of care have you had?
Medical care
Rehabilitation / Physical therapy
Chiropractic care
None of the above

Next >>

8/30/2011

12:40:51 PM

Self-Reported Care
Medical care
What type of doctor did you see:Primary care MD
Orthopaedist
Neurologist
Other (specify below)
Specify:
How many visits did you have (total)?
visitsDid your doctor prescribe medication?
No
Yes
Indicate any self-care instructions given by the doctor(s)? (mark all that apply)
Exercise
Stretching
Over-the-counter medication
Restrictions on daily living
Bed rest
Other<< Previous

8/30/2011

Next >>

12:41:02 PM

Self-Reported Care
Chiropractic care
How many visits did you have (total)?
visitsIndicate the type of care that you received? (mark all that apply)
Manipulation/adjustment
Self-care instructions
Ice
Heat
Electrical stimulation
UltrasoundSoft tissue/massage
Tape/bracing
Other<< Previous

8/30/2011

Next >>

12:41:14 PM

Self-Reported Care
Self-care
Indicate care that you initiated on your own without the recommendation of ahealthcare provider? (mark all that apply)
ExerciseOver-the-counter medication
Nutritional supplements
Diet
MassageAcupuncture
None of the above
Other (specify below)
Specify:<< Previous

8/30/2011

Next >>

12:41:24 PM

Reactions and Discomforts

Page 1 of 1

SECTION
Reactions and Discomforts
During the past 2 weeks, have you seen a healthcare provider for any reason
besides routine care*?
No
Yes*Any planned visit to the physician such as preventive care, routine
physical exams, or maintenance exams. Please be sure to tell us of any
unplanned visit to the doctor or hospital.

If yes, please describe the reason for the visit and any treatment that wasprovided.



Next >>

http://w5.palmer.edu/dod_act1-train/ptforms/frmAE.aspx?v=0

6/25/2013

Reactions and Discomforts

Page 1 of 1

SECTION
Reactions and Discomforts
Were you hospitalized during the course of treatment?
No
Yes

If yes, please describe*:*Please be sure to include whether it was an ER visit only or not (andlength of visit), hospital admission and discharge dates.

<< Previous

http://w5.palmer.edu/dod_act1-train/ptforms/frmAE.aspx?v=0

Next >>

6/25/2013

Reactions and Discomforts

Page 1 of 1

SECTION
Reactions and Discomforts
During the past 2 weeks, have you experienced any discomfort and/or an
unpleasant reaction that you think could be connected to the treatment you
received in this study?
No
Yes

If yes, indicate what discomforts or reactions you experienced.
(check all that apply)

Reaction to medication(s)Muscle and/or joint sorenessNeck pain
Headache
Pain or tingling down the arm/hand or leg/footMid and upper backDizziness
Broken rib
Broken hip
Other<< Previous

http://w5.palmer.edu/dod_act1-train/ptforms/frmAE.aspx?v=0

Next >>

6/25/2013

Reactions and Discomforts

Page 1 of 1

SECTION
Reactions and Discomforts
Reaction to medication(s)Please describe the study treatment that you believe is connected to this
discomfort/reaction:

Were you hospitalized because of this reaction/discomfort?
No
Yes

If Yes, please describe*:*Please be sure to include admission and discharge dates.

<< Previous

http://w5.palmer.edu/dod_act1-train/ptforms/frmAE.aspx?v=0

Next >>

6/25/2013

Reactions and Discomforts

Page 1 of 1

SECTION
Reactions and Discomforts
Reaction to medication(s), continued
Name of medication:

Describe your reaction to the medicine:How would you rate the amount of discomfort?
No
Discomfort

0

1

Unbearable
Discomfort

2

3

4

5

6

7

8

9

10

<< Previous

http://w5.palmer.edu/dod_act1-train/ptforms/frmAE.aspx?v=0

Next >>

6/25/2013

Reactions and Discomforts

Page 1 of 2

SECTION
Reactions and Discomforts
Reaction to medication(s), continued
How long after the treatment did the discomfort/reaction begin?
Less than 30 minutes
30 minutes to 4 hours
4 hours to 24 hours
More than 24 hours

How long did the discomfort last?
Less than 1 day
1 day - 1 week
More than 1 week
Ongoing

Did you have to modify your normal daily activities at home and/or work?
Not at all
A little
Moderately
Could not perform daily activities

If you could not perform daily activities, please explain:<< Previous

http://w5.palmer.edu/dod_act1-train/ptforms/frmAE.aspx?v=0

Next >>

6/25/2013

Reactions and Discomforts

Page 1 of 1

SECTION
Reactions and Discomforts
Muscle and/or joint soreness
Please describe the study treatment that you believe is connected to this
discomfort/reaction:

Were you hospitalized because of this reaction/discomfort?
No
Yes

If Yes, please describe*:*Description should include date of admission and date of discharge.

<< Previous

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6/25/2013

Reactions and Discomforts

Page 1 of 1

SECTION
Reactions and Discomforts
Muscle and/or joint soreness, continued
Describe the discomfort from your muscle and/or joint soreness:

How would you rate the amount of discomfort?
No
Discomfort

0

1

Unbearable
Discomfort

2

3

4

5

6

7

8

9

10

<< Previous

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Next >>

6/25/2013

Reactions and Discomforts

Page 1 of 2

SECTION
Reactions and Discomforts
Muscle and/or joint soreness, continued
How long after the treatment did the discomfort begin?
Less than 30 minutes
30 minutes to 4 hours
4 hours to 24 hours
More than 24 hours

How long did the discomfort last?
Less than 1 day
1 day - 1 week
More than 1 week
Ongoing

Did you have to modify your normal daily activities at home and/or work?
Not at all
A little
Moderately
Could not perform daily activities

If you could not perform daily activities, please explain:<< Previous

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6/25/2013

Reactions and Discomforts

Page 1 of 1

SECTION
Reactions and Discomforts
Neck Pain
Please describe the study treatment that you believe is connected to this
discomfort/reaction:

Were you hospitalized because of this reaction/discomfort?
No
Yes

If Yes, please describe*:*Description should include date of admission and date of discharge.

<< Previous

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6/25/2013

Reactions and Discomforts

Page 1 of 1

SECTION
Reactions and Discomforts
Neck pain, continued
Describe the discomfort from your neck pain:How would you rate the amount of discomfort?
No
Discomfort

0

1

Unbearable
Discomfort

2

3

4

5

6

7

8

9

10

<< Previous

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Next >>

6/25/2013

Reactions and Discomforts

Page 1 of 2

SECTION
Reactions and Discomforts
Neck pain, continued
How long after the treatment did the discomfort begin?
Less than 30 minutes
30 minutes to 4 hours
4 hours to 24 hours
More than 24 hours

How long did the discomfort last?
Less than 1 day
1 day - 1 week
More than 1 week
Ongoing

Did you have to modify your normal daily activities at home and/or work?
Not at all
A little
Moderately
Could not perform daily activities

If you could not perform daily activities, please explain:<< Previous

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6/25/2013

Reactions and Discomforts

Page 1 of 1

SECTION
Reactions and Discomforts
Headache
Please describe the study treatment that you believe is connected to this
discomfort/reaction:

Were you hospitalized because of this reaction/discomfort?
No
Yes

If Yes, please describe*:*Description should include date of admission and date of discharge.

<< Previous

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6/25/2013

Reactions and Discomforts

Page 1 of 1

SECTION
Reactions and Discomforts
Headache, continued
Describe the discomfort from your headache:

How would you rate the amount of discomfort?
No
Discomfort

0

1

Unbearable
Discomfort

2

3

4

5

6

7

8

9

10

<< Previous

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Next >>

6/25/2013

Reactions and Discomforts

Page 1 of 2

SECTION
Reactions and Discomforts
Headache, continued
How long after the treatment did the discomfort begin?
Less than 30 minutes
30 minutes to 4 hours
4 hours to 24 hours
More than 24 hours

How long did the discomfort last?
Less than 1 day
1 day - 1 week
More than 1 week
Ongoing

Did you have to modify your normal daily activities at home and/or work?
Not at all
A little
Moderately
Could not perform daily activities

If you could not perform daily activities, please explain:<< Previous

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6/25/2013

Reactions and Discomforts

Page 1 of 1

SECTION
Reactions and Discomforts
Pain or tingling down the arm/hand or leg/footPlease describe the study treatment that you believe is connected to this
discomfort/reaction:

Were you hospitalized because of this reaction/discomfort?
No
Yes

If Yes, please describe*:*Description should include date of admission and date of discharge.

<< Previous

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Next >>

6/25/2013

Reactions and Discomforts

Page 1 of 1

SECTION
Reactions and Discomforts
Pain or tingling down the arm/hand or leg/foot, continued
Describe the discomfort:

How would you rate the amount of discomfort?
No
Discomfort

0

1

Unbearable
Discomfort

2

3

4

5

6

7

8

9

10

<< Previous

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Next >>

6/25/2013

Reactions and Discomforts

Page 1 of 2

SECTION
Reactions and Discomforts
Pain or tingling down the arm/hand or leg/foot, continued
How long after the treatment did the discomfort begin?
Less than 30 minutes
30 minutes to 4 hours
4 hours to 24 hours
More than 24 hours

How long did the discomfort last?
Less than 1 day
1 day - 1 week
More than 1 week
Ongoing

Did you have to modify your normal daily activities at home and/or work?
Not at all
A little
Moderately
Could not perform daily activities

If you could not perform daily activities, please explain:<< Previous

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6/25/2013

Reactions and Discomforts

Page 1 of 1

SECTION
Reactions and Discomforts
Mid and upper backPlease describe the study treatment that you believe is connected to this
discomfort/reaction:

Were you hospitalized because of this reaction/discomfort?
No
Yes

If Yes, please describe*:*Description should include date of admission and date of discharge.

