Care Outcomes for Chiropractic Outpatient Veterans Aim 3-pilot Trial
Phase: NA
Conditions: Low Back Pain, PTSD, Depression, Anxiety
Sponsor: Palmer College of Chiropractic

 
1 
 
 
Care Outcomes for Chiropractic Outpatient Veterans 
(COCOV): Clinical Trial Study Protocol 
 
 
 
 
Principal Investigators: 
 
Thad Abrams, MD, MS, Site Principal Investigator 
Iowa City Veterans Affairs Health Care System (ICVHCS) 
 
Christine Goertz, DC, PhD, Co-Principal Investigator 
Spine Institute for Quality 
 
Cynthia Long, PhD, Co-Principal Investigator 
Palmer Center for Chiropractic Research 
 
 
 
Supported by: 
 
National Institutes for Health -  
National Center for Complementary and Integrative Health 
CLINICAL TRIAL PLANNING GRANT (R34AT008427) 
Grant Title: Collaborative Care for Veterans with Spine Pain and Mental Health Conditions  
 
 
 
 
 
 
 
 
 

 
2 
     Tool Revision History 
Version Number: 9 
Version Date: 01 August 2018 
Summary of Revisions Made:  
V2 
-Added terminology to reinforce this is a pilot study; bolded appendix call-outs to alert 
reader to additional information. 
-Updated language of inclusion criteria 
-Updated data analysis information 
V3 
-Added Yale Center for Medical Informatics (YCMI) to Participating Study Sites 
 
-Updated sections 10.1 & 10.2 
 
-Added Carrie Franciscus to Support Personnel 
V4 
-All participants (not 15%) will be given exit interview 
 
-Providers will also be asked to complete an exit interview 
V5 
-Added Amy Minkalis, Elissa Twist, Greg Boyer, and Tracy Szabo to Support Personnel 
 
-Removed Julie Hartman from Support Personnel 
 
-Changed communication with participants from MyHealtheVet to REDCap 
V7 
-Page 7 – addition of study coordinator to PM job title 
 
-Page 8 – change of job title for Elissa Twist to assistant study coordinator 
 
-Page 9 – removal of Greg Boyer from research team 
-Page 15 – Section 4.1: 4th bullet clarifies inclusion criteria for the 75% who will have a 
mental health condition 
-Page 16 – Section 4.2: Clarification of cut-points for mental health screening tools and 
procedure if participant answers showing signs of suicidal ideation. 
-Page 17 – Section 4.3: Clarification for use of patient information 
-Page 18 – Section 4.3: Clarification of recruitment from chiropractic schedule 
-Page 24 – Section 6.2: Information on back-up study coordinator  
-Page 36 – Section 10.3.2: Steering committee responsibilities clarified 
-Page 38 – Section 11.3: Language added for use of study issued mobile device 
V8 
-removal of the 4 age cohorts to one single cohort of 40 participants 18+ 
V9 
-rewording of roles on title page 
-Page 27 – Section 6.2.2: addition of backup study coordinator to be trained and able to 
complete exit interviews. 
 
 
 

 
3 
TABLE OF CONTENTS 
Page 
FULL PROTOCOL TITLE ............................................................................................... 1 
Tool Revision History ...................................................................................................... 2 
TABLE OF CONTENTS .................................................................................................. 3 
STUDY TEAM ROSTER .............................................................................................. 6 
PARTICIPATING STUDY SITES ............................................................................... 10 
PRÉCIS ..................................................................................................................... 11 
1. STUDY OBJECTIVES .............................................................................................. 12 
1.1 
Primary Objective ............................................................................................ 12 
1.2 
Secondary Objectives ..................................................................................... 12 
2. BACKGROUND AND RATIONALE ......................................................................... 12 
2.1 
Background on Condition, Disease, or Other Primary Study Focus ................ 12 
2.2 
Study Rationale ............................................................................................... 13 
3. STUDY DESIGN ....................................................................................................... 14 
4. SELECTION AND ENROLLMENT OF PARTICIPANTS .......................................... 15 
4.1 
Inclusion Criteria ............................................................................................. 15 
4.2 
Exclusion Criteria ............................................................................................ 15 
4.3 
Study Enrollment Procedures ......................................................................... 16 
5. STUDY INTERVENTIONS ........................................................................................ 19 
5.1 
Interventions, Administration, and Duration .................................................... 19 
5.2 
Handling of Study Interventions ...................................................................... 20 
5.3 
Concomitant Interventions .............................................................................. 20 
5.3.1 Allowed Interventions .................................................................................. 20 
5.3.2 Required Interventions ................................................................................ 20 
5.3.3 Prohibited Interventions ............................................................................. 211 
5.4 
Adherence Assessment .................................................................................. 21 
6. STUDY PROCEDURES ............................................................................................ 22 
6.1 
Schedule of Evaluations ................................................................................. 22 
6.2 
Description of Evaluations............................................................................... 23 
6.2.1 Screening Evaluation .................................................................................. 23 
6.2.2 Enrollment, Baseline, and/or Randomization ............................................... 23 

 
4 
6.2.3 Blinding........................................................................................................ 26 
6.2.4 Followup Visits ............................................................................................ 27 
6.2.5 Completion/Final Evaluation ...................................................................... 287 
7. SAFETY ASSESSMENTS ...................................................................................... 287 
7.1 
Specification of Safety Parameters ............................................................... 297 
7.2 
Methods and Timing for Assessing, Recording, and Analyzing Safety 
Parameters ................................................................................................................ 28 
7.3 
Adverse Events and Serious Adverse Events ................................................. 28 
7.4 
Reporting Procedures ..................................................................................... 28 
7.5 
Followup for Adverse Events .......................................................................... 28 
7.6 
Safety Monitoring .......................................................................................... 309 
8. INTERVENTION DISCONTINUATION ................................................................... 309 
9. STATISTICAL CONSIDERATIONS .......................................................................... 29 
9.1 
General Design Issues .................................................................................... 29 
9.2 
Sample Size and Randomization .................................................................... 30 
9.3  
Definition of Populations ................................................................................. 30 
9.4 
Interim Analyses and Stopping Rules ............................................................. 30 
9.5 
Outcomes........................................................................................................ 30 
9.5.1 Primary Outcome ........................................................................................ 30 
9.5.2 Secondary Outcomes .................................................................................. 30 
9.6 
Data Analyses ................................................................................................. 30 
10. DATA COLLECTION AND QUALITY ASSURANCE ............................................. 31 
10.1 Data Collection Forms .................................................................................... 31 
10.2 Data Management .......................................................................................... 31 
10.3 Quality Assurance ........................................................................................... 34 
10.3.1 
Training .................................................................................................... 34 
10.3.2 
Quality Control Committee ....................................................................... 34 
10.3.3 
Metrics ..................................................................................................... 34 
10.3.4 
Protocol Deviations .................................................................................. 35 
10.3.5 
Monitoring ................................................................................................ 35 
11. PARTICIPANT RIGHTS AND CONFIDENTIALITY ................................................ 35 
11.1 Institutional Review Board (IRB) Review ........................................................ 35 
11.2 Informed Consent Forms ................................................................................ 35 
11.3 Participant Confidentiality................................................................................ 36 

 
5 
11.4 Study Discontinuation ..................................................................................... 36 
12. COMMITTEES ........................................................................................................ 36 
13. PUBLICATION OF RESEARCH FINDINGS ........................................................... 37 
14. REFERENCES ........................................................................................................ 38 
15. SUPPLEMENTS/APPENDICES ............................................................................. 44 
Refer to attached pdf 
 
 

 
6 
STUDY TEAM ROSTER  
 
Key Personnel 
Christine Goertz, DC, PhD, Co-Principal Investigator 
Spine Institute for Quality 
Phone: 301-335-0071 
cgoertz@spineiq.org 
 
Thad Abrams, MD, MS, Site Principal Investigator 
Iowa City Veterans Affairs Health Care System (ICVHCS) 
601 Highway #6 West, Iowa City, IA 52246 
Phone: 319-338-0581 x7618 
Fax: 319-887-4912 
thad-abrams@uiowa.edu 
 
Cynthia Long, PhD, Co-Principal Investigator 
Palmer Center for Chiropractic Research  
741 Brady St., Davenport, IA 52803 
Phone: 563-884-5157 
Fax: 563-884-5227 
LONG_C@palmer.edu 
 
Stacie Salsbury, PhD, RN, Co-Investigator 
Palmer Center for Chiropractic Research  
741 Brady St., Davenport, IA 52803 
Fax: 563-884-5227 
Phone: 563-884-5254 
stacie.salsbury@palmer.edu 
 
Robert Vining, DC, Co-Investigator 
Palmer Center for Chiropractic Research  
741 Brady St., Davenport, IA 52803 
Phone: 563-884-5690 
Fax: 563-884-5227 
robert.vining@palmer.edu 
 
 
 
Robert Wallace, MD, MS, Co-Investigator 

 
7 
University of Iowa College of Public Health 
200 Hawkins Dr, Iowa City, IA 52242 
Phone: 319-384-1551 
Fax: 319-384-4155 
robert-wallace@uiowa.edu 
 
Anthony Lisi, DC, Co-Investigator 
Yale Center for Medical Informatics (YCMI)  
300 George St., Suite 501 New Haven, CT 06511 
VA Connecticut Health Care System (VACHS) 
950 Campbell Ave., West Haven, CT 06516 
Phone: 203-932-5711 x5341 
Fax: 203-479-8108 
Anthony.Lisi@va.gov 
 
Lucille Burgo-Black, MD, Co-Investigator 
VA Connecticut Health Care System (VACHS) 
950 Campbell Ave. 
West Haven, CT, 06516 
Phone: 203-932-5711 x7742 
Fax: 203-479-8108 
Lucille.Burgo@va.gov 
 
Richard Branson, DC, Co-Investigator 
Minneapolis VA Health Care System 
One Veterans Drive 
Minneapolis, MN 55417 
Phone: 612-725-2000 
Fax: 612-467-1155 
Richard.Branson@va.gov 
 
Support Personnel 
 
Janice Hubbard, DC, MS, Project Manager/Study coordinator 
Palmer Center for Chiropractic Research  
741 Brady St., Davenport, IA 52803 
Phone: 563-884-5125 
Fax: 563-884-5227 
janice.hubbard@palmer.edu 
Lance Corber, MSITM, Lead Data Manager 

 
8 
Palmer Center for Chiropractic Research  
741 Brady St., Davenport, IA 52803 
Phone: 563-884-5228 
Fax: 563-884-5227 
lance.corber@palmer.edu 
 
Gina Bonavito-Larragoite, DC, FIAMA, Study Clinician 
Iowa City Veterans Affairs Health Care System (ICVHCS) 
601 Highway #6 West, Iowa City, IA 52246 
Phone: 319-338-0581 x6004 
Fax: 319-887-4912 
Gina.Bonavito-Larragoite@va.gov 
 
Gregory Norton, DC, FIAMA, Study Clinician 
Iowa City Veterans Affairs Health Care System (ICVHCS) 
601 Highway #6 West, Iowa City, IA 52246 
Phone: 319-338-0581 x6004 
Fax: 319-358-9276 
Gregory.Norton2@va.gov 
 
Amy Minkalis, DC, MS, CCRP, Research Assistant 
Palmer Center for Chiropractic Research  
741 Brady St., Davenport, IA 52803 
Phone: 563-884-5199 
Fax: 563-884-5227 
amy.minkalis@palmer.edu 
 
Elissa Twist, DC, MS, FIAMA, CCRP, Assistant Study Coordinator 
Palmer Center for Chiropractic Research  
741 Brady St., Davenport, IA 52803 
Phone: 563-884-5891 
Fax: 563-884-5227 
elissa.twist@palmer.edu 
 
 
 
 
 
 
Tracy Szabo, RN, Primary Care Mental Health Integration Nurse 

 
9 
Iowa City Veterans Affairs Health Care System (ICVHCS) 
601 Highway #6 West, Iowa City, IA 52246 
Phone: 319-338-0581 x6303 
Fax: 319-887-4912 
Tracy.szabo@va.gov 
 
 
 
 

 
10 
PARTICIPATING STUDY SITES  
 
Iowa City Veterans Affairs Health Care System 
601 Highway #6 West, Iowa City, IA 52246 
Phone: 319-338-0581  
 
VA Community Based Outpatient Clinic (CBOC), Coralville, IA 
520 10th Ave. #100, Coralville, IA 52241 
Phone: 319-358-2406 
 
Yale Center for Medical Informatics (YCMI) 
300 George St., Suite 501 New Haven, CT 06511 
Phone: 203-737-5379 
 
Palmer Center for Chiropractic Research  
741 Brady St., Davenport, IA 52803 
Phone: 563-884-5150 
 
STUDY OVERSIGHT AGENCIES AND PERSONNEL  
 
Palmer College of Chiropractic Institutional Review Board 
1000 Brady St., Davenport, IA 52803 
Phone: 563-884-5757 
 
University of Iowa Human Subjects Office Institutional Review Board (IRB-03) 
600 Newton Road, Suite 105, Iowa City, IA 52242-1098 
Phone: 319-335-6564 
 
Data and Safety Monitoring Committee 
Eric Hurwitz, DC, PhD, Chair 
1960 East West Road, Biomed D-201, Honolulu, HI 96822 
Phone: 808-956-7425 
 
NCCIH Program Officer 
Eve Reider, PhD 
Division of Extramural Research National Center for Complementary and Integrative 
Health (NCCIH) 
6707 Democracy Boulevard II, Suite 401, Bethesda, MD 20892 
Phone: 301-443-8374 
 

