Enhancing the Success of Functional Restoration Using Integrative Pain Therapies: a Comparative Effectiveness Analysis of Active Duty Service Members With Chronic Pain
Phase: NA
Conditions: Chronic Pain
Sponsor: Madigan Army Medical Center

 
 
 
 
 
 
 
 
 
 
Study title:  
Enhancing the Success of Functional Restoration Using  
Integrative Therapies:  
Comparative Effectiveness Analysis in Active Duty Service Members  
with Chronic Pain 
 
 
Current Approved Protocol 
 
 
 
 
Date of Initial Approval of Original Protocol: 4/28/2015 
Date of Approval of Most Recent Protocol Modification: 7/9/20 
Today’s date: 11/23/20 

EIRB Protocol Template (Version 1.2)
1.0
General Information
*Please enter the full title of your study:
Enhancing the Success of Functional Restoration Using Integrative Therapies: Comparative 
Effectiveness Analysis in Active Duty Service Members With Chronic Pain
*Please enter the Protocol Number you would like to use to reference the protocol:
215050
* This field allows you to enter an abbreviated version of the Protocol Title to quickly identify
this protocol.
Is this a multi-site study (i.e. Each site has their own Principal Investigator)?
No
Does this protocol involve the use of animals?
Yes
No
2.0
Add Site(s)
2.1 List sites associated with this study:
Primary 
Dept?
Department Name
Army - Madigan Army Medical Center (MAMC)
3.0
Assign project personnel access to the project
3.1 *Please add a Principal Investigator for the study:
FLYNN, DIANE MCFADDEN, MD
Select if applicable
Student
Site Chair
Resident
Fellow
3.2 If applicable, please select the Research Staff personnel:
A) Additional Investigators
SNOW, TYLER JAY 
Associate Investigator
N

B) Research Support Staff
Mcquinn, Honor MARY, DNP 
 Research Coordinator
3.3 *Please add a Protocol Contact:
 
FLYNN, DIANE MCFADDEN, MD 
The Protocol Contact(s) will receive all important system notifications along with the Principal 
Investigator. (i.e. The protocol contact(s) are typically either the Protocol Coordinator or the 
Principal Investigator themselves).
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Add the name of the individual authorized to approve and sign off on this protocol from your Site 
(e.g. the Site Chair).
4.0
 
Project Information
4.1  Is this a research study?
 Yes   
 No
4.2  What type of research is this?
Biomedical Research
Clinical trial (FDA regulated)
Behavioral Research
Educational Research
Psychosocial Research
Oral History
Other
4.4  Is this human subjects research (Activities that include both a systematic investigation designed to 
develop or contribute to generalizable knowledge AND involve a living individual about whom an 
investigator conducting research obtains data through intervention or interaction with the individual 
or identifiable private information.  Activities covered by 32 CFR 219.101(a) (including exempt 
research involving human subjects) and DoDI 3216.02)?
 Yes   
 No
4.5  Do you believe this human subjects research is exempt from IRB review?
  Yes   
  No
5.0
 
Personnel Details
5.1  

Will you have a Research Monitor for this study?
Yes 
No 
N/A 
Research Monitor Role:
If applicable, you may nominate an individual to serve as the Research Monitor:
No Users have been selected.
6.0
 
Data/Specimens
6.1  Does the study involve the use of existing data or specimens only (no interaction with human 
subjects)?
  Yes   
  No
7.0
 
Funding and Disclosures
7.1  Source of Funding:
Funding Source
Funding Type
Amount
:
Congressionally Directed 
Medical Research Program 
(CDMRP)
:
Research Development 
Testing and Evaluation 
(RDT&E) funds
999981
Total amount of funding:
999981
7.2  Do you or any other Investigator(s) have a disclosure of a personal interest or financial nature 
significant with sponsor(s), product(s), instrument(s) and/or company(ies) involved in this study?
  Yes   
  No
8.0
 
Study Locations
8.1  List any Research Team members without EIRB access that are not previously entered in the 
protocol:
Name:
(Last, First, M.I.)
Phone Number:
 
Email Address:
 
Associated Institution:
 

Doorenbos, Ardith Z.
Role on Protocol:
206-616-0927
doorenbo@uw.edu
University of 
Washington
Name:
(Last, First, M.I.)
Role on Protocol:
Phone Number:
 
Email Address:
 
Associated Institution:
 
8.2  Has another IRB reviewed this study?
  Yes   
  No
IRB Name
Review Date
Determination
No records have been added
8.3  Is this a collaborative or multi-site study? (e.g., are there any other institutions involved?)
 Yes   
 No
8.4  Study Facilities and Locations:
Institution
Site Name
Site Role
FWA or DoD 
Assurance 
Number
Assurance 
Expiration 
Date
Is there an 
agreement?
IRB 
Reviewing 
for Site
University 
of WA
Other
00006878
01/29/2025
: CRADA
: RHC - P 
IRB
Other:
Other 
Institution 
Site
Site Role
FWA or DoD 
Assurance 
Number
FWA or DoD 
Expiration 
Date
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agreement?
IRB 
Reviewing 
for Site
No records have been added
8.5  Are there international sites?
Attach international approval documents, if applicable, when prompted. Note: Ensure local research 
context has been considered
  Yes   
  No
8.6  Is this an OCONUS (Outside Continental United States) study?
  Yes   
  No
Select  the area of responsibility:
Have you obtained permission from that area of responsibility? (This is a requirement prior to study 
approval)
  Yes   
  No

9.0
 
Study Details
9.1  Abstract/ Summary:
Summarize the proposed study in 500 words or less, to include the purpose, the subject population, the 
study’s design type, and procedures
Pain is an urgent public health concern that significantly impairs the physical, psychological, and social 
functioning of both those experiencing it and their significant others. The National Center for Health 
Statistics noted that 40% of people reporting pain indicate moderate to severe degradation in their 
functioning; this results in tremendous costs to treat or manage the problem. This problem is 
compounded exponentially by the injuries sustained as a direct result of the recent conflicts in Iraq and 
Afghanistan. Pain due to musculoskeletal injuries, sustained both on and off the battlefield, is a leading 
cause of both short- and long-term disability among Soldiers. Pain-related attrition from active-duty is 
also significant, with only 13% of service members returning to duty in the field when pain is their 
primary diagnosis. To address these concerns, the Army Surgeon General chartered the Pain 
Management Task Force (PMTF) in August 2009, to evaluate the state of pain management in the 
military. The resulting 
 delineated 109 recommendations 
2010 Pain Management Task Force Report
to be implemented in phases across the continuum of military medicine and formed the basis for a 
Comprehensive Pain Management Campaign Plan (CPMCP). Of specific relevance to this proposal, one of 
the goals of the CPMCP is the implementation of a Musculoskeletal Action Plan (MAP; PMTF 
, that emphasizes the prevention, early identification and proper rehabilitation 
Recommendation 4.2.5)
and reintegration of service members suffering from acute and chronic musculoskeletal injuries related to 
pain.
Functional restoration (FR) is an intensive, medically-supervised interdisciplinary program, combining 
quantitatively-directed exercise progression with a multimodal disability management approach, 
incorporating psychological and case management techniques. This rehabilitation process is a variant of 
chronic pain management based on the bio-psychosocial model of pain and disability, incorporating a 
sports medicine approach to rehabilitation. The program is specifically intended for rehabilitation of 
musculoskeletal injuries, and its effectiveness has been extensively demonstrated in civilian populations 
as well as preliminary evaluations among injured military personnel. Our 
 is to improve 
long-term goal
pain management and function for military personnel by facilitating timely and appropriate use of 
integrative pain management strategies along with a function restoration program.
9.2  Key Words:
Provide up to 5 key words that identify the broad topic(s) of your study
non-pharmacologic pain therapies, integrative, military
9.3  Background and Significance:
Include a literature review that describes in detail the rationale for conducting the study. Include 
descriptions of any preliminary studies and findings that led to the development of the protocol.  The 
background section should clearly support the choice of study variables and explain the basis for the 
research questions and/or study hypotheses.  This section establishes the relevance of the study and 
explains the applicability of its findings
The Impact of Pain in the United States
Chronic pain is an urgent public health concern that significantly impairs the physical, psychological, and 
social functioning of both those experiencing it and their significant others.
 The Institute of Medicine 
1,2
recently estimated that more than 100 million adults in the United States, over one-third of the 
population, experience some form of chronic pain,  with symptoms of pain being the most common 
2

reason people consult a primary care physician.
Despite the magnitude of this problem, pain is severely 
3 
underrepresented in the content of medical education.  Consequently, treatment of pain is often 
4
fragmented and is highly variable.  In addition, the National Center for Health Statistics noted that 40% 
5
of people reporting chronic non-cancer pain  indicate moderate to severe degradation in their functioning6
which results in tremendous treatment costs. Specifically, it is estimated that chronic pain costs 
approximately $635 billion per year in health care and reduced productivity. These costs have increased 
5-fold in the past decade and will likely increase with the aging population.  However, these increases in 
2
health care expenditures have not translated into improvements in clinical outcomes.
 Most 
7,8
importantly, these costs do not reflect the incalculable impact of pain on the lives of patients and their 
significant others.
In the military health care system, the problems and costs associated with chronic pain are compounded 
exponentially by the injuries sustained as a direct result of the conflicts in Iraq and Afghanistan. Pain due 
to injuries sustained both on and off the battlefield is a leading cause of both short- and long-term 
disability among Soldiers.
 Approximately 48% of military veterans report suffering from pain
 and 
9-11
12
40% who seek care in Veterans Health Administration facilities are diagnosed with a pain condition
.  De
13
ployment in multiple tours of duty were associated with significantly higher rates of chronic widespread 
pain.
 Pain-related attrition from active-duty is also significant, with only 13% of military personnel 
14
returning to duty in the field when pain is their primary diagnosis.15
The Military Health Care Comprehensive Pain Management Campaign Plan
The Army Surgeon General chartered the Pain Management Task Force (PMTF) in August 2009.  This 
multidisciplinary group of task force members, spanning multiple medical specialties and leadership roles 
within the Department of Defense (DoD) and the Veterans Health Administration (VHA), was assigned 
responsibility for evaluating the state of pain management in the military, to identify best pain 
management practices and to recommend systems of pain care to ensure treatment is implemented in a 
consistent and uniform manner across the continuum of care.  The final report, released as the 2010 
, delineated 109 recommendations to be implemented in phases 
Pain Management Task Force Report
across the continuum of military medicine.
 Acting on the PMTF report, the Army Medical Department of 
16
the Office of the Surgeon General launched a Comprehensive Pain Management Campaign Plan (CPMCP).1
 The CPMCP summarizes the major tasks and objectives of the campaign, notes the importance of 
7
implementing tools and infrastructure, and identifies integrative pain management and non-
pharmacological therapies as key objectives of the campaign. To realize the objectives of this campaign, 
several initiatives were identified, including (1) promoting partnerships between DOD networks 
, and 
and academic institutions to leverage expertise
(2) research on non-pharmacological 
.
approaches to pain control using integrative pain management strategies
Another significant goal of the CPMCP is the implementation of a Musculoskeletal Action Plan (MAP; 
, that emphasizes the prevention, early identification and proper 
PMTF Recommendation 4.2.5)
rehabilitation and reintegration of military personnel suffering from acute and chronic musculoskeletal 
injuries related to pain. A major goal of MAP is to evaluate data on outcomes, costs, and return on 
investment of these rehabilitation-focused treatments. While prevention strategies are critical in reducing 
the likelihood of occurrence for musculoskeletal injuries, development of adequate early identification 
and rehabilitative strategies are important to prevent further psychosocial and physical deconditioning, 
and the subsequent development of chronic pain-related disability. Identifying and implementing an 
optimal rehabilitative program as part of the military healthcare system’s broader pain program is vital to 
accomplishing the goals of the PMTF. The functional restoration approach to rehabilitation, an intensive 
interdisciplinary rehabilitation program based on a sports medicine paradigm, may be a significant part in 
an optimal rehabilitative program. Therefore, the current objectives of military pain medicine underscore 
the importance of leveraging the expertise of military and civilian clinical programs and research, 
increasing the use of validated non-pharmacological treatment modalities, and evaluating the 
effectiveness and value of these initiatives through high-quality research. The US Army’s CPMCP 
underscores the importance of two major concepts of this proposal, namely, the 
implementation of multimodal integrative pain management therapies and a structured 
interdisciplinary rehabilitation program for military personnel suffering from pain-related 
disability. More importantly, this proposal aims to systematically investigate the benefits of 
combined integrative modalities and intensive, interdisciplinary rehabilitation by leveraging 
the expertise of military and academic pain researchers.
Table 1. Summary of Pain Management Task Force Recommendations for Enhancing 
Integrative Pain Management and promoting the Musculoskeletal Action Plan.
 