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6/25/2013

Reactions and Discomforts

Page 1 of 1

SECTION
Reactions and Discomforts
Mid and upper back, continued
Describe the discomfort:

How would you rate the amount of discomfort?
No
Discomfort

0

1

Unbearable
Discomfort

2

3

4

5

6

7

8

9

10

<< Previous

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6/25/2013

Reactions and Discomforts

Page 1 of 2

SECTION
Reactions and Discomforts
Mid and upper back, continued
How long after the treatment did the discomfort begin?
Less than 30 minutes
30 minutes to 4 hours
4 hours to 24 hours
More than 24 hours

How long did the discomfort last?
Less than 1 day
1 day - 1 week
More than 1 week
Ongoing

Did you have to modify your normal daily activities at home and/or work?
Not at all
A little
Moderately
Could not perform daily activities

If you could not perform daily activities, please explain:<< Previous

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6/25/2013

Reactions and Discomforts

Page 1 of 1

SECTION
Reactions and Discomforts
Dizziness
Please describe the study treatment that you believe is connected to this
discomfort/reaction:

Were you hospitalized because of this reaction/discomfort?
No
Yes

If Yes, please describe*:*Description should include date of admission and date of discharge.

<< Previous

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6/25/2013

Reactions and Discomforts

Page 1 of 1

SECTION
Reactions and Discomforts
Dizziness, continued
Describe the discomfort:

How would you rate the amount of discomfort?
No
Discomfort

0

1

Unbearable
Discomfort

2

3

4

5

6

7

8

9

10

<< Previous

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6/25/2013

Reactions and Discomforts

Page 1 of 2

SECTION
Reactions and Discomforts
Dizziness, continued
How long after the treatment did the discomfort begin?
Less than 30 minutes
30 minutes to 4 hours
4 hours to 24 hours
More than 24 hours

How long did the discomfort last?
Less than 1 day
1 day - 1 week
More than 1 week
Ongoing

Did you have to modify your normal daily activities at home and/or work?
Not at all
A little
Moderately
Could not perform daily activities

If you could not perform daily activities, please explain:<< Previous

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6/25/2013

Reactions and Discomforts

Page 1 of 1

SECTION
Reactions and Discomforts
Broken rib
Please describe the study treatment that you believe is connected to this
discomfort/reaction:

Were you hospitalized because of this reaction/discomfort?
No
Yes

If Yes, please describe*:*Description should include date of admission and date of discharge.

<< Previous

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Next >>

6/25/2013

Reactions and Discomforts

Page 1 of 1

SECTION
Reactions and Discomforts
Broken rib, continued
Describe the fracture:How long after the treatment did you first suspect a fracture/injury?
Less than 30 minutes
30 minutes to 4 hours
4 hours to 24 hours
More than 24 hours

How long was it until you sought medical treatment for the fracture?
Less than 1 day
1 day - 1 week
More than 1 week
Ongoing<< Previous

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6/25/2013

Reactions and Discomforts

Page 1 of 1

SECTION
Reactions and Discomforts
Broken hip
Please describe the study treatment that you believe is connected to this
discomfort/reaction:

Were you hospitalized because of this reaction/discomfort?
No
Yes

If Yes, please describe*:*Description should include date of admission and date of discharge.

<< Previous

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Next >>

6/25/2013

Reactions and Discomforts

Page 1 of 1

SECTION
Reactions and Discomforts
Broken hip, continued
Describe the fracture:How long after the treatment did you first suspect a fracture/injury?
Less than 30 minutes
30 minutes to 4 hours
4 hours to 24 hours
More than 24 hours

How long was it until you sought medical treatment for the fracture?
Less than 1 day
1 day - 1 week
More than 1 week
Ongoing<< Previous

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6/25/2013

Reactions and Discomforts

Page 1 of 1

SECTION
Reactions and Discomforts
Other reaction/discomfort
Please describe the study treatment that you believe is connected to this
discomfort/reaction:

Were you hospitalized because of this reaction/discomfort?
No
Yes

If Yes, please describe*:*Description should include date of admission and date of discharge.

<< Previous

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Next >>

6/25/2013

Reactions and Discomforts

Page 1 of 1

SECTION
Reactions and Discomforts
Other reaction/discomfort, continued
Describe the reaction/discomfort:

How would you rate the amount of discomfort?
No
Discomfort

0

1

Unbearable
Discomfort

2

3

4

5

6

7

8

9

10

<< Previous

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Next >>

6/25/2013

Reactions and Discomforts

Page 1 of 2

SECTION
Reactions and Discomforts
Other reaction/discomfort, continued
How long after the treatment did the reaction/discomfort begin?
Less than 30 minutes
30 minutes to 4 hours
4 hours to 24 hours
More than 24 hours

How long did the reaction/discomfort last?
Less than 1 day
1 day - 1 week
More than 1 week
Ongoing

How much did the reaction/discomfort affect your normal daily activities at home
and/or work?
Not at all
A little
Moderately
Could not perform daily activities

If you could not perform daily activities, please explain:<< Previous

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Next >>

6/25/2013

Thank you

Thank you!
Thank you for your time!
Your next questionnaire will be available on. You will receive areminder at that time.
Please take this time to verify your contact information is current.

https://w5.palmer.edu/dod_act1-train/ptforms/frmEnd.aspx[11/30/2012 10:33:54 AM]

Month 3 Assessment
SECTION
Pain Rating Scales
Select the number that best describes your low back pain at its worst during thepast 24 hours?
No
Pain
0

Worst
Possible
Pain

1

2

3

4

5

6

7

8

9

10

Select the number that best describes your average low back pain during thepast week?
No
Pain
0

Worst
Possible
Pain

1

2

3

4

5

6

7

8

9

10

Next >>

8/30/201112:03:38 PM

Roland Morris Disability Questionnaire
When your back hurts, you may find it difficult to do some of the things you
normally do.
This list contains sentences that people have used to describe themselves when
they have back pain. When you read them, you may find that some stand out
because they describe you today. As you read the list, thing of yourself today.
When you read a sentence that describes how you feel today, choose YES. If thesentence does not describe you, then choose NO.
Remember, only choose YES if you are sure that the sentence describes
you today.
No

Yes

I stay home most of the time because of my back.
I change position frequently to try and get my backcomfortable.
I walk more slowly than usual because of my back.
Because of my back, I am not doing any jobs that I
usually do around the house.
Because of my back, I use a handrail to get upstairs.
Because of my back, I lie down to rest more often.
Because of my back, I have to hold on to something to
get out of an easy chair.
Because of my back, I try to get other people to do things
for me.

Next >>

8/30/201112:05:35 PM

Roland Morris Disability Questionnaire
Remember, only choose YES if you are sure that the sentence describes you
today.
NoYes

I get dressed more slowly than usual because of my back.
I only stand up for short periods of time because of myback.
Because of my back, I try not to bend or kneel down.
I find it difficult to get out of a chair because of my back.
My back is painful almost all of the time.
I find it difficult to turn over in bed because of my back.
My appetite is not very good because of my back.
I have trouble putting on my socks (stockings) beause of
the pain in my back.

Go To Next Question >Skip To Next Section >>8/30/201112:09:01 PM

Roland Morris Disability

SECTION                  Roland Morris Disability Questionnaire             Remember, only choose YES if you are sure that the sentence describes you
today.
  No

Yes

I only walk short distances because of my back pain.
I sleep less well because of my back pain.
Because of my back pain, I get dressed with help fromsomeone else.
I sit down for most of the day because of my back.
I avoid heavy jobs around the house because of myback.
Because of my back pain, I am more irritable and badtempered with people than usual.
Because of my back, I go upstairs more slowly thanusual.
I stay in bed most of the time because of my back.

  https://w5.palmer.edu/dod_act1-train/ptforms/frmRM.aspx[11/30/2012 10:55:23 AM]<< Previous  

Next >>

Back Pain Function Scale
On the questions listed below, we are interested in knowing whether you arehaving ANY DIFFICULTY at all with the activities because of your backproblem for which you are currently seeking attention. Please porvide an answer
for each activity.
Today, do you or would you have any DIFFICULTY at all with thefollowing activities BECAUSE OF YOUR BACK PROBLEM?

(choose one response on each line)

Unableto
Quite aA little
perform Extreme
bit ofbit ofModerateNo
activity difficulty difficulty difficulty difficulty difficulty

Any of your usual work,
housework, or school
activities
Your usual hobbies,
recreational, or sporting
activities
Performing heavy activities
around your home
Bending or stooping
Putting on your shoes orsocks (pantyhose)
Lifting a box of groceries
from the floor

Next >>

8/30/201112:09:35 PM

Back Pain Function Scale
Today, do you or would you have any DIFFICULTY at all with thefollowing activities BECAUSE OF YOUR BACK PROBLEM?

(choose one response on each line)

Unableto
Quite aA little
perform Extreme
bit ofbit ofModerateNo
activity difficulty difficulty difficulty difficulty difficulty

Sleeping
Standing for 1 hour
Walking a mile
Going up or down 2 flightsof stairs (about 20 stairs)
Sitting for 1 hour
Driving for 1 hour<< Previous

8/30/2011

Next >>

12:09:46 PM

Bothersomeness
During the past week, how bothersome have each of the following symptoms
been? (choose one response for each symptom)
Not at all
bothersome

Slightly
bothersome

Moderately
bothersomeVerybothersome

Extremely
bothersome

Low back pain
Leg pain (sciatica)
Neck pain

During the past week, how much did pain interfere with your normal work
(including both work outside the home and housework)?
Not at all
A little bitModerately
Quite a bit
Extremely

Next >>

8/30/201112:10:08 PM

BothersomenessIf you had to spend the rest of your life with the symptoms you have right now,
how would you feel about it?
Very dissatisfied
Somewhat dissatisfied
Neither satisfied nor dissatisfied
Somewhat satisfied
Very satisfied

During the past 4 weeks, about how many days did you cut down on the things
you usually do for more than half the day because of your low back pain?
# of days

During the past 4 weeks, how many days did low back pain keep you from going
to work or school?
# of days<< Previous

8/30/2011

Next >>

12:10:21 PM

Health Survey - PROMIS-29
In the past 7 days...
WithoutanydifficultyWith alittledifficulty

With
some
difficulty

With
much
difficulty

Unableto do

Are you able to do chores
such as vacuuming or yard
work?
Are you able to go up anddown stairs at a normalpace?
Are you able to go for awalk of at least 15
minutes?
Are you able to run
errands and shop?

