Integrated Supported Biopsychosocial Self-Management for Back Related Leg Pain
Phase: NA
Conditions: Low Back Pain, Sciatica, Back Related Leg Pain, Pain, Chronic, Intervertebral Disc Displacement
Sponsor: University of Minnesota

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SUPPORT Study Protocol V3 May 2022 
Integrated Supported Biopsychosocial Self-Management for Back 
Related Leg Pain (SUPPORT trial) 
 
 
Principal Investigators: 
 
Brent Leininger DC, MS 
Co-Principal Investigator and Contact PI, Clinical Coordinating Center 
Earl E. Bakken Center for Spirituality & Healing 
University of Minnesota, Mayo Memorial Building C504 
420 Delaware Street, Minneapolis, MN 55414 
 
Gert Bronfort PhD, DC 
Co-Principal Investigator, Clinical Coordinating Center 
Earl E. Bakken Center for Spirituality & Healing 
University of Minnesota, Mayo Memorial Building C504 
420 Delaware Street, Minneapolis, MN 55414 
 
Phone: 612-626-6477 
Email: supportstudy@umn.edu 
 
Supported by: 
The National Center for Complementary and Integrative Health 
Grant # R34AT011209 
NCT # NCT05022121 
V2 October 2021: 11/16/2021 
V3 May 2022: 5/24/2022 
V4 July 2022: 7/18/2022 
 
 

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SUPPORT Study Protocol V3 May 2022 
 
 
Table of Contents: 
STUDY PROTOCOL REVISIONS 
7 
STUDY TEAM ROSTER 
7 
PARTICIPATING STUDY SITES 
12 
1. STUDY OBJECTIVES 
14 
1.1. 
Aim One 
14 
1.2. 
Aim Two 
14 
1.3. 
Supplemental Aims 
15 
2. BACKGROUND AND RATIONALE 
15 
2.1. 
Background on Condition, Disease, or Other Primary Study Focus 
15 
2.2. 
Preliminary Studies 
22 
2.3. 
Study Rationale 
23 
3. STUDY DESIGN 
24 
3.1. 
Rationale for Study Design 
24 
3.2. 
Rationale for Supplemental Aims 
25 
3.2. 
Sampling, Target Population, & Location 
26 
3.3. 
Covid-19 Impact on Trial Conduct 
26 
4. SELECTION AND ENROLLMENT OF PARTICIPANTS 
26 
4.1. 
Inclusion Criteria 
26 
4.2. 
Exclusion Criteria 
27 
4.3. 
Study Enrollment Procedures 
27 
5. STUDY INTERVENTIONS 
29 
5.1. 
Interventions, Administration and Duration 
29 
5.1.1. 
Supported Self-Management (SSM) - Experimental Intervention 
29 
5.1.2. 
Medical Care (MC) - Comparison Intervention 
31 
5.2. 
Handling of Study Interventions 
33 
5.2.1. 
Supported Self-Management (SSM) - Experimental Intervention 
33 
5.2.1.1. Required Interventions 
33 
5.2.1.2. Allowed Interventions 
34 
5.2.1.3. Prohibited Intervention 
35 

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SUPPORT Study Protocol V3 May 2022 
5.2.2. 
Medical Care (MC) - Comparison Intervention 
35 
5.2.2.1. Required Interventions 
35 
5.2.2.2. Allowed Interventions 
35 
5.2.2.3. Prohibited Interventions 
35 
5.3. 
Concomitant Interventions 
36 
5.3.1. 
Required Interventions 
36 
5.3.2. 
Allowed Interventions 
36 
5.3.3. 
Prohibited Interventions 
37 
5.4. 
Adherence Assessment 
37 
5.5. 
Intervention Fidelity 
37 
6. STUDY PROCEDURES 
37 
6.1. 
Schedule of Evaluations 
37 
6.2. 
Description of Evaluations 
39 
6.2.1. 
 Pilot Study Screening Evaluations 
39 
6.2.2 
Enrollment, Baseline, and/or Randomization 
42 
6.2.3. 
Blinding 
43 
6.2.4 
Follow-up Visits 
44 
6.2.5. 
Compensation 
46 
7. SAFETY ASSESSMENTS 
47 
7.1. 
AEs and SAEs, Expectedness, and Relatedness- Definitions 
47 
7.2 
Adverse Event Identification 
48 
7.3 
Follow-up for Adverse Events 
49 
7.4 
Reporting Procedures 
49 
7.5. 
Known Expected Risks 
50 
7.6. 
Safety Monitoring 
52 
7.7. 
Potential Benefits 
52 
8. INTERVENTION DISCONTINUATION 
52 
9. STATISTICAL CONSIDERATIONS 
53 
9.1. 
General Design Issues 
53 
9.2. 
Sample Size 
54 
9.3. 
Treatment Assignment Procedures 
54 
9.4. 
Outcomes 
54 

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SUPPORT Study Protocol V3 May 2022 
9.4.1. 
Primary Outcomes 
54 
9.4.2. 
Secondary Outcomes 
55 
9.4.3. 
Qualitative Data 
56 
9.5. 
Data Analyses 
56 
10. DATA COLLECTION AND QUALITY ASSURANCE 
57 
10.1. 
Data Collection Forms 
57 
10.2. 
Data Management 
57 
10.2.1. Data security and storage 
57 
10.3. 
Quality Assurance and Control 
58 
10.3.1. 
Quality Assurance 
58 
10.3.2. 
Training 
58 
10.3.3. 
Quality Control Committee 
58 
10.3.4. 
Metrics 
58 
10.3.5. 
Protocol Deviations 
59 
10.3.6. 
Monitoring 
60 
11. PARTICIPANT RIGHTS AND CONFIDENTIALITY 
61 
11.1. 
Institutional Review Board (IRB) Review 
61 
11.2 
Informed Consent Forms 
61 
11.3 
Participant Confidentiality 
61 
11.4. 
Study Discontinuation 
62 
12. COMMITTEES 
62 
13. STUDY TIMELINE 
63 
14. PUBLICATION OF RESEARCH FINDINGS & FUTURE RESEARCH 
63 
15. REFERENCES 
64 
 
 
 
 
 
 
 

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SUPPORT Study Protocol V3 May 2022 
ABBREVIATIONS 
AE 
 
 
Adverse Event 
BCTs  
 
Behavioral Change Techniques 
BCW  
 
Behavior Change Wheel  
BRLP  
 
Back Related Leg Pain 
BPS  
 
Biopsychosocial 
CNP  
 
Certified Nurse Practitioner 
Co-I 
 
 
Co-Investigator 
Co-PI  
 
Co-Principal Investigator 
COM-B 
 
Capability, Opportunity, and Motivation – Behavior system 
CRF  
 
Case Report Form 
CTSI  
 
Clinical Translational Sciences Institute  
CV 
 
 
Curriculum Vitae 
DC 
 
 
Doctor of Chiropractic 
DNP  
 
Doctor of Nursing Practice 
DEA  
 
Drug Enforcement Administration 
ER 
 
 
Emergency Room 
HEAL  
 
Healing Encounters and Attitudes Lists  
HE 
 
 
Home Exercise 
IRB 
 
 
Institutional Review Board 
JD 
 
 
Juris Doctor 
LBP 
 
 
Low Back Pain 
M 
 
 
Month 
MA 
 
 
Master or Arts 
MBA  
 
Master of Business Administration  
MBR  
 
Multidisciplinary biopsychosocial rehabilitation  
MC 
 
 
Medical Care 
MD 
 
 
Medical Doctor 
MCISc 
 
Master of Clinical Science  
MN 
 
 
Minnesota 
MOP  
 
Manual of Operations 
MS 
 
 
Master of Science 
NCCIH 
 
National Center for Complementary and Integrative Health 
NIH 
 
 
National Institutes of Health 
NSAIDs 
 
Non-Steroidal Anti-inflammatory Drugs 
OTC  
 
Over-The-Counter 
PA 
 
 
Pennsylvania 
PhD  
 
Doctor of Philosophy 
PI 
 
 
Principal Investigator 
PROMIS 
 
Patient-Reported Outcomes Measurement Information System 
PT 
 
 
Physical Therapist 
QTF  
 
Quebec Task Force 
RCT  
 
Randomized Clinical Trial 
RMDQ 
 
Roland Morris Disability Questionnaire 
RN 
 
 
Registered Nurse 
RNI 
 
 
Report of New Information 

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SUPPORT Study Protocol V3 May 2022 
Rx 
 
 
Prescription 
SAE  
 
Serious Adverse Event 
SARP  
 
Study Accrual and Retention Plan 
SMT  
 
Spinal Manipulation Therapy 
SSM  
 
Supported Self-Management 
SUPPORT 
 
Biopsychosocial Self-Management for Back Related Leg Pain trial 
TIDieR 
 
Template for intervention description and replication 
UMN  
 
University of Minnesota 
W 
 
 
Week 
 
 

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SUPPORT Study Protocol V3 May 2022 
STUDY PROTOCOL REVISIONS 
Protocol 
Version 
Number 
Revision 
Date 
Summary of Changes 
Protocol Section(s) 
V2 
October 
2021 
Updated study personnel; Clarified that the 
collaborative development between the study 
provider and participant of an individualized SSM 
treatment plan is a standard element of the SSM 
intervention; Removed BRLP knowledge assessment 
for participants and the Pain Attitudes and Beliefs 
Scale for study providers.  
Study team roster; 
Study interventions 
(5.2.1); Study 
procedures (6.2) and 
Study outcomes (9.2) 
V3 
April 
2022 
Updated study personnel; Added supplemental study 
aims funded via administrative supplement in 
addition to methods for completing the supplemental 
aims; Reduced number of assessments for SSM 
related measures; updated participating sites. 
Study team roster; 
Study Objectives (1.3); 
Background and 
Rationale (2.0); 
Rationale for Study 
Design (3.2); Selection 
and Enrollment of 
Participants (4.1-4.3); 
Study procedures (6.1; 
6.2.2); Compensation 
(6.2.5); Known 
Expected Risks (7.5); 
Qualitative Data 
(9.4.3); Study timeline 
(13.0) 
V4 
July 
2022 
Increased the potential number of enrolled 
participants for the primary study aims 
Rationale for Study 
Design (3.1); 
Enrollment, Baseline, 
and/or Randomization 
(6.2.2); Statistical 
Considerations (9.1); 
Study Timeline (13) 
 
 
 
 
 
 
STUDY TEAM ROSTER 
Investigator Team- University of Minnesota 
Brent Leininger, DC, MS 
Co-Principal Investigator & Contact PI 
Earl E. Bakken Center for Spirituality & Healing 
University of Minnesota, Mayo Memorial Building C504 
420 Delaware Street, Minneapolis, MN 55414 
Phone: (612) 301-9007 
Email: lein0122@umn.edu 
 
Gert Bronfort, DC, PhD 
Co-Principal Investigator  
Earl E. Bakken Center for Spirituality & Healing 

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SUPPORT Study Protocol V3 May 2022 
University of Minnesota, Mayo Memorial Building C504 
420 Delaware Street, Minneapolis, MN 55414 
Phone: (952) 905-8554 
Email: bronf003@umn.edu 
 
John Connett, PhD 
Co-Investigator 
Biostatistics, Epidemiology and Research Design 
Clinical and Translational Science Institute 
University of Minnesota 
717 Delaware Street SE, 2nd Floor, Minneapolis, MN 5455 
Phone: (612) 626-9010  
Email: john-c@ccbr.umn.edu 
 