 
11 
Care Outcomes for Chiropractic Outpatient Veterans (COCOV) 
 
Objectives  
The primary objectives of this pilot clinical trial are to evaluate the feasibility, safety 
and acceptability of an integrative care pathway that includes chiropractic care, for the 
coordinated care for Veterans Administration (VA) patients with chronic low back pain 
(cLBP), with an emphasis on those with mental health comorbidity, in preparation for 
the conduct of an appropriately powered multi-site randomized controlled trial (RCT). 
The secondary objectives are to collect study outcomes at the baseline visit (BV) and 
at weeks 3, 5, 7, and 10 to: 1) assess the success of collecting outcomes; 2) 
determine the outcome measures to use in a future RCT; and 3) determine 
preliminary intervention effect sizes and variability to aid in sample size determination 
for a future RCT. 
Design and Outcomes   
This pilot study is a single-arm clinical trial. All participants will be asked to complete 
study outcomes which include the Roland Morris Disability Questionnaire (RMDQ), 
Brief Pain inventory (BPI), as well as the Patient Health Questionnaire-9 (PHQ-9), 
Generalized Anxiety Disorder 7-item Scale (GAD-7), Post-traumatic Stress Disorder 
Checklist-Civilian Version (PLC-C), Alcohol Use Disorders Identification Test (AUDIT), 
Keele Start Back Screening Tool (STarT Back), self-efficacy for managing symptoms 
(SF8a), self-care behaviors, Expectations for Complementary and Integrative 
Treatments Questionnaire (EXPECT), Healing Encounters and Attitudes Lists (HEAL), 
and Pain Intensity, Enjoyment of Life, General Activity Assessment Tool (PEG) 
questionnaires, and the Pain Assessment Screening Tool and Outcomes Registry 
(PASTOR) assessment, includes LBP intensity and interference as measured by the 
Defense and Veterans Pain Rating Scale (DVPRS), pain, disability, mental health, 
quality of life enjoyment and satisfaction. 
Interventions and Duration  
All participants will receive up to 10 weeks of chiropractic care and will complete 
outcome assessments at weeks 3, 5, 7, and 10 of the study. 
Sample Size and Population  
This pilot study will recruit 40 veterans aged 18 and older, who have cLBP from the Iowa 
City VA Health Care System (ICVAHCS) and the Coralville, Iowa Community-Based 
Outpatient Clinic (C-CBOC), also a VA setting. We plan to enroll 40 participants, some  
of whom may have a mental health comorbidity.  
 
 
 

 
12 
1. STUDY OBJECTIVES 
1.1 
Primary Objective 
The primary objectives of this pilot, uncontrolled clinical trial are to evaluate the 
feasibility, safety and acceptability of an integrative care pathway that includes 
chiropractic care, for the coordinated care for Veterans Administration (VA) patients 
with chronic low back pain (cLBP), with an emphasis on those with mental health 
comorbidity, in preparation for the conduct of an appropriately powered multi-site 
randomized controlled trial (RCT). Specifically, the pilot will focus on the following: 
• 
Feasibility will be assessed by monitoring recruitment, retention, and visit 
compliance and assessing trial management protocols and ability to meet 
regulatory deadlines. 
• 
Safety will be assessed by monitoring Adverse Events (AEs). 
• 
Participant and provider perceptions of the pilot will be assessed with a 
structured, qualitative exit interview. 
 
1.2 
Secondary Objectives  
To collect study outcomes (LBP disability, PASTOR, mental health assessments) at 
the baseline visit (BV) and at weeks 3, 5, 7, and 10 to: 1) assess the success of 
collecting outcomes; 2) determine the outcome measures to use in a future RCT; and 
3) determine preliminary intervention effect sizes and variability to aid in sample size 
determination for a future RCT.  
2. BACKGROUND AND RATIONALE- 
2.1 
Background on Veterans with Chronic Pain and Mental Health Conditions   
The coinciding problems of chronic pain and mental illness are of great concern for 
patients seeking care within the Department of Veterans Affairs (VA) healthcare 
facilities.1-3 Of the 5.7 million veterans treated in VA facilities in 2012, more than half 
reported chronic pain syndromes,2 including chronic low back pain (cLBP).4-9 Veterans 
also experience many mental health comorbidity, such as depression, anxiety, post-
traumatic stress disorder (PTSD), and substance abuse.10-12 Veterans in pain are often 
managed using overlapping pain and mental illness with prescription drugs, including 
opioids, psychotropic medications, and sleep agents.2;13 These potentially harmful drug 
combinations, which have demonstrated only nominal positive impact on chronic 
musculoskeletal (MSK) pain, put veterans at high risk for diminished quality of life, drug 
addiction, and opioid overdose. Non-pharmacological treatments for chronic pain, which 
also may provide relief of mental health symptoms, may be welcomed complementary 
therapies for veterans suffering from these conditions.   
 
 
 
 
 
 
 
 
 

 
13 
2.2 
Study Rationale   
In addition to developing solutions to the critical issue of non-pharmacological pain 
management for veterans with comorbid pain and mental health conditions, the COCOV 
clinical trial planning grant addresses multiple aspects of 2 intentions from the 2016 
NCCIH Strategic Plan.  
1: Advance fundamental science and methods development. 
• 
This trial will assess PASTOR, which includes numerous Patient-Reported 
Outcomes Measurement Information System (PROMIS)-based instruments, using 
innovative electronic data collection methods and compare the utility of these new 
measures against legacy instruments in the veteran population.  
2: Improve care for hard-to-manage symptoms.  
• 
This trial will evaluate an integrative care pathway that includes chiropractic care for 
the treatment of cLBP with mental health comorbidity (depression, anxiety and 
PTSD).    
• 
This trial will be conducted in the “real world” clinical setting of a VA healthcare 
facility and will test the safety and efficacy of chiropractic care for patients with active 
mental health comorbidity, a population often excluded from RCTs of manual 
therapies.    
  
The DoD/VA Pain Management Task Force has adopted a team-based, stepped-care 
model that combines pharmacological strategies for pain management with 
complementary and integrative health (CIH) modalities.2 Chiropractic care, one such CIH 
therapy, has demonstrated evidence of efficacy and safety for the management of pain 
and disability for LBP and other MSK disorders.14;15 Within the DoD/VA model, 
chiropractic care is a Tier 1 treatment modality, which pairs clinic-based spinal 
manipulative therapy (SMT, considered a passive therapy in the DoD/VA model) with 
self-correcting exercises (active therapy) for patients with pain.1 Few studies have 
evaluated the efficacy of chiropractic care for veterans’ experiencing pain, disability, or 
mental health conditions.16-20  
 
The conceptual model for the potential relationship between chiropractic care and relief 
of MSK pain and mental health symptoms is depicted in Figure 1. Patients with MSK 
pain and pain at multiple locations often report depression, anxiety and other mental 
health symptoms.21 Chronic pain may 
perpetuate mental health comorbidity 
as these conditions share common 
pathophysiological pathways.22;23 
Research has shown that the non-
specific effects of empathetic doctor 
communication and therapeutic alliance 
improves clinical outcomes.24-28 We 
hypothesize that chiropractic care 
offers relief for pain and mental health 
symptoms through the direct effects of 
treatment-focused CMT, as well as 
through the indirect, non-specific 
effects of the team-based relationship 
with the clinician. 
 
Figure 1. Conceptual model of the potential relationship 
between chiropractic care and relief of musculoskeletal pain 
and mental health symptoms 

 
14 
However, chiropractic care is not delivered in isolation from other treatments within the 
VA. Thus, we will test a feasible, effective, patient-centered, guideline-based, integrative 
care model that integrates chiropractic into VA Patient Aligned Care Teams (PACTs). 
This integrative care pathway will involve primary care providers, mental health 
professionals, and doctors of chiropractic (DCs) engaged in the treatment of veterans 
with cLBP, with or without mental health comorbidity. While DCs are providing services 
within VA in increasing numbers over the past 13 years, as with any new service, 
adoption and appropriate placement faces challenges. Many VA providers may know 
little about the clinical approaches used by DCs.29 Similarly, DCs may not be fully aware 
of the processes involved in the delivery of primary care services within VA or the 
healthcare needs of veterans with mental illness.30 Consistent with the intent of the R34 
mechanism, this pilot study will not include formal tests of outcomes, but will collect 
preliminary data regarding the feasibility, perceptions, safety, tolerability, and target 
outcomes relevant to planning future RCTs. Thus, the purpose of this pilot clinical 
trial is to evaluate the feasibility, safety and patient perceptions of an integrative 
care pathway, developed through a consensus-based process, for the coordinated 
care for VA patients with cLBP and mental health comorbidity.  
3. STUDY DESIGN 
 
This pilot study is a single-arm clinical trial of 40 veterans aged 18 and older, who have 
cLBP from the ICVAHCS and the Coralville, Iowa Community-Based Outpatient Clinic 
(C-CBOC), also a VA setting. Participants will receive up to 10 weeks of chiropractic 
care, including but not limited to SMT, mobilization, active exercises, and self-care 
recommendations. See Appendix A for Study Flow. We will recruit 40 veterans with 
cLBP with or without a mental health comorbidity such as anxiety, depression and/or 
PTSD. Participants will receive co-managed care by a collaborative care team that 
includes a primary care provider, DC, and/or mental health professional, as the 
individual’s health status warrants. 
 
The primary patient-reported outcome is LBP-related disability as measured by the 
Roland Morris Disability Questionnaire (RMDQ) and the Brief Pain Inventory (BPI). 
Secondary patient-reported outcomes include PHQ-9, GAD-7, PLC-C, AUDIT, STarT 
Back, self-efficacy for managing symptoms (SF8a), self-care behaviors, EXPECT, 
HEAL, and PEG questionnaires, and the PASTOR assessment, which includes 
measures of LBP intensity and interference as measured by the DVPRS, pain, 
disability, mental health, quality of life enjoyment and satisfaction. Outcomes will be 
collected at BV and at 3, 5, 7, and 10 weeks. Outcomes will be obtained by participant 
self-report through web-based direct-entry using REDCap (Research Electronic Data 
Capture). We will also evaluate health service use, including the number of visits to the 
DC, as well as primary care, mental health, and other providers, and medication use 
using electronic health record (EHR) through EHR extraction.  
 
The Palmer Center for Chiropractic Research (PCCR) will take responsibility for all 
aspects of project management, data collection and management, and statistical 
analyses. The Yale Center for Medical Informatics will be responsible for extracting EHR 
data on participant demographics and health service use. The ICVAHCS will be 
responsible for developing EHR-data extraction methods for recruitment purposes, 
providing DCs with mental health training, and will assist in participant recruitment. The 

 
15 
ICVAHCS will also be responsible for assisting veterans with setting up the online 
patient portal access. Licensed DCs at the ICVAHCS will provide the chiropractic care.   
4. SELECTION AND ENROLLMENT OF PARTICIPANTS  
4.1 
Inclusion Criteria 
Individuals interested in participating in this pilot study must meet all of the following 
inclusion criteria: 
• 
Veterans age 18 years or older 
• 
Self-reported chronic LBP 
• 
Ability to comprehend study details 
• 
For 75% of the study population: one or more mental health conditions 
defined as depression, anxiety, or post-traumatic stress disorder 
 
4.2 
Exclusion Criteria 
All candidates meeting any of the exclusion criteria at baseline will be excluded from 
study participation. Exclusion criteria are:  
• 
Use of chiropractic care within the past 90 days 
• 
Impaired cognitive ability  
• 
Not a candidate for chiropractic care  
• 
Not able to attend chiropractic appointments 
• 
Potential suicide risk 
• 
Unable to complete questionnaires without help from a proxy 
 
Table 1. Eligibility Criteria 
 
Deciding 
Study Team 
Member 
Rationale  
Inclusion Criteria 
1.Veterans age 18 and older 
Project 
Manager 
Study population 
2.Self-reported cLBP: persisted 3 or more months and 
pain on at least half the days in the past 6 months 
Project 
Manager 
Study population, 
standardized definition 
3.Able to comprehend study details  
Project 
Manager 
Able to comprehend 
study details and make 
decisions without 
limitations or impairment 
4.For 75% of the study population: one or more mental 
health conditions defined as depression, anxiety, or post-
traumatic stress disorder 
Project 
Manager 
Study population 
Exclusion Criteria 
1. Received any chiropractic care outside VA or any VA 
related chiropractic services within past 90 days. 
Project 
Manager 
prevent potential 
carryover effects 
2. Impaired cognitive ability such that a potential 
participant is unable to provide fully informed consent, 
Project 
Manager 
Prohibits informed 
consent  

 
16 
 
Definition of Chronic LBP: We define chronic LBP consistent with the NIH task force 
on Research Standards.31 Individuals who report LBP as an ongoing problem for more 
than 3 months and who also report LBP as an ongoing problem during at least half the 
days in the past 6 months will be classified as meeting the criteria for chronic LBP.  
 