Next >>

8/30/201112:10:34 PM

Health Survey - PROMIS-29
In the past 7 days...
Never

RarelySometimes

Often

AlwaysI felt fearful.
I found it hard to focus
on anything other than
my anxiety.
My worries
overwhelmed me.
I felt uneasy.

Next >>

8/30/201112:10:49 PM

Health Survey - PROMIS-29
In the past 7 days...
Never

RarelySometimes

Often

AlwaysI felt worthless.
I felt helpless.
I felt depressed.
I felt hopeless.

<< Previous

8/30/2011

Next >>

12:11:10 PM

Health Survey - PROMIS-29

Page 1 of 1

SECTION
Health Survey - PROMIS-29
During the past 7 days...
Not
at allA
little bit

Somewhat

Quite
a bit

Very
much

Not
at allA
little bit

Somewhat

Quite
a bit

Very
much

I feel fatigued.
I have trouble starting
things because I am
tired.

In the past 7 days...

How run-down did you
feel on average?
How fatigued were you
on average?

<< Previous

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6/25/2013

Health Survey - PROMIS-29
In the past 7 days...
Very poor

Poor

Fair

Good

Very goodNot
at allA
little bit

Somewhat

Quite
a bit

Very
much

My sleep quality was...

In the past 7 days...

My sleep wasrefreshing.
I had a problem withmy sleep.
I had difficulty falling
asleep.

<< Previous

8/30/2011

Next >>

12:11:37 PM

Health Survey - PROMIS-29
In the past 7 days...
Not
at allA
little bit

Somewhat

Quite
a bit

Very
much

I am satisfied with howmuch work I can do(include work at home).
I am satisfied with myability to work (include
work at home).
I am satisfied with myability to do regularpersonal and household
responsibilities.
I am satisfied with myability to perform mydaily routines.

<< Previous

8/30/2011

Next >>

12:11:50 PM

Health Survey - PROMIS-29
In the past 7 days...
Not
at allA
little bit

Somewhat

Quite
a bit

Very
much

How much did paininterfere with your day
to day activities?
How much did paininterfere with workaround the home?
How much did paininterfere with yourability to participate insocial activities?
How much did paininterfere with yourhousehold chores?

<< Previous

8/30/2011

Next >>

12:12:00 PM

Health Survey - PROMIS-29
In the past 7 days...
How would you rate your pain on average?
No
Pain
0

Worst
Imaginable
Pain

1

2

3

4

5

6

7

8

9

10

Next >>

8/30/201112:12:14 PM

Health Care and Medication Use
Since the beginning of your current episode of pain, from which of thefollowing providers have you sought treatment for your low back pain?
(Choose all that apply)

Primary care doctor
Medical specialist (specify type below)
Doctor of Osteopathy
Doctor of Chiropractic
Acupuncturist
Massage therapist
Physical therapist
Pain clinic or pain specialist
Counselor or mental health specialist
N/A
Other (specify type below)
Specify:During the past week, how often have you taken pain relieving medication(including prescription and over-the-counter medications or supplements)?
0 days
1-2 days
3-4 days
5-6 days
7 daysNext >>

8/30/201112:12:25 PM

Health Care and Medication Use
During the past week, have you taken non-narcotic analgesics?
Examples: Acetaminophen, Tylenol, Tylenol Extra Strength, Ultram, etc.
No
Yes, for back pain ONLY
Yes, for other reasons ONLY
Yes, for back pain AND other reasons
During the past week, have you taken non-steroidal anti-inflammatory
drugs (NSAIDS)?
Examples: Advil, Aleve, Aspirin, Bextra, Celebrex, Disalcid, Excedrin, Excedrin
PM, Feldene, Ibuprofen, Indomethacin, Meclomen, Motrin, Maproxen/Naprosyn,
Relefen, Sulindac, Trilisate, Tolectic, etc.
No
Yes, for back pain ONLY
Yes, for other reasons ONLY
Yes, for back pain AND other reasons<< Previous

8/30/2011

Next >>

12:12:35 PM

Health Care and Medication Use
During the past week, have you taken sedatives or muscles relaxants?
Examples: Alprazolam, Ambien, Baclofen, Diazepam, Donnatal, Flexeril,
Lorazepam, Meprobamate, Methocarbamol/Robaxin, Norflex, Phenergan,
Phenobarbital, Skelaxin, Soma, Temazepam, tizanidine, Tranxene, Tylenol PM,
Valium, Xanax, Zanaflex, etc.
No
Yes, for back pain ONLY
Yes, for other reasons ONLY
Yes, for back pain AND other reasons
During the past week, have you taken narcotic analgesics?
Examples: ASA w/ Codeine, Darvocet, Darvon, Demerol, Dilaudid, Fentanyl,
Meperidine, Morphine, Oxycodone, Percodan, Talwin, Tylenol-3, Tylenol w/
Codeine, Tylox, Vicodin, etc.
No
Yes, for back pain ONLY
Yes, for other reasons ONLY
Yes, for back pain AND other reasons<< Previous

8/30/2011

Next >>

12:12:50 PM

Health Care and Medication Use

SECTION                       Health Care and Medication Use              During the past week, have you taken anti-depressants?
Examples: Amitriptyline, Celexa, Desipramine, Doxepin, Effexor, Imipramine, Lexapro,
Nortriptyline, Paxil, Prozac/Fluoxetine, Trazodone, Wellbutrin, Zoloft, etc.

No
Yes, for back pain ONLY
Yes, for other reasons ONLY
Yes, for back pain AND other reasons

During the past week, have you taken supplements?
Examples: vitamins/minerals, fish oil, protein powder, Glucosamine, Chondroitin Sulfate, etc.

No
Yes, for back pain ONLY
Yes, for other reasons ONLY
Yes, for back pain AND other reasons   

https://w5.palmer.edu/dod_act1-train/ptforms/frmHCM.aspx[11/30/2012 10:57:51 AM]

Tobacco Use

Tobacco Use             Which of the following topics did your study provider talk to you about in thelast three months? (check all that apply)
Tobacco-related health problems
Setting a date to quit all tobacco use
Tips to help you quit all tobacco use
Telephone tobacco quit lines
Tobacco cessation groups/classes
Nicotine patches, nicotine gum, or nicotine lozenges
Prescription medications (such as Chantix, Zyban, nicotine inhaler)
Natural ways to quit tobacco (such as acupunture, hypnosis, herbal
supplements)
None of the above
I have not seen my study provider in the last 3 months

   https://w5.palmer.edu/dod_act1-train/ptforms/frmTobaccoCig.aspx[11/30/2012 10:59:39 AM]

Tobacco Use
Did your Doctor of Chiropractic give you written materials related to tobacco use?
No
Yes
If Yes,Did you read them?
Did not read them
Read all or parts of them
If you read them,
How helpful were the written materials?
1 Not at all helpful
2
3 Somewhat helpful
45 Very helpful
Which statement best describes your smoking during the past 7 days?
For both of these answers, go to 'During
I smoked regularly.
the past 7 days, how many cigarettes did
I smoked once in a while. you smoke on a typical day?'I have not smoked at all, not even a puff.
Go to Question 'When did you
last smoke a cigarette?'<< Previous

8/30/2011

Next >>

4:08:51 PM

Tobacco Use
When did you last smoke a cigarette?
Less than 1 week ago
1 - 4 weeks ago

Continue here when 'I havenot smoked at all, not even apuff.

1 - 2 months ago
2 - 3 months ago
How confident are you that you will remain a non-smoker?
1 Not at all confident
2
3 Somewhat confident
4
5 Very confident<< Previous

8/30/2011

Next >>

4:09:49 PM

Tobacco Use

Page 1 of 1

Tobacco Use
When you quit smoking, which methods or product did you use?
(check all that apply)

Did not make a serious attempt to quit
Went cold turkey (quit with no help)
Made a quit plan
Set a specific date to quit
Nicotine patches, nicotine gum or nicotine lozenges
Prescription medication (Zyban, Wellbutrin, Chantix)
Telephone tobacco quit line
Self-help guide
Chiropractic adjustment/careAcupuncture/acupressure
MassageHypnosis
Biofeedback
Meditation/yoga/relaxation/imagery
Herbal or botanical supplements
Homeopathy
Other
If Other, please specify:<< Previous

http://w5.palmer.edu/dod_act1-train/ptforms/frmTobaccoCig.aspx?v=2

Next >>

6/25/2013

Tobacco UseContinue here when 'I smokedregularly' or 'I smoked once in awhile' were marked.