Roni Evans, DC, MS, PhD 
Co-Investigator  
Earl E. Bakken Center for Spirituality & Healing 
University of Minnesota, Mayo Memorial Building C504 
420 Delaware Street, Minneapolis, MN 55414 
Phone: (612) 301-9004 
Email: evans972@umn.edu 
 
Linda Hanson, DC, MS 
Co-Investigator 
Earl E. Bakken Center for Spirituality & Healing 
University of Minnesota, Mayo Memorial Building C504 
420 Delaware Street, Minneapolis, MN 55414 
Phone: (612) 626-6477 
Email: hans4236@umn.edu 
 
Craig Schulz, DC, MS 
Co-Investigator  
Earl E. Bakken Center for Spirituality & Healing 
University of Minnesota, Mayo Memorial Building C504 
420 Delaware Street, Minneapolis, MN 55414 
Phone: (612) 301-9003 
Email: schu1385@umn.edu 
 
Investigator Team-University of Pittsburgh 
Carol Greco PhD 
Co-Investigator 
Department of Psychiatry 
University of Pittsburgh School of Medicine 
580 S. Aiken Avenue, Suite 310 
Pittsburgh, PA 15232 
Phone: (412) 623-3023 

9 
SUPPORT Study Protocol V3 May 2022 
Email: grecocm@upmc.edu 
 
Michael Schneider DC, PhD 
Co-Investigator 
School of Health and Rehabilitation Sciences 
University of Pittsburgh Bridgeside Point 1 
100 Technology Drive, Suite 210, Pittsburgh, PA 15219 
Phone: (412) 383-6640 
Email: mjs5@pitt.edu 
 
Research Staff 
Oliver Ang, PT, MCISc 
Physical Therapist 
Earl E. Bakken Center for Spirituality & Healing 
University of Minnesota, Mayo Memorial Building C504 
420 Delaware Street, Minneapolis, MN 55414 
Email: ang00005@umn.edu 
 
John Jodzio, BA 
Research Administrator 
Earl E. Bakken Center for Spirituality & Healing 
University of Minnesota, Mayo Memorial Building C504 
420 Delaware Street, Minneapolis, MN 55414 
Phone: (612) 301-9006 
Email: jodz0001@umn.edu 
 
Alex Haley, JD, MBA 
Research Staff  
Earl E. Bakken Center for Spirituality & Healing 
University of Minnesota, Mayo Memorial Building C504 
420 Delaware Street, Minneapolis, MN 55414 
Phone: (612) 624-9459 
Email: haley045@umn.edu 
 
Douglas Kennedy, PhD 
Research Staff 
Earl E. Bakken Center for Spirituality & Healing 
University of Minnesota, Mayo Memorial Building C504 
420 Delaware Street, Minneapolis, MN 55414 
Phone: (612) 625-6946 
Email: kenne829@umn.edu 
 
Heidi Mendenhall, DC, MS, DACBR 
Project Manager Assistant/Chiropractor 
Earl E. Bakken Center for Spirituality & Healing 
University of Minnesota, Mayo Memorial Building C504 

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SUPPORT Study Protocol V3 May 2022 
420 Delaware Street, Minneapolis, MN 55414 
Phone: (612)-626-6477 
Email: hmendenh@umn.edu 
 
Amy Perkins NP-F 
Nurse Practitioner 
Earl E. Bakken Center for Spirituality & Healing 
University of Minnesota, Mayo Memorial Building C504 
420 Delaware Street, Minneapolis, MN 55414 
Phone: 952-288-3031 
Email: perkinsa@umn.edu 
 
Carly Thiner NP-F 
Nurse Practitioner 
Earl E. Bakken Center for Spirituality & Healing 
University of Minnesota, Mayo Memorial Building C504 
420 Delaware Street, Minneapolis, MN 55414 
Phone: 952-836-5559 
Email: deboe086@umn.edu 
 
Don Thorpe, DC 
Chiropractor 
Earl E. Bakken Center for Spirituality & Healing 
University of Minnesota, Mayo Memorial Building C504 
420 Delaware Street, Minneapolis, MN 55414 
Phone: (903) 821-6893 
Email: thorp167@umn.edu 
 
Blong Vang, DC 
Chiropractor 
Earl E. Bakken Center for Spirituality & Healing 
University of Minnesota, Mayo Memorial Building C504 
420 Delaware Street, Minneapolis, MN 55414 
Phone: (651) 210-9657 
Email: leex0298@umn.edu  
  
Jennifer “Jenny” Walter, MScN, APRN, CNP 
Earl E. Bakken Center for Spirituality & Healing 
University of Minnesota, Mayo Memorial Building C504 
420 Delaware Street, Minneapolis, MN 55414 
Phone: 612-710-9176 
Email: jhague@umn.edu 
 
Lynn Winkel DC 
Earl E. Bakken Center for Spirituality & Healing 
University of Minnesota, Mayo Memorial Building C504 

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SUPPORT Study Protocol V3 May 2022 
420 Delaware Street, Minneapolis, MN 55414 
Phone: 218-340-6436 
Email: lwinkel@umn.edu 
 
 
Consultants 
Ronald Glick, MD  
Associate Professor, Departments of Psychiatry and 
Physical Medicine & Rehabilitation 
University of Pittsburgh School of Medicine 
580 S. Aiken Avenue, Suite 310 
Phone: (412) 623-1611 
Email: glickrm@upmc.edu 
 
Francis Keefe PhD 
Department of Medicine 
2200 W Main St., Suite 340, Durham, NC 27705 
Phone (919) 416-3400 
Email: keefe003@mc.duke.edu 
 

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SUPPORT Study Protocol V3 May 2022 
PARTICIPATING STUDY SITES 
 
University of Minnesota-Twin Cities 
Integrative Health & Wellbeing Research Institute 
Earl E. Bakken Center for Spirituality & Healing 
University of Minnesota, Mayo Memorial Building C504 
420 Delaware Street, Minneapolis, MN 55414 
 
University of Minnesota Urban Research and Outreach Engagement Center (UROC) 
2001 Plymouth Ave N 
Minneapolis, MN 55411 
https://uroc.umn.edu/ 
 
All research activities will be conducted by University of Minnesota researchers and 
staff. Research activities will occur at the following location through a business use 
agreement: 
 
The Berman Center for Outcomes & Clinical Research, 
825 South 8th Street, Suite #440  
Minneapolis, MN 55404 
http://bermancenter.org/ 
 
The University of Minnesota will serve as the sole clinical site for this research and will 
assume the following responsibilities: 
 
● Design and develop the protocol, manual of operations, informed consent and case 
report forms.  
● Collect and maintain critical regulatory documents from affiliated investigators, e.g. 
resume/CV, medical/clinical license, certification of completion of training, signed COI 
disclosure forms 
● Store and/or manage data, data analysis, and data and monitoring activities 
● Ensure informed consent is obtained and documented from each subject in 
compliance with federal regulations 
● Recruitment, screening, and enrollment of participants 
● Protection of participants’ rights  
● Provide study specific training to the research personnel  
● Develop and coordinate randomization scheme and process  
● Monitor compliance with protocol and track deviations from the study protocol 
● Track, report, and maintain documentation of all serious adverse events and 
unanticipated problems and disseminating the information to appropriate oversight 
boards 
● Provide periodic updates to affiliated investigators on subject enrollment, general 
study progress, and relevant scientific advances  
● Develop and maintain the MOP  
● Retention of specific records (e.g., original consent) 

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SUPPORT Study Protocol V3 May 2022 
● Development of the data flow and data management procedures, including data entry, 
error identification, and correction  
● AE monitoring and reporting 
● Quality control procedures  
● Generating and disseminating reports (e.g., enrollment, AEs, participant status, site 
performance, quality control) 
 

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SUPPORT Study Protocol V3 May 2022 
1. STUDY OBJECTIVES 
Our long-term objective is to shift the current paradigm away from unimodal, symptom-
based care, to an individualized, whole person, behavioral targeted approach for BRLP. 
In response to current evidence gaps, we are conducting a pilot study to assess the 
feasibility of a future phase II multi-site randomized clinical trial (RCT). Informed by our 
previous and ongoing research20 the Integrated SUPPORTed Biopsychosocial Self-
Management for Back Related Leg Pain trial will assess the comparative effectiveness of 
a novel supported self-management (SSM) intervention delivered by PTs or DCs versus 
Medical Care (MC). Importantly, our team has a unique opportunity to leverage 
recruitment from our ongoing clinical trial (NCCIH UH3AT008769), which excludes a large 
number of chronic BRLP patients. The R34 aims are:  
 
1.1. 
Aim One 
To conduct a Planning Phase to develop detailed protocols, train personnel, and secure 
regulatory approvals. We will place special emphasis on working with DCs and PTs to 
provide competency-based training in the SSM intervention. SSM focuses on whole 
person care delivery, and integrates psychosocial strategies (e.g. progressive muscle 
relaxation, relaxed breathing, guided imagery, pacing, relaxation, problem solving, 
cognitive restructuring, interpersonal communication) with physically oriented ones (e.g. 
exercises, SMT) specifically for chronic BRLP.  
 
1.2. 
Aim Two 
To assess feasibility of the SUPPORT trial through achievement of pre-specified targets 
for:   
a. Recruiting and enrolling individuals with chronic BRLP by assessing recruitment 
rates 
(screens/month; 
% 
women 
and 
minorities); 
enrollment 
rates 
(participants/month; % women and minorities); and screened participants’ views 
and perspectives (identification of barriers and facilitators for research 
participation) 
 
b. Delivering experimental and comparison interventions by assessing acceptability 
and adherence (% never receiving treatment; % receiving prohibited treatments 
during intervention phase); % attending required sessions; % participating in home 
practice and taking medications as directed; % satisfied with treatment); provider 
intervention fidelity rates (% of required activities delivered) and participant and 
provider views (barriers and facilitators to engaging in/providing interventions; 
views regarding affordability, practicality, effectiveness, acceptability, and equity) 
 
c. Data collection by assessing follow up rates of future clinical trial outcome 
measures (% of complete assessments at 12 weeks and six months, in addition to 
% of completed weekly pain surveys) 
 

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SUPPORT Study Protocol V3 May 2022 
1.3. 
Supplemental Aims 
In addition to the primary aims, NCCIH approved the following supplemental aims as part 
of the parent R34 pilot study. These aims address the original objective of assessing the 
feasibility of a future phase II RCT, with additional emphasis on engaging individuals often 
underrepresented in CIH back pain research. 
 
1. To develop procedures and processes that transparently define how researchers 
and community members will work together on the proposed research.  
APPROACH: Based on the literature, preliminary work and collaboration with a 
Community Advisory Team, we will develop clearly articulated manuals of operations, 
including a collaborative team charter that describes how researchers, the Community 
Advisory Team, and community members will work together on the parent trial and 
beyond. 
 
2. To explore and describe the barriers and facilitators underrepresented populations 
encounter in relation to participating in CIH back pain research.  
APPROACH:  We will collect qualitative data from an additional sample of community 
members (n=20-30) from traditionally underrepresented groups and use deductive 
analyses using established models and frameworks. 
 
3. To develop community-informed study procedures and materials and assess 
community members’ and participants’ views of them. 
APPROACH: We will use an iterative design, development, implementation, and 
evaluation process successfully used by our team, to create recruitment, screening, 
enrollment, intervention, monitoring, and dissemination processes and materials that are 
culturally sensitive and meet diverse participant needs in relation to engaging in CIH pain 
research. 
 