Definition of Mental Health Condition: For the purposes of this pilot study, we are 
limiting mental health conditions to anxiety, depression, and/or PTSD. Patients will be 
considered eligible if they have a current diagnosis of one of these 3 mental health 
conditions as determined by a clinician guided review of their medical records. The 
conditions must be identified in a problem list and the medical records should reflect a 
provider of record who is actively managing the condition. A list of potential subjects will 
also be identified by screening the EHR for veterans with low back pain and the three 
identified comorbid mental health conditions by using ICD-9/10 codes using published 
methods.32 Participants with these mental health comorbidity will have active 
management (within last 90 days) evidenced by primary care or mental health provider 
documentation. Patients will also be considered classified for having one of the stated 
mental health conditions if they meet a minimum cut-point score on any of the following 
3 measures. Cut-points are a score of 10 on either the PHQ-9 or GAD-7 or a score of 31 
on the PCL-C. The PHQ-9 and GAD-7 instruments are standard measures to screen for 
depression and anxiety. Cut-points were determined by the site PI who is specialty 
certified in mental health and they are consistent with values recommended in relevant 
literature.89-92 
 
Veterans with suicidal ideation are not eligible for the study. However, patients may 
develop suicidal ideation during the course of the study. These symptoms will be 
recorded via the online symptom database (PHQ-9). Should the patient indicate in 
question 9 “Thoughts that you would be better off dead or of hurting yourself in some 
way” with any response other than “not at all”, REDCap will flag the response and 
immediately send a notification to the PM. In the event this occurs, the PM will 
immediately alert the treating provider and the study site PI (Dr. Abrams) of the suicidal 
ideation. The treating provider will contact and manage patient care and the site PI will 
be alerted but remain independent of this management. Only in cases where the 
provider is unable to be contacted or the psychiatrist of the day (POD) is unreachable 
will the site PI (Dr. Abrams) be contacted for management. For all patients, emergency 
contact names will be collected so study personnel may enlist additional help to ensure 
including those with a legally authorized representative 
or guardian who renders medical decisions for them. 
3. Not a candidate for chiropractic care due to 
contraindication (e.g., inflammatory spondyloarthropathy, 
surgical intervention needed, recent spinal/pelvic 
fracture) or other clinical factors. 
DC 
Not a candidate for 
chiropractic care as a 
management strategy for 
chronic LBP 
4. Not able to attend chiropractic appointments per 
recommended chiropractic treatment plan. 
Project 
Manager 
Study compliance 
5. Active suicide monitoring flag listed in EHR as high or 
moderate risk, or individuals who report active suicidal 
ideation to the DC, primary care, or mental health 
provider within 30 days of BV.   
Project 
Manager, 
DC, PC, or 
MH 
Suicide risk 
6. Not able to complete questionnaires without the help 
of a proxy. 
Project 
Manager 
 

 
17 
veteran safety and evaluate the need for more specialized care. Regular contact will 
occur between the referring providers and the site PI via conferences and normal clinical 
collaboration within the Primary Care Mental Health Integration (PCMHI) model.    
In addition, VA provider staff are trained in specific protocols to address issues related to 
worsening of depression and risk for self-harm (See Appendix B Suicide Risk 
Protocol).   
 
 
 
 
 
4.3 
Study Enrollment Procedures  
Recruitment: One feasibility aim of this pilot study is to test our recruitment and 
retention strategies. We plan to enroll 40 participants to test the utility of the integrative 
care pathway for veterans. An additional goal is to test our ability to recruit women and 
ethnic/racial minorities for a larger trial. We will work with the VA Women’s Health 
Practice-Based Research Network toward this goal. Avenues to be tested include 
oversampling these groups in samples identified through the EHR, targeting women’s 
healthcare clinics as part of our overall recruitment strategy, and creating flyers and 
other study recruitment materials that are inclusive.  
 
Our a priori approach is to recruit participants through a 3-pronged recruitment strategy: 
1) invite potential participants to be screened for the study using EHR, 2) referral through 
the existing models of care, or 3) standard direct recruitment procedures. We will modify 
recruitment strategies as needed and with IRB-approval should the following methods be 
found insufficient to reach our enrollment targets.   
 
1) Strategy 1: Letter invitation for screening using EHR    
VA Corporate Data Warehouse (CDW) will be used to conduct the EHR pre-
screening protocol. Each patient record has unique identifiers comprised of formula-
based encryptions of the individual’s Social Security Number (SSN). The identifier for 
a given patient is consistent across datasets and fiscal years. Access to files that 
translate scrambled to real SSNs is possible with special authorization, which will be 
obtained through an IRB-approved process granted by the Data Acquisition and 
Request Tracking system.   
 
Data files will identify potential participants for initial contact via recruitment letter on 
ICVAHS patients with a visit to a primary care provider with a low back pain ICD-10 
code (See Appendices C-D. ICD-9/10 Diagnosis List). We will extract patient 
identifiable data to allow us to contact potential participants, including full name, 
address, age, sex, race, ethnicity, service connected %. We will use the patient 
gender and race/ethnicity to evaluate processes for recruitment of women and 
minorities into the study. This step using the pre-screen EHR database is necessary 
to determine participants initially eligible for contact regarding the study. Service 
connection percentage will be used to describe the study sample in scientific 
presentations and publications. Because one goal of this study is to ensure women 
and minorities are included, gender and race/ethnicity status data will inform 
recruitment strategy decisions for a follow-up trial.  
 

 
18 
Veterans identified as potential participants will receive an IRB-approved template 
letter printed on VA letterhead explaining: 1) they were identified through the use of 
routinely collected clinical data captured as part of their VA care; 2) the basic 
parameters of their potential study eligibility; 3) the study objectives; 4) anticipated 
treatments performed by the DC, which would be considered usual chiropractic care; 
and 5) a request that they call a dedicated line at the Palmer research center  or 
complete a postcard that accompanies the letter and mail it back to the study team. 
The dedicated phone line is only for research participants. It is what we have used in 
our previous studies. This is not answered live, but requests that callers leave 
contact information. The PM/study coordinator and back-up study coordinators are 
the only members of the study team to gather this information, put the contact 
information in REDCap and then delete from the voicemail. This will help limit too 
many calls coming to the PM study cell phone for simple inquiries on the study. The 
postcard contains simple boxes asking additional eligibility questions and willingness 
to participate in the research study. If a potential study participant fails to return the 
postcard or call the research line, the PM will call, confirm receipt of the letter, and 
ask them to send in the postcard or ask if they are interested in the study. Following 
confirmation of initial eligibility, the PM will advise potential participants on next steps 
for study consideration.  
 
2) Strategy 2: Developing and testing of research engagement using existing 
patient flow through existing models of care 
Congruent with the VA model of delivering care, veterans are assigned a Patient 
Aligned Care Team (PACT) for primary care services and coordination of other 
referrals. Providers will incorporate a brief screening procedure into the routine clinic 
assessments to identify veterans who may be eligible for study participation. Clinic 
personnel will review patient records on key inclusion criteria, including back pain 
location and duration and current mental health diagnosis, and query patients about 
their interest in learning more about a study of chiropractic care for LBP. If the patient 
indicates a willingness to learn more about the study, recruitment materials will be 
delivered by clinic personnel at the point of care to facilitate patient referral from the 
PACT to the study PM. Included in this strategy is recruitment directly from the 
chiropractic schedule for patients who have already been referred by their PCP to 
see a chiropractor for cLBP but have not heard of the study yet. Additionally, we will 
develop and test EHR-embedded consult templates for referral to the study.   
 
3) Strategy 3: Standard direct recruitment procedures 
We will recruit VA patients directly using informational items describing the study, 
including contact information, in coordination with the local VA research office. 
Examples of such items are brochures, flyers, and pens. Distribution will be focused 
on the chiropractic clinics themselves, targeting patients who have not seen the DC 
in the prior 3 months, as well as areas where the highest volume of primary care 
patients are encountered and at IRB-approved outreach events. We will also conduct 
provider and staff in-service educational sessions, visits to local community-based 
outpatient clinics (CBOCs), and local veteran socialization and care centers (e.g., 
Veterans of Foreign Wars (VFW), Vet Centers). Interested veterans recruited 
through these methods will be asked to call the PM for additional information about 
the study. 
  

 
19 
Enrollment: Another feasibility aim is to determine the rate of enrollment into the clinical 
trial. We anticipate enrollment to occur at the rate of 6-8 participants per month over a 
period of 6 months. 
. 
The PM will screen interested veterans on objective eligibility criteria using a telephone 
interview (See Appendix G Phone Screen). The PM will confirm initial eligibility and 
advise potential participants on next steps for study consideration. Potential participants 
who had been seen in VA chiropractic clinics within the past 2 years and meet other 
inclusion/exclusion criteria (those who have been to the DC in the past 90 days are not 
eligible) will be advised to contact the given chiropractic clinic directly to schedule a 
baseline assessment, consistent with VA policy. All other potential participants will be 
advised to contact their primary care provider for a referral to the chiropractic clinic. 
Baseline study visits will include the informed consent process (See Appendix H 
Informed Consent Document), and a screening interview with the PM (See Appendix I 
Baseline Screening). After signing the informed consent document and completing the 
BV, the PM will perform a final screen to confirm eligibility, with an emphasis on ensuring 
that the Veteran has not had any of the suicide risk factors listed in Table 1. The 
appropriate clinical evaluation by a VA DC (See Appendix J Chiropractor Screening) 
will occur at the initial chiropractic visit. Following the chiropractic evaluation, eligible 
participants still meeting eligibility criteria (Table 1) will be formally enrolled into the trial 
by the PM. For those not meeting trial criteria, data on the reasons for ineligibility will be 
recorded. Ineligible participants will receive routine care in the chiropractic clinic and/or 
be referred for other LBP treatment consistent with VA management practices. 
Retention: Participant retention strategies include frequent contact via MyHealtheVet 
(for those with internet and a computer), convenient scheduling of chiropractic visits with 
take-home appointment calendars, reminders of upcoming visits at each session, day-
before reminder calls, follow-up calls, and rescheduling of missed appointments. This 
method of contact is for clinical appointments at the VA and monitored by VA clinic 
offices. 
Participants also will complete outcome assessments online. Participants will have a one 
week window of time to complete electronic assessments. The Data Core Manager and 
PM will monitor compliance and provide additional reminders to participants to complete 
assessments as necessary. An automated email reminder to complete assessment will 
be sent to participants via REDCap the day the assessment window opens, and the day 
the assessment is actually due. The PM will make personal contact via texts/calls at 
least once in an attempt to remind the participant to complete the assessments during 
the active assessment window. Once the active window closes for weeks 5 and 10, the 
PM will contact participants that did not respond to try and complete a Computer 
Assisted Telephone Interview (CATI). Up to three attempts will be made within 7 days 
following window close date. 
Incentives, Compensation and Travel Reimbursement   
1) Incentives: To increase awareness of the COCOV Trial, VA staff and potential 
participants will be given small novelty items such as pens or keychains that contain 
research study contact information, free-of-charge throughout the recruitment period. 
Upon enrollment, participants will receive a wallet-sized plastic card listing study 
contact information to facilitate communication with study staff. This concept was a 
successful retention tool in a previous study focused on recruitment of veterans.33 

 
20 
2) Compensation: Participants will be compensated for their time spent in the 
completion of study data collection procedures. Participants will receive a $25 gift 
card after completing assessments at BV, Week 5 and Week 10. Upon completion of 
all study assessments, an additional $25 gift card will be given, for a potential total of 
$100 in study compensation.  
3) Travel Reimbursement: 
The research team will make an effort to arrange research data collection coinciding 
with existing healthcare visits when possible. However, when research visits, the 
baseline visit and exit interview, are required for data collection outside existing 
clinical appointments the Veteran will be reimbursed using the following procedures. 
Travel payments will be made at .56$ per mile for distances beyond 20 miles. The 
veteran’s social security number and address will be confirmed and a check will be 
mailed for their travel from the Palmer Center for Chiropractic Research. 
5. STUDY INTERVENTIONS  
5.1  
Interventions, Administration, and Duration  
 
1) Interventions: As this pilot study is a trial, chiropractic care will consist of usual 
chiropractic procedures for the management cLBP. Treatment approaches will be 
based on a clinical evaluation, which may include diagnostic testing, to determine a 
working diagnosis, rule out pathology, and/or to screen for conditions requiring 
referral or other co-management. We anticipate that chiropractic care often will 
include some form of SMT or mobilization to address the patient’s specific needs. 
DCs will recommend other interventions such as rehabilitative exercise, stretching, or 
nutritional and lifestyle advice based upon clinical findings and patient 
goals/preferences. We will monitor treatments provided through EHR chart 
abstractions conducted following completion of chiropractic care at Week 10.  
 
As per typical VA care, DCs will monitor the participant’s health status throughout the 
trial and initiate referrals as clinically indicated. Referrals to primary care and mental 
health providers will be consistent with the chiropractic integrated care pathway 
developed during Phase 2 of the COCOV study (See Appendix K Integrated Care 
Pathway). We anticipate the most common communication and referral methods will 
occur through note-review and countersign procedures, which are already 
established among VA providers using the VA electronic health record, but may also 
occur in person or via phone conversations.  
 
2) Administration of Chiropractic Care: Chiropractic care will be administered by 
licensed DCs who are current employees of the ICVAHCS.   
 
3) Intervention Duration/Dose: Participants will receive chiropractic care at a 
frequency of 1-2 visits per week for a duration up to 10 weeks, with the frequency 
and duration of care individualized within established VA parameters and per the 
COCOV chiropractic integrated care pathway (See Appendix K). For this trial, the 
minimum treatment dose is 1 visit to the DC, while the maximum treatment dose is 
12 visits to the DC.  
 
5.2 
Handling of Study Interventions  
Study participants will be expected to follow care recommendations given to them by 

 
21 
their health care providers, including visit frequency, as well as complete study 
assessments at the indicated times during their study participation.  
 
5.3 
Concomitant Interventions 
 
Data regarding participant care for cLBP that is delivered within VA will be obtained from 
VA EHR. In addition, participants will be asked to describe any care they received for the 
cLBP outside of VA system, including use of complementary therapies and self-care. 
The following is a list of allowed, required and prohibited interventions in this trial.  
 