During the past 7 days, how many cigarettes did you smoke on a
typical day?
(# of cigarettes)

How soon after you wake up do you usually smoke your first cigarette?
Less than 5 minutes
5-30 minutes
31-60 minutes
More than 60 minutes
Do you experience strong cravings to smoke when you have to go without acigarette for more than an hour or two?
Never
SeldomSometimes
Often
Always<< Previous

8/30/2011

Next >>

4:10:41 PM

Tobacco Use

Page 1 of 2

Tobacco Use
During the past 6 weeks, how many times have you made a serious attempt toquit smoking (gone at least 24 hours without smoking)?
None
1 time2 times
3 timesMore than 3 times

If you made an attempt to quit, which of the following methods or products did
you use? (check all that apply)
Did not make a serious attempt to quit
Went cold turkey (quit with no help)
Made a quit plan
Set a specific date to quit
Nicotine patches, nicotine gum or nicotine lozenges
Prescription medication (Zyban, Wellbutrin, Chantix)
Telephone tobacco quit line
Self-help guide
Chiropractic adjustment/careAcupuncture/acupressure
MassageHypnosis
Biofeedback
Meditation/yoga/relaxation/imagery
Herbal or botanical supplements
Homeopathy
Other
If Other, please specify:<< Previous

http://w5.palmer.edu/dod_act1-train/ptforms/frmTobaccoCig.aspx?v=0

Next >>

6/25/2013

Tobacco Use
Are you seriously thinking about quiting smoking in the next 30 days?
No
YesMark the number that shows how you feel about quitting.
0 No thought of quitting
1
2 Should consider quitting some day
3
4 Should quit but not quite ready5
6 Thinking about cutting down or quitting
7
8 Have cut down and seriously considering quitting
9
10 Ready to quit now<< Previous

8/30/2011

Next >>

4:11:13 PM

Tobacco Use
Do you also use chewing tobacco or snuff?
No
Yes
If Yes,What kind of tobacco is more important to you?
Chewing tobacco/snuff
Cigarettes<< Previous

8/30/2011

Next >>

4:11:33 PM

Tobacco Use

Appears if question above was'yes' or 'yes' on the chewing
tobacco/snuff question on
baseline.

Which statement best describes your use of chewing tobacco or snuff during thepast 7 days?
For both of these options, go to question 'In
a typical day, how often did you use chewing
I used chewing tobacco/snuff once in a while. tobacco/snuff, even once?'
I have not used chewing tobacco/snuff at all, not even one dip.
Go to question 'When did you last use chewing tobacco or
snuff?'
I used chewing tobacco/snuff regularly.

<< Previous

8/30/2011

Next >>

4:11:54 PM

Tobacco Use
When did you last use chewing tobacco or snuff?

Continue here when
'I have not usedchewing tobacco/snuff, not even on
dip.' was marked.

Less than 1 week ago
1 - 4 weeks ago
1 - 2 months ago
2 - 3 months ago
How confident are you that you will remain a non-chewer?
1 Not at all confident
2
3 Somewhat confident
4
5 Very confident<< Previous

8/30/2011

Next >>

4:12:09 PM

Tobacco Use

Page 1 of 1

Tobacco Use
When you quit smoking, which methods or product did you use?
(check all that apply)

Did not make a serious attempt to quit
Went cold turkey (quit with no help)
Made a quit plan
Set a specific date to quit
Nicotine patches, nicotine gum or nicotine lozenges
Prescription medication (Zyban, Wellbutrin, Chantix)
Telephone tobacco quit line
Self-help guide
Chiropractic adjustment/careAcupuncture/acupressure
MassageHypnosis
Biofeedback
Meditation/yoga/relaxation/imagery
Herbal or botanical supplements
Homeopathy
Other
If Other, please specify:<< Previous

http://w5.palmer.edu/dod_act1-train/ptforms/frmTobaccoCig.aspx?v=2

Next >>

6/25/2013

Continue here if either 'I use chewing
tobacco/snuff regularly' or 'I use
Tobacco Usechewing tobacco/snuff once in awhile' were marked.
In a typical week, how many days do you use chewing tobacco or snuff?
(# of days / week)

How many days does a can/tin/pouch last you?
(# of days)

How soon after you wake up do you use chewing tobacco or snuff?
Less than 5 minutes
5-30 minutes
31-60 minutes
More than 60 minutes
Do you experience strong cravings for a dip/chew when you go more than one
hour or two without one?
Never
SeldomSometimes
Often
Always<< Previous

8/30/2011

Next >>

4:15:47 PM

Tobacco Use

Page 1 of 2

Tobacco Use
During the past 6 weeks, how many times have you made a serious attempt toquit smoking (gone at least 24 hours without smoking)?
None
1 time2 times
3 timesMore than 3 times

If you made an attempt to quit, which of the following methods or products did
you use? (check all that apply)
Did not make a serious attempt to quit
Went cold turkey (quit with no help)
Made a quit plan
Set a specific date to quit
Nicotine patches, nicotine gum or nicotine lozenges
Prescription medication (Zyban, Wellbutrin, Chantix)
Telephone tobacco quit line
Self-help guide
Chiropractic adjustment/careAcupuncture/acupressure
MassageHypnosis
Biofeedback
Meditation/yoga/relaxation/imagery
Herbal or botanical supplements
Homeopathy
Other
If Other, please specify:<< Previous

http://w5.palmer.edu/dod_act1-train/ptforms/frmTobaccoCig.aspx?v=0

Next >>

6/25/2013

Tobacco Use
Are you seriously thinking about quiting chewing tobacco/snuff in the next 30
days?
No
Yes
Mark the number that shows how you feel about quitting.
0 No thought of quitting
1
2 Should consider quitting some day
3
4 Should quit but not quite ready5
6 Thinking about cutting down or quitting
7
8 Have cut down and seriously considering quitting
9
10 Ready to quit now<< Previous

8/30/2011

Next >>

4:16:38 PM

Thank you

Thank you!
Congratulations!
You have completed your study participation.
We greatly appreciate your volunteering forthis study and the military. You have made a
difference!
If you have any final questions, pleasecontact your local Project Manager.

If you are done, you may close this window.

https://w5.palmer.edu/dod_act1-train/ptforms/frmEnd.aspx[11/30/2012 11:07:32 AM]             Department of Defense‐Low Back Pain Clinical Trial

Appendix B: Tobacco Course Handouts
Presentation: Helping your Patients Quit‐ Guide
Activity 1
Activity 2
Activity 3
DC Quick Reference Guide
Provider Instruction for Quit Plan
The Personal Quit Plan
Quit Plan‐ Follow‐Up
Patient Materials

245Department of Defense‐Low Back Pain Clinical Trial
Presentation: Helping your Patients Quit‐ Guide
1

2

3

4

5

6

7

8

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Department of Defense‐Low Back Pain Clinical Trial
9

10

11

12

13

14

15

16

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Department of Defense‐Low Back Pain Clinical Trial
17

18

19

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Department of Defense‐Low Back Pain Clinical Trial
Activity 1 ‐ Invent your tobacco user
You will use this character during your activities today. This is a character you will play as you practice
the helping conversation steps. Therefore, it should be someone you feel comfortable representing.
A few tips:
1. Keep it friendly. You will interact with the characters of others.
2. Consider basing your character on someone you know!
3. Remember, 70% of tobacco users are at least thinking of quitting.
My tobacco user:
First Name: ________________________________________________
Motivators for quitting:
1. ________________________________________________________
2. ________________________________________________________
3. ________________________________________________________
Barriers to quitting:
1. ________________________________________________________
2. ________________________________________________________
3. ________________________________________________________
Readiness to quit:☐Not ready☐Thinking of quitting☐Preparing to quit
☐Making an attempt

Actions you are thinking of taking:________________________________________________________________________________________________________________________________________________________________________________________________________________________

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Department of Defense‐Low Back Pain Clinical Trial
Activity 2 – Motivation and Opportunity
Your motivation and barriers to addressing tobacco use
What are your top 3 reasons to help your patients stop using tobacco?
________________________________________________________________________________________________________________________________________________________________________________________________________________________
What are the top 3 barriers you see to helping patients on a regular basis?
________________________________________________________________________________________________________________________________________________________________________________________________________________________
What can you do to overcome these barriers or work around them?
________________________________________________________________________________________________________________________________________________________________________________________________________________________Creating your opportunity
When do you see yourself bringing up the issue of tobacco use (i.e. at first visit, only after a couple ofvisits, etc)?
________________________________________________________________________________________________________________________________________________________________________________________________________________________

Opening lines
Write down some sample “opening lines” that you could use to start the conversation.
________________________________________________________________________________________________________________________________________________________________________________________________________________________

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Department of Defense‐Low Back Pain Clinical Trial
Role‐play using invented tobacco user
What did you say or how were you able get any motivators and/or barriers the patient/client had inregards to quitting?
________________________________________________________________________________________________________________________________________________________________________________________________________________________
What were the motivators?
________________________________________________________________________________________________________________________________________________________________________________________________________________________
What were the barriers?
________________________________________________________________________________________________________________________________________________________________________________________________________________________
What did you say or how were you able to help motivate the patient/client to quit?
________________________________________________________________________________________________________________________________________________________________________________________________________________________How did the patient/client respond to your help?
________________________________________________________________________________________________________________________________________________________________________________________________________________________

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Department of Defense‐Low Back Pain Clinical Trial
Activity 3 ‐ Role‐play using scenario cards
What did you say or how were you able get any motivators and/or barriers the patient/client had inregards to quitting?
________________________________________________________________________________________________________________________________________________________________________________________________________________________
What were the motivators?
________________________________________________________________________________________________________________________________________________________________________________________________________________________
What were the barriers?
________________________________________________________________________________________________________________________________________________________________________________________________________________________
What did you say or how were you able to help motivate the patient/client to quit?
________________________________________________________________________________________________________________________________________________________________________________________________________________________How did the patient/client respond to your help?
________________________________________________________________________________________________________________________________________________________________________________________________________________________
What tools did you use or refer to in your conversation (e.g., Personal Quit Plan, referral to quitting
resources)?
_______________________________________________________________________________________________________________________________________________

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Department of Defense‐Low Back Pain Clinical Trial

References

HELPING YOUR PATIENTSFiore MC, Bailey WC, Cohen SJ, et al. Treating Tobacco Use and
Dependence. Clinical Practice Guideline Update. Rockville, MD: U.S.