2. BACKGROUND AND RATIONALE 
2.1. 
Background on Condition, Disease, or Other Primary Study Focus 
The United States is in the midst of an unprecedented chronic pain crisis. Low back pain 
(LBP) is the most common and disabling chronic pain condition and affects 40 to 80% of 
adults at some point in their lives.1,2 
 
Back related leg pain (BRLP) is one of the most burdensome and complex variations of 
the very prevalent and costly LBP conditions. It can be defined by a constellation of 
symptoms characterized by radiating pain originating from the lumbar spine and traveling 
into the proximal or distal lower extremity with or without neurologic signs.20,22 Clinically, 
BRLP is classified in two ways: without nerve root involvement (the majority of cases) 
which is typically referred pain from spinal structures such as a ligament, joint, disc, or 

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SUPPORT Study Protocol V3 May 2022 
muscle;4,20,22,23 and with nerve root involvement (the most severe cases), often with a 
suspected pathoanatomic cause (e.g. spondylolisthesis, disc herniation, stenosis, 
etc.).4,22,24 However, the cause-effect relationship between pathoanatomical findings and 
BRLP can rarely be established with certainty, as pathoanatomic findings are very 
common in asymptomatic individuals.25 Further, like other chronic pain conditions, central 
sensitization likely plays a key role in BRLP as well.26,27 
 
BRLP affects 30 to 60% of those with LBP,4,5 and is associated with greater pain severity, 
back-related disability, depression, anxiety, and social interference than LBP alone.4-6 
Those with BRLP are also more likely to take time off work and be unemployed.28 BRLP 
sufferers also use more healthcare including repeat general practitioner visits, physical 
therapy referrals, and hospitalizations.28 In the U.S., BRLP with nerve root involvement 
has been found to have annual costs 2.5 times higher compared to LBP.29 Further, these 
more complicated BRLP cases are more likely to be prescribed opioids, undergo 
diagnostic imaging, visit an ER, become hospitalized, and receive spinal surgery,29 all of 
which are associated with increased risks and costs. It is clear that BRLP sufferers require 
better front-line care than what is currently being offered.  
 
BRLP is a very complex condition comprised of more than a biological or pathoanatomic 
cause, and is influenced by a web of interrelated physical, psychological, and social 
factors. Important biological or physical risk factors associated with BRLP include severity 
of physical symptoms such as back pain, leg pain, inability to sit, fatigue, stiffness, sleep 
difficulty, and strength loss.7 Psychological risk factors, including depression, poor 
cognitive and emotional coping strategies, and stress have been associated with poorer 
outcomes for BRLP sufferers,8 while positive beliefs about recovery have a protective 
effect.7 Overall, social risk factors have been under-studied, however there is evidence 
that occupational factors and lack of social support can have a negative impact on BRLP 
outcomes.8-10 Drawing from the larger pain field, poor quality relationships and social 
stressors (e.g. due to isolation, ostracism, injustice, invalidation, etc.) can play a role in 
impeding adaptive pain behaviors.38,39  
 
Medical Care of BRLP 
There is a wide 
range of treatments 
used 
in 
clinical 
practice 
for 
BRLP.16,29 
The 
majority of cases 
are 
not 
optimally 
managed, 
as 
demonstrated 
by 
persistent levels of 
disability,4-6 
and 
frequent 
use 
of 
unimodal, 
pathoanatomic-
focused treatments, which have limited scientific backing, and often fail to meet patient 
Table 1. Medical Treatments for BRLP 
Treatment 
Evidence of effectiveness compared to placebo (unless 
noted) 
Non-steroidal 
anti-
inflammatories 
Weak evidence for overall improvement, but no improvement in 
pain or function12,29,30 
Benzodiazepines 
Weak evidence of no effect on function12,30 
Systemic 
Corticosteroids 
Evidence of no effect on pain and possible small effect on 
function12,30  
Spinal injections 
Evidence for small short-term treatment effects for pain and 
function13,31,32 
Surgery*    
Evidence for improvement in pain and function compared non-
surgical interventions14,33 
Evidence is unclear or non-existent for Acetaminophen, Antidepressants, Muscle 
Relaxants, Opioids, and Anticonvulsant medications 12,302,30  
*Reserved for severe cases of BRLP unresponsive to conservative therapy and when 
neurologic signs and pain distribution are accompanied by concordant imaging findings 
of spinal stenosis, spinal instability or disc herniation34-36 

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SUPPORT Study Protocol V3 May 2022 
needs.11-15 The evidence for common medical care treatments for BRLP is summarized 
in Table 1. An important limitation of these approaches is reliance on the clinician, rather 
than promoting active self-management.40,41 Further, most of these interventions are 
associated with significant risks including gastrointestinal complications with NSAIDs; 
hyperglycemia and infection with corticosteroids; addiction, abuse, and overdose with 
benzodiazepines and opioids; hematoma, bleeding, and dural puncture with spinal 
injections; and hospital-acquired infection, sepsis, or other serious complications with 
surgery.11,13,42,43  
 
Conservative and Complementary Care Treatments for BRLP 
There has been very little research investigating conservative and complementary 
treatments for BRLP (see Table 2). Physical therapists (PTs) and chiropractors (DCs) are 
the most common 
providers 
of 
conservative 
and 
complementary 
treatments for BRLP 
in 
the 
U.S. 
Approximately 64% 
of 
patients 
seek 
care from physical 
therapists (PT) and 
32% from doctors of 
chiropractic (DC) for 
BRLP16 to help manage symptoms and restore movement and functional ability. 
Historically, treatments by these providers have been primarily biologically or physically 
oriented, and include a mix of passive and active treatments (e.g. ergonomic advice, 
exercise, and manual treatments, like spinal manipulation therapy and traction).46 A 
recent systematic review of non-invasive treatments for LBP conditions reported limited 
evidence to support the use of exercise and spinal manipulation for BRLP,31 which was 
partially informed by a trial performed by our team and is further described in Preliminary 
Studies.20 Serious risks with these treatments are very rare and common side effects are 
usually self-limiting (e.g. soreness and increased pain).31 
 
Self-Management Behaviors and BRLP: Challenges and Solutions 
An important and relatively recent observation has been that chronic pain, including 
BRLP, is much like other chronic health conditions and requires ongoing 
management.47,48 Rather than rely on passive and provider-based therapies over the 
long-term, a preferred solution is to engage pain sufferers in healthy self-management 
behaviors to successfully address pain themselves.40,48 While patients recognize the 
need to take responsibility for their care, they often require assistance from health care 
providers to initiate and maintain self-management successfully.49,50 Self-management, 
like any human behavior, is complex and requires attentiveness to the patient’s 
biopsychosocial needs and risk factors. This includes assessing patients’ capabilities 
(e.g. Do they have the knowledge, skills, and physical capacity?), opportunities (e.g. Do 
Table 2. Conservative & Complementary Treatments for BRLP 
Treatment 
Evidence of effectiveness 
Exercise 
Weak evidence for small improvements in pain and function compared 
to usual care or sham exercise30 
Spinal 
Manipulation 
Weak evidence for small improvements in pain when added to home 
exercise and advice; unclear evidence compared to other active 
treatment30,43 
Traction 
Weak evidence of no improvement in pain or function compared to 
sham or other active treatments30,44 
Evidence is unclear or non-existent for Pilates, Yoga, Tai Chi, Psychological therapies, 
Acupuncture, Massage, Ultrasound, TENS, PENS, EMS, Inferential Therapy, 
Superficial Heat or Cold, Low-level Laser Therapy, Short-wave Diathermy, Lumbar 
Supports, and Taping30 

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SUPPORT Study Protocol V3 May 2022 
they have the resources?), and motivations (e.g. Do they have the beliefs and 
optimism?),51-53 and providing support based on individual needs.  
 
When coupled with the complexity of chronic pain conditions, like BRLP, designing and 
studying effective self-management interventions can be challenging. Importantly, 
advances in behavioral health fields have provided theoretical and evidence-based 
frameworks and models that can be used to guide the process.47,51,54  One such model is 
the Behavior Change Wheel (BCW) which represents a synthesis of 19 behavioral 
theoretical frameworks (and thus is more comprehensive in addressing the complexity of 
human behavior versus a single theory driven model). We have used the BCW along with 
the biopsychosocial model, to develop our conceptual framework and model for the SSM 
intervention (see Figure 2). This has guided choices regarding: the modifiable factors that 
should be targeted (e.g self-efficacy beliefs, self-management skills, etc.); the evidence-
informed modalities to include (e.g. physical exercises, cognitive strategies, etc.); the 
most appropriate intervention elements for delivering (e.g. education, training, etc.); and 
the most salient behavioral change techniques (e.g. instructions and demonstrations, 
practice and rehearsal, etc.).55,56 
 
Biopsychosocial Interventions for LBP and BRLP 
Treating pain as a primarily physical phenomenon is inadequate.40,48 While the 
biopsychosocial (BPS) model has been promoted for the past several decades,57,58 most 
treatment approaches still fail to address the comprehensive range of interwoven factors 
implicated in BRLP and LBP conditions.40 While there have been attempts to apply the 
BPS model to pain management,57,59 there are still many gaps, particularly for BRLP.  
 
Multidisciplinary approaches: Team based approaches with multiple providers from 
complementary disciplines has been one way of integrating different therapies to address 
patients’ BPS needs.40,59 However, these multi-disciplinary approaches have significant 
challenges including patient inconvenience (multiple appointments with different 
providers), and the substantial system resources needed to coordinate care across 
provider types, which often results in disjointed and unsatisfactory care.40 Further, the 
research evidence suggests that the benefits of multi-disciplinary interventions may not 
outweigh the costs. A systematic review of 41 trials examining multi-disciplinary 
biopsychosocial rehabilitation (MBR) programs for chronic LBP59 found an advantage 
compared to usual care or physical treatments for reducing pain and disability and 
increasing the likelihood of return to work. The authors cautioned that the modest 
benefits, may not outweigh resources and costs required to deliver care, and suggested 
MBR be reserved for the most severe cases. Since that review we identified 6 additional 
trials which generally confirm these findings.60-65 
 
Mono-disciplinary approaches: There are pragmatic advantages to having the 
biopsychosocial elements of care delivered by a single practitioner, including improved 
accessibility, harmonized care, decreased patient burden, and potentially lower costs.66 
Physical therapists (PTs) and chiropractors (DCs) are the most common providers of 
non-pharmacologic treatment for back pain conditions in the U.S.17 This makes them 
optimally positioned for delivering integrated psychosocial strategies to complement 

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SUPPORT Study Protocol V3 May 2022 
biological/physical approaches,46,67 and play a critical role in the frontline non-drug 
management of BRLP.18,19 Indeed, there have already been shifts in both the PT and DC 
fields to integrate more psychosocial aspects into their care models to better support 
patient self-management.46,67-69 
 
Most of the evidence to date regarding mono-disciplinary care for biopsychosocial (BPS) 
pain management, focuses on PT care for LBP. Two recent systematic reviews have 
assessed the effectiveness of PT-led BPS interventions compared to education/advice or 
physical focused care (e.g. exercise, manual treatment).70,71 Both reviews concluded that 
PT-led BPS interventions were superior to education/advice. The reviews reached 
different conclusions regarding effects compared to physical oriented treatment, with one 
review reporting similar outcomes71 and the other reporting a small advantage for BPS 
interventions.70 This is likely due to limitations of these reviews which resulted in exclusion 
of several original trials. Overall, trials comparing mono-disciplinary BPS interventions to 
physical treatments for chronic LBP have reported either similar effects72-74 or an 
advantage for biopsychosocial interventions.75,76  
 
Of note are two of the larger trials assessing PT-led biopsychosocial interventions, which 
included large subgroups of BRLP patients and reported more improvement in pain and 
physical function compared to education77,78 and usual PT care.76 While these findings 
are promising, it is not possible to draw firm conclusions regarding the effectiveness of 
PT-led BPS interventions for BRLP from these two studies. The effectiveness of DC-led 
BPS interventions also remains unknown. 
 