1.  
2.  
3.  
4.  
5.  
6.  
7.  
1.  
2.  
3.  
4.  
Incorporate integrative and alternative therapeutic modalities into a patient-centered plan 
of care.
Adopt a tiered approach for the effective integration of integrative modalities to augment pain 
management for military and veteran populations.
Establish integrative pain medicine capabilities at Department of Defense and Veterans Health 
Administration Regional Pain Centers of Excellence (RPCoE) and Department of Defense 
medical treatment facilities (Army, Navy, and Air Force) to champion integrative pain care with 
a focus on the best clinical practices, education, and research.
Establish baseline data on the clinical integrative practices being used, along with provider and 
patient perspectives, through a comprehensive Department of Defense survey, utilizing 
existing survey models (if appropriate).
Develop an advisory board, with scholarly leaders in various integrative medicine fields, to 
assist in the development of appropriate programs, ensure proper credentialing of providers, 
and establish necessary guidelines for outcome measures and uniform quality of care.
Establish standardized and appropriate strategic communication plans on integrative health 
care methods for pain management.
Develop and fund pilot programs across the Department of Defense for the delivery of 
integrative pain management.
Request Health Affairs undertake the evaluation of integrative medicine modalities in Tier I 
(acupuncture, yoga, chiropractic, therapeutic medical massage, biofeedback, mind-body 
therapies) for inclusion as covered TRICARE benefits.
Musculoskeletal Action Plan: Integrate the prevention, early identification, and
treatment of injuries as a component of the comprehensive pain management strategy.
Develop an education and STRATCOM program focused on musculoskeletal injury prevention 
and human performance optimization, early identification, and management, rehabilitation, 
and reintegration.
Integrate the Musculoskeletal Action Plan education program and concepts into the pain 
education and training program.
Create an organizational structure, culture, and climate for awareness and execution of the 
Musculoskeletal Action Plan by collaborating with DoD and stakeholders within the Army 
(includes FORSCOM, TRADOC, MEDCOM, USUHS, AMEDD C&S, etc.).
Resource prevention and treatment programs that emphasize evidence-based practices. 
Capture relevant and available data to identify trends, cost, and return on investment. Utilize 
data to assist in the prioritization of resources.
 
Army Medicine 2020 Campaign Plan
The Army Medicine 2020 Campaign Plan identifies the priority lines of effort for the Army Medical 
Department.  The Campaign Plan emphasizes the importance of improving rehabilitation, reintegration 
and recovery through improved pain management. In addition, the Campaign Plan supports intra- and 
extra-mural research that sustains the DoD pain management mission
.   
18
Evidence for Increasing the Use of Multimodal Integrative
Pain Management in Military Settings
The use of integrative treatment modalities has increased in the United States over the last decade. The 
National Health Interview Survey reports increasing numbers of Americans using and paying out of 
pocket for some form of complementary and integrative treatment modality.
 For example, in 2007, 
19-21
over 38% of adults and 12% of children used some form of complementary approach to treatment within 
the 12 months prior to the survey.
 Pain complaints were the most common reason for integrative 
19
medicine consultations, with back pain being the most common. Other causes of increased interest in 
integrative pain therapies include the deterioration of the relationship between the patient and health 
care provider in the allopathic medical system, the growing awareness of serious adverse effects of 
medications,
 and the inability of the allopathic medical system to adequately treat chronic disease.
 
22
23 T
here is positive evidence for the effectiveness of integrative approaches to pain management. 
Several recent systematic reviews and studies, many published in 2013, report the 
.
effectiveness of a variety of integrative modalities used to treat pain disorders

Acupuncture
A systematic review of acupuncture for nonspecific chronic low back pain, conducted on all published 
randomized controlled trials (RCTs) on acupuncture through May 2012, yielded 32 studies.
 Overall, 
24
acupuncture had statistically and clinically meaningful improvements in self-reported pain and function 
when compared to sham procedures. Additional benefits were indicated when acupuncture was used in 
addition to usual care. However, the authors of that study caution that the results should be interpreted 
within the context of certain limitations, such as heterogeneity in patient characteristics among the 
studies, as well as low methodological quality of some of the RCTs reviewed based on methodological 
quality assessments using the Cochrane risk-of-bias tool. Another recent systematic review examined the 
effectiveness of acupuncture for lumbar spinal stenosis.
 This review included six RCTs and 
25
nonrandomized controlled clinical trials published in Chinese medical journals. Overall, there was a trend 
supporting the effectiveness of acupuncture in combination with standard care on pain, function, and 
quality of life up to 6 months post treatment. Like the previous study, caveats included methodological 
weaknesses in study design, which warrant more robust research before conclusive evidence can be 
presented on the effectiveness of acupuncture for treating pain.
Finally, a recently published pilot study conducted at Madigan Army Medical Center (MAMC) investigated 
the effectiveness of acupuncture, in combination with other complementary adjuvant treatments, for 
treating generalized anxiety disorder (GAD).
Study participants (  = 37) received acupuncture 
26 
N
treatments weekly for a 6-week duration, combined with adjuvant treatments such as yogic breathing 
exercises, self- and/or partner-assisted massage therapy using scented oils, episodic journaling, nutrition 
counseling, and exercise. Using a pre-to-post comparison, the study reported significant reductions in 
self-reported anxiety scores on both the Generalized Anxiety Disorder 7-item (GAD-7) and the 
Depression Anxiety Stress Scale 21-item (DASS-21). Additionally, there was an observed reduction in 
use of anxiolytic medications. Despite the use of multiple modalities, which may imply treatment burden, 
voluntary participation and completion of the treatment regimen was modestly high, at a 68% 
completion rate.
Mind-Body Therapies
Mind-body therapies, which is a broad category composed of modalities such as yoga, Tai Chi, Qigong, 
meditation, deep breathing, and mindfulness-based therapies, have been used with modest effectiveness 
for treating psychosocial disorders as well as functional deficits due to pain and disability. A recent 
systematic review yielded 13 RCTs that investigated mindfulness-based therapies for treating 
somatization disorders.
 Compared to control groups, the results indicated moderate effects in favor of 
27
mindfulness-based therapy for reducing self-reported pain, symptom severity, depression, and anxiety 
associated with somatization disorders.
Of specific importance to military medicine, mindfulness-based therapies are also associated with positive 
treatment effects on patients suffering from post-traumatic stress disorder (PTSD). A review of the 
literature on the broader application of mind-body techniques (including yoga, Tai Chi, Qigong, 
meditation, deep breathing, and mindfulness-based stress reduction) indicated significant treatment 
benefits, including reduced pain, anxiety, anger, and depression; increases in self-esteem, ability to 
relax, and coping skills; and effective mitigation of PTSD-specific symptoms such as intrusive memories, 
avoidance, and emotional arousal.28
The use of yoga as a primary or adjuvant therapy for chronic pain disorders has also increased in 
popularity in recent years. Indeed, this modality of mind-body therapy is currently offered to military 
personnel being treated for pain at MAMC. One systematic review on 10 RCTs that investigated the 
effectiveness of yoga for low back pain reported positive results.
 Yoga, in combination with standard 
29
care, was associated with strong evidence for both short-term and long-term reductions in pain, as well 
as short-term improvements in back-specific disability and patients’ global perception of improvement. 
Moderate evidence was also reported for yoga reducing back-specific disability in the long-term. Similar 
evidence was also observed in a recently published study on the effect of yoga for treating chronic neck 
pain.
 However, yoga as a treatment modality for fibromyalgia and rheumatic diseases such as 
30
osteoarthritis indicated no beneficial effect.31
Another major component of mind-body therapies involves the use of biofeedback as an adjuvant to 
standard care. Two systematic reviews, which included RCTs as well as nonrandomized controlled trials, 
indicated relatively small treatment effects for improvement in pain and function following biofeedback 
modalities.
 However, the aggregated treatment effect in these reviews were likely due to 
32,33
methodological weaknesses in many of these studies that were identified by the systematic reviews. To 
that end, two recently published studies investigating the feasibility of novel methods of delivering 
biofeedback support report some promising evidence. These included a biofeedback-based cognitive 
behavioral therapy modality for patients suffering from temporomandibular disorder,
 as well as 
34

telehealth delivery of education and biofeedback instruction to women veterans suffering from trauma-
induced chronic pain and depression.
 Both studies indicate preliminary evidence for improvements in 
35
pain and function, as well as enhanced coping skills.
Manual Therapies
Within the broad category of manual therapies, chiropractic and therapeutic medical massage are two 
major modalities that have received considerable attention. To date, systematic reviews on both 
modalities, when used to treat pain, have indicated some evidence for its benefits. A systematic review 
investigating the broader modality of manual and manipulative therapies (including chiropractic, in RCT 
and non-RCT designs) for upper extremity pain and temporomandibular disorder concluded that there is 
a moderate short-term benefit for reducing pain.
 Similarly, moderate effects for improving outcomes 
36
for pain are also reported for therapeutic medical massage. A systematic review published by the 
Cochrane Back Review Group reviewed 13 RCTs and concluded that massage may be beneficial for 
patients suffering from subacute and chronic non-specific low back pain.
 Two more-recent systematic 
37
reviews of massage therapy for low back pain, neck pain, and shoulder pain indicated some benefit in 
improving pain and function, however, as with chiropractic, the effects were maintained only in the short-
term.
 Although these reviews indicate moderate evidence for the beneficial effect of manual 
38,39
therapies, several limitations exist in experimental design within the body of evidence, including 
heterogeneous patient populations and unstandardized outcome measures across studies that make it 
challenging to draw strong conclusions about the efficacy of manual therapies.
 
40 The integrative 
modalities are of significance to the US Army’s Comprehensive Pain Management Campaign 
Plan, and are prioritized for implementation in Army medical treatment facilities. These 
integrative pain management modalities are currently used to treat military personnel at 
MAMC.
The Functional Restoration Approach to Pain and Disability Management
Functional restoration (FR) is an intensive, medically-supervised interdisciplinary program, combining 
quantitatively-directed exercise progression with a multimodal disability management approach, 
incorporating psychological and case management techniques.
 This rehabilitation process is a variant 
41
of chronic pain management based on the biopsychosocial model of pain and disability, incorporating a 
sports medicine approach to rehabilitation. The program is specifically intended for rehabilitation of 
musculoskeletal injuries in the occupational setting, and its effectiveness has been extensively 
demonstrated in civilian populations.
The majority of published FR studies to date have been conducted among civilian populations and mainly 
evaluated the programs’ effectiveness at facilitating return to work in low back pain patients with 
occupational disability.
 Using return to work and/or the number of days of sick leave taken as the 
42-48
main outcome is relevant because the associated costs of disability compensation and productivity losses 
constitutes a substantial portion of the long-term costs of disability.
 In a systematic review of FR 
49,50
programs for chronic low back pain, FR programs had a positive impact on the return to work rate in the 
majority of studies (from 65% to 90%).
It should be noted, however, that the variation in the return to 
51 
work rate is likely associated with the social security system of the country where the program was 
developed. Another possible reason for the different results in the studies might be that study design, 
patient population, FR program planning, and other external factors were different and therefore not 
directly comparable. Other outcomes that have been shown to be positively impacted on the long-term 
(over approximately 5 years) by the FR program include significantly better functioning on activities of 
daily living, increased physical activity, and reductions in healthcare utilization and days of sick leave.52
Notably, several prospective outcome studies have been conducted to explore what clinical 
characteristics of patients predict success in FR programs.
 This is an important factor, since FR 
53-55
programs are expensive and time intensive. The results of these studies indicated that older age, more 
days of sick leave, no job availability, and higher pain intensity were significantly correlated to poorer 
outcomes one year after entry into the study. Other studies have also noted that untreated psychosocial 
factors and secondary gain motivation predict program non-completion as well as poorer outcomes 
following FR.
 Notably, the data from these studies suggest that efforts should be made to propose 
56-59
such programs at an earlier stage of disability, and prior attention to psychosocial factors should be 
conducted as a work-up towards enrolling patients into an FR program.
To date, only one study has been published on the effectiveness of the FR program in a military patient 
population suffering from pain-related disability.
 Findings from this study showed positive evidence of 
60
FR program outcomes. Participants in the FR program improved significantly compared to the standard 
treatment group (medication management and injection therapeutics) on self-reported pain, disability, 
functional status, and fitness for military duty at the post-treatment, 6-month, and 1-year follow-up 
points. This is the only systematic research study that has been conducted among the military personnel 

using standardized functional capacity tests on endurance and lifting strength alongside patient-reported 
outcomes.
 