Department of Health and Human Services. Public Health Service. 2008.

The Cochrane Database of Systematic Reviews 2006

Copyright © 2006 The Cochrane Collaboration. Published by John Wiley andSons, Ltd.

QUIT TOBACCOA Guide for Doctors of ChiropracticDepartment of Defense‐Low Back Pain Clinical Trial
Dosing and Administration of
Prescription Medication for
Tobacco Cessation
Chantix

Chantix(Varenicline)

Chantix (varenicline) is a prescription medicine
to help adults 18 and over stop smoking.
Chantix helps reduce the urge to smoke.
Chantix is a non-nicotine pill, that targets
nicotine receptors in the brain, attaches tothem, and blocks nicotine from reaching them.

Dosages/Cost

0.5 mg pill
1 mg pill
12 weeks duration$120 per 30 day supply w/o insurance

DosingDuration

Instructions

Side Effects

Contraindications

Adapted from:The W.I.S.H. Program
Judith S. Gordon, PhD, PI
Funded by the National Institute on Drug Abuse
Grant #R21-DA021349

Week 1
Day 1 – 3: 0.5 mg. tablet per day
Day 4 – 7: 0.5 mg. tablet twice per day
Weeks 2 – 12
1 mg. table twice per day
3 months
Start taking Chantix 7 – 14 days before theQuit Date. The patient can keep smoking
during this time. Stop smoking on the Quit
Date.
Take Chantix after eating and with a full glass(8 ounces) of water.
Nausea, sleep problems (trouble sleeping,changes in dreaming), constipation, gas,
vomiting.
Some people have had changes in behavior,hostility, agitation, depressed mood, suicidal
thoughts or actions. Persons with a history ofdepression of other mental health problems.
Page 9Department of Defense‐Low Back Pain Clinical Trial

Dosing and Administration ofOver-the-Counter Medications for
Tobacco Cessation

Tobacco Cessation Protocol

Nicotine Gum
Nicotine Gum(polacrilex)

Dosages/Cost

DosingDuration
Instructions
Side Effects

Maximum nicotine levels achieved within 2030 minutes of chewing.
Nicorette - 2 and 4 mg pieces
2 mg - $47 / 110 pieces (weekly cost ̴ $24)
4 mg - $53 / 110 pieces (weekly cost ̴ $27)
Generic nicotine polacrilex (various)
2 mg - $30 / 110 pieces (weekly cost ̴ $15)
4 mg - $40 / 110 pieces (weekly cost ̴ $20)
> 20 cigs per day, use one 4 mg piece everyhour,< 20 cigs per day, use one 2 mg piece everyhour.
2-3 months
Chew until spicy flavor begins, then flatten
and “park” between cheek and gum for
maximum absorption. Remove after 1/2
hour. Acidic beverages decrease absorption.
Jaw fatigue, hiccups, belching, nausea.

1. Ask all patients about tobacco use (see Sample Assessment below).
2. Relate tobacco use to health issues and Advise patients to quit
(see page 2).
3. Assess patients’ readiness to quit (see page 2).
4. If patient is ready to quit, Assist them by:
a.
b.
c.
d.

Setting a quit date (see page 2)
Providing written materials
Discussing medications (see pages 6-8)
Providing referrals to tobacco cessation resources

5. Arrange for referrals to tobacco cessation resources, and discusstobacco use at every visit.

Page 8Page 1

Department of Defense‐Low Back Pain Clinical Trial
Advising Patients to Quit
Example 1: “I think you should consider quitting smoking now. As

your chiropractor, I need you to know that quitting
smoking is one of the most important things you can
do to protect your health. And quitting may help yourback injury to heal more quickly.”

Example 2: “You’ve been having on-going problems with backpain. You and I both want your health to improve, so I
must advise you that quitting smoking is a crucial partof your treatment.”

Dosing and Administration ofOver-the-Counter Medications for
Tobacco Cessation
Nicotine Patch
Transdermal
nicotine patch

Dosages/Cost

Assessing Patients’ Readiness to Quit
Example 1: “Have you thought about quitting in the next few

weeks?” If yes: “Are you ready to make a Personal
Quit Plan today?”Example 2: “Have you ever tried to quit before?” If yes: “Would
you be willing to work with me to make a Personal Quit
Plan to quit again?”

DosingDurationIf the patient is not ready to quit, consider using motivational
interviewing techniques at each visit to increase the patient’s
readiness to quit over time.
Instructions

Setting a Quit Date
Example:“It’s great that you’re ready to quit. Pick a date in thenext few weeks to be your ‘quit date”. I’ll give yousome materials to take home and we can discuss otherways I can help you quit.”
Page 2

Side Effects

Continuous delivery of nicotine provides constantblood levels. Requires 2-3 days to achieve maximal
serum levels.
Nicoderm CQ 21, 14, 7 mg/ 24 hr
All: $50 / 14 patches (weekly cost ̴ $25)
Nicotrol 15mg/16 hr $50 / 14 patches(weekly cost ̴ $25)
Other Generic Nicotine Transdermal Patches
21, 14, 7 mg - $40 / 28 patches (weekly cost ̴ $20)
>10 cigs per day, start with highest dose of given
brand.
5 - 10 cigs per day, use mid-range dose.
6 - 8 weeks. No increase in cessation with longer
duration.
Suggest:• Weeks 1-4: highest dose of given brand• Weeks 4-6: next lowest dose of brand• Weeks 6-8: lowest dose
Taper recommended for psychological reasons, butdoes not increase efficacy.
No smoking while on patch, rotate to new hairless skinsite each day, remove before bed if insomnia.
May consider supplement with 2 mg gum first 48 hrs
while plasma levels building.
Skin reactions including pruritus, edema, rash; sleep
disturbance.
Rotate to new site if skin irritation. If
irritation persists, switch to gum or lozenge.
If sleep disturbance occurs, remove patch before bed
and reapply on waking.
Page 7

Department of Defense‐Low Back Pain Clinical Trial

Dosing and Administration ofOver-the-Counter Medications for
Tobacco Cessation
Nicotine Lozenge
Nicotine
Lozenge
Dosages/Cost

DosingDuration
Instructions

Side Effects

Full dose of nicotine is released gradually byplacing a lozenge in the mouth and sucking on it
until it dissolves completely.
Commit Lozenges
2, 4 mg. $40 / 72-count packs (weekly cost ̴ $40)
9 lozenges/daily during initial 6 weeks of therapy.
4 mg if first cigarette within 30 min of
awakening; 2 mg if more than 30 min after
awakening.
1 lozenge every 1-2 hrs for 6 wks, then every 4-8
hrs for last 3 wks.
12 weeks
Place the lozenge in mouth and allow to dissolve
slowly over 20-30 mins. Do not chew, bite, or
swallow lozenge. Avoid eating or drinking acidic
beverages (i.e., orange juice, coffee) 15 min priorto, during, or after using a lozenge.
Headache, diarrhea, flatulence, heartburn,hiccups, nausea, coughing, sore throat, and upper
respiratory infection (occurring in > 5% of
patients).

Page 6

Motivation Tips
5 Steps of Motivational Interviewing
Using a few simple techniques can help you to deal with patients who
are resistant to change. The following techniques are based on“Motivational Interviewing” developed for use with resistant patients,
including tobacco users and other substance abusers.
1. Express empathy: Show your patients that you understand how
difficult quitting can be.

“It sounds like you’ve tried to quit before and the stress was toomuch to deal with. Quitting may seem impossible sometimes.”

2. Develop discrepancy: Ask patients about the pros and cons of
their tobacco use. Point out inconsistencies.

“You said that you want you to be rid of the pain in your back, but
you don’t want to quit smoking. If you want to get better, we mayneed to do whatever it takes.”

3. Avoid argumentation: Be flexible with your patient and avoid
statements that will encourage disagreement.

“I care about you, and this issue is so important that I'm willing todiscuss your smoking even knowing that you may get angry withme.”

4. Roll with resistance: Accept those patients who are not readyto quit; let them know it’s their decision.

“And it may very well be that when we're through, you'll decidethat it's worth it to keep on smoking as you have been. It may be
too difficult to make a change. That will be up to you.”

5. Support self-efficacy: Help patients set realistic goals. Identify
their strengths and skills to quit, and encourage those behaviors.

Page 3

Department of Defense‐Low Back Pain Clinical Trial
Most tobacco users attempt to quit “cold turkey” (abrupt cessationof nicotine without tapering, support or use of medication), but only
5% are successful each year. The cessation methods listed below
have been shown by research to be effective. Smokers who use
Cessation Method

How it Works

Advice from healthcare providers

Brief, simple, advice that includes
information, relapse prevention andproblem-solving skills.

TelephonecounselingSupport, information, and counselingprovided via telephone.

Individual and group
counselingSupport, information, and counselingprovided face-to-face.

Group cessation
programs

Group provides support to quit.

Social support

Support from a health care provider,spouse, other relative or friend

Aversion therapy

Pairs smoking with negative effects –rapid smoking requires smokers totake a puff every few seconds until
nauseous.

All forms of Nicotine
Replacement
Therapy

NRT aims to reduce withdrawal
symptoms by replacing nicotine in the
blood.

Bupropion SR(Zyban®,Wellbutrin®)

Blocks neural re-uptake of dopamine&/or norepinephrinre

Varenicline(Chantix®)

Varenicline (as the tartrate salt) is apartial agonist selective for α4β2
nicotinic acetylcholine receptor
subtypes.

these methods are significantly more likely to quit successfully.