5.3.1 
Usual Medical Care 
Participants will have access to the same usual medical care available to all veterans 
during the study timeframe. Usual care will be defined as any care designated by the 
PACT provider of record. In most cases this will be a combination of treatments or 
referrals that could consist of 1) systemic medications (e.g., nonsteroidal anti-
inflammatory drugs (NSAIDS)), 2) topical therapies (e.g., creams), 3) low 
intervention transcutaneous treatments (transcutaneous electrical nerve stimulation 
(TENS), ultrasound, trigger point injections), 4) supportive braces; and 5) referrals to 
physical therapy or specialty care for invasive procedures such as nerve blocks 
or spinal injections. 
    
5.3.2 
Required Interventions 
The chiropractic care provided by study DCs will be a structured approach to typical 
evidence-based, combination care management of patients with cLBP as commonly 
delivered in VA and as described above. This will include standard diagnostic 
elements such as review of medical records, patient history and physical examination, 
and additional diagnostic testing if indicated. In shared decision-making with 
participants, the DCs will develop an individualized treatment plan including patient 
education on chronic pain, patient instruction/engagement in active strategies such as 
therapeutic exercise, body mechanics/ergonomics, and self-management advice. 
Manual treatment will include SMT and/or mobilization, and/or massage/myofascial 
therapies. DCs will engage in routine collaborative communication with other 
providers as indicated. In order to provide an approach that is generalizable yet 
still allows pragmatic decision making at the clinician level, we will use a 
patient care pathway based upon algorithms that the investigators have previously 
developed through a Delphi process. Examples of manual therapies that may be 
delivered to participants (based upon the treatments currently used by DCs at 
ICVHCS) include the following: 
 
SMT to the low back region will be most commonly performed with the patient in a 
side-lying position and the free hip and knee bent. The DC will contact the patient’s 
bent lower extremity with his/her own thigh to stabilize the lower body. With one hand, 
the DC will stabilize the patient’s free shoulder or upper arm. With the other hand, the 
DC will apply a high-velocity, low amplitude manual thrust toward a lumbar or 
sacroiliac joint complex. This procedure often results in local joint gapping referred to 
as cavitation.34  
 
Manually held instruments, such as an Activator (Activator Methods International LTD, 

 
22 
Phoenix AZ) may also be employed. These instruments are hand-held spring-loaded 
devices that deliver a quick impulse, or thrust, of several millimeters to a target 
vertebrae or joint.35 Hand-held mechanical devices are often used when manually 
delivered interventions are not well-tolerated or otherwise preferred by patients.  
 
Trigger point therapy consists of manually applying pressure to abnormally taut areas 
within muscles.36;37 These are tender areas that sometimes refer pain to remote 
areas.38;39 Pressure is applied for several seconds within patient tolerance to break a 
self-perpetuating cycle causing pain, hypertonicity, and inflammation in a muscle. 
Increased circulation following pressure removal is thought to help remove 
inflammation within the muscle region.  
 
Gua sha is characterized by applying friction (or scraping = Gua) to a body region 
using an instrument such as a coin or spoon.40 The result being a bruising effect (sha) 
noticeable on the skin of the area treated. Some evidence suggests that Gua sha 
improves microcirculation in surface tissues and modulates anti-inflammatory activity 
within the body, thus contributing to reduced pain often reported following treatment.41    
 
5.3.3 
Prohibited Interventions  
It is not our intent to expressly prohibit any interventions during participation in 
the trial. However, we will ask providers and patients to avoid acupuncture during 
the active treatment phase of the study. While acupuncture is available through the 
ICVAHCS chiropractic clinic, the delivery of this intervention would serve as a 
confounder to the chiropractic intervention given this pilot trial’s small sample size.  
 
 
5.4 
Feasibility Assessment  
For this pilot trial, feasibility measures will focus on the extent to which participants 
complete their scheduled assessments and complete all scheduled treatment visits 
to the DC. See feasibility measures in Appendix L and M, Feasibility Outcomes 
and Feasibility Metrics. 
 
 

 
23 
6. STUDY PROCEDURES  
6.1 
Schedule of Evaluations 
Assessment 
Phone 
Screen:  
Baseline 
Visit  
Initial 
DC Visit Week 3 
Week 5 
Week 7 Week 10 
EHR 
Demographics 
X* 
 
 
 
 
 
 
X 
Confirm Eligibility Criteria 
X* 
X 
X 
 
 
 
 
X 
Informed Consent  
 
X 
 
 
 
 
 
 
Medication & Medical Hx 
 
 
 
 
 
 
 
X 
Chiropractic Examination 
 
 
X 
 
 
 
 
 
Enrollment 
 
 
X 
 
 
 
 
 
RMDQ (back disability) 
 
X 
 
 
X 
 
X 
 
Brief Pain Inventory 
 
X 
 
 
X 
 
X 
 
PHQ-9 (depression) 
 
X 
 
 
 
 
X 
 
GAD-7 (anxiety) 
 
X 
 
 
 
 
X 
 
PLC-C (PTSD) 
 
X 
 
 
 
 
X 
 
AUDIT (alcohol) 
 
X 
 
 
 
 
X 
 
PASTOR 
 
 
 
 
 
 
 
 
     DVPRS (pain/QOL) 
 
 
X1 
 
X 
 
X 
 
     Pain Questions 
 
 
X1 
 
X 
 
X 
 
     Body Diagram 
 
 
X1 
 
X 
 
X 
 
     PROMIS Global 
Health 
 
 
X1 
 
X 
 
X 
 
     PROMIS Neuro Pain 
 
 
X1 
 
X 
 
X 
 
     PROMIS Pain Int. 
 
 
X1 
 
X 
 
X 
 
     PROMIS Phys Funct 
 
 
X1 
 
X 
 
X 
 
     PROMIS Fatigue 
 
 
X1 
 
X 
 
X 
 
     PROMIS Sleep 
 
 
X1 
 
X 
 
X 
 
     PROMIS Depression 
 
 
X1 
 
X 
 
X 
 
     PROMIS Anxiety 
 
 
X1 
 
X 
 
X 
 
     PROMIS Emot Dist 
 
 
X1 
 
X 
 
X 
 
     PROMIS Satisfaction 
 
 
X1 
 
X 
 
X 
 
     PROMIS Alcohol 
 
 
X1 
 
X 
 
X 
 
     TBI QOL Headache 
 
 
X1 
 
X 
 
X 
 
     PTSD Screen 
 
 
X1 
 
X 
 
X 
 
     Opioid Use 
 
 
X1 
 
X 
 
X 
 
     Treatment History 
 
 
X1 
 
X 
 
X 
 
     Pain Medication 
 
 
X1 
 
X 
 
X 
 
     Alignment to 
Treatment 
 
 
X1 
 
X 
 
X 
 
STarT Back 
 
 
X1 
 
 
 
X 
 
SF8a (self-efficacy) 
 
 
X1 
 
 
 
X 
 
Back Pain Activities  
 
 
X1 
 
 
 
X 
 
EXPECT (expectations) 
 
 
X1 
 
 
 
 
 
HEAL (non-specific 
effect) 
 
 
X2 
 
 
 
X3 
 
PEG (pain and activity) 
 
 
 
X 
 
X 
 
 

 
24 
1 Measure completed before first treatment. 
2 Measure completed after first treatment. 
3 Measure completed before final visit.  
* Items will be asked of Veterans and confirmed with EHR screening 
 
6.2 
Description of Evaluations  
 
6.2.1 
Screening Evaluation 
 Consenting Procedure 
Informed consent will be obtained in 2 stages. First, veterans interested in 
participating in this pilot study will be asked for a verbal consent to answer initial 
phone screen questions. If a veteran meets initial study eligibility, a second written 
informed consent will be obtained by the project manager, who will be the primary 
study coordinator, when the veteran arrives at BV. The PM will review the informed 
consent documents with the veteran and allow for any questions before the veteran 
voluntarily signs the consent document and HIPAA forms. Current informed consent 
documents will be monitored for correct IRB approval dates and maintained 
according to IRB standards. When the PM is not available, a back-up study 
coordinator will complete phone screens and consent potential participants.  
Electronic Health Record (EHR) Data Extraction  
EHR data will be utilized to provide initial screening information and to confirm 
eligibility criteria. Items collected from the EHR include age, and contact information.  
Screening 
Upon initial interest, veterans will contact the PM for a phone screen to determine 
initial eligibility. After obtaining verbal consent, the phone screen will consist of age 
and medical history pertaining to study eligibility. 
If the veteran meets preliminary eligibility, he or she will be invited to attend a BV. 
Because participants must also be eligible for chiropractic care, an initial chiropractic 
visit must also be scheduled. The BV will not be scheduled until the initial 
chiropractic visit is scheduled. 
The BV will be scheduled up to 10 days before or on the day of the initial chiropractic 
visit, depending on schedule availability. At the BV, veterans will provide written 
informed consent. Upon signing the informed consent document, veterans will 
complete study contact information (preferred address, phone, and emergency 
contacts) and review final eligibility criteria. Enrollment will be completed upon 
chiropractic examination, which determines the final eligibility criterion.  
6.2.2 
Enrollment and Outcome Assessments 
 Enrollment 
Participants will be enrolled into the study after completing an examination performed 
by the DC at the Initial Chiropractic Visit and the PM has reviewed all forms to 
confirm completeness and eligibility. This date will be recorded by the PM as the 
enrollment date. All assessments in the study will use the enrollment date at the 
initial treatment date. 
Adverse Events 
 
 
 
 
X 
 
X 
 
Qualitative Exit Interview 
 
 
 
 
 
 
X 
 

 
25 
 Patient-reported Outcome Measures and Other Assessments 
Patient-reported outcomes will be obtained by participant self-report through 
REDCap a secure web-based direct-entry application; the schedule of data 
collection is shown above. The assessments at baseline and weeks 3, 5, 7 and 10 
will be collected through REDCap with the primary endpoint at 10 weeks from 
enrollment. During the BV the PM will use a password protected, limited access, 
laptop owned by Palmer College of Chiropractic. The information transmitted will be 
encrypted and no data will be stored on the laptop. Baseline interview is completed 
by reading questions to a participant and entering verbal responses to the web 
form. If the participant is eligible after the baseline interview, the PM will log out and 
instruct participant on how to access REDCap to complete the first set of BV 
questionnaires, and participants will receive email invitations which includes a link to 
their REDCap questionnaires for each remaining time point, to be completed on 
their own device.  If a participant cannot complete the questionnaires online at any 
time-point, they may complete them by CATI with the PM. The PM will read the 
questions aloud and enter the verbal responses directly into REDCap. CATIs for or 
week 5 and week 10 will only include the Roland Morris Disability Questionnaire 
and the Brief Pain Inventory. Each data collection instrument is described below 
and included in Appendix N, Study Assessments. 
 
• 
Roland Morris Disability Questionnaire (RMDQ). As in our previous LPB 
studies42-46, we will use the patient self-report modified 24-item version of the 
RMDQ to assess LBP related disability. The RMDQ may be the most common 
and respected assessment instrument in LBP outcomes research. It is a one-
page questionnaire related to low back pain disability with documented reliability 
and validity.47 The RMDQ can discriminate between different forms of treatment 
for back pain, and is sensitive to clinical change. The RMDQ has been chosen 
for a number of clinical trials of LBP treatments for its excellent metric properties, 
ease of use, patient acceptance, and high face validity. 
 
• 
Brief Pain Inventory (BPI) – Short Form: This self-reported instrument will be 
used to assess pain intensity and pain interference. The BPI was developed to 
assess the pain associated with cancer, but is now used for many types of 
pain.89-90 The scored items of the survey includes 4 questions to rate pain 
intensity using a 0-10 numeric rating scale (NRS). The final 7 questions use a 0-
10 NRS to rate how pain interferes with activities of daily life, mood, 
relationships, sleep and enjoyment of life.  
 
• 
Patient Health Questionnaire (PHQ-9): This instrument is self-reported with 
nine items and will be used to assess depressive disorder.52;53 Total scores range 
from 0 to 27 with a score of 10-14 considered to be in the moderate range. It has 
been tested in primary care settings and has a test-retest reliability of 0.81 to 
0.96. Per VA practice, this instrument is delivered by primary care providers 
annually. 
 
• 
Generalized Anxiety Disorder-7 (GAD-7): This instrument is self-reported with 
seven items and will be used to assess generalized anxiety disorder.52;54 At a cut 
off score of 10, it has a sensitivity of 0.89 and specificity of 0.82 for identifying 
patients with GAD in primary care settings. Per VA practice, this instrument is 
delivered by primary care providers annually. 

 
26 
 
• 
PTSD Checklist-Civilian (PCL-C): This 17-item, self-reported instrument will 
assess PTSD.56-58 A total severity score is determined by summing scores from 
each of 17 items. A change of 5-10 points represents the minimum threshold for 
determining treatment response; a 10-20 point change represents a clinically 
significant change in PTSD symptom severity. This instrument is given annually 
in the VA following OEF/OIF (Operation Enduring Freedom/Operation Iraqi 
Freedom) deployment return, then every five years after that. 
 
Note: PHQ-9, GAD-7, and PCL-C are measures used at the ICVAHCS as the 
current standard of care.  
 
• 
Alcohol Use Disorders Identification Test (AUDIT): Developed by the World 
Health Organization (WHO), this 10-item screening questionnaire determines 
harmful or hazardous consumption of alcohol, correctly classifying 95% of people 
as having a clinical diagnosis of an alcohol abuse disorder.55  Per VA practice, 
this instrument is delivered by primary care providers annually. 
 