Low back pain (LBP) and health inequity. While there have been increased calls to 
improve the study of LBP by using a more whole person or holistic biopsychosocial 
approach, change has been slow and investigation of social aspects has been especially 
under-addressed. In particular, broader knowledge about the social conditions that 
contribute to health inequity related to LBP, are relatively sparse.158  
 
From the limited research that has been done, important disparities are evident. Those 
with lower education and income are more likely to experience LBP that is chronic, as 
well as worse outcomes. The strongest evidence for associations are between education 
and multidimensional aspects of socioeconomic status (e.g. income, employment status, 
home ownership).158 While prevalence rates are similar between white and Black 
Americans, Black Americans are more negatively impacted with higher severity and 
disability.159 Disparities in back pain care are also prevalent. A recent, large observational 
study of older U.S. adults seeking care for back pain noted Blacks and Hispanics used 
less healthcare and also had less improvement in clinical outcomes relative to whites.160 
The opioid epidemic has hit low-income white communities the hardest, where opioid 
prescriptions and deaths due to overdose are most prevalent.161 While Black Americans 
are less likely to be prescribed opioids for back pain (an advantage in this case),162,163 
they are also more likely to be under-assessed and under-treated in many areas including 
screening, diagnostic imaging, use of physical therapy, and surgery.164  
 

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SUPPORT Study Protocol V3 May 2022 
Health equity can be viewed as social justice in health and is related to the bioethical 
principle of justice; it is achieved when health inequities are eliminated creating equitable 
opportunities to attain optimal health regardless of social position or socially-determined 
circumstances.165 For research in Complementary and Integrative Health (CIH) for LBP, 
health equity will mean gaining a better understanding about the barriers and facilitators 
underrepresented groups encounter and the actionable steps that can be taken to 
address them. 
 
Importantly, it is essential that the full range of biopsychosocial factors be considered. 
Indeed, understanding and assessing contextual multilevel determinants of health which 
contribute to health inequity is critical yet underdeveloped across all health fields.165,166 
There is a great need to better understand the dynamic interactions between proximal 
and distal social contexts (e.g. family, work, community, culture, sociopolitical) that affect 
underrepresented populations participation in LBP and CIH research.  
 
Research and health inequity. While efforts have been made to address inequity in 
health research, there is still much to be done. Inclusion of minorities in NIH-funded 
clinical trials has increased over the past 25 years (from 2.8% to 11.1%), but minorities 
are still widely underrepresented. Non-Hispanic white Americans represent 60.7% of US 
population, but account for nearly 90% of clinical trial populations.167 In the field of 
musculoskeletal pain research representation of Hispanic and Black patients in 
orthopedic clinical trials have been 2 to 3.5 times lower relative to census estimates.168 
Enrollment of minorities in rheumatoid arthritis trials is also significantly lower than their 
representation within the population (16% vs 40%).169  
 
Disparities also exist in regards to CIH use in the American population, with lower use 
among Hispanics (22%) and non-Hispanic Blacks (19.3%) relative to non-Hispanic whites 
(37.9%). Use of CIH is also lower for the less educated (15.6% in adults w/o high school 
degree compared to 42.6% in adults with college degree) and the poor (20.6% of poor 
report CIH use compared to 38.4% of non-poor.)170  
 
Systematic efforts to assess participation of traditionally underrepresented groups in CIH 
studies is also lacking. In the PI’s own K01 CIH pain focused research (publication in 
preparation), participation rates of racial and ethnic groups and those with lower income 
and education fall well short of representing national estimates of pain sufferers (see 
Preliminary Studies). Thus, we can surmise that overall, the CIH research for spine pain 
has yielded findings that are generalizable to only a limited segment of the population, 
which has important bioethical and translational implications for the field.  
 
Overcoming health inequity in CIH pain research. Enhancing stakeholder 
engagement has emerged as an important priority for increasing participation of 
underrepresented populations in research. Community based participatory research and 
community engaged research practices have become increasingly popular in many health 
fields171,172 but have yet to gain significant traction in CIH research for pain.158 General 
strategies that are advocated for improving engagement of hard to reach populations 
include multi-factor approaches for involving community groups and organizations across 

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SUPPORT Study Protocol V3 May 2022 
all stages of research.173 It is also essential to gain a better understanding of social 
contexts, including barriers and facilitators to engagement including mistrust, competing 
demands, unintended outcomes, misconceptions of research, cultural congruence, and 
others.165,174,175 Attention must also be paid to the specific challenges related to the 
condition and interventions under study.176  
 
Limitations 
& 
Gaps 
in 
Research 
of 
Biopsychosocial 
Self-Management 
Interventions 
Evidence to support mono-disciplinary BPS interventions for BRLP is encouraging. 
However, existing studies have significant limitations, leaving critical gaps in our scientific 
understanding. 
 
● Greater attention needs to be paid to intervention design so it aligns with BRLP-
specific risk factors, patient needs, and desired outcomes to fully realize the potential 
of BPS interventions for active self-management (an important goal for overcoming 
rising costs and disability).51 This includes approaching self-management as a set of 
behaviors, and intentionally choosing evidence and theory informed strategies that 
map to relevant behavioral outcomes, rather than clinical outcomes alone (e.g. pain 
and disability). 
● Methodologically rigorous research of conservative and complementary approaches 
for BRLP is lacking. Further, the existing literature on BPS and self-management 
interventions is very heterogenous, with a wide range of goals, rationale, content, 
training, frequency, intensity, mode of delivery, and attention to intervention fidelity, all 
which could have a substantial impact on study related outcomes. While better 
designed BPS studies targeting self-management for LBP are emerging,54,79 none to 
our knowledge address the more complicated and burdensome BRLP conditions.   
● Engaging communities in CIH research for chronic pain is inherently complex and 
is more likely to succeed when grounded in established models and frameworks 
to guide the work. The proposed supplemental research brings together models 
used in the parent pilot study to systematically study back-related leg pain for 
improving pain self-management behaviors with features from the ConNECT 
Framework to address health equity. We will focus on augmenting the parent study 
by applying the following features from the ConNECT framework:  
o Paying greater consideration to social contexts (e.g. the situational and 
interactive influences on health). For CIH and LBP this includes socioecological 
determinants, as well as biological/physical and psychological influences.  
o Fostering a norm of inclusion (e.g. consistently engaging diverse groups). This 
means systematically and consistently using community-based research 
strategies to intentionally reach underrepresented groups in CIH pain research, 
monitor progress, and making these efforts the norm, not the exception.  
o Doing more, earlier to ensure long-term equitable diffusion of study innovations 
to facilitate real world benefit for all. For CIH and LBP conditions this means 
bridging the gap between research and practice, which to date, has been a 
challenge. While the parent study addresses this in part by engaging clinician 
stakeholders (who will be tasked with administering the CIH interventions 
should they prove effective), the administrative supplement proposes to extend 

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SUPPORT Study Protocol V3 May 2022 
stakeholder engagement to include community members’ from traditionally 
underrepresented populations in CIH 
and LBP research.  
 
2.2. 
Preliminary Studies 
 
Collectively, 
this 
investigative 
team 
has 
substantial experience conducting comparative 
effectiveness 
studies 
of 
conservative, 
complementary, and conventional approaches for 
LBP conditions.20,21,81-91  
A Mixed Methods Study of Spinal Manipulation 
and Home Exercise for Back Related Leg Pain 
We conducted one of the few large randomized 
studies of non-drug therapies for BRLP, which 
was published in Annals of Internal Medicine.20 The study included BRLP participants 
with and without neurological signs (20% had neurological signs), but excluded 
individuals with potential indications for surgery (e.g. spinal stenosis, spinal instability, 
progressive neurological deficits). Spinal manipulative therapy (SMT) targeted mobility 
and symptom relief, and was delivered by chiropractors (up to 20 sessions). Home 
exercise (HE) was delivered over 4, 60-minute sessions and focused on teaching patients 
exercises and postural strategies. Clinical outcomes (Table 3): SMT & HE resulted in 
significantly greater reduction in leg pain, at 12 weeks, but not 52 weeks compared to HE 
alone. Similar findings were  
observed for most secondary outcomes, including medication use. Expected adverse 
events (e.g. increased pain severity) were mild to moderate, self-limiting, and reported 
less frequently in the SMT & HE group. Qualitative outcomes: The quality of patient-
provider interactions was the most frequently cited theme informing satisfaction.21 
Limitations: It remains unknown how these interventions compare to common types of 
medical care. Also, the primary focus of both interventions was on the physical aspects 
of BRLP and did not purposefully address psychological and social factors. This is 
reflected by fewer improvements in the psychosocial outcomes (e.g. SF-36 mental health 
domain) compared to those that are ‘physically oriented’ (e.g. pain, disability). 
This study demonstrated DCs could successfully and safely evaluate and treat patients 
with chronic BRLP. The findings are encouraging in light of the current, very limited BRLP 
treatment literature, and suggests a need to compare similar non-medical interventions 
to conventional medical care. Further, in recognizing the complex nature of BRLP, there 
is an opportunity to better train DCs and PTs to capitalize on patient-provider interactions 
and intentionally use behavior change techniques to integrate evidence based 
psychosocial treatments with physically oriented modalities (SMT, HE). 
Spinal Manipulation and Patient Self-Management for Preventing Acute to Chronic 
Back Pain (PACBACK) study (UG3/UH3) Our team recently completed a pilot study of 
92 participants with acute low back pain (UG3), which led to an ongoing randomized trial 
Table 3. 
SMT & HE vs HE 
Outcome 
12 weeks 
52 weeks 
Leg pain 
-10% points 
(-19 to -2) 
-7% points 
(-15 to 2) 
Disability 
-11% points 
(-17 to -5) 
-6% points 
(-12 to 1) 
Improvement 
-11% points 
(-16 to -6) 
-6% points 
(-13 to -1) 
Satisfaction 
-15% points 
(-20 to -10) 
-12% points 
(-18 to -7 
Medication use 
56% vs 63% 
42% 
vs 
66% 
Less med days 
OR=1.8 
(1.0 to 3.1) 
OR=2.6 
(1.4 to 4.7) 
Self-efficacy* 
4% points 
(1 to 8) 
1% point 
(-2 to 5) 
*Not reported in primary manuscript 