61 Functional restoration has extensively improved outcomes in the civilian 
population and prevented long-term disability while promoting a return to optimal function. 
To date, no studies in the military healthcare settings have identified prognostic factors for 
successful completion of FR, as well as maintaining satisfactory long-term outcomes. 
Additionally, there is insufficient published data on the potential benefits of combining FR with 
a course of integrative pain management modalities.
9.4  
Objectives/Specific Aims/Research Questions:
Describe the purpose and objective(s) of the study, specific aims, and/or research questions/hypotheses
Aim 1: Evaluate the benefit of a program of multimodal pain management therapies prior to 
an intensive functional restoration program, relative to standard care.
            Hypothesis: Patients who complete an IM program prior to FR will demonstrate significantly 
greater improvements in pain and physical function going into the FR program, relative to 
standard care.    At post-FR, patients who completed an IM program prior to FR will demonstrate 
significantly improved outcomes on pain severity and physical function at discharge from the 
program and at 3-months and 6-months post-FR, relative to standard care.
Aim 2: Identify prognostic factors, including demographic factors, psychologic factors, and 
readiness factors that predict successful outcomes on pain severity and function, as 
measured by the Defense and Veterans Pain Rating Scale and PROMIS functional 
status score, respectively, following intensive interdisciplinary functional restoration.
In addition to IM vs standard care, secondary predictors of outcomes         following FR will 
include: demographic factors (age, military rank, race,          household income), psychosocial 
factors (depression, anxiety, anger); sleep quality and fatigue; medical board status for 
disability; duration of pain-related disability; prescription opioid dosage; and functional capacity 
measures of strength and endurance.  It is expected that service members with more severe 
psychological distress and disability at baseline will experience lower rates of positive response 
following FR.
 
 
Aim 3. Evaluate the relationship between legacy paper questionnaires included in the PASTOR-
plus packet with PASTOR submeasures.
           
We will compare legacy paper questionnaires completed by study subjects which include the 
Tampa Kinesiophobia Questionnaire, Patient Activation Measure, Pain Self-Efficacy Questionnaire, 
Chronic Pain Acceptance Questionnaire and Roland-Morris Disability Questionnaire, and Pain 
Catastrophizing Scale with PROMIS measures included in the electronic PASTOR assessment, 
including pain interference, depression, anxiety, anger, and physical function.  This will determine 
if there are legacy questionnaires with prognostic value which should be added to PASTOR.
 
Aim 4: Evaluate the relationship between self-reported physical function (from PASTOR) and 
clinician-supervised tests of physical function, such as exercise treadmill test at all time 
points.
 
We will compare self-reported physical function with clinician-supervised tests of physical function 
to determine if PASTOR respondents over or under-estimate their physical capacity.
 
Aim 5: Determine whether outcomes differ between the subgroup of participants who 
completed FR program 4 days per week x 3 weeks vs 2 days per week x 6 weeks
 
During the course of the study, a protocol modification was approved to allow subjects to 
participate in the FR program with an extended 2 days per week over 6 week schedule with the 
same number of treatment hours as the original 4 days per week for 3 weeks.  We will evaluate 
outcomes in both groups to determine if one treatment approach yielded superior outcomes to 
the other.
 
Aim 6: Compare outcome measures collected within narrow timelines to those collected within 
flexible timelines.

 
We attempted to collect outcome measures at the following timepoints: 1) within one month 
before starting treatment; 2) within the last day of pre-FR stage through the first day of FR stage; 
3) on the last day of FR; 4) 3- and 5) 6- months after the end of FR.  However, this precise 
collection schedule was not always possible.  For example, baseline measures were collected more 
than one month before the start of treatment for study subjects who had conflicts such as military 
training exercises, personal or family illness or planned leisure travel which postponed the start of 
study treatment.  Collection of follow-up measures was sometimes earlier or later than desired 
when study subjects with conflicts were unavailable at the time outcomes were requested.  We 
plan to compare outcomes collected within the above timeframes with those collected within 
timeframes with modest and moderate flexibility as outlined in section 11.3. This analysis will 
inform the design of future pragmatic clinical trials in determining acceptable timeline parameters 
for collection of pain outcomes.
 
 
Aim 7: Determine if patient activation, pain catastrophizing, self-efficacy or pain acceptance 
moderates or mediates pain and function outcomes.
 
We will determine if level of patient activation, catastrophizing, self-efficacy and pain acceptance as 
measured by legacy questionnaires completed by study subjects have an impact on pain and functional 
outcomes.
 
 
 
9.5  Study Design:
Describe study design in one to two sentences (e.g., prospective, use of existing records/data
/specimens, observational, cross-sectional, interventional, randomized, placebo-controlled, cohort, etc.). 
Specify the phase – Phase I, II, III, or IV – for FDA-regulated investigational drug research
A comparative effectiveness study, using a prospective randomized cohort design, with patients assigned 
to either (i) a course of integrative pain management modalities (IM) or (ii) standard care (SC), for three 
weeks prior to beginning a course of FR.
9.6  Target Population:
Describe the population to whom the study findings will be generalized
Active duty service members with chronic pain
9.7  Benefit to the DoD:
State how this study will impact or be of benefit to the Department of Defense
Improving the quality of pain care for active duty service members is a major priority of the Department 
of Defense.  In 2009, the Army Surgeon General chartered the Pain Management Task Force (PMTF) to 
evaluate the state of pain management in the military. The resulting 2010 Pain Management Task Force 
Report delineated 109 recommendations to be implemented in phases across the continuum of military 
medicine and formed the basis for a Comprehensive Pain Management Campaign Plan (CPMCP). The 
CPMCP defines several goals and objectives, and these include (1) partnering with DOD and VA 
networks, civilian, and academic institutions to leverage expertise, and (2) implementing and researching 
non-pharmacological approaches to pain control using integrative pain management strategies. Of 
specific relevance to this proposal, one of the goals of the CPMCP is the implementation of a Musculoske
(MAP), which emphasizes the prevention, early identification and proper rehabilitation 
letal Action Plan 
and reintegration of service members with acute and chronic musculoskeletal injuries related to pain. A 
major goal of MAP is to evaluate data on outcomes, costs, and return on investment of these 
rehabilitation-focused treatments. More recently, the 
 was 
Army Medicine 2020 Campaign Plan
implemented which emphasizes pain management as a continued priority of the Army Medical 
Department. 

10.0
 
Study Procedures and Data management
10.1  Study Procedures:
Describe step-by-step how the study will be conducted from beginning to end
Project Setting
The Interdisciplinary Pain Management Clinic (IPMC) at MAMC provides chronic pain care to active duty 
Soldiers, sailors and airmen in the Puget Sound area.  The IPMC has a staff of 32 medical professionals 
including physicians board certified in anesthesiology, pain medicine, physical medicine, family medicine 
and palliative care and providers of health psychology, nurse case management, physical therapy, 
occupational therapy, clinical pharmacology, chiropractic, acupuncture, medical massage therapy and 
yoga therapy. Structured treatment programs at this facility include the FR and IM programs.
Design
A comparative effectiveness study, using a prospective randomized cohort design, with patients assigned 
to either (i) a course of integrative pain management modalities (IM) or (ii) standard care (SC), for three 
weeks prior to beginning a course of FR. Upon completion of the pre-FR treatment arms, all patients will 
be enrolled into the FR program for the duration of three weeks (up to 96 contact hours; 4 full day 
session/week). Because it is anticipated that some participants who randomize to the standard FR 
program may be interested in IM, the standard FR group will be offered the option of IM following 
completion of the FR program. Outcomes will be collected longitudinally at several time points during the 
course of the study, including at: (i) baseline, prior to initiation of treatment arms; (ii) completion of pre-
FR treatment, before initiation of FR program; (iii) completion of FR program; (iv) 3-months, and 6-mont
hs post-FR. Figure 1 illustrates the study design and the multiple points of outcomes assessment 
throughout the study.
 
Procedures

Recruitment
All military personnel referred to the Madigan Interdisciplinary Pain Management Clinic have an initial 30-
minute orientation group class with a nurse case manager (NCM) who provides an overview of 
interdisciplinary pain care.  At the conclusion of this class, all new patients are provided a laptop 
computer and instructed to complete the baseline Pain Assessment Screening Tool and Outcomes 
Registry (PASTOR) questionnaire.  Immediately following the IPMC orientation class, all new patients 
have a 90-minute introduction to the role of cognitive behavioral therapy in pain care.  Within the 
following two weeks, each patient has an initial comprehensive visit with a physician to determine the 
pain diagnosis and treatment plan. 
If the physician determines that the patient is a candidate for the FR program and the patient is willing to 
commit to this intensive treatment approach, the patient is evaluated by a physical therapist to measure 
baseline functional status and to determine if he/she has the physical stamina to successfully participate 
in FR. 
The research coordinator or research assistant will perform a brief screen of each potential subject’s 
medical record to determine if he/she has any excluding conditions.  If the potential subject has no 
excluding conditions, the research coordinator or research assistant will meet with him/her to explain the 
study and to request their consent for study participation. The commanding officer for each subject will 
be contacted and asked to approve the subject’s absence from work as needed for the 6-9 week program.
Randomization
Then, each patient will be randomized to one of two treatment groups: the standard FR program or the 
FR + integrative modalities (IM) program.  Because it is assumed that some participants who randomize 
to the standard FR program may be interested in IM, the standard FR group will be offered the option of 
IM following completion of the FR program.  The components of the intervention and control treatments 
are shown in Table 2.
Standard care is comprised of twice weekly health psychology group therapy, twice weekly physical 
therapy and once-twice weekly occupational therapy during the three weeks prior to FR.  Participants on 
chronic opioid therapy will also be seen by a clinical pharmacist for evaluation for opioid taper. The IM 
program is comprised of twice weekly acupuncture and chiropractic and once weekly yoga and myofascial 
release instruction by massage therapist.  If indicated, biofeedback and individual massage may also be 
used. The FR program includes four full days of therapy per week for three weeks.  Each FR treatment 
day will include approximately four-hours of physical activity and one hour each per day of health 
psychology group therapy and an educational session. Examples of the daily schedules for SC, IM and FR 
is shown in Figure 2.  In an effort to meet enrollment targets, patients who are otherwise eligible for FR 
program participation but cannot commit to 4 full days of therapy for a three-week period will be given 
the option of 2 full days of therapy over a six-week period for the same number of contact hours.
 