• 
Pain Assessment Screening Tool and Outcomes Registry (PASTOR): 
PASTOR is a comprehensive, on-line, data collection tool for chronic pain based 
upon the NIH Patient Reported Outcomes Measurement Information System 
(PROMIS) and adopted by the DoD/VA Pain Management Task Force. PASTOR 
contains many of the domains recommended by the NIH Task Force 
recommendations31 for a minimum dataset for cLBP. Specific measures include 
the Defense & Veterans Pain Rating Scale (DVPRS), an enhanced 11-item (0-
10) numeric rating scale (NRS) that improves on standard pain NRS by including 
a Faces Rating Scale component; ‘traffic light’ color-coding system to delineate 
mild, moderate and severe pain; and word descriptors indicating pain perceptual 
experiences and functional limitations from the painful episode, paired with 4, 0-
11 NRS items to quantify the impact of pain on general activity, sleep, mood, and 
stress. PASTOR incorporates PROMIS measures for mental health conditions 
(PTSD, depression, anxiety, anger, and alcohol use), physical and social 
function, fatigue, and pain interference with daily activities to provide graphical 
representation of improvements or declines in patient status that are compared to 
matched US samples on age, race/ethnicity and sex. PASTOR is the ideal 
instrument for accomplishing the parallel goals and functions to “implement and 
effectively use health information technology” and “innovate and strengthen 
methods for researchers to improve measurement of patient-centered outcomes 
of treatments and other interventions for individuals with multiple chronic 
conditions.”48 It provides a 3-page Clinician Report with information on pain 
treatment history and current opioid use and PASTOR takes 20-30 minutes to 
self-administer, and can be completed off-station to fit the Veterans’ work/home 
schedule. Psychometric testing of the DVPRS 2.0 in 307 active duty service 
members and Veterans with acute or chronic pain reported acceptable internal 
consistency reliability and test-retest reliability on the 5-items, with excellent inter-
rater reliability for correctly ordering the pain faces with intensity measures, and 
highly rated superiority of the instrument again other pain rating scales.49 DVPRS 
was significantly correlated with the Pain Disability Questionnaire, Veterans 
RAND-36, and Brief Pain Inventory in VA outpatients.50 
 

 
27 
• 
STarT Back Screening Tool: This is a 9-item, validated tool developed by Keele 
University to be used as a screening tool for patients with low back pain51. It 
stratifies patients based on their prognosis of persistent disabling symptoms and 
allows practitioners to group patients into 3 categories (low, medium, or high risk 
of poor outcome). 
 
• 
Self-Efficacy for Managing Symptoms (SF8a): Developed by PROMIS, this 8-
item, self-reported tool will assess a person’s level of confidence to control their 
symptoms and keep them from interfering with activities. 
 
 
 
• 
Back Pain Activities: These assess self-care strategies were developed from 
previous studies that collected patient-reported self-care activities59;60 utilized at 
baseline and week 10. 
 
• 
EXPECT (Expectations for Complementary and Alternative Medicine 
Treatments): This questionnaire was developed to assess individuals’ 
expectations of treatments for chronic pain.61 
 
• 
Healing Encounters and Attitudes Lists (HEAL): HEAL is a validated item-
bank comprised of 6 domains developed through PROMIS methodology.62 We 
will use HEAL to assess nonspecific factors known to influence patient outcomes, 
including perceptions of the doctor-patient relationship,63-69 treatment 
expectancy,70;71 and positive or negative outlook.72 HEAL will be administered 
after the Initial Chiropractic Visit and during the week before the Week 10 
assessment period.  
 
• 
Pain, Enjoyment, and General Activity (PEG): The PEG is a 3-item tool to 
improve assessment and monitoring of chronic pain. Questions assess average 
pain intensity (P), interference with enjoyment of life (E), and interference with 
general activity (G).73 In future clinical trials, PEG questions will be collected via 
SMS text messaging, which is beyond the scope of this pilot trial. However, this 
will provide the study team with experience using this instrument and is being 
collected at Week 3 and Week 7 to offset the other outcome measures collected 
at Week 5 and Week 10. 
 
• 
Qualitative Exit Interviews: We will conduct a process evaluation using a mixed 
methods approach to assess non-specific treatment factors and stakeholder 
experiences with the study interventions to better understand how site-specific 
variations influence the implementation of chronic pain interventions. Qualitative 
interviews at Week 10 will evaluate how Veterans and clinicians experienced the 
study interventions, assess their perceptions of non-specific treatment effects, 
and gather recommendations for implementation of these services across VA 
settings. The interview will be scheduled at weeks 8-10 of the study or up to two 
months after week 10, depending on when we are able to contact the participant. 
The PM, Dr. Stacie Salsbury (Co-I), or the assistant study coordinator will 
conduct the individual, semi-structured interviews with participants either in 
person or by phone, depending on the participants preferance. Questions are in 
Appendix O Exit Interview Questions. Providers will also be invited to 

 
28 
complete an exit interview after all participants have completed their study 
activities. Dr. Salsbury will train the PM and the assistant study coordinator in a 
standardized interview schedule and interview best practices and provide 
annual/as needed re-trainings to assure adherence to interview protocols. The 
interview schedule will include a section with the identical questions for all 
participants to elicit perceptions of treatment factors and healthcare setting which 
will be modeled upon items from the HEAL instrument. Interviews will be digitally 
audio-recorded, last about 15 minutes in duration, professionally transcribed, and 
assessed for data quality before data analysis. 
 
Compliance, Co-interventions, and Attrition:  
During the course of the study, feasibility metrics will be monitored by the PM and 
the research team. These metrics include processes relating to recruitment, informed 
consent, trial enrollment, treatment scheduling, retention, and communication. 
Protocol quality measures, EHR data extraction, and adequacy of outcome 
measures will also be recorded. See Appendix L, Feasibility Outcomes and 
Appendix M, Feasibility Metrics. 
 
 Randomization 
As this is a single-arm trial, no randomization occurs during this pilot study. 
 
6.2.3 
Blinding 
No blinding of participants occurs during this trial. All health care providers, co-
investigators, and the PM will be blinded to study outcome measures.   
 
6.2.4 
Follow-up Visits 
Because of the pragmatic nature of this pilot study, participants will be scheduled for 
follow-up visits as indicated by their provider. Study assessments will take place 
independently of care visits, but will coincide with weeks of care since study 
enrollment. The following assessments will be collected at the indicated times during 
study participation online. Participants will have a window of one week to complete 
each assessment.   
 
 
6.2.5 
Completion/Final Evaluation 
Upon completion of the week 10 assessments, the PM will contact the participant to 
complete the qualitative exit interview, as described above.  
7. SAFETY ASSESSMENTS  
Chiropractic care includes manually applied therapies including active and passive 
exercise, friction and non-friction based myofascial therapies, and non-thrust joint and 
thrust joint manipulation.  
 
Adverse events from chiropractic care are common and similar to those experienced by 
patients undergoing other manual therapies such as physical therapy or massage. 
Adverse events are usually mild, short lasting, and self-resolving musculoskeletal 

 
29 
symptoms such as stiffness, joint or muscle soreness, and increased or radiating pain in 
the region treated.74 Many adverse events associated with chiropractic care are likely not 
caused by interventions; rather, by normal variations in symptoms inherent to 
musculoskeletal conditions such as neck and back pain.74 Less commonly reported 
adverse events include dizziness, nausea, tinnitus, anxiety, and muscle spasm.75,76 
Serious adverse events associated with chiropractic care are extremely rare. Serious 
adverse events associated with chiropractic care for low back pain are so uncommon 
that population-based risk ratios are unknown.77   
High-velocity spinal manipulation to the cervical spine has been hypothesized to 
increase risk for vertebral artery dissection and stroke due to excessive carotid or 
vertebral artery stretching/kinking. However, cervical spine manipulation results in less 
stretch/strain to the major neck arteries than what occurs during normal range of 
motion.78;79 Several epidemiological studies have consistently shown an equivalent, 
extremely low, risk of suffering a cerebrovascular accident whether or not patients visit a 
primary care practitioner or doctor of chiropractic.80-85 This research strongly suggests 
patients who experience cerebrovascular accidents following chiropractic care most 
likely experience events despite, rather than because of, an intervention.86 
7.1 
Specification of Safety Parameters 
DCs are trained to avoid or modify therapies for patients who exhibit a relative or 
absolute contraindication. An examination will be performed by the DC as part of the 
eligibility determination process. Clinical evaluation will also occurring during each 
chiropractic visit before treatment is delivered. The eligibility exam is designed to identify 
participants with a suspected or confirmed condition that prevents the safe delivery of 
chiropractic care, the need for referral or diagnostic testing. Individuals identified with 
these factors during eligibility examination will be excluded from participation until such a 
time when the comorbid condition, diagnostic evaluation, or alternate treatment is 
resolved or no longer necessary. 
 
As outlined in the Data Safety and Monitoring Plan below, an independent Data and 
Safety Monitoring Committee (DSMC) will provide scientific and ethical oversight for the 
clinical trial. 
7.2 
Methods and Timing for Assessing, Recording, and Analyzing Safety 
Parameters 
We will inquire about adverse events at weeks 5 and 10 using a questionnaire asking 
“Did you experience any discomfort or unpleasant reaction after any of your chiropractic 
treatments?” “Yes” responses will be followed by indicating a category (e.g., increased 
pain, stiffness, muscle weakness, headache). Severity of symptoms will be rated by 
checking one of the following categorical responses: Symptoms did NOT require 
changing or modifying regular activities; Symptoms required modifying regular activities 
or for which treatment is needed; Symptoms required bed rest, lost work, or prevented 
you from regular activities; Life-threatening or required in-patient hospitalization (please 
explain). Duration of symptoms will also be recorded (less than 24 hrs; 24-48 hrs; 48hrs-
1 week; 1-4 weeks; >4 weeks). 
Participants will also be instructed to contact study staff if they experience a change in 
health status or significant pain, discomfort or distress regardless of whether or not they 
believe it may be associated with treatment including after final treatment. Participants 

 
30 
are also asked to inform the PM of any unplanned emergency room or hospitalizations 
for either LBP or mental health issues.   
7.3 
Adverse Events and Serious Adverse Events  
We will define an adverse event (AE) as any untoward health occurrence that may 
present itself during the clinical trial and that may or may not have a causal relationship 
with chiropractic care. We will use the FDA definition of serious adverse event (SAE), 
which is any adverse experience occurring during treatment that results in any of the 
following outcomes: death, a life-threatening adverse experience, in-patient 
hospitalization or prolongation of existing hospitalization, a persistent or significant 
disability/incapacity, or a congenital anomaly/birth defect. Unanticipated Problems 
Involving Risk to Subjects or Others (UPIRSOs) are similar in that they are unexpected, 
related or possibly related to participation in the research and may involve a greater risk 
of harm. Events not meeting the criteria for immediate reporting will be submitted to the 
IRBs in summary format during the annual continuing review. All SAEs and UPIRSOs 
will be reported according to VA and/or IRB requirements. 
7.4 
Reporting Procedures 
Adverse events meeting IRB reporting criteria will be communicated to each respective 
IRB. Additionally, all adverse events that may have an effect on the safety or rights of 
study volunteers will be reported to the DSMC as required. Events not meeting the 
criteria for immediate reporting will be submitted to the IRBs in summary format during 
the annual continuing review. All SAEs and UPIRTSOs will be reported according to VA 
and/or IRB requirements. 
7.5 
Follow-up for Adverse Events 
The PM will follow-up by phone when participant answers indicate “symptoms were life-
threatening or required in-patient hospitalization” on the questionnaire (Appendix P) 
inquiring about discomfort or unpleasant reactions from treatment. The PM will also 
follow-up by phone with any participants that reported any hospital admission or ER visit 
for LBP or mental health conditions. The PM will collect information regarding AE’s. The 
senior clinician will grade each event and report as necessary. 
7.6 
Safety Monitoring  
An NIH/NCCIH approved DSMC will consist of individuals independent of the 
participating sites. Members will have expertise in chiropractic, medicine, psychiatry, 
epidemiology, clinical trials and biostatistics. The DSMC will meet at least twice per year 
either in person or by teleconference. The DSMC will approve the pilot study protocol, 
informed consent document, and human research participant protection procedures 
before trial implementation. To monitor trial data, the DSMC will review status reports 
prepared by the trial biostatistician that include recruitment accrual; enrolled participant 
baseline characteristics and other enrollment data; follow-up assessment completion; 
treatment compliance; protocol deviations and other clinical trial data. To monitor 
participant safety, the DSMC will review reportable adverse events every six months and 
will assess any serious adverse events upon report receipt. This pilot study will have an 
annual Research Compliance Officer (RCO) review. 