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SUPPORT Study Protocol V3 May 2022 
(n=1180, UH3). Drs. Greco and Evans (Co-Is), designed and developed a DC and PT 
delivered supported self-management (SSM) intervention (adapted from a Pain Coping 
Skills program).66,92,93 SSM was developed in collaboration with a multi-disciplinary group 
of researchers including DCs, PTs, and psychologists and consists of 4-8, 60-minute 
sessions, targeting the modifiable physical and psychological risk factors associated with 
acute LBP. Intervention elements include physical and postural exercises, integrated with 
cognitive strategies (e.g. relaxed breathing, progressive muscle relaxation, mental 
imagery), delivered with and without SMT. PTs and DCs are trained to use patient-
centered communication and whole person assessment tools to tailor care to meet patient 
needs. 
Select Pilot & Feasibility Outcomes: A total of 5 DCs and 4 PTs were trained by Drs. 
Greco and Evans (~20 hours). Prior to training, qualitative data suggested providers 
lacked the tools and training to support patients’ psychosocial needs; they also expressed 
feeling limited in their ability to motivate patients in self-care. Provider confidence in the 
SSM program improved from pre-training to post-training. Patient adherence to the SSM 
intervention was high with 41/46 individuals (89%) attending required sessions. Follow up 
rates were also high (94% for weekly pain severity, 98% for monthly surveys of disability 
and other outcomes). These findings, along with suggestions from providers, were used 
to refine the SSM intervention and supporting materials for the ongoing PACBACK trial. 
The investigators’ current and previous research20 has led to this R34 pilot study, which 
will address an important group of patients with chronic BRLP, who are currently ineligible 
to participate in the PACBACK trial (BRLP is not the condition of interest, and the focus 
is on acute LBP  of <12 weeks duration). We will leverage recruitment from PACBACK to 
enroll patients in the R34. Similarities in study design will facilitate protocol development, 
increasing this R34’s efficiency, and likelihood of meeting feasibility targets (Table 5). The 
R34 will provide the opportunity to collaborate with a Clinical Advisory Team to refine and 
implement a new SSM intervention specific to BRLP, and to sufficiently train DCs and 
PTs in the additional psychosocial elements and behavior change techniques required to 
meet the more complicated needs of chronic BRLP patients.7 
2.3. 
Study Rationale         
There is insufficient high-quality research examining conservative and conventional 
treatments for BRLP, the most disabling and costly of the LBP conditions. In light of 
increasing calls for safe and effective treatments that diminish unhealthy pain 
management behaviors (e.g. inactivity, overuse of medications including opioids), the 
timing is imminent for PTs and DCs to play a larger role in initiating and guiding patients’ 
self-management using evidence-based behavioral strategies that educate, motivate, 
and support patients from a biopsychosocial perspective.  
 
In response to the current evidence gaps and limitations in the existing research, we 
propose a pilot study to assess the feasibility of key study methods including recruitment, 
enrollment, intervention acceptability and credibility, participant adherence, provider 
fidelity, and data collection in preparation for a multi-site randomized clinical study. The 
Integrated SUPPORTed Biopsychosocial Self-Management for Back Related Leg Pain 

24 
SUPPORT Study Protocol V3 May 2022 
(SUPPORT) trial will assess the comparative effectiveness of a novel supported self-
management (SSM) intervention delivered by PTs or DCs, to Medical Care (MC).  
 
This research addresses NCCIH high priority areas of integrated mind body approaches 
for symptom management of BRLP, one of the most disabling, costly, and understudied 
LBP conditions, with enhanced efforts for engaging under-represented populations. The 
R34 pilot study will establish the essential foundation for the first RCT comparing an 
innovative SSM intervention to medical care for BRLP. In doing so, DCs and PTs can 
play a more impactful role guiding BRLP patients’ healthy pain self-management 
behaviors, resulting in less BRLP disability, and better overall health and wellbeing. 
3. STUDY DESIGN 
3.1. 
Rationale for Study Design 
While this team has previously investigated conservative interventions for chronic BRLP, 
the focus has been on primarily biological/physical interventions. Given the complex web 
of interrelated physical, psychological, and social factors contributing to chronic BRLP, 
we have developed a comprehensive evidence and theory informed supported self-
management (SSM) intervention. Further, comparisons to medical care (MC) are much 
needed. Thus, this pilot study provides an opportunity to set a solid foundation for future 
research efforts, including a multi-site, phase II hybrid effectiveness - implementation 
randomized clinical trial assessing the effectiveness of 12 weeks of PT or DC delivered 
SSM compared to MC for chronic BRLP in terms of behavioral and clinical outcomes (see 
section 6).  
 
For AIM 1, we will focus on critical Planning Phase activities based on the team’s previous 
experience.20,81-88 This will include: 
● Preparation of detailed protocols, procedures and materials, as well as securing 
necessary regulatory approvals and training study personnel.  
● Also, we will work with a clinician advisory panel of PTs and DCs to further refine the 
SSM intervention and clinician training strategy. 
 
For AIM 2, we will conduct a randomized mixed methods pilot study (n=40-50) using 
qualitative and quantitative data to assess the feasibility of recruitment, enrollment, 
intervention acceptability and credibility, participant adherence, provider fidelity, and data 
collection activities for the future multi-site, phase II randomized clinical trial. Table 5 
details feasibility targets and Table 6 describes protocol refinement measures. Figure 1 
provides an overview of the pilot study. Section 6 provides additional information about 
evaluations and outcomes.  
Participant involvement will occur from the point of their initial online screening (which is 
followed by an in-person clinical screen) to the last follow up data collection endpoint (6 
months after randomization/enrollment). The total time for subject involvement is 
approximately 7 months.  

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SUPPORT Study Protocol V3 May 2022 
 
3.2. 
Rationale for Supplemental Aims 
The nature of the future hybrid effectiveness/implementation RCT design requires 
participation of multiple levels of stakeholders in addition to those taking part in the 
randomized pilot study. Through their participation, important partnerships will be formed, 
and critical contextual information will be gathered which will inform the optimization of 
the future RCT, and adapt the experimental intervention (SBSM) so that it is suitable for 
implementation over the long term.   
For Supplemental AIM 1, we will assemble a Community Advisory Team (CAT) to develop 
a clearly articulated CAT manual of operations that includes a collaborative team charter 
that describes how researchers, the CAT, and community members will work together on 
the parent pilot study and beyond. 
For Supplemental AIM 2, we will collect additional qualitative data from a sample of 
individuals (n=20-30) from traditionally underrepresented groups. This is an extension of 
the mixed methods pilot study to assess the feasibility of the future multi-site, phase II 
randomized clinical trial with an emphasis on exploring intervention acceptability and 
credibility.  
For Supplemental AIM 3, we will use information from Supplemental Aim 2, in consultation 
with the Community Advisory Team assembled as part of Supplemental Aim 1, to engage 
in an iterative design, development, implementation, and evaluation process successfully 
used by our team, to create recruitment, screening, enrollment, intervention, monitoring, 
and dissemination processes and materials for the future full-scale trial, that are culturally 
sensitive and meet diverse participant needs in relation to engaging in CIH pain research. 
 

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SUPPORT Study Protocol V3 May 2022 
3.2. 
Sampling, Target Population, & Location 
The University of Minnesota (UMN) will serve as the clinical site for the pilot study to first 
establish feasibility of delivering the SSM and MC interventions. Participants will be 
offered the option to attend videoconference appointments for visits where in-person 
activities aren’t necessary. Persons who are unable to use Zoom will be seen in-person, 
and thus will not be excluded if they do not have the means to participate remotely. Zoom 
is a University of Minnesota supported HIPAA compliant app that allows videotelephony 
and online chat services through a cloud-based peer-to-peer software platform. This 
application has been used extensively in research by this study team (UH3AT008769, 
R33AT009110).  
 
This pilot study (including the supplemental aims) is in anticipation of a larger scale clinical 
trial that will be performed at clinical research centers affiliated with the UMN in 
Minneapolis, MN and the University of Pittsburgh in Pittsburgh, PA. The study will draw 
from the Minneapolis/St. Paul metropolitan area which has a total population of 3.03 
million, 25% of which are non-white.94 See Section 4 and the Study Accrual and Retention 
Plan (SARP) for additional information related to recruitment and enrollment of 
participants.   
 
3.3. 
Covid-19 Impact on Trial Conduct  
University of Minnesota policies and guidelines for mitigating the risk of Covid-19 to 
participants and study staff will be followed. Participants will be provided with 
standardized information on Covid-19 and research participation during consent. All 
participants and staff will be screened for signs, symptoms, and potential exposure to 
Covid-19 prior to all in-person study visits. Study recruitment, screening, enrollment and 
intervention activities for the project are anticipated to begin in the Fall of 2021. In the 
event that in-person activities are not possible due to the Covid-19 pandemic, trial 
procedures will be modified to ensure all visits can be conducted remotely. Our team has 
designed and implemented remote screening protocols (including assessment of 
neurological deficits associated with BRLP) for our ongoing NCCIH PACBACK trial. The 
SMT component of the SSM experimental intervention will be paused until in person visits 
can safely resume.  
4. SELECTION AND ENROLLMENT OF PARTICIPANTS 
4.1. 
Inclusion Criteria            
Participants must meet the following inclusion criteria to participate in the pilot study: 
● Back-related leg pain (BRLP) consistent with the Quebec Task Force (QTF) 
classifications 2-4 (radiating pain into proximal or distal extremity with or without 
neurological signs).22,95 
● 18 years of age or older.  

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SUPPORT Study Protocol V3 May 2022 
● Back-related leg pain severity of 3 or higher at all screening assessments (0 to 10 
scale) 
● Episode duration of 12 weeks or more 
● Ability to read English fluently  
 
4.2. 
Exclusion Criteria            
Participants meeting any of the following exclusion criteria at baseline will not be allowed 
to participate in the pilot study:  
● Spinal stenosis (QTF 7) 
● Specific, non-mechanical causes of BRLP (QTF 11; e.g. infection, tumor) 
● Contraindications to study interventions (e.g. spinal fracture (QTF 5)) 
● Inflammatory conditions of the lumbar spine (QTF 11) 
● Lumbar fusion 
● Progressive neurological deficits 
● Cauda equina syndrome 
● Pregnancy, nursing 
● Ongoing care from another healthcare provider for BRLP 
○ Individuals taking prescribed medications for BRLP with the potential for 
withdrawal symptoms (e.g. opioids, antidepressants, corticosteroids) will be 
referred to their provider to ensure prescription medications are safely tapered 
● Severe unmanaged comorbid conditions (e.g. substance abuse, major depressive 
disorder, stage 3 hypertension). 
Also, as part of the supplemental aims to the pilot study, qualitative interviews will be 
performed with additional stakeholders to provide important contextual information 
required as part of the hybrid effectiveness/implementation design. These stakeholders 
are intended to provide perspectives from individuals with LBP who are often 
underrepresented in CIH LBP research.  Inclusion criteria will be 18 years of age and 
older, with an episode of LBP (with our without leg pain) and at least one of the following: 
non-white race; low health services access; lack of health insurance coverage; lower 
income; higher food insecurity; gender identity of LGBTQ+; and willingness to participate 
in qualitative data collection. 
4.3. 
Study Enrollment Procedures            
Recruitment of Participants 
Participants are recruited to participate in this study using the following strategies: 
● Leveraging ongoing recruitment efforts of an NIH funded multi-year study 
(UH3AT008769) of acute and subacute LBP led by Co-PI Bronfort, and Co-I 
Schneider, which routinely excludes chronic BRLP sufferers during screening 
(approximately 150 per month).  
● Using resources offered through the UMN Clinical and Translational Science Institute 
(CTSI, NIH UL1TR000114). This includes StudyFinder, which extracts data from UMN 

28 
SUPPORT Study Protocol V3 May 2022 
affiliated enrolling studies listed on ClinicalTrials.gov; and ResearchMatch, an 
electronic volunteer recruitment registry that also provides information about UMN 
studies. 
● Advertising through University affiliated newsletters, websites, Facebook and other 
social media, and clinics (e.g., Clinics and Surgery Center). Posters will also be 
distributed publicly throughout the UMN campus and surrounding communities.  
● Reaching under-represented populations through collaboration with the UMN Urban 
Research and Outreach-Engagement Center and the CTSI’s Community 
Engagement Studio. (e.g. through presentations, mentions in organizational 
newsletters, etc.).  
● The SARP details additional plans to recruit participants underrepresented in research 
(e.g. race, ethnicity, age, education, income, ability, gender and sexual orientation). 
● As part of supplemental aim 1, we will work with a Community Advisory Team (CAT) 
comprised of 6-10 community leaders from organizations including the YMCA of the 
North’s Equity Innovation Center, Social Responsibility Team and ForeverWell 
Outreach Team; the University of Minnesota’s Office of Public Engagement and the 
Robert J. Jones Urban Research and Outreach Engagement Center (UROC) and 
others. The Community Advisory Team will meet quarterly to connect researchers to 
community members; educate and coach researchers in historical issues related to 
health disparities, cultural agility and competence; review engagement reports; and 
make recommendations for prioritization of engagement strategies based on 
community member input. 
 