Table 2. Intervention and Standard Care
 
Approximate Contact 
hours
Intervention 
Group
Control Group
Standard Pre-FR Care (SC)
   CBT 90-minute orientation
   Health psychology / CBT group 
therapy
   Physical therapy/occupational 
therapy warm-up
   Clinical pharmacist evaluation 
(if taking opioids)
 
90-minutes
2 hrs/wk x 3 weeks
2-3 hrs/wk x 3 weeks
 
1-2 hours during 3 
weeks
 
X
X
X
 
X
 
X
X
X
 
X
IM prior to FR:
   Chiropractic
   Acupuncture
   Yoga
   Biofeedback (if indicated)
3 weeks comprised of:
15-minutes, twice per 
week
1-hr, twice per week
1-hr per week
45-min per week
 
X
X
X
X
X
 

   Foam roller class
   Medical massage (if indicated)
1-hr per week
1-hr every other week
X
FR program:
   Physical training
   Health psychology/CBT group 
therapy
   Didactic education
3 weeks comprised of:
4-hrs per day, 4 days 
per week
1-hr per day, 4 days per 
week
1-hr per day, 4 days per 
week
-or-
6 weeks comprised of:
4-hrs per day, 2 days 
per week
1-hr per day, 4 days per 
week
1-hr per day, 4 days per 
week
 
 
X
X
X
 
X
X
X
 
X
X
X
 
 
X
X
X
IM after FR:
   Chiropractic
   Acupuncture
   Yoga
   Biofeedback (if indicated)
   Foam roller class
   Medical massage (if indicated)
3 weeks comprised of:
15-minutes, twice per 
week
1-hr, twice per week
1-hr per week
45-min per week
1-hr per week
1-hr every other week
 
X (patient option)
X (patient option)
X (patient option)
X (patient option)
X (patient option)
X (patient option)
X (patient option)
 
 
Patient-Reported Outcomes
Patient demographic data and patient-reported outcomes will be collected using the DOD’s Pain 
Assessment Screening Tool and Outcomes Registry (PASTOR).
 This Web-based patient-reported 
62
outcomes tool, currently used at Madigan IPMC,
  was designed to reduce the burden of patient 
63
questionnaires during clinical contact through modern information technology and to make use of well-
 already available. It uses the computerized 
established and validated pain-related assessments
adaptive learning system of the Patient Reported Outcome Measurement Information System (PROMIS), 
which contains a large, validated databank of all surveys from the literature and was developed by the 
National Institutes of Health (NIH). Notably, PASTOR is one of the major recommendations from the 
2010 Army Pain Management Task Force Report. PASTOR will serve two major purposes: first, it will 
collect longitudinal outcomes data on patients treated in military hospitals in an outcomes registry; and 
second, it will provide a summary outcomes report on each patient for the IM and FR clinical team for 
review at during each assessment period. The PASTOR outcomes report (which includes the specific 
outcomes and treatment data collected) is presented in Section 6: Surveys, Questionnaires, and Other 
Data Collection Instruments – PASTOR. It is currently beginning a beta-test phase in select Army and 
Navy medical treatment facilities (including MAMC), and will be implemented during 2015-16 as standard 
of care for pain assessment at Army hospitals nationwide.
 
All patients will complete scheduled assessments according to the following timeline of the study:
1.  At baseline, prior to randomization to SC or IM
2. At completion of SC or IM, prior to initiation of FR program
3. At completion of FR program

Table 3. Patient-Reported Outcome Measures in PASTOR
Primary Outcomes
Defense and Veterans Pain Rating Scale (DVPRS)64
Pain Intensity 10-pt Numeric Rating Scale (NRS)
Physical Function Subscale of PROMIS Global Health65
Secondary Outcomes
    PROMIS Pain Interference66
    PROMIS Depression67
    PROMIS Anxiety67
    PROMIS Emotional Distress - Anger67
    PROMIS Sleep Disturbance68
    PROMIS Fatigue69
    Patient-defined activity goal70
   Patient Activation Measure (PAM)71
   Drug Use Questionnaire (DAST-10)72
   Pain Catastrophizing Scale (PCS)73
   Tampa Scale for Kinesiophobia (TSK11)74
   Pain Self Efficacy Questionnaire (PSEQ)75
   Chronic Pain Acceptance Questionnaire (CPAQ8)76
Canadian Occupational Performance Measure (COPM)81
Roland-Morris Disability Questionnaire80
    Opioid utilization screener*
Current opioid regimen
Duration of pain and of opioid treatment
Morphine equivalent dose
Pain relief from opioids**
*Data on utilization and dosage are electronically extracted by PASTOR from the CHCS Electronic 
Medical Database.
**Patient self-reports pain relief if applicable.
4. At 3-months post-FR program
5. At 6-months post-FR program
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Based on six months of experience with use of PASTOR at the Madigan Interdisciplinary Pain 
Management Center, the time required to complete this study’s PASTOR measures is expected to be 

approximately 20 minutes at baseline and 15 minutes at each follow-up time point. Because the PASTOR 
platform is a secure, web-based system, participants will have the option of completing PASTOR from the 
convenience of their homes.  The psychometrics of PASTOR are discussed in section 7.3.4.
Upon completion of a PASTOR assessment, a three-page report is generated (see Section 6: Surveys, 
Questionnaires, and Other Data Collection Instruments – PASTOR) that summarizes all domains 
measured and displays them longitudinally once there are two or more assessments completed. Raw 
data will be stored in the PASTOR outcomes registry and made available to the research study after 
patient identifiers have been removed. It is planned that PASTOR will eventually include other validated 
measures relevant to pain, including the Patient Activation Measure, Pain Catastrophizing Scale, Tampa 
Scale for Kinesiophobia, Pain Self-efficacy Questionnaire and Chronic Pain Acceptance 
Questionnaire.  Until these measures are added to electronic PASTOR assessment tool, these additional 
questionnaires will be administered in paper form at the same intervals that PASTOR is administered.
In February 2016, the Army Functional Restoration Workgroup determined that the Rolland-Morris 
Disability Score and the Canadian Occupational Performance Measure should be among the standardized 
outcome measures used by all Army FR programs, so these outcome measures are also included.
Upon the completion of the functional restoration program participants will complete the global 
improvement scale in order to support psychometric analysis to determine the minimal importance 
difference for primary outcome variable – pain impact score.  This will require the addition of a 1-2 
questions to the current paper-based questionnaire administered at the post-FRP time interval.
 
Functional Tests on Endurance and Isokinetic Lifting Strength and Flexibility
Functional capacity tests on endurance and lifting strength are standard outcomes used in FR programs, 
to complement patient-reported outcomes. These functional measures, similar to that used to screen 
patients for the inclusion criteria, include
:
61
Naughton Treadmill Test: Measures the pace and duration of time on a treadmill. It is expected 
that with improved functional capacity after FR, patients will be able to endure a faster treadmill 
pace for a longer duration of time.
Floor-Knuckle Lift Test: Lifting weights from floor to knuckle height. It is expected that with 
improved functional capacity after FR, patients will be able to lift heavier weights.
Floor-Shoulder Lift Test: Lifting weights from floor to shoulder height. It is expected that with 
improved functional capacity after FR, patients will be able to lift heavier weights.
40-ft Carry Test: Carrying a weight and walking at least 40-feet in distance. It is expected that 
with improved functional capacity after FR, patients will be able to carry heavier weights over the 
40-feet distance.
7-to-1 Pyramid Test: The 7-1 pyramid is a functional physical assessment that consists of push-
ups, back extensions, rowers, squats, dips, and burpees.  The patient will begin with 7 repetitions 
of the listed exercises, then 6 repetitions of each exercise, and so on down to 1 repetition of each 
exercise.  The patient completes as many as possible in 10 minutes.  If the patient is able to get 
to 1 repetition of each exercise then the pyramid starts over with 8 repetitions of each exercise, 
then 7, and so on down to 1.  There are 3 specific modifications for each of the 6 different 
exercises.  If a patient is unable to complete the exercise in the specified way then the patient will 
be shown modification #1 and so on through modification #3 if necessary.  The patient is scored 
on total repetitions completed.
10.2   Data Collection:
Describe all the data variables, information to be collected, the source of the data, how the data will be 
operationally measured, and approvals needed for use of information from DoD databases
 
Table 8. Data Collection Variables
Variable
Data Source
Time points
Demographic data
DHA SDD, PASTOR
Baseline
Pain intensity
DVPRS (PASTOR)
 
 

 
 
 
 
 
 
 
 
 
 
Baseline, before and after SC; 
before and after FR; 3- and 6-
months post-FR
Physical function
Subscale of PROMIS Global Health 
(PASTOR)
Pain interference
PASTOR
Depression
PASTOR
Anxiety
PASTOR
Emotional distress-anger
PASTOR
Sleep disturbance
PASTOR
Fatigue
PASTOR
Patient-defined activity 
goal
PASTOR
PAM
PASTOR
DAST-10
PASTOR
PCS
PASTOR
TSK
PASTOR
PSEQ
PASTOR
CPAQ8
PASTOR
Current pain medications
PASTOR, CHCS
Morphine-equivalent 
dosage per day
DHA SDD
Current pain relief from 
medications
PASTOR
 
Functional measures
(floor-knuckle and floor-
shoulder lift tests, 40ft 
carry test, McNaughton 
treadmill test, 7-to-1 
Pyramid measures)
As measured by a physical 
therapist
  
Pain Intensity and PROMIS Measures
The individual validated scales and clinical screening tools in PASTOR are summarized in Table 3. Pain 
 will be rated on a 0 – 10 scale (0 = no pain, 10 = worst possible pain). All PROMIS measures 
intensity
are administered using computerized adaptive testing, thus ensuring a low response burden to the 
patient. The recall period is 7 days. The PROMIS 
 item bank specifically focuses not on 
pain interference
the more commonly measured pain intensity, but on pain interference, defined as interference of pain in 
daily activities involving physical, psychological, and social functioning. The PROMIS depressive 
 consist of items that address sadness, loss of interest, worthlessness, low self-esteem, 
symptoms
loneliness, and interpersonal alienation. The PROMIS 
 consists of an item bank that addresses 
anxiety
fearfulness, worry, and nervousness. The PROMIS 
 item bank assesses 
emotional distress – anger
angry mood, negative social cognitions, verbal aggression, and efforts to control anger. The PROMIS glob
 item pool assesses health in general. The global health items include global ratings of the five 
al health
primary PROMIS domains, physical function, fatigue, pain, emotional distress, social health, as well as 
perceptions of general health that cut across domains. The PROMIS 
 item bank 
sleep disturbance
assess perceptions of sleep quality, sleep depth, and restoration associated with sleep; perceived 
difficulties and concerns with getting to sleep or staying asleep; and perceptions of the adequacy of and 

satisfaction with sleep. The PROMIS 
 consists of items that address fatigue from mild subjective 
fatigue
feelings of tiredness to overwhelming and sustained sense of exhaustion. PASTOR also includes 11 items 
related to prior and current treatment modalities; 5 items asking about health care utilization and a 3 
item opioid utilization screener.
Supplemental Assessments
PASTOR also includes a battery of supplemental assessments that are relevant for screening and monitoring 
patient outcomes on several other domains of importance to patients enrolled in a functional restoration 
program. 
These measures are also summarized in Table 3 above. The Patient Activation Measure (PAM)
 is a 22-
 71
item survey on four stages of activation: (1) believing the patient role is important, (2) having the 
confidence and knowledge necessary to take action, (3) actually taking action to maintain and improve 
one's health, and (4) staying the course even under stress. The PAM demonstrates excellent reliability 
(Cronbach’s alpha = 0.91), and strong evidence for construct validity in differentiating health status by 
activation levels (r = 0.38, p < 0.01). The Drug Abuse Screen Test (DAST-10)
 is a short-form clinical 
72
screener for potential drug abuse and was initially developed based on the criteria for the Diagnostic and 
Statistical Manual for Mental Disorders (DSM III-R). The measure has excellent discriminant validity 
between patients with lifetime drug abuse disorders and those without the diagnosis (correctly classifies 
> 93% based on Receiver Operating Characteristic analysis). The Pain Catastrophizing Scale (PCS)
 is 
 73
a 13-item three-dimension survey of catastrophizing that include items measuring a patient’s tendency 
for (1) rumination, (2), magnification, and (3) helplessness. The PCS demonstrates excellent 
discriminant validity in context of both experimental pain and clinical pain, with higher PCS scores 
strongly correlated with negative pain-related thoughts, emotional distress, and greater perceived pain. 
The Tampa Scale for Kinesiophobia (TSK-11)
 is an 11-item survey assessing pain-related fear of 
74
physical activity in patients with back pain. The TSK-11 has good internal consistency (Cronbach’s 
alpha=0.79), test-retest reliability (ICC=0.81, SEM=2.54), and responsiveness (SRM=-1.11). The Pain 
Self-Efficacy Questionnaire (PSEQ)
 is a 10-item survey assessing patients’ self-efficacy beliefs with 
75
respect to their pain, and has excellent internal consistency (Cronbach’s alpha = 0.92), test-retest 
reliability (r = 0.73), and construct validity against other domains of health such as mental health, pain 
assessments, and coping behaviors. Lastly, the Chronic Pain Acceptance Questionnaire (CPAQ-8)
 is an 
76
8-item survey of (1) the degree to which patients engage in life activities regardless of pain (activity 
engagement), and (2) willingness to experience pain, or the inverse of engaging in behaviors to limit 
pain (pain willingness). The CPAQ-8 had good internal consistency (Cronbach’s alpha = 0.77 – 0.89) and 
demonstrated good construct validity against other domains of health such as depression, anxiety, pain 
interference and pain severity.  The reliabilities of the supplemental assessments will be applied for 
correction for attenuation in future analyses whenever applicable.
 