Page 4

Department of Defense‐Low Back Pain Clinical Trial
The cessation methods listed below may be helpful in assistingsome tobacco users to quit, however, insufficient studies(randomized controlled trials) exist to establish theireffectiveness.

Page 5

Cessation Method

How it Works

Exercise

Increasing physical activity
minimizes weight gain.

Hypnotherapy

Alters the state of consciousness
and aims to weaken the desire tosmoke, strengthen the will to quitor help subject to concentrate onquit program.

Acupuncture

Stimulates particular points on
the body with the aim of reducing
nicotine withdrawal symptoms.

Cold laser therapy

Cold laser beams stimulate thebody’s acupoints. Aims to release
endorphins to simulate the effectsof nicotine.

Silver acetate (gum,lozenge & spray)

Produces an unpleasant metallic
taste when combined withsmoking (aversion therapy).

Herb - Lobelia (Indian
tobacco)Lobeline has effects on the
nervous system similar to
nicotine. Aims to reduce
withdrawal symptoms

Herbs for anxiety(oat straw, skullcap,
valerian, lemon balmand vervain.

For treatment of anxiety – aims
to lessen desire to smoke.

Department of Defense‐Low Back Pain Clinical Trial

Provider Instructions for Using the Personal Quit Plan

The Personal Quit Plan provides a framework for chiropractors to personalize a brief 3-5 minuteinteraction with the patient. This personalized plan can then be given to the patient to take home.
Page 1 of the Personal Quit Plan offers motivational information about the benefits of quitting.
Help your patients to identify their own reasons for quitting.
Page 2 offers five steps containing the five key steps for quitting tobacco. Working with thepatient, you can easily identify strategies for avoiding and dealing with cessation barriers, as wellas learning new skills and behaviors.
Pages 2 – 3 can be used to discuss treatment plans and ways to prevent relapse. It works bestwhen you and your patient complete the plan together.
The Personal Quit Plan also provides space for a plan that may include a follow-up visit and/orreferral information, as well as additional resources.
Page 4 can be used to track your patients’ progress over time, and help you modify the Quit Planat subsequent visits.

Adapted from the U.S. Department of Health and Human Services Public Health Service, and the W.I.S.H. Program,
Judith S. Gordon, PhD, PI. Funded by the National Institute on Drug Abuse; Grant #R21-DA021349

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Department of Defense‐Low Back Pain Clinical Trial
The Personal Quit Plan
You Can Quit Smoking or Chewing Tobacco!

With Support and Advice from Your Chiropractor
A Personalized Quit Plan for: ____________________________________
Today’s Date: _____________________
Reasons for Quitting
I Have Many Good Reasons for Quitting:□ I will reduce my inflammation and pain.
□ I will shorten my recovery time.
□ I will live longer and live healthier.
□ The people I live with, especially my children, will be healthier.
□ I will have more energy and breathe easier.
□ I will lower my risk of heart attack, stroke, or cancer.
□ My sense of taste and smell will be better.
□ I will feel more in control of my life.
□ I will save money.
Other reasons:____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________How much money I will save:$_____ (pack or tin price) x ____ (number of packs/tins used per week) = $_____ saved per week
□ What else could I do with this money:_______________________________________________________________________________________________________________________________________________________________________________________________________________

Five Keys for Quitting
1. Get Ready.
□ I will set a quit date and stick to it—not even a single puff or dip!
□ I will think about past quit attempts. What worked and what did not?
My Quit Date is:_____________________________________________________________________
2. Get Support and Encouragement.
□ I will tell my family, friends, and coworkers I am quitting.
□ I will talk to my chiropractor &/or other health care providers.
□ I will get group, individual, or telephone counseling.

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Department of Defense‐Low Back Pain Clinical Trial
Who Else Can Help Me Quit:__________________________________________________________________________________________________________________________________________
3. Learn New Skills and Behaviors.
□ I will get rid of ALL cigarettes, ashtrays or chewing tobacco in my home, car, or
workplace.
□ When I first try to quit, I will change my routine.
□ I will stay in nonsmoking areas.
□ I will breathe in deeply when I feel the urge to smoke or chew. These urges usually last
only 3 to 5 minutes. I will try to wait it out, or distract myself e.g. wash my hands, take ashower.
□ I will plan something enjoyable to do every day.
□ I will reduce my stress e.g. relax by taking deep breaths, go for a walk.
□ I will drink a lot of water and other fluids.
□ I will keep myself busy.
□ I will reward myself often. Use my “cigarette or chew money” to buy myself a treat.
Other Skills and Behaviors I Can Use:__________________________________________________________________________________________________________________________________________

4. Get Tobacco Cessation Treatment and Use It Correctly.


Several effective treatments are now available over-the-counter:□ Nicotine gum□ Nicotine patch□ Nicotine lozenge
 Other effective treatments are available by prescription.
 I also recommend the following treatments to help with withdrawal symptoms:__________________________________________________________________________________________________________________________________________My Treatment Plan:
Treatment: ____________________________________________________________
Instructions: ________________________________________________________________________________________________________________________________
5. Be Prepared for Slips or Difficult Situations.
If you’ve tried to quit before, don’t give up. Be prepared for challenges, especially in the first few weeks.
□ I will avoid alcohol.
□ I will be careful around other smokers or chewers.
□ I will improve my mood in ways other than smoking or chewing e.g. reward myself, try
newactivities.
□ I will eat a healthy diet and stay active.
Other Ways I Will Prepare:_____________________________________________________________________
Resources:________________________________________________________________________________________________________________________________
Referral:___________________________________________________________________________________________________________
Chiropractor
Date

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Department of Defense‐Low Back Pain Clinical Trial

The Personal Quit Plan Follow‐Up
Patient’s Name: _____________________________________
Current tobacco status:❑ Quit on:

Today’s Date: ____________________________❑ Returned to Using Tobacco. Quit for: ___________ hours/days❑ Cut down to: _____________ pack(s)/tin(s) per day❑ No change
Quitting Methods Used:____________________________________________________________________________________________________________________________________________________________
What Methods Worked Well:____________________________________________________________________________________________________________________________________________________________
Successes:____________________________________________________________________________________________________________________________________________________________
Challenges:____________________________________________________________________________________________________________________________________________________________
Lessons Learned:____________________________________________________________________________________________________________________________________________________________
Recommendations:____________________________________________________________________________________________________________________________________________________________
Comments:__________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

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Department of Defense‐Low Back Pain Clinical Trial
Patient Materials
Self‐Help Cessation Guides
Clearing the Air, National Cancer Institute. Available at:https://cissecure.nci.nih.gov/ncipubs/detail.aspx?prodid=P133
Spit Tobacco: A Guide for Quitting. National Cancer Institute. Available at:https://cissecure.nci.nih.gov/ncipubs/detail.aspx?prodid=P121
Motivational Fact SheetsHarms of Smoking and Health Benefits of Quitting. National Cancer Institute. Available at:https://cissecure.nci.nih.gov/ncipubs/detail.aspx?prodid=F032
Smokeless Tobacco and Cancer. National Cancer Institute. Available at:https://cissecure.nci.nih.gov/ncipubs/detail.aspx?prodid=F029
Secondhand Smoke and Cancer. National Cancer Institute. Available at:https://cissecure.nci.nih.gov/ncipubs/detail.aspx?prodid=F031

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Department of Defense‐Low Back Pain Clinical Trial

Appendix C: Tobacco Cessation DC questionnaire
1. How much training have you personally received in helping your patients quit using tobacco?
1 None2 Less than 1 hour3 1‐3 hours
4 More than 3 hours
2.

Does your office have printed materials (pamphlets, brochures, guide books) for patients about
quitting tobacco?
1 No
2 YesFor the next few questions, please answer how often you currently perform various procedures on yourpatients.
3. Ask about their tobacco use
4. Document tobacco use in chart
If they use tobacco, do you:
5. Discuss health hazards of tobacco use
6. Advise them to quit using tobacco
7. Help them to set a specific date to quit
8. Create a personal quit plan
9. Give written motivational materials
10. Give written self‐help guide
11. Document cessation activities in chart
12. Discuss nicotine products (patches, gum,lozenges)
13. Discuss prescription medication (Zyban,
Wellbutrin, Chantix)
14. Schedule a follow‐up visit specifically for
tobacco use
15. Refer to a telephone tobacco quit line
16. Refer to individual tobacco cessation counseling
17. Refer to group tobacco cessation counseling
18. Follow‐up after visit by phone or mail

265

Never
1
1

Rarely22Sometimes
3
3

Often
4
4

Always
5
5

1
1
1
1
1
1
1

2
2
2
2
2
2
2

3
3
3
3
3
3
3

4
4
4
4
4
4
4

5
5
5
5
5
5
5

1

2

3

4

5

1

2

3

4

5

1

2

3

4

5

1
1
1
1

2
2
2
2

3
3
3
3

4
4
4
4

5
5
5
5

Department of Defense‐Low Back Pain Clinical Trial

Indicate how much you disagree or agree to each of the following statements:

19. It is appropriate for Doctors of Chiropractic(DCs) to assess and document their patients’tobacco use.
20. DCs should advise patients who smoke
cigarettes to quit.
21. DCs should assist their patients who smoke toquit.
22. I can be effective in helping my patients to quit
smoking.
23. DCs should advise patients who use smokelesstobacco (chewing tobacco, snuff or snus) toquit.
24. DCs should assist their patients who use
smokeless tobacco to quit.
25. I can be effective in helping my patients to quit
using smokeless tobacco.
26. I am interested in learning new ways to help
patients quit using all forms of tobacco.