Participants' private medical and/or employment records will not be accessed for 
recruitment purposes. Participant’s electronic medical records (e.g., EPIC records) will 
not be accessed by research staff.  
 
Documentation of reasons for ineligibility and for non-participation of eligible candidates 
A comprehensive list of all candidates who were screened, whether or not they were 
enrolled, and the reasons for ineligibility or non-participation (if applicable) will be 
maintained electronically. A summary of the number of candidates screened and enrolled 
with reasons for ineligibility or non-participation will be monitored by the study team at 
routine meetings.  
 
Consent Procedures 
A full description of the consent process is described in section 6, Study Procedures. All 
participants will provide written or electronic consent prior to enrollment. 
 
Randomization/Enrollment 
Enrolled subjects will be randomized using blocked randomization (with varying block 
sizes) following stratification for back-related leg pain classification (QTF classification 2, 
3, or 4).95 Computer generated random treatment assignments will be generated by an 
independent study statistician and conveyed electronically through REDCap (the 
electronic study database) at the time of enrollment to preserve allocation concealment. 
Screening clinicians and study staff will be blinded to upcoming treatment assignments. 

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SUPPORT Study Protocol V3 May 2022 
5. STUDY INTERVENTIONS 
The Template for Intervention Description and Replication (TIDieR) checklist has been 
used 
to 
guide 
the 
description of the study 
interventions80 
to 
facilitate future results 
interpretation, as well 
as dissemination and 
replication. 
Table 
4 
illustrates the standard 
elements common to 
both 
interventions. 
Participating clinicians 
will be trained and certified in study protocols and intervention specific content (see below 
for additional details). 
The main intervention period is 12 weeks long. All patients will be asked to limit treatment 
to their assigned intervention for the main 12-week intervention period. Participants in 
both groups will be monitored during the intervention phase for the development of 
exclusion criteria impacting participant safety which will result in withdrawal from the study 
intervention along with a referral for appropriate care (e.g. development of progressive 
neurological deficits). All patients will receive basic standardized information regarding 
the etiology, prognosis, and basic self-management of back-related leg pain.  
Patients in both groups can take over-the-counter medications, for any reason, as 
necessary during the entire trial period. Participants may also continue to engage in any 
self-management practices for BRLP that were used prior to trial enrollment (e.g. 
exercises, heat application). Following the main 12-week intervention period, participants 
who experience a recurrence or worsening of back-related leg pain symptoms will be 
given the option to receive further care in their assigned treatment arm, as is typical in 
real-world settings. Additional care for back-related leg pain recurrences may occur until 
week 26. Intervention documentation will include data regarding training and resources 
required to deliver the interventions. Visit specific information including type or component 
of treatment, frequency and dose, side effects, etc. will also be measured. These are 
documented in standardized case report forms.  
 
5.1. 
Interventions, Administration and Duration            
5.1.1. Supported Self-Management (SSM) - Experimental Intervention 
Rationale, theory, goals: The program is theory-informed and adapted from previous 
cognitive behavioral and self-management programs.20,66,92,93 The primary goal is to 
enhance patients’ ability to manage their BRLP symptoms in both the short and long-term 
by engaging in healthy physical, psychological, and social self-management behaviors 
(see Figure 2).40,51 
Table 4. Common Intervention Elements (Experimental & Comparison Groups) 
Initial intervention period 
12 weeks; # of visits determined collaboratively by 
provider and patient (once minimum is reached) 
Restrictions 
No outside care during main 12-week intervention 
period 
Ongoing care 
If recurrence or worsening of BRLP after 12 weeks, 
can receive care in assigned group 
Procedures 
Appointment reminders, follow up for missed 
appointments provided 
Standardized information 
Modified “Back in Action” book covering evidence 
based BRLP messages 
Over the counter medication 
As necessary 
Location 
UMN affiliated outpatient clinic in Minneapolis 

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SUPPORT Study Protocol V3 May 2022 
 
Description: The intervention is comprised of an integration of the following core 
intervention elements and 12-15 behavioral change techniques (BCTs)55,56 targeting 
important modifiable biopsychosocial factors for BRLP and which can be successfully 
delivered by PT or DCs. These include: 
 
● Physical factors of strength, activity, mobility, posture, and pain symptoms;8,101 
● Psychological factors including beliefs (self-efficacy, fear-avoidance, catastrophizing), 
thoughts, emotions, and stress;8-10,41 and  
● Social factors including social support and interpersonal relationships. 
 
Providers will use standardized checklists for each session, to ensure they address the 
required elements (see 5.2.1 below). 
 
Dose/Schedule: 6-12 sessions, up to 60 minutes per session, over 12 weeks.  
 
Mode of delivery: One to one, in person or via videoconference when applicable; 
supplemented with the use of phone, videoconference, and/or email check-ins.  
  
Location: UMN outpatient research facility or via videoconference when applicable 
 
Tailoring and individualization: At the first session, the PT or DC will work with the patient 
to assess their needs and collaboratively develop an individualized treatment plan. This 
will include review of BPS baseline measures (see Table 5); a brief physical examination 
that includes manual palpation and brief postural, strength, and mobility assessments; 
completion of a Wellbeing Wheel (based on risk factors and the BPS model) and self-
evaluation of what it would take to engage in adaptive pain behaviors (COM-B Self-
Evaluation Questionnaire V1).55 These will be re-assessed as needed. In addition, a “Self-
Reliance Check In” will be completed at 6 weeks to initiate a conversation regarding 
release to self-care. 
Side Effects/Risks: The risks associated with SSM are considered low for subjects who 
meet the inclusion/exclusion criteria; to further minimize risks licensed doctors of 
chiropractic (DC) and physical therapists (PT) will be trained and certified by investigators, 
and monitored for fidelity to ensure they are implementing SSM in a manner that optimizes 
patient safety. Experienced investigators and consultants will be readily available as 
needed to consult with DCs and PTs to clinically manage adverse events as needed. The 
core elements of SSM include physical and psychosocial strategies.  
Physical: Side effects associated with manual treatment and exercise are common and 
benign. Approximately 35% of participants in our previous BRLP trial reported expected 
self-limiting adverse events that were mild to moderate in severity (e.g. increased pain, 
soreness).20 Serious adverse events following manual treatment to the lower back are 
rare and are estimated to occur once per million to several million visits and include 
cauda equina syndrome, disc herniation, fracture, hematoma or hemorrhagic cyst.31, 146 
Psychosocial. Subjects may experience some short-lasting emotional discomfort during 
and outside the sessions when practicing the psychosocial exercises and strategies 

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SUPPORT Study Protocol V3 May 2022 
(e.g. of relaxed breathing, guided imagery, pacing, relaxation, pacing, problem solving, 
cognitive restructuring, interpersonal communication, etc.). 
 
Providers: Licensed PTs and DCs with a minimum of 3 years of clinical experience will 
be provided an estimated 30 hours of training.  
 
Training: The goal of SSM training is to facilitate providers’ confidence and ability to act 
as an effective coach for patients’ in their self-management. We will use methods 
effectively implemented in the investigators’ previous and ongoing studies including video 
presentations, demonstrations, and simulated patient practice with feedback from 
investigators responsible for the SSM intervention (CG, RE).  
Training content will include the essential information related to the core intervention 
elements and BCTs, and will emphasize patient-centered communication as a key part 
of delivery.15 Clinicians will be assessed for key competencies prior to certification. 
Competencies will be adapted from ongoing and previous studies with input from The 
Clinician Advisory Panel comprised of PTs and DCs during the Aim 1 Planning Phase. 
 
5.1.2. Medical Care (MC) - Comparison Intervention 
Rationale, theory, goals: The goal of medical care management for BRLP is to reduce 
pain and disability associated with the condition. This is achieved through the use of 
medications targeting pain and inflammation. Medical care is a commonly used standard 
approach for managing BRLP in the U.S., and thus is appropriate as an active comparison 
group. 
 
Description: Medical care will be comprised of primarily medication management, which 
is a standard first-line approach for back-related leg pain in primary care. Choice of 
medications is informed by the current evidence 12,104 and the American College of 
Physicians guidelines on noninvasive treatment for LBP.11  
 

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● Nonsteroidal anti-inflammatory drugs (NSAIDs) will be used as a first-line approach. 
● Second-line medications include systemic corticosteroids, skeletal muscle relaxants, 
acetaminophen, benzodiazepines, antiseizure medications, lidocaine patches, 
serotonin and norepinephrine reuptake inhibitors, tricyclic antidepressants and weak 
opioids (e.g. Tramadol, Tylenol with Codeine) for participants unable to tolerate or 
unresponsive to first-line medications. 
● Strong opioids will not be allowed for the management of chronic BRLP, as the current 
CDC recommendations prefer non-opioid medications for chronic pain and there is a 
lack of evidence regarding their use for BRLP.12,105 
 
Medication Choice: Decisions regarding medication selection will be made collaboratively 
between the provider and patient after a discussion of the potential risks, benefits, past 
experience, and preferences for different medications.  
 
Schedule: Minimum of 2 visits (up to 30 minutes in length) to review clinical presentation, 
risk/benefit profile and participant preference for first and second-line medications, and 
response to previous care. 
 
Visit type: The initial visit will be in-person or via videoconference; additional visits will 
occur in person, by videoconference, or by phone. 
Medication Delivery: Medications will be taken orally or applied topically to the skin. 
Injections will not be allowed. Medications will not be stored at or distributed to participants 
in the UMN clinic. Prescriptions for medications from the study provider will be sent to the 
patient’s preferred pharmacy. Participants will pick up prescribed medications at their 
preferred pharmacy. Over the counter (OTC) medications will be picked up by the 
participant at their retailer of choice.  
All medications are paid for by the study. Participants are not required to use their medical 
insurance benefits to participate, and there are no out of pocket costs for the participants.   
 
Location: UMN outpatient research facility or videoconference 
 
Visit Frequency: Decided collaboratively by the provider and participant, as normally 
occurs in clinical practice. 
Side-Effects: Pharmacological therapies are associated with increased AEs compared to 
placebo.7  
Non-steroidal anti-inflammatory drugs (NSAIDs) will be used as a first-line medication. 
Serious risks include cardiovascular events (heart attack, stroke, heart failure, high blood 
pressure), gastrointestinal bleeding, allergic reaction (hives, skin irritation, respiratory 
distress, edema), kidney failure, skin reactions, liver failure, and asthma attacks.  Other 
side effects include stomach pain, constipation, diarrhea, gas, heartburn, nausea, 
vomiting and dizziness.  