Authors’ approval to include the PCS, TSK11, PSEQ and CPAQ-8 assessment tools in PASTOR has been 
obtained and copies have been uploaded to IRBNet.  Author approval to use the PAM is pending.  If not 
received, this tool will be omitted from PASTOR.  A licensure agreement has been established for use of the 
DAST10 tool.
 
Standardized Army FR Outcomes. In February 2016, the Army Functional Restoration Workgroup met to 
decide on a standard set of outcome measures to be implemented in all Army FR programs.  In addition to 
the measures included in the original protocol, the workgroup determined that the Canadian Occupational 
Performance Measure, Rolland-Morris Disability Score and the 7-to-1 Pyramid Test would also be measured 
at each Army FR program.
 
Psychometric analysis of the minimal important difference for the Pain Impact Score. The NIH Taskforce on 
Standards for research on low back pain recommend measuring the pain impact score, a composite score 
which includes consideration of pain intensity, physical function and pain interference .  In 2016, Deyo, et al  
1
2
reported good psychometric performance of the PROMIS Pain Impact Score and suggested that the Pain 
Impact Score was a meaningful outcome measure for any musculoskeletal pain condition. Because PASTOR 
already collects the component measures of the pain impact score, the pain Impact Score was previously 
selected as the primary outcome measure for this study. 
 
In order to compute the number needed to treat to achieve benefit, the minimum important difference 
(MID) must be known.  The MID for the Pain Impact Score has not yet been empirically determined; 
however, it has been proposed that an improvement or worsening of 3 or greater is a reasonable 
estimate of the MID.   
2
 
The MID for other pain outcomes, such as pain intensity was empirically determined by asking the 
questions we propose to add to the questionnaire completed by study subjects at the completion of the 
functional restoration program.
  We propose to collect preliminary data during the remainder of this 
3,4
study to determine if a specific change in pain impact score correlates with different levels of subjective 

improvement or worsening.  This analysis will contribute to understanding of the minimum importance 
difference in the Pain Impact Score and will contribute to future research that uses the Pain Impact Score 
as an outcome measure.
Management of Collected Data
Data metrics from all surveys will be stored within data collection sheets which include: Bio-Forward Flex 
Tracker, COPM Database Tracker, Enrollment Log Tracker, Functional Measures Database Tracker, Pastor Plus 
Database Tracker, and a Pyramid Measures Tracker. Clinical research staff will maintain these data collection 
sheets with assistance from the IPMC medical providers who collect the data during study visits.
 
 
The PI will manage, maintain, and secure all study documents and materials. The PI as the primary 
control point, combined with a small supporting research team, will help protect against disclosure.
10.3  At any point in the study, will you request, use, or access PII from the Military Health System 
(MHS)?
 Yes   
 No
10.4  Have you consulted with an MHS data expert to determine the data elements to be extracted or the 
information system(s) to access? 
Consulting with a data expert often saves time later in the compliance process because the data expert 
can advise on the data available in the numerous MHS information systems, the quality of that data and 
the methods for encrypting and collapsing data.  To schedule a consult with an MHS data expert, send 
an email to: (
)
dha.ncr.pcl.mbx.privacyboard@mail.mil
Yes, then complete the questions below according to the data consult 
No, then complete the questions below according to the best of your knowledge (NOTE: It is highly 
recommended that you work with an MHS data expert) 
10.5  Indicate whether you plan to receive a data extract from the MHS or plan to access an information 
system directly to create a data set:
A data extract is when the MHS or a contractor provides the data set directly to the researcher.  When 
receiving a data set through data extract, the researcher may indicate whether the data elements should 
be provided as is, encrypted or collapsed.  In contrast to a data extract, access to an information system 
means that the researcher may directly access an MHS information system and create a data set for the 
research study
Data Extract
Access
10.6  Do you intend to use only de-identified data from the MHS in your research study?
There are different two methods for de-identifying data pursuant to HIPAA:
1) Safe Harbor Method: Removing all of the identifiers listed in Table 1 below, provided that the 
researcher does not have actual knowledge that the remaining data can be used alone or in combination 
with other information to identify the individual who is the subject of the information
2) Statistical Method: An expert, with appropriate knowledge of and experience with generally accepted 
statistical and scientific principles and methods for rendering information not individually identifiable, 
determines that the data is not individually identifiable
  Yes   
  No
10.7  If your research study requires access to an MHS information system, please indicate the system to 
obtain data:

If you do not know which system(s) contain the data elements you need, refer to the Guide for DoD 
Researchers on Using MHS Data or seek guidance from an MHS data expert:
 
PHI Systems:
MHS Information System
Requesting Data
: AHLTA
: Yes
: M2
: Yes
: PDTS
: Yes
PII-Only Systems:
MHS Information System
Requesting Data
De-Identified Data & Other Systems:
Information System
Requesting Data
Expense Assignment System
DHA Opioid Registry
: Yes
Army PASBA
: Yes
10.8  Do you intend to merge or otherwise associate the requested data with data from any sources 
outside of the MHS, including other DoD systems that are not part of the MHS?
Yes, will merge data  
No, will not merge data 
10.9  Indicate the categories of data that you will request from MHS systems or MHS health care 
providers about research participants or relatives, employers, or household members of the 
research participants.
Data Element(s)
MHS
Non-MHS Systems
1. Names
2. Postal address with only 
town, city, state and zip code
3. Postal address with all 
geographic subdivisions smaller 
than a state, including street 
address, city, county, precinct, 
zip code and their equivalent 
geocodes, except for the initial 
three digits of a zip code if, 
according to the current 
publicly available data from the 
Bureau of Census: 1) the 
geographic unit formed by 
combining all zip codes with the 
same three initial digits 

contains more than 20,000 
people; and 2) the initial three 
digits of a zip code for all such 
geographic units containing 
20,000 or fewer people is 
changed to 000
4. Dates including all elements 
(except year) directly related to 
an individual, including birth 
date, admission date, discharge 
date, and date of death
5. Ages over 89 and all 
elements of dates (including 
year) indicative of such age, 
unless you will only request a 
single category of “age 90 or 
older”
6. Telephone numbers
7. Fax numbers
8. Electronic mail addresses
9. Social Security numbers 
(SSNs)
10. Medical record numbers
11. Health plan beneficiary 
numbers
12. Account numbers
13. Certificate/license numbers
14. Vehicle identifiers and serial 
numbers, including license plate 
numbers
15. Device identifiers and serial 
numbers
16. Web Universal Resource 
Locators (URLs)
17. Internet Protocol (IP) 
address numbers
18. Biometric identifiers, 
including finger and voice prints

1.  
2.  
19. Full-face photographic 
images and any comparable 
images
20. Any other unique 
identifying number, 
characteristic, or code (DEERs 
ID, EDIPN, Rank)
If you are obtaining SSNs, provide a justification as to why and explain why a substitute cannot be used
10.10  Is it possible that the data will become identifiable because of triangulation, a small cell size, or 
any unique data element(s)?
Triangulation means using different data elements that are not themselves identifiable but that when 
combined can be used to identify an individual. For example, triangulation would be using rank and race 
together to determine the identity of an individual with a particular health condition
Small cell size means that there are only a small number of eligible individuals that satisfy the category 
description.  Guidance for acceptable cell size is available from the Centers for Medicare and Medicaid 
Services. For example, the rank category of four star generals with a particular diagnosis may be less 
than 30 so the rank category may need to be expanded to include lower ranks
A unique data element includes any unique features that are not explicitly enumerated in the categories 
of data in rows 1 – 19 of Table 1 above, but that could be used to identify an individual.  Examples of 
unique data elements include: 1) a unique number, such as a medical record number or EDIPN; 2) a 
unique code, such as a diagnosis code or a bar code on an electronic health record; and 3) any unique 
characteristic, such as the rank of general or admiral, or a race or gender combined with another unique 
characteristic
Yes, there is a reasonable possibility the data will become identifiable 
No, there is no reasonable possibility the data will become identifiable 
10.11  HIPAA Privacy Rule and Use of Protected Health Information in Research:
N/A – will not use or disclose protected health information (PHI) 
HIPAA Authorization will be obtained 
Use of a limited data set where a data use agreement will be obtained 
Waiver/alteration of HIPAA Authorization is being requested 
10.12  Managing Data (Data Management and/or Sharing Plan ) and/or Human Biological Specimens for 
this Study:
Include in this section the plan for acquiring data (both electronic and hard copy), access during the 
study, data/specimen storage and length of time stored, shipment/transmission, and the plan for 
storage and final disposition at the conclusion of the study. Describe any data agreements in place for 
accessing data within and/or outside of your institution (e.g., Data Sharing Agreement, Data Use 
Agreement, Business Agreements, etc.)
The following is an explanation of how study data will be managed.
Master Key.    Will include information on the name, date of birth and Social Security number for 
each study subject and documentation that each is a suitable study subject based on inclusion
/exclusion criteria. These data will be maintain in an excel spreadsheet on a secure, password-
protected server. 
Subject data sheets.  Will include each study subjects study ID number, their age, military rank, 
military occupational specialty (MOS), military unit, date consent obtained, result of 
randomization, starting and ending dates of participation in standard care, integrative modalities 
care and functional restoration and functional outcome measures (floor-knuckle lift test; knuckle-
shoulder lift test, 40-foot carry test and Naughton treadmill test).  Final data analysis of this de-
identified data will be done at the University of Washington.   

3.  
4.  
5.  
6.  
7.  
8.  
9.  
10.  
11.  
12.  
13.  
14.  
15.  
16.  
17.  
18.  
19.  
Informed consent forms.  Will be stored in a locked file cabinet at Madigan Army Medical Center 
(MAMC) in the office of the study administrative staff.
PASTOR data.  Study subjects will complete PASTOR electronic questionnaires periodically during 
the study period.  PASTOR is managed by the Army Analytics Group (AAG).  PASTOR data for 
study subjects will be transferred using AMRDEC to the Defense Health Agency Solution Delivery 
Division (DHA/SDD) to be merged with data compiled by DHA/SDD (and explained in #10 below). 
Patients will have access to their responses and the trends of those responses over time.  All 
Interdisciplinary Pain Management Clinic (IPMC) providers and primary care providers involved in 
the care of these patients will have access to PASTOR results.
Physical therapy functional measures.  Each patient will have pre- and post-intervention 
assessments by a physical therapist.  These data will be maintained on a secure, password-
protected server.  Physical Therapy (PT) measures are the standard of care for patients enrolled 
in the Functional Restoration (FR) Program and are available to the entire FR provider team.
Surface –EMG measures.  Each patient will have pre- and post-intervention surface 
electromyography assessments to measure muscle tension.  These measurements will be 
maintained on a secure, password-protected server. 
Opioid Dosage.  Opioid dosage and Risk Index of Serious Overdose or Respiration Depression 
(RIOSORD) score will be derived from the DHA Opioid Registry and recorded at baseline, at the 
conclusion of stage 2 treatment and 3 and 6 months post treatment.  These data will be compiled 
by the DHA/SDD through an approved data sharing agreement explained in #10 below.
Military Medical Readiness. Military medical readiness will be compiled from the Army Medical 
Protections System (MEDPROS) by the Defense Health Agency Clinical Support Program Solution 
Delivery Division through an approved data sharing agreement using the same process to be used 
for opioid dosage and explained in #10. 
Treatment hours.  Number of contact hours in the Interdisciplinary Pain Management Center for 
medical providers, physical therapy, occupational therapy, health psychology, chiropractic, 
acupuncture, yoga and massage, nurse case management, education as well as interventional 
procedures will be tracked from the baseline period through up to six months after completion of 
therapy.  These data will be compiled by the Defense Health Agency Clinical Support Program 
Solution Delivery Division through an approved data sharing agreement using the process to be 
used for opioid dosage and explained in #10.
Process for data sharing.  Data sharing agreements will be established between 1) the PI, DHA
/SDD and the University of Washington, as well as 2) the PI, PASBA, DHA/SDD and the University 
of Washington and will reflect the following process:
The MAMC PI will securely transfer to DHA/SDD a list of consented study subjects, including: 
name and EDIPN, randomization group, date of randomization and dates of study treatment start 
and completion.
The MAMC PI will also securely transfer to DHA/SDD outcome measures collected at MAMC 
including PASTOR and PASTOR Plus measures and Canadian Occupational Performance Measure.
PASBA will provide baseline and end-of-study military readiness status to DHA/SDD.
DHA/SDD will extract all requested data from applicable databases and merge with data provided 
by the PI and PASBA.
DHA/SDD will de-identify the merged data per HIPAA guidelines, assign pseudo-identifiers and 
securely transfer to the University of Washington researchers for analysis.
At the end of the study, the PI and the research team at the University of Washington will delete 
any data related to the study.
PASTOR, physical therapy, and surface EMG data will be accessible to IPMC’s providers involved in 
the care of each patient. PT measures are accessible to the entire FR clinical team.  Only research 
personnel and representatives of USAMRMC will have access subject data sheets and consent 
forms. 
Data Security Procedures for Transfer, Implementation, and Storage of Data:  All computers used 
to collect and send data during implementation of the study or to receive or store data at the 
central location will be password-protected. A password will be required to open Windows and a 
different password will be required to open the customized protocol software. Electronic 
information will be stored on the secure dedicated server with appropriate firewalls. Servers are 
scanned for viruses, and systems are in-place to detect attempts at unauthorized entry.
Data Transfer Procedures: Transfer of protocol data will occur by a secure data transfer site used 
by DHA/SDD. These data are stored on a dedicated server protected from viruses and 
unauthorized entry.