Strongly
DisagreeSomewhat
Disagree

Neither
Agree nor
DisagreeSomewhat
Agree

Strongly
Agree

1

2

3

4

5

1

2

3

4

5

1

2

3

4

5

1

2

3

4

5

1

2

3

4

5

1

2

3

4

5

1

2

3

4

5

1

2

3

4

5

4
4
4
4
4
4
4
4
4

A Large
Barrier
5
5
5
5
5
5
5
5
5

Please rate the following barriers to incorporating tobacco cessation activities into your practice.
Not aBarrier
1
1
1
1
1
1
1
1
1

27. Patient resistance/complaints
28. Amount of time required
29. Lack of reimbursement mechanisms
30. Staff resistance
31. Concerns about effectiveness32. Lack of training in tobacco cessation
33. Lack of patient materials
34. Lack of referral resources
35. Other (specify):______________________________

2
2
2
2
2
2
2
2
2

3
3
3
3
3
3
3
3
3

Which of the following currently describes your tobacco use most currently?
(Please mark one answer under each heading)
37. Smokeless Tobacco (ST)36.
Smoking1 Regular smoker
1 Regular ST user
2 Occasional smoker
2 Occasional ST user
3 Former smoker
3 Former ST user
4 Experimented with smoking
4 Experimented with ST
5 Never smoked5 Never used ST

266

Department of Defense‐Low Back Pain Clinical Trial

Appendix D: Assessment Reminder and Follow‐Up Protocol
Purpose and Rationale
Data collected are patient‐centered outcomes that have been conveniently designed for the participant tocomplete on any device that has internet. We have created a protocol for the site PM to monitor and assist
participants by reminding them when their study assessments are due. Participants are asked to provide email
address and phone contact information at the time of consent for this purpose.
Methods for Participant Contact
Email
The web system is designed to automatically send the participant an email on the first day that the assessment
is available for completion and on the due date if the assessment has not been completed. The respective site
PM are copied on all of these emails. Additional emails may be sent by the site PM as needed to remind
participant that the respective assessment is due.
Text Message/Phone Contact
The site PM may also utilize text messaging and/or phone contact as needed to remind participant thatassessment is available. The site PM will track methods used for each participant at each assessment.

ACT1 Questionnaire Reminder Scripts
E‐mail (‐3/‐7 days before date due)Thank you for your continued participation in the ACT Low Back Pain study. As a reminder, we ask that you fill out
assessments at week 2, 4, 6, and month 3. It is time for your {week/month} XX assessment. Please complete thisassessment by XX/XX/XXXX at https://www.backtoaction.org If you have any questions, please contact me at
XX@palmer.edu (site PM’s contact information).
Thank you, Site PM https://www.backtoaction.org
Reminder, your login is your email address.

E‐mail (Due Date‐ Day 0)
It has been exactly XX weeks since your enrollment into the ACT study. This means that your {week/month} XX assessment
needs to be completed. Please complete this assessment by XX/XX/XXXX at https://www.backtoaction.org. If you have any
questions, please contact me at XX@palmer.edu (site PM’s contact information).
Thank you, Site PM https://www.backtoaction.org
Reminder, your login is your email address.

Personal Call/Text/Voicemail Message from Site PM (as needed)Thank you for your continued participation in the ACT study.
As a reminder, your ACT assessment for {week/month} xx needs to be completed by, XX/XX/XXXX. Please go tohttps://www.backtoaction.org at your earliest convenience to complete. Reminder, your login is your email address.
Thank you, Site PM

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Department of Defense‐Low Back Pain Clinical Trial
Protocol for Collecting Missed Outcomes at Week 6/Month 3:
For outcomes skipped at Week 6 and Month 3, the respective site‐PM will attempt to contact the participant by phone tocollect the primary outcome measures: Numerical Pain Rating Scales, Roland Morris Disability Scale, and Reaction andDiscomforts (see Appendix A). Initial contacts may be made to the participant using text, email or voice message; however,data collected has to be interview style over the telephone. All attempted contacts to the participant will be tracked. Thisdata will be kept on a secure spreadsheet or on the project web‐based system, which only site PMs, lead PMs, and CTCC
Data Managers have access.

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Department of Defense‐Low Back Pain Clinical Trial
Appendix E: Paper-Based Data Collection Forms
DoD-ACT1
Participant Name (print):_________________________________________
Administered by (print): ____________________
Signature: _______________________________
Clinic: _________________________________

Exam

Administered on:__ __ / __ __ / 2 0 __ __
month

day

year

DE UserID: __ __ __ __ Date __ __ / __ __ / 201 __1. Is the low back pain caused by a visceral source or systemic
condition (e.g., renal / GI disease, endometriosis, MS, malignancy)?

1 No

2 Yes

2. Is there a condition warranting delay in low back pain treatment?

1 No

2 Yes

3. Is there a history of spinal fracture (past 8 weeks) or
spinal surgery (past 12 weeks)?

1 No

2 Yes

4. Do you suspect spinal / paraspinal infection, tumor(s) inflmammatory
spondyloarothrapy (i.e. rheumatoid arthritis) or severe osteoporosis?

1 No

2 Yes

5. Is there altered mental capacity compromising
health status assessment?

1 No

2 Yes

6. Is further testing / evaluation needed to rule out pathology?

1 No

2 Yes

7. Does the participant have a PTSD classification?

1 No

2 Yes8. Notes:
Treatment Recommendations: (Mark all that apply)1 Prescription Medications: Muscle relaxants  Narcotic Antidepressants  Anesthetic/Steriods  NSAIDs
2 Referral To:
 Physical Therapy  Chiropractic  Neurology  Orthopedic
3 Self-Care Recommendations: OTC medications  Exercises  Behavior Modification  Other
4 Other, specify:

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Department of Defense‐Low Back Pain Clinical Trial

ICD Codes (Mark all that apply)
719.45721.3
722.93722.2
722.73
724.2
724.3
724.4
724.8
729.1

ENM / CPT Codes (Mark all that apply)

Sacroiliac arthralgia / SI joint arthralgia
Lumbosacral spondylosis without
myelopathy (facet arthrosis) (facet
hypertrophy)
Disc disorder of lumbar region, other,
unspecified, NOS

99201

Problem Focused New Patient Eval.

99202

Expanded New Patient Eval.

99203

Detailed New Patient Eval.

99204

Comprehensive New Patient Eval.

99211

Est. Patient Eval. – Minimal

Discogenic Pain
Intervertebral disc disorder with myelopathy
lumbarLumbalgia

99212

Est. Patient Eval. – Problem Focused

99213

Est. Patient Eval. – Expanded

99214

Ext. Patient Eval. - Detailed

Sciatica
Lumbosacral neuritis or radiculitis
Lumbar Facet Syndrome (Other symptoms
refer to back)

20550

Drain/inject, ligament/cyst

20610

Drain/inject joint/bursa

96372

Intramuscular Injection (Dr. supervised)

97010

Hot/Cold Packs

97014
97035

Electrical Muscle Stimulation
Ultrasound

97039

Mechanical Massage

97110

Therapeutic Exercise

97112

Neuromuscular Re-Ed

97124

Massage

97116

Gait training therapy

97139
97140

Physical (unlisted) medicine procedure
Manual Therapy Technique(specify)_______________
Trigger Point
Therapeutic Activities
Self management training
Physical performance test

737.2

Myalgia / myofascial pain
Lordosis (acquired) (postural)(hyperlordosis)

739.3
739.4
846.1
847.2
847.3
847.4

Nonallopathic lesions of lumbar region NOS
Nonallopathic lesions of sacral region NOS
Sacroiliac (ligament) sprain
Lumbar sprain / strain
Sprain of sacrum
Sprain of coccyx

97140
97530
97535
97750

Tx Form

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Department of Defense‐Low Back Pain Clinical Trial

DOD-ACT1

Participant Name (print):________________________________________
Administered by (print): ____________________
Signature: ______________________________
Administered on:__ __ / __ __ / 2 0 __ __monthTreatment Form

day

year

DE UserID: __ __ __ __ Date __ __ / __ __ / 201 __Spinal Adjustment Details
Level

Technique

Notes:

Specific Therapy

Notes:

Modality Details
Area

Discharged / Released from care:□ Yes □ No

Tobacco Cessation Details
Mark all that apply:□ Not in tobacco cessation study□ Did not consult on tobacco cessation today,
12

due to: ____________________________□ Discussed health hazards of tobacco use□ Advised to quit using tobacco□ Set a specific date to quit
□ Created a personal quit plan
□ Gave written motivational materials
3
4
5
6
7

□ Gave written self-help guide□ Discussed nicotine products□ Discussed prescription medications□ Referred to a telephone quit line
□ Referred to individual tobacco cessation
8
9

10
11
12

counseling□ Plan to follow-up after visit by phone, text or
13

email

□ Followed up with patient as part of continuing
14

care / Encouraged patient to stick with quit plan.
Tx Form

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Department of Defense‐Low Back Pain Clinical Trial
ICD Codes Mark all that apply:
719.45721.3
722.93722.2
722.5

CPT Codes Mark all that apply:

Sacroiliac arthralgia / SI joint arthralgia
Lumbosacral spondylosis without
myelopathy (facet arthrosis) (facet
hypertrophy)
Disc disorder of lumbar region, other,
unspecified, NOS
Discogenic Pain
Degeneration of thoracic / lumbarintervertebral disc739.4

Intervertebral disc disorder withmyelopathy lumbar
Lumbalgia
Sciatica
Lumbosacral neuritis or radiculitis
Lumbar Facet Syndrome (Other
symptoms refer to back)Myalgia / myofascial pain
Lordosis (acquired) (postural)(hyperlordosis)
Nonallopathic lesions of lumbar region
NOS
Nonallopathic lesions of sacral region
NOS