 
31 
8. INTERVENTION DISCONTINUATION  
Given the nature of the intervention under study, no formal stopping rules will be used. 
The DSMC will make recommendations to the PI and funding agency regarding study 
progress, termination, or trial modifications. Interventions may be discontinued if 
recommended by their treating clinician. In addition, Participants are able to discontinue 
interventions at any time for any reason.  
9. STATISTICAL CONSIDERATIONS  
9.1 
General Design Issues  
This pilot study is a single-arm clinical trial. The primary objectives (See Appendix L, 
Feasibility Outcomes) are to evaluate the feasibility, safety and acceptability of an 
integrative care pathway that includes chiropractic care, for the coordinated care for 
Veterans Administration (VA) patients with chronic low back pain (cLBP), with an 
emphasis on those with mental health comorbidity, in preparation for the conduct of 
an appropriately powered multi-site randomized controlled trial (RCT). The secondary 
objectives are to collect study outcomes at the baseline visit (BV) and at weeks 3, 5, 
7, and 10 to: 1) assess the success of collecting outcomes; 2) determine the outcome 
measures to use in a future RCT; and 3) determine preliminary intervention effect 
sizes and variability to aid in sample size determination for a future RCT. 
All participants will be asked to complete study outcomes (See Appendix N, Study 
Assessments) which include the Roland Morris Disability Questionnaire (RMDQ), 
Brief Pain Inventory (BPI), as well as the Patient Health Questionnaire-9 (PHQ-9), 
Generalized Anxiety Disorder 7-item Scale (GAD-7), Post-traumatic Stress Disorder 
Checklist-Civilian Version (PLC-C), Alcohol Use Disorders Identification Test (AUDIT), 
Keele Start Back Screening Tool (STarT Back), self-care behaviors, Healing 
Encounters and Attitudes Lists (HEAL), Expectations for Complementary and 
Integrative Treatments Questionnaire (EXPECT), and Pain Intensity, Enjoyment of 
Life, General Activity Assessment Tool (PEG) questionnaires, and the Pain 
Assessment Screening Tool and Outcomes Registry (PASTOR) assessment, which 
includes measures LBP intensity and interference as measured by the Defense and 
Veterans Pain Rating Scale (DVPRS), pain, disability, mental health, quality of life 
enjoyment and satisfaction. 
9.2 
Sample Size  
Chronic pain and mental health conditions can be widespread across Veterans of all 
ages. Because of this, we plan to recruit 40 Veterans 18 and older with cLBP who may 
or may not have any mental health conditions. 
9.3  
Definition of Populations 
This section is not applicable as this is a pilot, single-arm trial. 
9.4 
Interim Analyses and Stopping Rules 
This section is not applicable as this is a pilot, single-arm trial. 

 
32 
 9.5 
Outcomes  
 
9.5.1 
Primary Outcome   
The primary objectives of this clinical trial are to evaluate the feasibility, safety 
and acceptability of an integrative care pathway that includes chiropractic care, 
developed through a consensus-based process, for the coordinated care for 
Veterans Administration (VA) patients with chronic low back pain (cLBP), with 
an emphasis on those with mental health comorbidity (see Appendix L).  
• 
Feasibility will be assessed by monitoring recruitment, 
retention, and visit compliance and assessing trial 
management protocols and ability to meet regulatory 
deadlines. 
• 
Safety will be assessed by monitoring Adverse Events (AEs). 
• 
Participant and provider perceptions of the pilot will be 
assessed with a structured, qualitative exit interview. 
 
9.5.2 
Secondary Outcomes   
To collect study outcomes at BV and at weeks 3, 5, 7, and 10 to determine 
preliminary effect sizes. Outcome measures include the Roland Morris 
Disability Questionnaire, BPI, PHQ-9, GAD-7, PLC-C, AUDIT, STarT Back, 
SF8a, self-care behaviors, HEAL, EXPECT, and PEG questionnaires, the 
PASTOR assessment, which includes measures of pain, disability, mental 
health, quality of life and patient satisfaction, and the qualitative exit interview 
(see Appendix N). 
 
9.6 
Data Analyses  
Qualitative data analysis will be conducted using NVIVO software (QSR International 
Pty Ltd., Victoria, Australia). Coding will use inductive and deductive approaches, 
building on the HEAL instrument as an initial codebook. To enhance trustworthiness 
of study findings, Dr. Salsbury and another coder will dual code all transcripts using 
the constant comparative method and thematic content analysis.87 Coders will meet 
for frequent reconciliation to establish and refine the codebook and finalize the 
analysis. Qualitative data will be compared across individuals to understand the 
range, variability, and areas of consensus and divergence on the benefits and 
usefulness of the study interventions for managing cLBP and to understand patient 
perceptions of their VA healthcare environment. 
Quantitative data analysis will be done in SAS/STAT (Release 9.4). We will calculate 
descriptive statistics, including mean, SD, median and interquartile range for numeric 
variables and counts and percents for categorical variables, for all participants overall, 
for each cohort, and by sex and race. This will allow us to estimate effect sizes overall 
and for each cohort. Our primary outcomes are for feasibility as stated in Appendix L; 
there is no need to perform formal data analyses to measure these feasibility 
outcomes 

 
33 
10. DATA COLLECTION AND QUALITY ASSURANCE 
10.1 Data Collection Forms  
Data collection for outcome assessments will be completed by participant self-report 
through REDCap a secure, password protected web-application.  
The Lead Data Manager programed the data collection instruments in REDCap and 
facilitated form testing by users (see more details below). 
10.2 Data Management  
10.2.1 Data Management of Patient-Reported Outcome Assessments  
The Office of Data Management & Biostatistics (ODM) will support data 
management, provide technical support, and execute procedures for data 
security and data quality control, storage and back-up. Data security and 
confidentiality will be carefully monitored. Our data monitoring plan is as follows: 
 
REDCap: Study data will be collected and managed using REDCap electronic 
data capture tools hosted at Palmer College of Chiropractic. REDCap is a 
secure, web-based application designed to support data capture for research 
studies, providing 1) an intuitive interface for validated data entry; 2) audit trails 
for tracking data manipulation and export procedures; 3) automated export 
procedures for seamless data downloads to common statistical packages; and 4) 
procedures for importing data from external sources. 
 
REDCap modules will include patient eligibility checks, participant baseline 
screening questionnaire, participant tracking and report generation. Data entry 
interfaces will be programmed with appropriate participant flow restrictions, 
validation schemes and skip patterns. Password protected logins for project 
personnel will control access to modules and reports within REDCap. REDCap 
will be developed and tested by data-related personnel on a development server 
and then published to the training site for further testing and training by other 
study personnel. After testing is complete the site will be published to the official 
project site that resides on a secure production web server. The Data Core 
Manager and REDCap Administrator will monitor the quality of the web 
applications and related databases, manage change requests and create 
documentation. All participant questionnaires will be administered via the web 
which can be completed at any computer available to the participant. During the 
baseline screening, the participant will confirm an email address that will be used 
to provide secure access on outcome assessments. Data management and 
quality control of web forms will be performed using REDCap’s real-time, web-
based reports.  
 
Web Security: REDCap is secured with Certified Secure Socket Layers (SSL) 
256-bit encryption (RSA 2048), hosted (IIS V10.0) and maintained by Palmer 
College of Chiropractic Information Technology department. It is 21 CFR part 11 
compliant. All data collected via REDCap will be stored on an internal MySQL 
Server 5.7. Palmer servers reside behind a stateful layer 7 hardware firewall with 
permissions determined by Active Directory. Only select study personnel will 

 
34 
have access to project data, which will be backed up nightly to an off-site server. 
Fields will be flagged as patient identifiers within REDCap and removed from 
datasets created for analysis in SAS System for Windows (Release 9.4) by an 
experienced data manager. 
 
Audio recordings: Digital audio recordings will be encrypted at interview and 
transferred per electronic data transfer protocol below. Using approved 
processes we used during the COCOV Aim 1 interviews, digital files will be 
uploaded to a VA-approved professional service for transcription, with final 
transcripts reviewed for identifying information, cleaned, and saved to data 
storage as below.   
 
Data Storage: All data will be stored on a secured internal MySQL Server to 
which only specified ODM personnel will have access. Reports needed to 
facilitate efficient project management will be built in the REDCap report 
modules. Server back-up will be performed nightly by IT. The Windows Server 
environment is password protected with Microsoft Windows Active Directory and 
meets HIPAA standards. The Lead Data Manager will generate, transfer and 
store de-identified datasets on secured servers as requested by the 
Biostatistician. Copies of final datasets, tables, programs, and documentation will 
be burned on encrypted DVDs and securely stored on site within a fireproof safe. 
Standard validation reports will be run after each upload to re-test accuracy of 
queries and database scripts. The Project Manager will save contact information 
for recruitment and study participants on laptop. The entire hard-drive will be 
encrypted using Microsoft BitLocker. All study related data will be kept in secure 
server environment for 3 years from last budgeted expenditure, at which time 
only de-identified data will be stored for data sharing purposes. 
10.2.2 Data Management of EHR Data:  
Members of the Yale Center for Medical Informatics will extract EHR data once a 
month by programmers experienced in acquiring data from the national 
databases of the VA Corporate Data Warehouse (CDW). The data will be 
uploaded into a VA SQL Server database on VA Informatics and Computing 
Infrastructure (VINCI) workspace for secure storage, query and manipulation of 
participant data.  
 
Data Cleaning of EHR Data: Quantitative data sources include electronic “data 
dumps” from the EHR CDW files with multiple records per patient (including 
pharmacy, inpatient and outpatient visits, administrative codes, and laboratory 
pathology results). Each of these sources requires inspection, pre-processing, 
and cleaning prior to data analysis. This process will include: a) Data verification 
– to assure that data type is correct and within defined range; and b) data 
merging and creation of datasets appropriate for analysis (frequently de-
normalization and variable creation).  
 
Gender, race, and zip code of residence will be gathered from the national 
patient care database. Age will be calculated on the date of entry into the study. 
BMI will be calculated from vital signs data height and weight. The presence of 
medical and psychiatric conditions will be based on ICD-9/10 codes. The 
classification of alcohol, drug, and psychiatric disorders using VA data will be 

 
35 
based on previously validated methods. Encounters will be defined using clinic 
stop codes that represent services of interest (e.g. emergency department, pain 
management, physical therapy). Many domains have been mapped to the 
Observational Medical Outcomes Partnership (OMOP) common data model to 
create analyzable variables from the CDW and we will use these as appropriate 
within VINCI CDW environment. 
 
Data Security and Archiving: Security to protect study data include storing data 
on the production database servers maintained by VA VINCI environment, and 
analysis in the VINCI environment with tools such as SAS, R, STATA.  In 
addition, all data will also be backed up to an off-site server on a routine basis. 
This will protect study data in the event of a disk failure or a catastrophe. In 
addition, patient IDs will be removed and a study ID assigned to protect patient 
confidentiality when datasets are created for analysis. 
 
 
10.2.3 Data Utilization of Iowa City VA Patient Records 
Retrospective VA administrative data will be utilized to identify eligible Veterans 
for study invitation. This data exists on VA servers behind password protected 
firewalls accessible to researchers who are listed on the IRB and who have 
completed the annual VA Human Subjects and Privacy Training, as well as VA 
Research Data Security and Privacy Training. The Electronic records containing 
HIPAA protected data (computer files, electronic databases, etc.) and the study 
database will be stored on a server behind the VA firewall. The database folder is 
only accessible to IRB approved research team members. This project data will 
be stored on the server, which is maintained, backed-up, and secured in a locked 
server room by the Iowa City VA’s The Office of Information & Technology 
(OI&T) department. The server can only be accessed by individuals with an 
OI&T-created network account. Data are further secured using network directory 
permissions assigned by OI&T at the direction of the Principal Investigator (PI). 
This ensures that only study personnel with the approval of the PI (in accordance 
with IRB requirements) have access to identifiable human subject/patient data. 
Additionally, files on the network that contain identifiable human subject data are 
password protected, and individuals accessing the server on a client machine are 
instructed to password protect their screen saver in order to maintain data 
security. All data entry and analysis will occur on VA owned servers and desktop 
computers. 
 
10.3 Quality Assurance  
10.3.1 Training 
Project team members will coordinate with VA department administrators to 
identify providers willing to participate in the pilot study (1-2 DCs, 1-2 primary 
care providers, and 1-2 mental health providers) and establish training modules 
during lunch times and presentations on at least two occasions, once prior to 
initial of recruitment and within six weeks of initiation of data collection. The 
format will be similar to that used in the COCOA Clinical Trial.52;88 We will also 
use email to communicate study updates to providers. Training will begin with an 
inter-professional discussion of the background and expertise of team members. 

 
36 
We anticipate that integrative care model training will enable each provider to 
learn how their roles can facilitate MSK and mental health care for common 
patients. At subsequent trainings, we will introduce evidence-based chiropractic 
treatment protocols and the integrative care pathway, including referral 
processes and communication logistics. Training focused on diagnosing and 
triaging mental health conditions will be available to providers through online 
continuing medical education materials provided through the VA. 
  