10.13  Managing Data (Data Management and/or Sharing Plan) and/or Human Biological Specimens for 
Future Research:
If the study involves collecting, storing, or banking human specimens, data, or documents (either by the 
Investigator or through an established repository) for FUTURE research, address. How the specimens
/data will be used, where and how data/specimens will be stored (including shipping procedures, storage 
plan, etc.), whether and how consent will be obtained, procedures that will fulfill subjects’ request as 
stated in the consent, whether subjects may withdraw their data/specimens from storage, whether and 
how subjects may be recontacted for future research and given the option to decline, whether there will 
be genetic testing on the specimens, who will have access to the data/specimens, and the linkage, the 
length of time that data/specimens will be stored and conditions under which data/specimens will be 
destroyed
Not applicable
11.0
 
Statistical/Data Analysis Plan
11.1  Statistical Considerations:
List the statistical methods to be used to address the primary and secondary objectives, specific aims, 
and/or research hypotheses.  Explain how missing data and outliers will be handled in the analysis.  The 
analysis plan should be consistent with the study objectives.  Include any sub-group analyses (e.g., 
gender or age group).  Specify statistical methods and variables for each analysis.  Describe how 
confounding variables will be controlled in the data analysis
The statistical methods that will be used for each study aim are explained in section 11.3.
 
Approach to Missing Data.
The amount of missing data will be first quantified where possible, and determined by the amount of 
missing data that occurs, three indirect tests of the mechanism of missingness will be explored: (1) 
baseline demographic characteristics of those who ever and never missed data by group allocation will be 
compared (an indirect test to rule out missing completely at random [MCAR]); (2) the difference 
between mean utility scores of participants with missing and non-missing data will also be compared (an 
additional indirect test to rule out MCAR) and (3) controlling for the probability of providing missing data, 
the mean scores of those that never and ever missed in intervention and control groups will be compared 
(an indirect test of missing not at random [MNAR]). While analysis using mixed models allows all 
observed data to be included in the analysis under the assumption that the data are MCAR, if substantial 
missing data occurs, multiple imputation or mean conditional imputation will be used with subsequent 
sensitivity analyses to explore the impact of imputation on results. To address the issue of artificially 
reduced estimates of stochastic uncertainty produced by imputation, bootstrapping procedures will be 
used on the entire imputation and estimation process.
 
 
11.2  Sample Size Estimation:
Estimated required sample size: 152
Estimated participant drop out + withdrawal: 28%
Total enrollment requirement: 210
Total MAMC enrollment: 210
11.3  Data Analysis Plan:
Primary (i.e., primary outcome variables) and secondary endpoints. The primary outcome endpoints are pain 
intensity and functional status as measured by the PASTOR questionnaire.  In addition, secondary predictors 
of outcomes measures will be evaluated, including demographic factors (age, military rank, household 
income, race), measures of pain interference, depression, anxiety, anger, sleep quality, fatigue, medical 
board status for disability, duration of pain-related disability, prescription opioid dosage and functional 
capacity tests for endurance and strength.  

 
Data analysis.
Aim 1: Evaluate the benefit of a program of multimodal integrative pain management 
therapies prior to an intensive functional restoration program, relative to standard 
care.
            
 Patients who complete an IM program prior to an FR program will demonstrate 
Hypothesis:
significantly greater improvements in pain and physical function going into the FR program, 
relative to standard care.  At post-FR, patients who completed an IM program prior to FR will 
demonstrate significantly improved outcomes on pain severity and physical function at discharge 
from the program and at 3-months post-FR, relative to standard care.
Analytical Technique: We will use a hierarchical linear model (HLM) for a cluster-randomized trial with 
time nested within patients.
 HLM affords an integrated approach to studying the structure and 
77
predictors of individual change, and provides the appropriate standard errors and correct statistical 
inferences for clustered data. HLM models allow the use of data from patients who are missing one or 
more observations, where the assumption holds that data are missing at random. Some patients will not 
follow the intervention protocol, either deliberately by not doing the intervention or due to extenuating 
circumstances that prevent their participation with the intervention protocol. We will use an intent-to-
treat analysis.
We will initially complete analyses without the inclusion of pre-randomization covariate information. In all 
analyses, the data will be examined for appropriateness of the statistical assumptions underlying fitted 
models (e.g., distribution of regression residuals, identification of multivariate outliers representing 
influential data points, tests for departures from linearity). The primary analysis will examine differences 
between the control and intervention groups’ outcome scores at the 3 month assessment point. To 
control for inflation of Type I error rates due to co-primary outcomes, alpha will be set to 0.025 for each 
test of the outcome variables. 
If recruitment targets are exceeded to a sufficient magnitude, secondary analyses of change in pain 
severity and physical function using responder analysis will also be performed.  When consensus on 
minimally important difference (MID) exists, that MID will be used to define response.  For PROMIS 
measures that do not have consensus MID measures, an improvement of one-half of one standard 
deviation on the PROMIS scale will be considered the minimally important difference for a positive 
response.  Responder analyses require higher sample sizes to detect statistically significant differences 
but are the preferred method of assessing treatment effect, and permit meaningful comparisons between 
randomized clinical trials. 78
Aim 2: Identify prognostic factors that predict successful outcomes on pain severity and 
function following intensive interdisciplinary functional restoration.
            In addition to IM vs standard care, secondary predictors of outcomes following FR will include 
baseline measures of: demographic variables (age, military rank, race, military occupation), 
pain characteristics (location, duration, character), psychosocial factors (depression, anxiety, 
anger); sleep quality and fatigue; medical board status for disability; duration of pain-related 
disability; prescription opioid dosage; and functional capacity tests for endurance and strength.
Analytical Technique: The co-primary outcomes for pain severity and physical function will be analyzed 
using a Sequential Multiple Regression model.
 The model will adjust for baseline measures of the co-
79
primary outcomes and pre-FR treatment groups, before assessing the relative importance of secondary 
outcomes measures (baseline measures of pain interference, depression, anxiety, anger, sleep quality, 
fatigue, medical board status for disability, duration of pain-related disability, prescription opioid dosage, 
and functional capacity tests for endurance and strength). Relative importance of predictors among these 
secondary outcomes will be reported by their respective regression beta weight coefficients. To control 
for inflation of Type I error rates due to co-primary outcomes, alpha will be set to 0.025 for each test of 
the outcome variables in their respective regression models.
 
Aim 3: Evaluate the relationship between legacy paper questionnaires included in the PASTOR-plus packet 
with PASTOR submeasures.
 
We will compare legacy paper questionnaires completed by study subjects which include the 
Tampa Kinesiophobia Questionnaire, Patient Activation Measure, Pain Self-Efficacy Questionnaire, 
Chronic Pain Acceptance Questionnaire and Roland-Morris Disability Questionnaire, and Pain 
Catastrophizing Scale with PROMIS measures included in the electronic PASTOR assessment, 
including pain interference, depression, anxiety, anger, and physical function.  This will determine 
if there are legacy questionnaires with prognostic value which should be added to PASTOR.
 
 

Analytical Technique: We will use correlation analysis to determine the relationship between 
legacy paper questionnaires and PASTOR submeasures.
 
Aim 4: Evaluate the relationship between self-reported physical function (from PASTOR) and 
clinician-supervised tests of physical function, such as exercise treadmill test at all 
.
timepoints
 
We will compare self-reported physical function with clinician-supervised tests of physical function 
to determine if PASTOR respondents over or under-estimate their physical capacity.
 
 
Analytical Technique: We will use correlation analysis to explore the relationship between self- 
report and clinician supervised tests of physical function.  
 
 
Aim 5: Determine whether outcomes differ between the subgroup of participants who 
completed FR program 4 days per week x 3 weeks vs 2 days per week x 6 weeks.
 
During the course of the study, a protocol modification was approved to allow subjects to 
participate in the FR program with an extended 2 days per week over 6 week schedule with the 
same number of treatment hours as the original 4 days per week for 3 weeks.  We will evaluate 
outcomes in both groups to determine if one treatment approach yielded superior outcomes to 
the other.
 
Analytical Technique: We will use a Sequential Multiple Regression model.
 We will assess the 
79
relative importance of the FR delivery method (either 4 days per week x 3 weeks vs. 2 days per 
week x 6 weeks  controlling for treatment group on our primary outcomes of pain and physical 
function as well as on the secondary outcomes measures (depression, anxiety, anger, sleep 
quality, fatigue, medical board status for disability, duration of pain-related disability, prescription 
opioid dosage, and functional capacity tests for endurance and strength).
 
Aim 6: Compare outcome measures collected within narrow timelines to those collected within 
flexible timelines.
 
We attempted to collect outcome measures at the following timepoints: 1) within one month 
before starting treatment; 2) within the last day of pre-FR stage through the first day of FR stage; 
3) on the last day of FR; 4) 3- and 5) 6- months after the end of FR.  However, this precise 
collection schedule was not always possible.  For example, baseline measures were collected more 
than one month before the start of treatment for study subjects who had conflicts such as military 
training exercises, personal or family illness or planned leisure travel which postponed the start of 
study treatment.  Collection of follow-up measures was sometimes earlier or later than desired 
when study subjects with conflicts were unavailable at the time outcomes were requested.  We 
plan to compare outcomes collected within the above timeframes with those collected within 
timeframes with modest and moderate flexibility as outlined in the following table. This analysis 
will inform the design of future pragmatic clinical trials in determining acceptable timeline 
parameters for collection of pain outcomes.
 
 
Baseline
End of pre-
FR stage
End of FR 
stage
Short-term
Intermediate-
term
Narrow 
timelines
w/in 1 month 
of treatment 
start
Last day of 
pre-FR up 
to  start of FR
Last day of FR
3 months 
after end of FR
6 months after 
end of FR
Modest 
flexibility
w/in 2 months 
of treatment 
start
< 2 treatment 
days 
before  end of 
pre-FR, 
through
2 
 <
treatment 
days after 
start of FR
< 2 treatment 
days 
before  end of 
FR, through <
7  calendar 
days after end 
of FR
2-4 months 
after end of FR
5-7 months 
after end of FR
Moderate 
flexibility
w/in 3 months 
of treatment 
start thru 2 
days after 
treatment 
start
<2 treatment 
days 
before  end of 
pre-FR, 
through
4 
 <
treatment 
days after 
start of FR
< 2 treatment 
days 
before  end of 
FR, through 
  calendar 
<30
days after end 
of FR
1-<5 months 
after end of FR
6-9 months 
after end of FR

 
 
Analytical Technique:  We will use a Sequential Multiple Regression model.
 We will assess the 
79
relative importance of the timing of assessments on our primary outcomes of pain and physical 
function as well as on the secondary outcomes measures (pain interference, depression, anxiety, 
anger, sleep quality, fatigue, medical board status for disability, duration of pain-related 
disability, prescription opioid dosage, and functional capacity tests for endurance and 
strength).  We will code an indicator variable to document every observation that occurs within 
the narrow timeline.  We will use an interaction term of this indicator with the intervention to see 
if the intervention shows a differential effect for those who adhere to the narrow assessment 
timelines.
 