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Second-line medications include systemic corticosteroids, skeletal muscle relaxants, 
acetaminophen, benzodiazepines, antiseizure medications, lidocaine patches, serotonin 
and norepinephrine reuptake inhibitors, and tricyclic antidepressants for participants 
unable to tolerate or unresponsive to NSAIDs. Serious risks with these medications 
include allergic reaction, seizures, infection, hyperglycemia, bone fracture, liver or kidney 
damage, and addiction or abuse. Other risks include sedation, drowsiness, fatigue, sleep 
problems, headache, weight gain, muscle weakness, mental/physical impairment, dry 
mouth, abdominal pain, anorexia, nausea, vomiting, gastritis, occult bleeding, dizziness, 
vertigo, tremor, syncope, and leukopenia. 
Several protections are in place to minimize risks, including reminding participants to take 
their medication as prescribed and to contact the study clinician if there are changes to 
their medication regimens to avoid drug-drug adverse interactions. Participants will be 
asked about current medications at every treatment visit to assess potential drug-drug 
adverse interactions. Also, clinicians will assess the potential for risk factors based on the 
patient’s medical history prior to prescribing/recommending (prescription and OTC) 
medications and will suggest the lowest effective dose(s) for the shortest time necessary.  
Study providers will discuss risk/benefit profiles for specific medications with participants 
before making a shared decision on what medication to prescribe. 
 
Providers: Medical care will be provided by a licensed medical provider with a minimum 
of 3 years of experience. Providers are required to have a DEA license.  
 
Training: Providers will receive 4 hours of training in protocols for medical visit activities, 
common intervention elements, medication prescription (first vs second-line), 
documentation, and adverse events. 
5.2. 
Handling of Study Interventions 
5.2.1. Supported Self-Management (SSM) - Experimental Intervention 
5.2.1.1. Required Interventions  
The following are considered standard elements of the SSM intervention:  
● Needs assessment and collaborative development of an individualized treatment plan. 
Includes review of BPS baseline measures, a brief physical examination that includes 
manual palpation and brief postural, strength, and mobility assessments; completion 
of a Wellbeing Wheel (based on risk factors and the BPS model) and self-evaluation 
of what it would take to engage in adaptive pain behaviors (COM-B Self-Evaluation 
Questionnaire V1). These will be re-assessed as needed. In addition, a “Self-Reliance 
Check In” will be completed at 6 weeks to initiate a conversation regarding release to 
self-care. 
 

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SUPPORT Study Protocol V3 May 2022 
● Education will be provided through the communication of key evidence-based 
information about chronic pain, BRLP, BPS factors, and self-management to enhance 
patients’ knowledge.48 
 
● Skill training will be provided as indicated in strategies and exercises directed towards 
enhancing physical, psychological, and social self-management skills. This includes 
physical exercises (e.g. postural, strength, stabilization and mobility exercises);20,31 
psychological strategies (e.g. progressive muscle relaxation, relaxed breathing, 
guided 
imagery, 
pacing, 
relaxation, 
problem 
solving, 
and 
cognitive 
restructuring);66,92,93 and social strategies, including pleasant activity planning with a 
social focus, and communication techniques for navigating relationships (e.g. work, 
family, friends) to garner support for self-sufficiency. Specific BCTs used as part of 
skill training include instructions, demonstrations, practice and rehearsal, self-
monitoring and graded progressions.55,56 
 
● Spinal manipulation therapies (SMT) are manual procedures applied by a practitioner 
to the lumbar and sacroiliac spinal regions. SMT has been shown to be effective in 
relieving symptoms and improving mobility.20,31,102,103 SMT will be applied as a “bridge 
therapy” as indicated, to support patients’ abilities to engage in the skill development 
described above.  
 
SMT will include soft-tissue work (e.g. cross-fiber stretch, light friction massage, etc.), 
mobilization (low velocity, low-high amplitude passive movements) and manipulation 
(high velocity, low amplitude thrust)  
 
● Enablement (by addressing barriers and facilitators) will also be applied as indicated 
to improve patients’ unhelpful beliefs about their capabilities to self-manage BRLP and 
overall wellbeing. Specific BCTs used as part of enablement include emotional 
support provided by the provider, value-based goal setting, and problem solving.55,56 
 
● Persuasion will be used as needed to influence patients BRLP beliefs, optimism, and 
motivation which are important for the adaptation of healthy pain coping behaviors. 
The following BCTs will be integrated into the intervention: verbal persuasion, focus 
on past successes, and framing/reframing.55,56 
 
● Resources and materials will be provided to support the patient and include a 
workbook and digital recordings (e.g. of the physical, psychological and social 
exercises and strategies described above).   
5.2.1.2. Allowed Interventions  
The following summarizes optional SSM elements (based on patient needs): 
● Soft tissue techniques which include cross-fiber stretch, longitudinal stretch, direct 
pressure, and deep friction applied to soft tissue from the lower ribs to the gluteal folds.  
● Lumbar neural mobilization 
● Heat may be used to facilitate the delivery of SMT (up to 10 minutes) 

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5.2.1.3. Prohibited Intervention  
SSM providers are prohibited from delivering: 
● Education or exercise recommendations beyond the scope of the SSM intervention or 
what is described under concomitant interventions 
● SMT to the neck, upper thoracic spine (above the sixth thoracic vertebrae), or 
extremity joints (e.g., hip joint) 
● Instrument assisted SMT (e.g., activator)  
● Passive modalities other than heat for facilitating SMT (e.g., TENS, ice) 
● Recommendations to use mind-body practices not described in required or allowable 
SSM interventions (e.g. yoga, Tai Chi) 
● Lumbar belts, strapping, taping, etc. 
● Recommendation of bed rest 
 
5.2.2. Medical Care (MC) - Comparison Intervention   
5.2.2.1. Required Interventions 
 
First or second-line medications for the management of chronic BRLP. Decisions 
regarding medication selection will be made collaboratively between the provider and 
patient after a discussion of risk/benefit profiles and preferences. 
● First-line medications include nonsteroidal anti-inflammatory drugs (NSAIDs) 
● Second-line medications include systemic corticosteroids, skeletal muscle relaxants, 
acetaminophen, benzodiazepines, antiseizure medications, lidocaine patches 
serotonin and norepinephrine reuptake inhibitors, tricyclic antidepressants, and weak 
opioids (e.g. Tramadol, Tylenol with Codeine) for participants unable to tolerate or 
unresponsive to first-line medications 
5.2.2.2. Allowed Interventions  
 
None 
5.2.2.3. Prohibited Interventions   
Medical providers are prohibited from recommending the following interventions: 
● Medication(s) not listed as first- or second-line under required interventions  
● Referral for physical therapy, manual treatment, cognitive behavioral therapy, or any 
treatments provided by a PT, DC, or psychologist.  
● Referral for interventional procedures (e.g., epidural steroid injections, intramuscular 
and facet joint injections) 
● Education or exercise recommendations beyond what is described under concomitant 
interventions 

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SUPPORT Study Protocol V3 May 2022 
● Recommendations to use Mind-body practices (e.g., yoga, Tai Chi, meditation) or 
intervention elements described in the SSM protocol 
● Lumbar belts, strapping, taping etc. 
● Recommending bed rest 
5.3. 
Concomitant Interventions 
 
5.3.1. Required Interventions 
All participants will receive basic standardized information regarding the generally 
favorable prognosis of chronic BRLP. We will provide patients with an updated version of 
the Back in Action book20 in print and/or electronic formats. The Back in Action book: 
● Encourages patients to engage in their normal activities as soon as possible, even if 
it causes some pain.  
● Encourages general aerobic exercise like walking, swimming, bicycling. 
● Provides a brief summary of the general causes of chronic BRLP and reassurance 
that the majority of cases do not require specialty care.  
● Emphasizes the patient’s role in facilitating their own recovery by providing some 
general recommendations for symptom management (e.g. changing positions 
frequently).  
5.3.2. Allowed Interventions 
 
● Participants will be allowed to use OTC medications as needed during the course of 
the study.  
● Participants will be allowed to continue self-care practices (e.g., heat, ice, stretching) 
for chronic BRLP they used prior to the study.  
● Participants assigned to SSM who experience a significant worsening of chronic BRLP 
symptoms that cannot be managed by the assigned and concomitant interventions 
will be referred to the study’s medical care provider for a short-course of ‘rescue 
medications’, using a protocol successfully implemented, but rarely required, in 
previous studies by the investigators.20    
○ Allowable ‘rescue medications’ will be identical to first- and second-line 
medications detailed in the medical care protocol. In addition, weak opioids (e.g. 
Tramadol) may be used in select cases. Decisions regarding ‘rescue medication’ 
selection will be made collaboratively between the provider and patient after a 
discussion of risk/benefit profiles and preferences. 
● Treating clinicians, in consultation with the PIs, may refer for specialty care in the case 
of AEs or chronic BRLP complications that cannot be adequately managed with the 
assigned intervention (e.g., progressive neurological deficits).  
● Participants will be encouraged to seek any required care for conditions unrelated to 
the study. 

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5.3.3. Prohibited Interventions 
  
Participants will be asked to limit treatment to their assigned intervention for the length of 
the initial 12-week intervention period. However, participants retain the right to 
discontinue study treatment at any time. Providers will be taught to refrain from delivering 
interventions that fall outside the scope of the study protocols (see above).  
5.4. 
Adherence Assessment      
The total number of treatments will be decided by the treating clinician based on each 
individual participant’s clinical presentation and response to care, as is done in clinical 
practice. We anticipate 6-10 visits being prescribed for most participants receiving SSM 
and 2-4 visits for most participants receiving medical care. Participant adherence to 
assigned interventions will be documented at each visit in the clinical notes. 
Treatment adherence is defined as: 
● Attending 2 or more Medical Care sessions or 6 or more SSM sessions 
And 
● Not dropping out of active treatment 
5.5. 
Intervention Fidelity        
We will apply robust fidelity activities based on our experience from previous studies to 
facilitate future intervention replication, internal validity, and accurate interpretation of 
outcomes.96-98 This includes training and certification (described in section 5.1); use of 
standardized intervention checklists to guide clinicians through each session; and 
monthly group meetings with key investigators to receive ongoing coaching in intervention 
protocols.99 
 
Fidelity assessments. All intervention visits will be video recorded with patient consent; 
a random selection of 10% will be reviewed for fidelity by study investigators. 
Standardized fidelity instruments will be used to document required, allowed, and 
prohibited intervention activities and elements. Individualized feedback will be provided 
to providers as needed based on fidelity assessments.99,100 Additionally, standardized 
treatment clinical report forms will be reviewed for required, allowed, and prohibited 
interventions. 
6. STUDY PROCEDURES 
Participation in the pilot study is expected to last approximately 7 months (from initial 
screening to month 6 follow up assessment). Participants will be sent their final evaluation 
(a self-report survey) six months after randomization.  
6.1. 
Schedule of Evaluations   
(See next page)         
  

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SUPPORT Study Protocol V3 May 2022 
 
Table 5. Pilot Study Data Collection Schedule 
Assessment 
Initial 
Screening 
 
Baseline 
1 
Baseline 2/ 
Enrollment 
(Day 0) 
 
Intervention 
Visits 
(Month 0-6) 
 
Weekly 
Follow-Up 
(Week 1-26) 
 
Monthly 
Follow-Up 
(Month 1-6) 
Follow-Up 
(Month 2) 
 
Follow-Up 
(Month 3) 
 
Follow-Up 
(Month 6) 
Informed Consent 
x 
x 
x 
 
 
 
 
 
 
Demographics 
x 
x 
 
 
 
 
 
 
 
Clinical History 
x 
x 
 
 
 
 
 
 
 
Physical Exam 
 
x 
 
 
 