All key personnel have completed the required education on the protection of 
human research subjects.  For Iowa City personnel, this includes training 
provided by the University of Iowa Human Subjects Office and the Iowa City VA 
Medical Center.  The University of Iowa and Iowa City VAMC require that all 
personnel complete human subjects training before they can engage in a 
research study.  The University of Iowa IRB keeps a database with the training 
records and ensures all Investigators are certified.  The IRB offers a web-based 
training through the CITI Company, or a face-to-face training with IRB 
members.  Both trainings provide a history of ethical guidelines in human 
subjects protections, how federal regulations have evolved, the composition and 
duties of an institutional review board (IRB), the requirements for informed 
consent, the different types of IRB review, and investigator responsibilities.   
10.3.2 Steering Committee  
The study Steering Committee is responsible for coordinating and overseeing the 
day-to-day operation of the clinical trial. Weekly meetings, in person and via 
teleconference, will be held to ensure the study remains on schedule, as well as 
troubleshoot issues and ensure compliance with the study protocol.  Within these 
meetings, the committee will discuss trial progress, data safety monitoring, 
recruitment and IRB communication. If required to address urgent concerns, 
additional meetings will be scheduled. The PM will monitor recruitment; 
assessment completion; protocol deviations and other clinical trial data and 
report this information to the steering committee on a weekly basis. Steering 
Committee members are listed in section 12. 
10.3.3 Metrics 
Progress on feasibility outcomes and feasibility metrics, as outlined in 
Appendices L and M, will be reported and reviewed on a monthly basis.  
10.3.4 Protocol Deviations 
Study events will be classified into three categories: Protocol deviations, protocol 
violations, and unanticipated events. A protocol deviation will be defined as any 
variance in the approved study protocol, criteria or procedure that does not affect 
the participant’s safety, rights, welfare or the integrity of the study and its 
resultant data. Protocol violations are deviations that increase the risk or 
decrease the benefit and/or affect the participant’s rights, safety, welfare and/or 
integrity of the resultant data. Events that do not meet the above definitions but 
may affect the rights, safety, welfare and/or integrity of the resultant data will be 
classified as unanticipated events.   
All study events will be reviewed by the PI at the PCCR. Details of these events 
will be recorded to ensure proper reporting in accordance with all regulatory 

 
37 
bodies. IRB submission of study events will be dictated by the reporting 
requirements for each IRB associated with the study. It is important to note that 
any event that may have an effect on the safety or rights of the volunteer, or the 
integrity of the study will be promptly reported to the DSMC. 
10.3.5 Monitoring 
Data management and quality control monitoring of REDCap will be performed 
by the Lead Data Manager. Automated reports will be viewed by the Lead Data 
Manager and Project Manager to determine if quality improvement actions must 
occur such as improved documentation, protocol revisions or personnel 
retraining. Final project datasets will be assembled by transferring data from 
REDCap to SAS System for Windows (Release 9.4). The Lead Data Manager 
will write and test SAS programs to create datasets as requested by the 
Biostatistician.  
 
11. PARTICIPANT RIGHTS AND CONFIDENTIALITY  
11.1 Institutional Review Board (IRB) Review  
This protocol, the informed consent document (Appendix H), and any subsequent 
modifications will be reviewed and approved by the IRBs responsible for oversight of the 
study, which include the Palmer College of Chiropractic IRB and The University of 
Iowa/Department of Veterans Affairs IRB-03.  
11.2 Informed Consent Forms 
Each participant will sign informed consent and related HIPAA documents before 
participating in study-related activities. The consent form will describe the purpose of the 
study, the procedures to be followed, and the risks and benefits of participation. Upon 
signing, each participant will receive a copy of the consent form and this fact will be 
documented in the participant’s record. In addition, copies of ICD and HIPAA forms will 
be given to ICVAHCS human subjects monitor on an annual basis.  
 
11.3 Participant Confidentiality  
To maintain participants’ confidentiality, all data collected will be stored at Palmer on a 
secured encrypted MySQL Server to which only specified ODM personnel will have 
access. Any reports needed to facilitate efficient project management will be built in the 
REDCap report modules. Server back-up will be performed nightly by IT. The Windows 
Server environment is password protected with Microsoft Windows Active Directory and 
meets HIPAA standards. The Lead Data Manager will generate, transfer and store 
datasets on secured servers as requested by the Biostatistician. Copies of final datasets, 
tables, programs, and documentation will be burned on encrypted DVDs and securely 
stored on site within a fireproof safe. 
A unique system generated participant identification number (PID) will be assigned 
during initial consent. The PID is not linked or derived from any participant related 
information. Identifiable data will be used for contact purposes only during the 
recruitment and study participation phases. After the participant has completed the study 

 
38 
all 18 individually-identifiable information will be removed from study related data 
sources. Only the participant ID will remain as an identifier for data management and 
analysis purposes. 
Any data, forms, reports, audio recordings, and other records that leave the site will be 
identified only by a PID to maintain confidentiality. All records will be kept in a locked file 
cabinet. All computer entry and networking programs will be done using PIDs only. 
Information will not be released without written permission of the participant, except as 
necessary for monitoring by IRB or the NCCIH. All study staff will be trained in 
confidentiality procedures and will receive the required Department of Veterans Affairs 
data security training. Consistent with VA policy, participants’ participation will be 
required to be noted in their medical chart.   
A study issued mobile phone will be used by the project manager to communicate with 
participants. This device will be password protected, with the PM and the Data Core 
Manager being the only persons with the password. Communication will consist of calls 
or text messages, however, participant information such as name and phone number will 
be deleted from the device. No protected health communication will be discussed via 
text message. 
11.4 Study Discontinuation  
The study may be discontinued at any time by the IRB, the NCCIH, or other government 
agencies as part of their duties to ensure that research participants are protected.  
12. COMMITTEES 
Steering Committee Members:  
 
Members of the COCOV Steering Committee include Christine Goertz, DC, PhD, 
Anthony Lisi, DC, Stacie Salsbury, PhD, RN, Robert Vining, DC, Cynthia Long, PhD, 
Robert Wallace, MD, MS, Thad Abrams, MD, MS, Lance Corber, MSITM, and Janice 
Hubbard, DC, MS. 
 
Data and Safety Monitoring Committee: 
An NIH/NCCIH approved DSMC will consist of individuals independent of the 
participating sites. Members have expertise in chiropractic, medicine, psychiatry, 
epidemiology, clinical trials, and biostatistics. The DSMC will meet at least twice per year 
either in person or by teleconference. The DSMC will approve the study protocol, 
informed consent, and human research participant protection procedures before trial 
implementation. To monitor trial data, the DSMC will review status reports prepared by 
the trial biostatistician that include recruitment accrual; enrolled participant baseline 
characteristics and other enrollment data; follow-up assessment completion; treatment 
compliance; study protocol deviations and other clinical trial data. To monitor participant 
safety, the DSMC will review reportable adverse events every six months and will 
assess any serious adverse events upon report receipt. Given the nature of the 
intervention under study, no formal stopping rules will be used. The DSMC will make 
recommendations to the PI and funding agency regarding study progress, termination, or 
trial modifications. 
 

 
39 
13. PUBLICATION OF RESEARCH FINDINGS  
Publication of the results of this trial will be governed by the policies and procedures 
developed by the Steering Committee.  
 
 

 
40 
14. REFERENCES  
 
(1)  Office of the Army Surgeon General. Pain Management Task Force, Final Report, May 
2010.  2010.  
 
(2)  US House of Representatives. Between peril and promise: facing the dangers of VA's 
skyrocketing use of prescription painkillers to treat veterans.  10-10-2013. House 
Committee on Veterans' Affairs, Subcommittee on Health.  
 
(3)  Horowitz S. Treating veterans' chronic pain and mental health disorders: an integrative, 
patient-centered approach. Alternative and Complementary Therapies 2013;19:133-138. 
 
(4)  Barry LC, Guo Z, Kerns RD, Duong BD, Reid MC. Functional self-efficacy and pain-
related disability among older veterans with chronic pain in a primary care setting. Pain 
2003;104:131-137. 
 
(5)  Kerns RD, Otis J, Rosenberg R, Reid MC. Veterans' reports of pain and associations 
with ratings of health, health-risk behaviors, affective distress, and use of the healthcare 
system. J Rehabil Res Dev 2003;40:371-380. 
 
(6)  Cleeland CS, Reyes-Gibby CC, Schall M et al. Rapid improvement in pain management: 
the Veterans Health Administration and the Institute for Healthcare Improvement 
Collaborative. Clin J Pain 2003;19. 
 
(7)  Dobscha SK, Corson K, Flores JA, Tansill EC, Gerrity MS. Veterans Affairs primary care 
clinicians' attitudes toward chronic pain and correlates of opioid prescribing rates. Pain 
Med 2008;9:564-571. 
 
(8)  Lew HL, Otis JD, Tun C, Kerns RD, Clark ME, Cifu DX. Prevalence of chronic pain, 
posttraumatic stress disorder, and persistent postconcussive symptoms in OIF/OEF 
veterans: polytrauma clinical triad. J Rehabil Res Dev 2009;46:697-702. 
 
(9)  Gironda RJ, Clark ME, Massengale JP, Walker RL. Pain among Veterans of Operations 
Enduring Freedom and Iraqi Freedom. Pain Med 2006;7:339-343. 
 (10)  Ginzburg K, Ein-Dor T, Solomon Z. Comorbidity of posttraumatic stress disorder, anxiety 
and depression: A 20-year longitudinal study of war veterans. J Affect Disorders 
2010;123:249-257. 
 (11)  Haskell SG, Gordon KS, Mattocks K et al. Gender differences in rates of depression, 
PTSD, pain, obesity, and military sexual trauma among Connecticut war veterans of Iraq 
and Afghanistan. J Womens Health 2010;19:267-271. 
 (12)  Durai UN, Chopra MP, Coakley E et al. Exposure to trauma and posttraumatic stress 
disorder symptoms in older veterans attending primary care: comorbid conditions and 
self-rated health status. J Am Geriatr Soc 2011;59:1087-1092. 
 (13)  Barry LC, Kerns RD, Guo Z, Duong BD, Iannone LP, Carrington Reid M. Identification of 
strategies used to cope with chronic pain in older persons receiving primary care from a 
Veterans Affairs Medical Center. J Am Geriatr Soc 2004;52:950-956. 

 
41 
 (14)  Bronfort G, Haas M, Evans R, Leininger B, Triano J. Effectiveness of manual therapies: 
the UK evidence report. Chiropr Osteopat 2010;18:3. 
 (15)  Bishop PB, Quon JA, Fisher CG, Dvorak MF. The Chiropractic Hospital-based 
Interventions Research Outcomes (CHIRO) study: a randomized controlled trial on the 

 
42 
effectiveness of clinical practice guidelines in the medical and chiropractic management 
of patients with acute mechanical low back pain. Spine J 2010;10:1055-1064. 
 (16)  Dunn AS, Passmore SR, Burke J, Chicoine D. A cross-sectional analysis of clinical 
outcomes following chiropractic care in veterans with and without post-traumatic stress 
disorder. Military medicine 2009;174:578-583. 
 (17)  Dunn AS, Julian T, Formolo LR, Green BN, Chicoine DR. Preliminary analysis of 
posttraumatic stress disorder screening within specialty clinic setting for OIF/OEF 
veterans seeking care for neck or back pain. J Rehabil Res Dev 2011;48:493-502. 
 (18)  Lisi AJ. Management of Operation Iraqi Freedom and Operation Enduring Freedom 
veterans in a Veterans Health Administration chiropractic clinic: a case series. J Rehabil 
Res Dev 2009;47:1-6. 
 (19)  Dunn AS, Green BN, Formolo LR, Chicoine DR. Chiropractic management for veterans 
with neck pain: a retrospective study of clinical outcomes. J Manipulative Physiol Ther 
2011;34:533-538. 
 (20)  Dunn AS, Green BN, Formolo LR, Chicoine D. Retrospective case series of clinical 
outcomes associated with chiropractic management for veterans with low back pain. 
Journal of rehabilitation research and development 2011;48:927-934. 
 (21)  Gerrits MM, van OP, van Marwijk HW, Penninx BW, van der Horst HE. Pain and the 
onset of depressive and anxiety disorders. Pain 2013. 
 (22)  Campbell LC, Clauw DJ, Keefe FJ. Persistent pain and depression: a biopsychosocial 
perspective. Biol Psychiatry 2003;54:399-409. 
 (23)  Maes M, Yirmyia R, Noraberg J et al. The inflammatory & neurodegenerative (I&ND) 
hypothesis of depression: leads for future research and new drug developments in 
depression. Metab Brain Dis 2009;24:27-53. 
 (24)  Zolnierek KB, Dimatteo MR. Physician communication and patient adherence to 
treatment: a meta-analysis. Med Care 2009;47:826-834. 
 (25)  Verheul W, Sanders A, Bensing J. The effects of physicians' affect-oriented 
communication style and raising expectations on analogue patients' anxiety, affect and 
expectancies. Patient Educ Couns 2010;80:300-306. 
 (26)  Thompson L, McCabe R. The effect of clinician-patient alliance and communication on 
treatment adherence in mental health care: a systematic review. BMC Psychiatry 
2012;12:87. 
 (27)  Di BZ, Harkness E, Ernst E, Georgiou A, Kleijnen J. Influence of context effects on 
health outcomes: a systematic review. Lancet 2001;357:757-762. 
 (28)  Jensen KB, Petrovic P, Kerr CE et al. Sharing pain and relief: neural correlates of 
physicians during treatment of patients. Mol Psychiatry 2013. 