Aim 7: Determine if patient activation, pain catastrophizing, self-efficacy or pain acceptance 
moderate or mediates pain and function outcomes.
 
We will determine if level of patient activation, catastrophizing, self-efficacy and pain acceptance 
as measured by legacy questionnaires completed by study subjects have an impact on pain and 
functional outcomes.
 
 
Analytical Technique: We will using a multiple linear regression approach to determine the roles 
of patient activation, pain catastrophizing, self-efficacy, and pain acceptance with regard to the 
intervention outcomes.  Baron and Kenny
 described mediation and moderation testing and their 
86
work has been developed further by methodologists.  We will use Hayes’ conditional process tools8
 to test if patient activation, pain catastrophizing, self-efficacy, and pain acceptance are affected 
7
by the intervention and help explain the outcomes, that is, if they are a mechanism for how the 
intervention helps people (mediation).  We will compare models with and without the mediating 
variables and partition the total effect of the intervention into indirect effects due to impact on 
hypothesized mediators and the remaining direct effects.  Using interaction terms, we will also 
examine if these variables may moderate the relationship of the intervention on the outcomes, 
helping explain who is responding best to the intervention.  This approach can be extended to 
determine if how the intervention works differs by participant characteristics, that is moderated 
mediation.
12.0
 
Participant Information
12.1  Subject Population:
Active duty service members with chronic pain
12.2  Age Range:
0-17
18-24
25-34
35-44
45-54
55-64
65-74
75+
12.3  Gender:
Male
Female
12.4  Special categories:

1.  
2.  
3.  
Minors /Children - “You must also consider the requirements of 45 CFR 46 Subpart D and DoDI 
3216.02, Enclosure 3, paragraph 7.d.”
Students
Employees - Civilian - “You must also consider the requirements of DoDI 3216.02, paragraph 7.e.”
Employees - Contractor
Resident/trainee
Cadets /Midshipmen - “You must also consider the requirements of DoDI 3216.02, Enclosure 3, 
paragraphs 7.e. and 12.”
Active Duty Military Personnel - “You must also consider the requirements of DoDI 3216.02, Enclosure 
3, paragraph 7.e.”
Wounded Warriors - “Depending on your intended subjects’ status, you may also need to consider the 
requirements of DoDI 3216.02, Enclosure 3, paragraph 7.e.”
Economically Disadvantaged Persons - “You must also consider the requirements of 32 CFR 219.111
(b).”
Educationally Disadvantaged Persons - “You must also consider the requirements of 32 CFR 219.111
(b).”
Physically Challenged (Physical challenges include visual and/or auditory impairment)
Persons with Impaired Decisional Capacity - “You must also consider the requirements of 10 USC 
980.”
Prisoners - “You must also consider the requirements of 45 CFR 46 Subpart C and DoDI 3216.02, 
Enclosure 3, paragraphs 7.b. and 7.c.”
Pregnant Women, Fetuses, and Neonates
Non-English Speakers
International Research involving Foreign Nationals - Headquarters Review is necessary
12.5  Inclusion Criteria:
Order 
Number
Criteria
1 
Significant functional impairment due to pain, requiring modification of military duties.
 
2 
Physically able to participate in up to four hours of physical activity (strength, flexibility, 
endurance training) per day:
Can stand up from and sit down on floor independently
Can complete at least 6 minutes of Naughton Treadmill Protocol. .
Able to complete at least 2 of the following:
-Lift 20 lbs from floor to knuckle height.
-Lift 20 lbs from floor to shoulder height.
-Carry 20 lbs at least 40 feet.
 
3 
Inadequate response to previous less intensive treatment
 
4 
Expresses motivation to take active role in regaining function
 
12.6  Exclusion Criteria:
Order 
Number
Criteria
1 
Major surgeries within past 6 months or planned within next 6 months.
 
2 
Unstable psychological disorders
 

3 
Active substance use disorder
 
4 
High dose opioids of ≥90 milligrams of morphine equivalent doses (MED)/day
 
5 
In the Medical Evaluation Board process and without defined availability for any treatment 
scheduling
 
13.0
 
Recruitment and Consent
13.1  Identification and Selection of Subjects:
Subjects will be selected from among the patients referred to the IPMC for whom an IPMC physician recommends 
participation in FR and who are determined by an IPMC physical therapist to meet minimal standards of physical 
function required for successfully FR participation.
13.2  Recruitment Process:
Study participants will be recruited from the population of patients who are referred to the Madigan 
Interdisciplinary Pain Management Center and who are determined by the treating physician to be a 
candidate for the FR program.  If the patient is willing to commit to this intensive treatment approach, he/she 
will be evaluated by a physical therapist to determine if he/she has the physical stamina to successfully 
participate in FR.  If so, his/her commanding officer will be contacted by a nurse case manager and asked to 
approve the patient’s absence from work as needed for the six-week program.  Any patients who receive 
approval from their commanding officer to participate in FR will be considered for inclusion in the study. 
13.3  Compensation for Participation:
No compensation for study
13.4  Eligibility Assessment Process:
A partial HIPAA waiver of authorization will be requested to allow the research coordinator or research 
assistant to perform a prescreen of medical records of potential subjects to determine if they have any 
excluding conditions.
13.5  Consent Process:
Are you requesting a waiver or alteration of informed consent?
 Yes   
 No
What type?
Waiver of documentation of informed consent
Waiver or alteration of informed consent
Please explain why you qualify for a waiver or alteration of informed consent:
Waiver is requested to determine if subjects are eligible for participation.  Eligible patients interestedin 
participation will undergo informed consent.
Please explain the consent process:

Following the prescreen process, any potential subjects will meet with the research coordinator or 
research assistant who will explain the study and request that the patient participate.  Patients who 
express an interest in participating will be consented.    Patients who decline to participate in the study 
will be given the option of proceeding with the integrative modalities program and/or the functional 
restoration program as recommended by their physician. 
Research staff will approach eligible patients during an out-patient IPMC visit or by telephone, explain 
the study and answer questions about the study (refer to Enrollment Script). If the patient express 
willingness to participate in the study at the time of this discussion, they will be consented. If eligible 
patients do not decline participation but request more time to consider participation, the research staff 
will re-contact them within 1 week of the initial contact to enable them to consent or decline.  Eligible 
patients who decline study participation will be asked to share reasons for refusal., A confidential list of 
patients who have been approached but who are not enrolled in the study will be maintained by the 
research staff to ensure that no patient is approached more than once. A HIPAA waiver of authorization 
is requested for the creation and maintenance of this list, as it poses minimal risk to patient privacy and 
is essential to ensure that patients do not perceive coercion to participate in the study. The number of 
eligible patients, those approached, enrolled, and the reasons for refusal, will be recorded.
13.6  DoDI 3216.02 requires an ombudsman to be present during recruitment briefings when research 
involves greater than minimal risk and recruitment of Service members occurs in a group setting. If 
applicable, you may nominate an individual to serve as the ombudsman.
N/A 
Propose ombudsman 
13.7  Withdrawal from Study Participation:
Explain the process for withdrawal and specify whether or not the subjects will be given the opportunity 
to withdraw their data their data/specimens in the event they wish to withdraw from the study
Participants may elect to discontinuation participation in the study at any time.  This decision will not 
affect their eligibility to continue the integrative modalities program or functional restoration program.  If 
they elect to discontinue participation in the integrative modalities (IM) and/or functional restoration (FR) 
program, they will be offered other appropriate therapies offered in the IPMC, such as medication 
management and/or interventional pain therapies.  On rare occasions patients in the IM program or FR 
program are disenrolled from the program by the clinical team.  Reasons include repetitive missed 
appointments and/or behavior that is disruptive to the treatment group.  Patients demonstrating these 
behaviors are counseled and given the opportunity to engage more effectively in treatment prior to 
disenrollment.
14.0
 
Risks and Benefits
14.1  
Risks of Harm:
Identify all research-related risks of harm to which the subject will be exposed for each research 
procedure or intervention as a result of participation in this study.  Consider the risks of breach of 
confidentiality, psychological, legal, social, and economic risks as well as physical risks.  Do not describe 
risks from standard care procedures; only describe risks from procedures done for research purposes
Risks:  Participation in this research study will involve treatment with physical and occupational therapy, 
acupuncture, chiropractic, yoga with or without medical massage and biofeedback.  All of these 
modalities are low risk treatments, and these risks will be explained to potential subjects during the 
informed consent process. 
 

Psychological distress: It is possible that some participants will experience psychological distress during 
pain therapies.  This risk will be mitigated by attempting to make the therapies as comfortable as 
possible for each participant. It is not anticipated, but in the event any psychological/emotional distress 
occurs, the PI will stop the therapy, and soothe, calm, and assist the participant in regaining control 
before the therapy continues.  In the event that this is not effective, the PI will refer the participant to 
the appropriate primary care provider or a health care professional at Madigan Army Medical Center.
Loss of Confidentiality:  This risk will be mitigated using several precautions discussed in Confidentiality 
of Research Data.
14.2  
Measures to Minimize Risks of Harm (Precautions, safeguards):
For each research procedure or intervention, describe all measures to minimize and/or eliminate risk of 
harms to subjects and study personnel
The therapeutic approach to treatment modalities will be adjusted as needed based on each patient’s 
response to therapy.  For example, if one chiropractic technique increases pain, other techniques will be 
employed to improve response. While mild muscle soreness is common in FR programs, it is unlikely that 
injury will occur.  If acute injuries do occur, the patients will be managed by IPMC medical staff or their 
primary care team within MAMC at no cost to the study participant. 
 
This risk of psychological distress will be mitigated by attempting to make the therapies as comfortable 
as possible for each participant. It is not anticipated, but in the event any psychological/emotional 
distress occurs, the PI will stop the therapy, and soothe, calm, and assist the participant in regaining 
control before the therapy continues.  In the event that this is not effective, the PI will refer the 
participant to the appropriate primary care provider or a health care professional at Madigan Army 
Medical Center.
The risk of loss of confidentiality will be mitigated using several precautions discussed in Confidentiality 
of Research Data.
14.3  
Confidentiality Protections (for research records, data and/or specimens):
Describe in detail the plan to maintain confidentiality of the research data, specimens, and records 
throughout the study and at its conclusion (e.g., destruction, long term storage, or banking). Explain the 
plan for securing the data (e.g., use of passwords, encryption, secure servers, firewalls, and other 
appropriate methods). If data will be shared electronically with other team members/collaborators 
outside the institution, describe the method of transmission and safeguards to maintain confidentiality. 
Explain whether this study may collect information that State or Federal law requires to be reported to 
other officials or ethically requires action, e.g., child or spouse abuse
Confidentiality of the Data.
Complete confidentiality cannot be promised, particularly for military personnel, because information 
bearing on health or illegal activities may be required to be reported to appropriate medical or command 
authorities.
 
The research records may be looked at by staff from Madigan Army Medical Center’s Department of 
Clinical Investigation and the Institutional Review Boards (IRB) of Madigan Army Medical Center. The 
records may be looked at by staff from the Army Clinical Investigation Regulatory Office (CIRO), Army 
Human Research Protections Office (AHRPO), the study sponsor, and other government agencies that 
provide oversight for human subject protection as part of their duties.
All identifying information will be excluded and/or removed from study documents to the greatest extent 
possible. Each individual screened for participation will be assigned a unique study identification 
number.  The study identification number links the individual to study documents and will be used to 

help prevent disclosure of identifiable personal information. Study identification numbers will be 
maintained by the PI on a master list that will be stored separately from other study documents in a 
locked cabinet.
 
Study documents will be stored in locked cabinets and on secure servers. Study documents in use will be 
managed on password protected computers with password protected storage devices with documents 
and files that do not contain identifiers.
 