846.1

Sacroiliac (ligament) sprain

847.2
847.3
847.4

Lumbar sprain / strain
Sprain of sacrum
Sprain of coccyx

722.73
724.2
724.3
724.4
724.8
729.1
737.2
739.3

272 of 273

99201
99202
99203
99204
99211
99212
99213
99214
98940
98941
98942
98943
97012
97010
97014
97035
97039
97039
97110
97112
97124
97140
97140
97530
99070A9300
99070A6265
99070A9300
99070E0230-25

Problem Focused New Patient Eval.
Expanded New Patient Eval.
Detailed New Patient Eval.
Comprehensive New Patient Eval.
Est. Patient Eval. – Minimal
Est. Patient Eval. – Problem Focused
Est. Patient Eval. – Expanded
Ext. Patient Eval. - Detailed
1-2 levels
3-4 levels
5 levels
Extremity
Traction
Hot/Cold Packs
Electrical Muscle Stimulation
UltrasoundMechanical Massage
Unlisted Modality_________
Therapeutic Exercise
Neuromuscular Re-Ed
Massage
Manual Therapy Technique
Trigger Point
Therapeutic Activities
Therabands
Tape/Immobility Device
Inflatable Ball
Ice Packs
ModifierDepartment of Defense‐Low Back Pain Clinical Trial

Appendix F: Participant Certification

273 of 273



StudyProtocol:DataAnalysisPlan

Date:

July2014



Version:2



ProjectTitle:

AssessmentofChiropracticTreatmentforLowBack
PainandSmokingCessationinMilitaryActiveDuty
PersonnelGrantTitle:

DefenseHealthProgram(DHP)ChiropracticClinicalTrialAward(W81XWHͲ11Ͳ2Ͳ0107)



CoͲPrincipalInvestigators:

IanDCoulter,PhD
RANDCorp/SamueliChairinIntegrativeMedicineChristineGoertz,DC,PhD
PalmerCollegeofChiropractic/ViceChancellorfor
ResearchandHealthPolicyJoanWalter,JD,PASamueliInstitute/VicePresident,MilitaryMedical
ResearchPrograms



CONFIDENTIALITYSTATEMENTTheinformationcontainedinthisdocument,especiallyunpublisheddata,isthepropertyofPalmerCollegeofChiropracticandisthereforeprovidedtoyouinconfidenceasaninvestigator,potential
investigator,orconsultant,forreviewbyyou,yourstaff,andanapplicableInstitutionalReview
Board/IndependentEthicsCommittee.ItisunderstoodthatthisinformationwillnotbedisclosedtootherswithoutwrittenauthorizationfromaCoͲPrincipalInvestigatorlistedabove.



1of4

Revisions:
7/24/2014

Originalstatisticianlefttheproject.Thenewprojectbiostatisticianrevisedthedata
analysisplanandsubmittedittotheData&SafetyMonitoringCommittee.Norevisions
wererecommended.



2of4DataAnalysis
TheanalysisteamwillconductthedataanalysesusingSASSystemforWindows(Release9.2).Theywill
collaboratewiththeinvestigatorsinpresentingandinterpretingtheresults.Descriptivestatisticsofparticipantbaselinecharacteristicswillbepresentedforeachtreatmentgrouptoassesstheir
comparabilityaswellasthegeneralizabilityofthesample.Descriptivestatisticsoftheprimaryand
secondaryoutcomevariableswillbepresentedforeachtreatmentgroupatbaseline,weeks2,4,6and
month3.
Theprimaryoutcomeanalysiswillfocusonthechangesfrombaselinetoweek6sincethisisthelength
ofthechiropracticcaregroup.Similaranalyseswillbeconductedincludingthe2week,4weekand3
monthwaves.Outcomemeasureswillbecomparedbetweenthechiropracticandmedicalcareonly
groupsatbaselinetocheckforimbalancesintherandomization.
AdifferenceͲofͲdifferencesapproachwillbeusedtocomparechangesovertimeinthechiropracticarm
tochangesovertimeintheconventionalmedicalcareonlyarm.Thiswillbeimplementedasa
regressionmodelratherthanbyliterallymodelingchangescores.Eachstudyparticipantwillcontributeanobservationforeachwaveofdatacollection.Theregressionmodelscanbeordinary,logistic,orderedlogisticorPoissondependingonthedistributionoftheoutcomemeasure.Asanexamplewepresent
thelogisticversionofthemodelthatmightbeusedforasimplesatisfiedvs.notsatisfiedsurvey
response.
Model1.PreͲPostComparisonofSatisfactionbetweenChiropracticandMedicalCare§ p ·ln ¨ ijt ¸¨1 p ¸
ijt ¹
©

**

E 0  E1W 1  E 2 xijt


Where pijt istheprobabilityparticipantirespondsassatisfiedintreatmentarmjintimeperiodt.t
takeson2values,0or1,forthebaselineand6weekstudyperiodsinthebasicmodel.The W1 takesonthevalue1inthechiropractictreatmentarmatweek6andtakesonthevaluezerointhemedicalcarearm. W1 takesonthevalueofzeroinbothtreatmentarmsinthebaselinewave. E1 isanestimateofthe
chiropractictreatmenteffect.Thismodelcanbeeasilymodifiedtoreflectmultipleposttimeperiods
(e.g.,weeks2,4,andmonth3).Participantlevelrandomeffectscanbeincludedtocontrolforclustering
withinparticipantovertime.Xcanincludeotherpatientlevelcovariatestocontrolforimbalancein
randomizationanddifferentialattrition.Itmayalsobefitforasingleoutcometypeorsimultaneouslyfit
acrossseveraloutcomestoaccommodatethecorrelationsbetweenoutcomeswithinparticipant.
Adjustedmeandifferencesand95%confidenceintervalsbetweenconventionalmedicalcarealoneand
conventionalmedicalcareplusCMTatweek6willbebasedonthefinalmodels.AnintentionͲtoͲtreat
analysiswillbeused.
WewillanalyzethedatausinganintentionͲtoͲtreatapproachinwhichparticipantswillbeanalyzed
accordingtotheiroriginaltreatmentallocation.Allobserveddatawillbeusedintheanalyses.Data
analyseswillbeperformedusingSAS/STAT(Release9.3)(SASInstituteInc.,Cary,NC).

3of4Theprimaryoutcomevariablesarenumericalpainratingscale(NRS)forlowbackpainandtheRolandͲMorrisdisabilityquestionnaire.Thesevariableswillbemodeledwithlinearmixedeffectsregression
overbaselineandweeks2,4,6,and12.Wewillincludetermsinthemodelfortime(asacategorical
variable),site,group,siteͲbyͲgroup,timeͲbyͲgroupandsiteͲbyͲtimeͲbyͲgroupinteractions,andthe
variablesintheminimizationalgorithm.Wewillchoosethecovariancematrixbycomparingthe
maximizedlogͲlikelihoodsandtheBayesianInformationCriteriaforseveralcovariancepatternmodelsagainsttheunstructuredcovariance.Diagnosticsoftheconditionalpredictedvaluesandconditional
residualswillallowustoassesstheassumptionofnormalityandfitforthemodel.Themainresultswillbebasedonthefinalmodelsforthe2primaryoutcomevariablesattheprimaryendpointof6weeks.IfthesiteͲbyͲtimeͲbyͲgroupinteractionissignificantatthe0.05level,resultswill
bereportedbysite.Adjustedbetweengroupmeansand95%confidenceintervalswillbereportedfor
allendpointsusingtheestimatesforthetimeͲbyͲgroupinteractions.Thiswillallowustocomparetheresultswiththoseinthepilotstudy(primaryendpoint4weekswitha2weekinterimassessment)and
toinvestigatethelongertermoutcomes.
SecondaryanalyseswillbeconsistentwiththerecentNIHTaskForcerecommendationsforaminimum
datasetforchroniclowbackpain.Inparticular,responderanalyseswillbeconductedforarangeof
improvementlevelsatweek6.Generalestimatingequationswithaworkingcovariancematrixwillbe
usedtoestimatethedifferencesinproportionsbetweengroups,adjustingforsite,siteͲbyͲgroupinteractionandtheminimizationvariables.
Wewillusetwoapproachestosensitivityanalysestoexaminethepossibleeffectsofmissingdataon
theresultsobtainedfromusingallobserveddata.Priortotheconductingthesensitivityanalyses,we
willidentifybaselinevariablesthatarepredictiveofmissingoutcomeswithlogisticregressionmodels.
Ourfirstapproachwillbeundertheassumptionthatdataaremissingatrandom.WewillusetheMarkovChainMonteCarlomethodinSASProcMItoimputemissingvaluesforeachoftheprimaryoutcomevariablesbasedonthefinalmixedmodelcovariates,theobservedoutcomevariableatbaselineandweeks2,3,6and12,andthebaselinevariablespredictiveofmissingdata.Wewillanalyzetheresultingdatasetsforeachof20imputationswiththelinearmixedeffectsmodelsthatarefitwith
allobserveddataanduseSASProcMIAnalyzetocombinetheresults.Thesecondapproachwillbe
undertheassumptionthatdataaremissingnotatrandom.Herewewillfollowthepatternmixture
approachdescribedbyCarpenterandKenward(2007).Wewillfirstimputemissingvaluesasdescribed
aboveforthemissingatrandomapproachandthenforeachparticipantineachtreatmentgroupfor
eachimputation,wewilldecreasetheimputedobservationbydifferentamountsrepresentingdifferentpatternsofresponses.Wewillthenanalyzetheresultingdatasetsforeachpatternandcombinethe
estimatesasdescribedabove.Ifthesensitivityanalysesshowsusthatconclusionsdifferbetweentheresultsbasedontheobserveddataandthatbasedonfulldatasetsunderdifferentmissingness
assumptions,wewillreportmultiplesetsofresults.
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