 
43 
 (29)  Wahner-Roedler DL, Vincent A, Elkin PL, Loehrer LL, Cha SS, Bauer BA. Physicians' 
attitudes toward complementary and alternative medicine and their knowledge of specific 
therapies: a survey at an academic medical center. Evid Based Complement Alternat 
Med 2006;3:495-501. 
 (30)  Sandefur R, Febbo TA, Rupert RL. Assessment of knowledge of primary care activities 
in a sample of medical and chiropractic students. J Manipulative Physiol Ther 
2005;28:336-344. 
 (31)  Deyo RA, Dworkin SF, Amtmann D et al. Report of the NIH Task Force on research 
standards for chronic low back pain. J Pain 2014;15:569-585. 
 (32)  Abrams TE, Vaughan-Sarrazin M, Richardson K, Cram P, Rosenthal GE. Patterns of 
illness explaining the associations between posttraumatic stress disorder and the use of 
CT. Radiology 2013;267:470-478. 
 (33)  Michalek AK, Kan D, Prochaska J. Engaging veterans with substance abuse disorders 
into a research trial: success with study branding, networking, and presence. Transl 
Behav Med 2015;5:167-176. 
 (34)  Xia T, Long CR, Gudavalli MR et al. Similar Effects of Thrust and Nonthrust Spinal 
Manipulation Found in Adults With Subacute and Chronic Low Back Pain: A Controlled 
Trial With Adaptive Allocation. Spine (Phila Pa 1976 ) 2016;41:E702-E709. 
 (35)  Devocht JW, Goertz CM, Hondras MA et al. A pilot study of a chiropractic intervention 
for management of chronic myofascial temporomandibular disorder. J Am Dent Assoc 
2013;144:1154-1163. 
 (36)  Dommerholt J, Simons DG. Myofascial Pain Syndrome--Trigger Points. Journal of 
Musculoskeletal Pain 2008;16:333-338. 
 (37)  Simons DG, Travell JG, Simons L. Myofascial pain and Dysfunction: The Trigger Point 
Manual. 1st ed. Baltimore: Williams and Wilkins, 1999. 
 (38)  Fernandez-de-Las-Penas C, Ge HY, Arendt-Nielsen L, Cuadrado ML, Pareja JA. 
Referred pain from trapezius muscle trigger points shares similar characteristics with 
chronic tension type headache. Eur J Pain 2007;11:475-482. 
 (39)  Fernandez-de-Las-Penas C, Ge HY, Alonso-Blanco C, Gonzalez-Iglesias J, Arendt-
Nielsen L. Referred pain areas of active myofascial trigger points in head, neck, and 

 
44 
shoulder muscles, in chronic tension type headache. J Bodyw Mov Ther 2010;14:391-
396. 
 (40)  Nielsen A. Gua sha research and the language of integrative medicine. J Bodyw Mov 
Ther 2009;13:63-72. 
 (41)  Nielsen A, Knoblauch NT, Dobos GJ, Michalsen A, Kaptchuk TJ. The effect of Gua Sha 
treatment on the microcirculation of surface tissue: a pilot study in healthy subjects. 
Explore (NY) 2007;3:456-466. 
 (42)  Devocht JW, Smith DL, Long CR et al. The effect of chiropractic treatment on the 
reaction and response times of special operation forces military personnel: study 
protocol for a randomized controlled trial. Trials 2016;17:457. 
 (43)  Goertz CM, Long CR, Vining RD et al. Assessment of chiropractic treatment for active 
duty, U.S. military personnel with low back pain: study protocol for a randomized 
controlled trial. Trials 2016;17:70. 
 (44)  Goertz CM, Salsbury SA, Vining RD et al. Collaborative Care for Older Adults with low 
back pain by family medicine physicians and doctors of chiropractic (COCOA): study 
protocol for a randomized controlled trial. Trials 2013;14:18. 
 (45)  Wilder DG, Vining RD, Pohlman KA et al. Effect of spinal manipulation on sensorimotor 
functions in back pain patients: study protocol for a randomised controlled trial. Trials 
2011;12:161. 
 (46)  Xia T, Wilder DG, Gudavalli MR et al. Study protocol for patient response to spinal 
manipulation - a prospective observational clinical trial on physiological and patient-

 
45 
centered outcomes in patients with chronic low back pain. BMC Complement Altern Med 
2014;14:292. 
 (47)  Roland M, Fairbank J. The Roland-Morris Disability Questionnaire and the Oswestry 
Disability Questionnaire. Spine 2000;25:3115-3124. 
 (48)  Cook KF, Buckenmaier C, III, Gershon RC. PASTOR/PROMIS (R) pain outcomes 
system: what does it mean to pain specialists? Pain Manag 2014;4:277-283. 
 (49)  Polomano RC, Galloway KT, Kent ML, Brandon-Edwards H, Morales C. Psychometric 
Testing of the Defense and Veterans Pain Rating Scale (DVPRS): A New Pain Scale for 
Military Population. Pain Medicine 2016;17:1505-1519. 
 (50)  Nassif TH, Hull A, Holliday SB, Sullivan P, Sandbrink F. Concurrent validity of the 
Defense and Veterans Pain Rating Scale in VA outpatients. Pain Medicine 
2015;16:2152-2161. 
 (51)  Hill JC, Dunn KM, Lewis M et al. A primary care back pain screening tool: identifying 
patient subgroups for initial treatment. Arthritis Rheum 2008;59:632-641. 
 (52)  Goertz C, Salsbury S, Vining R et al. Collaborative Care for Older Adults with low back 
pain by family medicine physicians and doctors of chiropractic (COCOA): study protocol 
for a randomized controlled trial. Trials 2013;14:18. 
 (53)  Kroenke K, Spitzer R, Williams J. The PHQ-9:validation of a brief depression severity 
measure. J Gen Intern Med 2001;16:606-613. 
 (54)  Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized 
anxiety disorder: the GAD-7. Arch Intern Med 2006;166:1092-1097. 
 (55)  http://www.integration.samhsa.gov/clinical-practice/screening-tools#drugs.  2017.  
 (56)  Wilkins KC, Lang AJ, Norman SB. Synthesis of the psychometric properties of the PTSD 
checklist (PCL) military, civilian, and specific versions. Depression and anxiety 
2011;28:596-606. 
 (57)  Blanchard EB, Jones-Alexander J, Buckley TC, Forneris CA. Psychometric properties of 
the PTSD Checklist (PCL). Behaviour research and therapy 1996;34:669-673. 
 (58)  Keen SM, Kutter CJ, Niles BL, Krinsley KE. Psychometric properties of PTSD Checklist 
in sample of male veterans. Journal of rehabilitation research and development 
2008;45:465-474. 
 (59)  Bodenheimer T, Lorig K, Holman H, Grumbach K. Patient self-management of chronic 
disease in primary care. JAMA 2002;288:2469-2475. 
 (60)  Dannecker EA, Gagnon CM, Jump RL, Brown JL, Robinson ME. Self-care behaviors for 
muscle pain. J Pain 2004;5:521-527. 
 (61)  Jones SM, Lange J, Turner J et al. Development and Validation of the EXPECT 
Questionnaire: Assessing Patient Expectations of Outcomes of Complementary and 

 
46 
Alternative Medicine Treatments for Chronic Pain. J Altern Complement Med 
2016;22:936-946. 
 (62)  Greco CM, Glick RM, Morone NE, Schneider MJ. Addressing the "it is just placebo" 
pitfall in CAM: methodology of a project to develop patient-reported measures of 
nonspecific factors in healing. Evid Based Complement Alternat Med 2013;2013:613797. 
 (63)  Staiger TO, Jarvik JG, Deyo RA, Martin B, Braddock CH. BRIEF REPORT: Patient-
physician agreement as a predictor of outcomes in patients with back pain. J Gen Intern 
Med 2005;20:935-937. 
 (64)  Lærum E, Indahl A, Sture Skouen J. What is "The Good Back-Consultation"? A 
combined qualitative and quantitative study of chronic low bakc pain patients' 
interactions with and perceptions of consultations with specialists. J Rehabil Med 
2006;38:255-262. 
 (65)  Shaw WS, Zaia A, Pransky G, Winters T, Patterson WB. Perceptions of provider 
communication and patient satisfaction for treatment of acute low back pain. J Occup 
Environ Med 2005;47:1036-1043. 
 (66)  Shaw WS, Pransky G, Roter DL, Winters T, Tveito TH, Larson SM. The effects of 
patient-provider communication on 3-month recovery from acute low back pain. J Am 
Board Fam Med 2011;24:16-25. 
 (67)  Farin E, Gramm L, Schmidt E. The patient-physician relationship in patients with chronic 
low back pain as a predictor of outcomes after rehabilitation. J Behav Med 2012;1-13. 
 (68)  Fuentes J, Armijo-Olivo S, Funabashi M, Miciak M, Dick B, Warren S. Enhanced 
therapeutic alliance modulates pain intensity and muscle pain sensitivity in patients with 
chronic low back pain: an experimental controlled study. Phys Ther 2014;94. 
 (69)  Ferreira PH, Ferreira ML, Maher CG, Refshauge KM, Latimer J, Adams RD. The 
therapeutic alliance between clinicians and patients predicts outcome in chronic low 
back pain. Phys Ther 2013;93. 
 (70)  Smeets RJ, Beelen S, Goossens ME, Schouten EG, Knottnerus JA, Vlaeyen JW. 
Treatment expectancy and credibility are associated with the outcome of both physical 

 
47 
and cognitive-behavioral treatment in chronic low back pain. Clin J Pain 2008;24:305-
315. 
 (71)  Kalauokalani D, Cherkin DC, Sherman KJ, Koepsell TD, Deyo RA. Lessons from a trial 
of acupuncture and massage for low back pain: patient expectations and treatment 
effects. Spine (Phila Pa 1976) 2001;26:1418-1424. 
 (72)  Smeets R, Vlaeyen J, Kester A, Knottnerus J. Reduction of pain catastrophizing 
mediates the outcome of both physical and cognitive-behavioral treatment in chronic low 
back pain. J Pain 2006;7:261-271. 
 (73)  Krebs EE, Lorenz KA, Bair MJ et al. Development and initial validation of the PEG, a 
three-item scale assessing pain intensity and interference. J Gen Intern Med 
2009;24:733-738. 
 (74)  Walker BF, Hebert JJ, Stomski NJ et al. Outcomes of Usual Chiropractic. The OUCH 
Randomized Controlled Trial of Adverse Events. Spine (Phila Pa 1976 ) 2013;38:1723-
1729. 
 (75)  Hurwitz EL, Morgenstern H, Vassilaki M, Chiang LM. Frequency and clinical predictors 
of adverse reactions to chiropractic care in the UCLA neck pain study. Spine (Phila Pa 
1976) 2005;30:1477-1484. 
 (76)  Cagnie B, Vinck E, Beernaert A, Cambier D. How common are side effects of spinal 
manipulation and can these side effects be predicted? Man Ther 2004;9:151-156. 
 (77)  Johnson C, Rubinstein SM, Cote P et al. Chiropractic care and public health: answering 
difficult questions about safety, care through the lifespan, and community action. J 
Manipulative Physiol Ther 2012;35:493-513. 
 (78)  Herzog W, Leonard TR, Symons B, Tang C, Wuest S. Vertebral artery strains during 
high-speed, low amplitude cervical spinal manipulation. J Electromyogr Kinesiol 2012. 
 (79)  Herzog W, Tang C, Leonard T. Internal Carotid Artery Strains During High-Speed, Low-
Amplitude Spinal Manipulations of the Neck. J Manipulative Physiol Ther 2012. 
 (80)  Whedon JM, Song Y, MacKenzie TA, Phillips RB, Lukovits TG, Lurie JD. Risk of Stroke 
After Chiropractic Spinal Manipulation in Medicare B Beneficiaries Aged 66 to 99 Years 
With Neck Pain. J Manipulative Physiol Ther 2015. 
 (81)  Cassidy JD, Boyle E, Cote P, Hogg-Johnson S, Bondy SJ, Haldeman S. Risk of Carotid 
Stroke after Chiropractic Care: A Population-Based Case-Crossover Study. J Stroke 
Cerebrovasc Dis 2016. 
 (82)  Cassidy JD, Boyle E, Cote P et al. Risk of vertebrobasilar stroke and chiropractic care: 
results of a population-based case-control and case-crossover study. Spine 
2008;33:S176-S183. 
 (83)  Boyle E, Cote P, Grier AR, Cassidy JD. Examining vertebrobasilar artery stroke in two 
Canadian provinces. Spine 2008;33:S170-S175. 

 
48 
 (84)  Church EW, Sieg EP, Zalatimo O, Hussain NS, Glantz M, Harbaugh RE. Systematic 
Review and Meta-analysis of Chiropractic Care and Cervical Artery Dissection: No 
Evidence for Causation. Cureus 2016;8:e498. 
 (85)  Kosloff TM, Elton D, Tao J, Bannister WM. Chiropractic care and the risk of 
vertebrobasilar stroke: results of a case-control study in U.S. commercial and Medicare 
Advantage populations. Chiropr Man Therap 2015;23:19. 
 (86)  Futch D, Schneider MJ, Murphy D, Grayev A. Vertebral artery dissection in evolution 
found during chiropractic examination. BMJ Case Rep 2015;2015. 
 (87)  Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health 
Res 2005;15:1277-1288. 
  (88)  Goertz C, Salsbury S, Vining R et al. Development of an interprofessional model of 
collaborative care by doctors of chiropractic and medical doctors for older adults with low 
back pain [abstract]. BMC Complem Altern M 2012;12:262. 
 (89)  El-Den S, Chen TF, Gan YL, Wong E, O'Reilly CL. The psychometric properties of 
depression screening tools in primary healthcare settings: A systematic review. J Affect 
Disord. 2018;225:503-22. 
  (90)  Muñoz-Navarro R, Cano-Vindel A, Moriana JA, Medrano LA, Ruiz-Rodríguez P, Agüero-
Gento L, et al. Screening for generalized anxiety disorder in Spanish primary care 
centers with the GAD-7. Psychiatry Res. 2017;256:312-7.  
  (91)  Takahashi T, Lapham G, Chavez LJ, Lee AK, Williams EC, Richards JE, et al. 
Comparison of DSM-IV and DSM-5 criteria for alcohol use disorders in VA primary care 
patients with frequent heavy drinking enrolled in a trial. Addict Sci Clin Pract. 
2017;12(1):17. 
  (92)  Wortmann JH, Jordan AH, Weathers FW, Resick PA, Dondanville KA, Hall-Clark B, et al. 
Psychometric analysis of the PTSD Checklist-5 (PCL-5) among treatment-seeking 
military service members. Psychol Assess. 2016;28(11):1392-403. 
15. SUPPLEMENTS/APPENDICES 
 
Refer to attached pdf