Database and master list will be stored on a password protected secure computer in the research 
coordinator’s office. Master list will also be stored on password protected Excel spreadsheet, accessible 
only to research coordinator, research assistant and PI. Master list will not leave Madigan. The de-
identified data will only be shared among the PI, AI, and the collaborators of this study. Only the PI, 
research coordinator, research assistant, and clinical staff involved in study visits will have access to 
forms containing PHI, these forms will be stored in a locked file cabinet in the research office and will not 
leave Madigan. PASTOR Data will be kept on a secure server. All data will be de-identified before being 
transferred to an electronic database at the University of Washington, on the 14
 floor of the Health 
th
Sciences Building for analysis. Data will be transferred via secure methods, and subject data will not be 
linked to other databases. Only authorized persons actively involved in conducting the study, monitoring 
safety and evaluating study results will have access to the records.
 
The following data types will be compiled by the Defense Health Agency Clinical Support Programs 
Solution Delivery Division (DHA/SDD) through an approved data sharing agreement.    The process for 
data management and de-identification of these data is explained in the data management section.
Demographic information for study subjects
Prescription data
Opioid dosage and associated risk of serious respiratory depression as reported in the Defense 
Health Agency Opioid Registry
Military medical readiness as reported in the Army Medical Protection System (MEDPROS)
Number of clinical encounters and number and type of interventional procedures which each 
subject underwent in the Madigan Interdisciplinary Pain Management Center during the study 
period
Diagnosis codes
 
Once data collection is complete, the master list will be destroyed.
The PI will manage, maintain, and secure all study documents and materials. The PI as the primary 
control point, combined with a small supporting research team, will help protect against disclosure.
14.4  
Potential Benefits:
Describe any real and potential benefits of the research to the subject and any potential benefits to a 
specific community or society
If the individuals in the research are considered experimental subjects (per 10 USC 980), and they 
cannot provide their own consent, the protocol must describe the intent to directly benefit all subjects
For us as a nation to continue achieving health care advances that enhance the health of military service 
members and promote a fit and ready force, it is important that service members be able to participate 
in ethically sound research. These health advances are also important for society in general.  Military 
health care research is often found to be relevant to civilian health care, particularly in the management 
of pain and trauma.  The potential benefits of participation in these treatment modalities include pain 
relief, improved functional improvements and improved mood. As the risks for the proposed study are 
minimal, the potential benefits outweigh the risks.

14.5  
Privacy for Subjects:
Describe the measures to protect subject’s privacy during recruitment, the consent process, and all 
research activities, etc.
Prospective study subjects will be informed about the study in a private area of the clinic or by telephone 
from the research staff office.  A Request for Partial Waiver of HIPAA Authorization for Recruitment will be 
requested to permit the research assistant or research coordinator to review potential subjects’ medical 
records to ensure there are no disqualifying conditions, such as impending surgery or unstable psychological 
status.  This review of medical records is required for all FR participants, regardless of study participation 
status.  Baseline and outcomes data that will be collected from study participants are the same data that are 
collected from all IPMC patients who participate in the functional restoration (FR) program, regardless of 
status of research project participation and are used to guide therapy.  The IPMC has been using these or 
similar measures since the FR program started in 2013.  Measures to ensure confidentiality are discussed in 
section 7.3.3.
14.6  
Incidental or Unexpected Findings:
Describe the plan to address incidental findings and unexpected findings about individuals from 
screening to the end of the subject’s participation in the research. In cases where the subject could 
possibly benefit medically or otherwise from the information, state whether or not the results of 
screening, research participation, research tests, etc., will be shared with subjects or their primary care 
provider. State whether the researcher is obligated or mandated to report results to appropriate military 
or civilian authorities and explain the potential impact on the subject
The study is low-risk; therefore we do not anticipate any serious adverse events.
The most likely adverse event associated with participation in this study is mild-self-limited muscular 
soreness in the initial days of functional restoration, as each participant begins the reconditioning 
process.   This is anticipated to occur in 75% of participants and to resolve within one week of onset.  These 
complaints will be addressed and managed by the IPMC physical and occupational therapy teams. 
This intervention qualifies as a Phase II clinical trial. We have developed a data and safety monitoring plan, 
which is outlined below.  The plan includes routine monitoring of adverse events by the PI and study staff.
Monitoring study safety. Study safety will be monitored quarterly and includes auditing a random 
selection of 5% of cases for compliance with IRB requirements, conformance with informed consent 
requirements, verification of source documents and investigator compliance. Conference calls or in-
person meetings are scheduled quarterly or on an as-needed basis with all data collectors and providers 
to review protocol and possible study safety issues. Booster sessions on administering the protocols will 
be given if needed. Each study team member will also receive a personal performance update with 
comments on protocol adherence and completeness of data. All violations of protocol are noted.
 
Identification of Adverse Events. Dr. Flynn will be responsible for monitoring the internal review of 
adverse events.  Adverse events will be identified by either intervention facilitators or study staff and 
reported to either Dr. Flynn within 72 hours of occurrence, who will determine whether the event qualifies for 
reporting to the IRB.
To help ensure consistency in reporting, adverse events and safety alerts will be tracked using a 
standardized form that records the date of the event, attribution of the event (e.g., intervention-related 
or external situation, such as a death in the family), resolution of the event (whether resolved or 
controlled), and date of resolution.
The format of the form was validated during our previous work and is shown in Table 1.
Table 1: Adverse Event Reporting Form with Sample Text Entries
Event
Date
Severity
Attribution
Operational 
definition
Resolution

1.  
2.  
3.  
4.  
Sample entry:
Suicidal 
behavior
XXX
Serious
Not 
intervention-
related/ 
assessed at 
baseline
Any risk or 
attempt to 
inflict 
serious 
bodily harm 
to self that 
may result 
in death
-Referral to 
mental 
health 
practitioner
-Event is 
ultimately 
resolved 
when the 
mental 
health 
practitioner 
determines 
that there is 
no further 
risk
 
In handling adverse events, project staff will follow the general principles devised for developing a safety 
plan for behavioral trials. Namely:
Adverse events queries should include domains plausibly affected by the interventions being 
tested. A primary question in defining adverse events in behavioral trials pertains to potential 
risks or negative events that can occur as a result of a specific intervention or of study 
procedures. Behavioral intervention research needs to also address behavioral, psychological, 
legal, economic, and social events, as these domains could be affected by the intervention being 
tested. To understand the adverse events or unexpected problems that can occur as a result of a 
behavioral intervention, it is important to monitor what the process of change will entail. These 
changes can be inherent to the mechanism of action of intervention under study. For example, 
addressing one’s fears or challenging false beliefs may increase the risk of suicidal thoughts or 
behavior. The research team will keep detailed field notes about each visit and phone call.
Monitoring should attempt to assess relationships between intervention and adverse events.
Systematic monitoring is essential to identifying unexpected events. In addition to immediately 
addressing a potential adverse event, the research team will discuss all active cases in depth 
during the weekly research team meetings, and any potential adverse events, safety alerts, or 
other concerns will also be discussed.
Effective monitoring is a shared responsibility that includes multiple stakeholders, namely the 
research team, the Advisory Committee, and the IRBs.
 
All events will be discussed on a monthly basis during research team meetings, and any adjustments to the 
intervention or study protocol will be negotiated and agreed upon by the team.
15.0
 
Study Monitoring
15.1  Data Monitoring Plan:
Describe the plan to monitor the data to verify that data are collected and analyzed as specified in the 
protocol. Include who will conduct the monitoring, what will be monitored and the frequency of 
monitoring
Study safety will be monitored quarterly and includes auditing a random selection of 5% of cases for 
compliance with IRB requirements, conformance with informed consent requirements, verification of 
source documents and investigator compliance. Conference calls or in-person meetings are scheduled 
quarterly or on an as-needed basis with all data collectors and providers to review protocol and possible 
study safety issues. Booster sessions on administering the protocols will be given if needed. Each study 
team member will also receive a personal performance update with comments on protocol adherence and 
completeness of data. All violations of protocol are noted.

15.2  Safety Monitoring Plan:
Describe the plan to monitor the data to ensure the safety of subjects
Study safety will be monitored quarterly and includes auditing a random selection of 5% of cases for 
compliance with IRB requirements, conformance with informed consent requirements, verification of 
source documents and investigator compliance. Conference calls or in-person meetings are scheduled 
quarterly or on an as-needed basis with all data collectors and providers to review protocol and possible 
study safety issues. Booster sessions on administering the protocols will be given if needed. Each study 
team member will also receive a personal performance update with comments on protocol adherence and 
completeness of data. All violations of protocol are noted.
15.3  Does your study require independent data and safety monitoring?
  Yes   
  No
16.0
 
Reportable Events
16.1  Reportable Events:
Consult with the research office at your institution to ensure requirements are met
• Describe plans for reporting expected adverse events. Identify what the expected adverse events will 
be for this study, describe the likelihood (frequency, severity, reversibility, short term management and 
any long term implications of each expected event)
• Describe plans for reporting unexpected adverse events and unanticipated problems. Address how 
unexpected adverse events will be identified, who will report, how often adverse events and 
unanticipated problems will be reviewed to determine if any changes to the research protocol or consent 
form are needed and the scale that will be used to grade the severity of the adverse event
All unanticipated problems involving risk to subjects or others and all serious adverse events 
or subject deaths related to the research will be reported within 48 hours of the research 
team’s knowledge of the event to the MTF IRB.  Submission of a complete written report in 
IRBNet will follow the initial notification within 10 working days.
17.0
 
Equipment/non-FDA Regulated Devices
17.1  Does the study involve the use of any unique non-medical devices/equipment?
  Yes   
  No
18.0
 
FDA-Regulated Products
18.1  Will any drugs , dietary supplements, biologics, or devices be utilized in this study?
Drugs
Dietary Supplements
Biologics
Devices
N/A

1.  
2.  
3.  
4.  
5.  
6.  
7.  
8.  
9.  
18.5  Sponsor (organization/institution/company):
N/A
If applicable, provide sponsor contact information:
19.0
 
Research Registration Requirements
19.1  ClinicalTrials.gov Registration:
Registration is not required 
Registration pending 
Registration complete 
19.2  Defense Technical Information Center Registration (Optional):
Registration is not required 
Registration pending 
Registration complete 
20.0
 
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20.2  Abbreviations and Acronyms:
AAG – Army Analytics Group
DHA – Defense Health Agency
EIDS – Enterprise Intelligence and Data Solutions
IPMC – Interdisciplinary Pain Management Center
M2 – Military Health System Mart
MAMC – Madigan Army Medical Center
MODS – Military Operational Data Systems
REACH program – 
stor tion through omplementary and Integrative 
ealth – interdisciplinary 
Re
A
C
H
program comprised of twice weekly chiropractic, acupuncture, yoga, massage and health psychology
SCOUT program – tandard are 
patient program - interdisciplinary program comprised of twice 
S
C
OUT
weekly physical therapy, occupational therapy and health psychology
SDD – Solution Delivery Division
UW – University of Washington
 

DEPARTMENT OF THE ARMY
REGIONAL HEALTH COMMAND-PACIFIC
INSTITUTIONAL REVIEW BOARD
9040 JACKSON AVENUE
TACOMA WA  98431-1100
MCHJ-CLI                                                                                            17 January 2018
MEMORANDUM FOR DIANE MCFADDEN FLYNN, MD - Madigan Army Medical 
Center (MAMC)
SUBJECT:  RHC-P IRB Office Acknowledgement of Research Project “Enhancing the 
Success of Functional Restoration Using Integrative Therapies: Comparative 
Effectiveness Analysis in Active Duty Service Members With Chronic Pain” 
PROTOCOL #215050
1. The subject EIRB protocol application has been reviewed by the Regional Health
Command-Pacific IRB Support Office.
2. This project retains the expiration date of 25 April 2018. In accordance with 32
CFR 219.109(e) the project must be reviewed for continuation by the RHC-P IRB by this
expiration date; reminders will be sent at 90, 60 and 30 days prior to this date.
3. The IRB point of contact for this review is the undersigned; 253-968-3524 or
Athena.m.rayner.civ@mail.mil.
Athena Rayner
IRB Manager
Regional Health Command-Pacific IRB