 
 
 
 
Inclusion/Exclusion Criteria 
x 
x 
x 
 
 
 
 
 
 
Quebec Task Force Classification 
 
x 
 
 
 
 
 
 
 
STarTBack Screening Tool Status 
 
x 
 
 
 
 
 
 
 
BRLP & LBP frequency & intensity 
 
x 
x 
 
x 
 
 
 
 
Disability, PROMIS-29+2 
 
x 
x 
 
 
x 
 
 
 
Productivity loss, Medication use, 
Healthcare use 
 
 
x 
 
 
x 
 
 
 
Social emotional support, Domain-specific 
life satisfaction, Perceived stress, Chronic 
pain acceptance, Chronic pain coping 
behaviors, Physical activity level, Self-
efficacy, Fear-avoidance beliefs, Pain 
catastrophizing 
 
 
x 
 
 
 
 
x 
x 
Treatment expectations 
 
 
x 
 
 
 
x 
 
 
Overall satisfaction, Use of key SSM skills, 
and Global improvement 
 
 
 
 
 
 
 
x 
x 
Patient-provider connection, healthcare 
environment 
 
 
 
 
 
 
x 
x 
 
Satisfaction with specific components of 
SBSM 
 
 
 
 
 
 
 
x 
 
Treatment administered 
 
 
 
x 
 
 
 
 
 
Adverse events* 
 
 
 
x 
 
x 
 
 
 
Qualitative Measures 
 
 
x 
 
 
 
 
x 
 
Study close out 
 
 
 
 
 
 
 
 
x 
*Participants can also report adverse events to the PI’s or study staff at any point during the trial. **Qualitative data will also be collected from providers regarding their 
views of barriers and facilitators to care; additionally, as part of supplemental aims, qualitative data will be collected from other stakeholders not taking part in the pilot 
study to assess their views. 

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SUPPORT Study Protocol V3 May 2022 
6.2. 
Description of Evaluations           
 
6.2.1.  
Pilot Study Screening Evaluations 
 
Consenting Procedures 
Potential participants will consent at 4 different time points: a brief initial online screen, a 
phone screen with study staff, and at two baseline screening appointments.  
Initial screening (Online/Phone) 
● Interested individuals will be initially screened by a web-based screening portal. 
An overview of the study will be provided during the web-screen, and electronic 
consent secured prior to collecting preliminary information on eligibility (e.g. age, 
English literacy, BRLP severity) 
● Following the web-based screening, potential participants will undergo a phone 
interview with study staff to confirm inclusion criteria (e.g. age, duration and 
severity of BRLP) and the lack of easily identifiable exclusion criteria (e.g. history 
of spinal fusion). Verbal consent to collect this information will be collected at the 
initiation of the phone interview. 
Baseline Screening Appointments 
● Potential participants will be given a hard or electronic consent form to review on 
their own that will describe the screening and study procedures at the first baseline 
screening appointment. See Section 11 for a full description of the consent form. 
They will be given ample time to review the form on their own and ask questions. 
● The Principal Investigators, research coordinator, or designee (i.e., research staff, 
an investigator) will review the consent form, section by section, one-on-one with 
each potential participant during the consent interview; participants will be invited 
to ask questions as they proceed through each section.  
● Easy to understand, IRB pre-approved, electronic and print informational 
materials, including visual media, will be used to facilitate understanding. 
● A signed and dated consent form will be obtained from each study candidate. All 
participants will be given a copy of the signed consent form for their personal 
records. 
● Original signed paper consent forms will be secured in the respective participants 
research file at the UMN. Signed e-consent forms will be maintained in REDCap.  
● Only individuals who demonstrate comprehension will be considered eligible to 
participate. Persons who are not able to read and write in English or consent for 
themselves are ineligible. 
● At the second baseline appointment, participants will confirm continued consent 
for the study prior to randomization.  
Consent & Human Subjects Training 
All research staff obtaining informed consent are required to undergo project specific 
human subjects training that addresses the essential components to the informed consent 
process. See Section 11 for additional information about the consent form. In addition, 

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SUPPORT Study Protocol V3 May 2022 
staff will complete human subjects training in accordance with the UMN’s human subjects 
and HIPAA training requirements.   
Changes to the Informed Consent Form 
In the event the informed consent form changes, following necessary IRB approvals, 
study staff will meet with the PI or designee and review changes to the form prior to 
conducting consent with a potential participant. See the Participants Rights and 
Confidentiality section for additional information.    
If potential participants need to be informed of specific changes in the risks or benefits of 
study participation, an addendum consent will be used. This addendum will be used to 
inform enrolled participants about significant new findings that may have a bearing on 
their willingness to continue participation in the study. The addendum consent will be 
given to the participant at a study visit or mailed to the participant's home. 
Screening Procedures 
Initial Screening (Online/Phone) 
● Following consent, potential participants will be asked a series of self-report questions 
through an online portal to screen basic eligibility. Persons who meet basic inclusion 
criteria (e.g., age, BRLP intensity of 3 or higher, English literacy) and who otherwise 
have no obvious exclusions (e.g., pregnancy, history of surgical fusion of lumbar 
spine) will be contacted by study staff, who will ask specific health-related, questions 
pertaining to inclusion (e.g., LBP episode duration). 
● Baseline screening visits (In-person) will occur as soon as possible, but the first 
baseline screening visit must occur within 30 days of completing the phone screen; 
otherwise, the phone screen will be redone. 
Baseline Screening Visit 1 
● Written or electronic consent will be collected from participants prior to any screening 
procedures at this visit.  
● Participants will complete study surveys to collect basic demographic information 
along with health history information to inform the detailed clinical evaluation and 
confirm eligibility. The surveys will include: 
○ Demographics 
○ Limited set of key patient-reported outcomes (see Table 5) 
○ Past and ongoing BRLP treatment      
○ Comorbid health conditions 
■ Participants reporting current or past history of mental health disorders and 
related treatment will undergo additional screening if unmanaged major 
depression is suspected or reported. Scores of 3 or higher on the Patient Health 
Questionnaire-2 (PHQ-2)147 will lead to additional screening for suicidality. A 
score of 2 or higher on question 12 from the Quick Inventory of Depressive 
Symptomatology-Self Report (QIDS-SR)148 for suicidal ideation will warrant 

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SUPPORT Study Protocol V3 May 2022 
exclusion and referral. Mental health resources will be provided to these 
participants (e.g. suicide hotlines, emergency services)     
■ Participants reporting potential substance abuse (having 6 or more drinks on a 
weekly basis, using illegal drugs, or prescription medication for non-medical 
reasons) will undergo additional screening for potential substance abuse. 
Scores ≥ 20 on the 10-item Alcohol Use Disorders Identification Test (AUDIT) 
for alcohol149or ≥ 6 on the 10-item Drug Abuse Screening Test (DAST)150-
152 are exclusionary and warrant referral. The AUDIT and DAST will be 
available to administer at any time if the clinician suspects a problem.  
● A licensed healthcare provider (e.g., DC, PT, advanced practice nurse) will conduct a 
clinical history and a focused low back and lower extremity physical exam that will 
include posture assessment, orthopaedic and neurological tests (e.g. straight leg 
raise, lower extremity muscle strength, sensation, and reflexes), palpation, and 
vascular assessments. Current medications and vitals will also be collected.   
● Women with reproductive potential will take a pregnancy test.  
● Suspicion of declining cognitive function during medical history/clinical exam will lead 
to administration of the Mini-mental state examination. A score of 23 or below is 
exclusionary.153 
● Eligible participants will complete baseline measures of self-reported study outcomes 
(see Table 5).  
 
Baseline Screening Visit 2 (within 21 days of Baseline Screening Visit 1) 
 
● Prior to the second baseline screening visit, investigators and study clinicians will 
review each case at weekly case review meetings for clinical eligibility determination. 
A review of inclusion and exclusion criteria based on the medical history, physical 
exam, and patient reported measures collected at the first baseline screening visit will 
be conducted for each participant. The review committee reaches consensus on every 
case and recommends exclusion, inclusion, or further evaluation to determine 
eligibility (e.g. diagnostic imaging). 
● Potential participants who present with signs and symptoms suggestive of a specific 
cause of BRLP (e.g., nephrolithiasis, cauda equina), contraindication to study 
treatments, (e.g., inflammatory arthropathies of the lower back), or other condition that 
warrants medical attention will be referred to their medical provider for follow-up and 
management.  
● Eligible participants will complete repeat assessments of key patient reported 
outcomes to confirm eligibility (i.e. BRLP intensity) and account for potential 
regression to the mean (See Table 5). Baseline measures of other self-reported study 
outcomes (clinical, behavioral, and mediating outcomes) will also be completed. 
● In addition, participants will provide feedback on key study recruitment and screening 
procedures using open-ended survey questions. 
● Confirmation of consent and randomization of eligible participants will occur at the 
second baseline screening visit. 
 

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6.2.2 Enrollment, Baseline, and/or Randomization 
Enrollment 
Enrollment is defined as the date of randomization at which point all eligibility criteria are 
confirmed and the individual has agreed to participate; this is recorded on a case-report 
form. AEs will be collected after the participant is enrolled. Participants will be told to 
contact study staff and/or providers about any health-related changes they experience. 
40-50 participants will be enrolled.  
Baseline Assessments 
Baseline measures will include demographic, occupational, clinical and behavioral 
characteristics, and mediating outcomes including the NIH Research Task Force’s 
minimum dataset for chronic LBP.111 The following will be collected at baseline: 
● Demographics including PhenX ToolkKit’s core measures for Social Determinants of 
Health155 
● Quebec Task Force Classification for spinal disorders95 and Pain Detect 
Questionnaire to identify neuropathic presentations of BRLP156 
● STarT Back Screening tool112  
Clinical Outcome Measures 
● BRLP and LBP frequency over the past week (number of days with BRLP symptoms). 
● BRLP and LBP intensity (0-10 pain scale) over the past week using the ordinal 11-box 
NRS (0=no BRLP/LBP, 10=the worst BRLP/LBP possible).  
● Disability will be measured with the 23-item Roland Morris Disability Questionnaire 
which was adapted and validated for BRLP.115 
● PROMIS-29 +2 includes measures of pain interference with normal activities, physical 
function, fatigue, sleep disturbance, anxiety, depression, and participation in social 
roles and activities.116-118 The PROMIS-29+2 also provides a preference-based 
summary of health-related quality of life.119 Other PROMIS/NIH Toolbox instruments 
will include social emotional support;116,117 domain-specific life satisfaction (e.g. work, 
family, housing);120 and perceived stress.122 
● Productivity loss related to BRLP (e.g., missed work, reduced productivity while at 
work) will be assessed using questions from the Institute for Medical Technology 
Assessment’s productivity cost questionnaire.123 
Behavioral Outcomes 
The following behavioral outcomes are chosen because they’re most likely to affect the 
experimental intervention: 
● Chronic pain coping behaviors will be measured using the Chronic Pain Coping 
Inventory - 2-item version.128 
● Over-the-counter and prescription medication use20 for BRLP, including class of 
medication and frequency of use. 

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SUPPORT Study Protocol V3 May 2022 
● Healthcare use for BRLP including MRIs, injections, hospitalizations, surgeries, and 
provider-based visits.20 
● Physical activity levels (e.g. amount of sedentary activity) measured with the 
International Physical Activity Questionnaire.129 
Mediating Outcomes 
Mediating outcomes and targets of the intervention theorized to affect the clinical and 
behavioral outcomes will also be collected to inform protocol refinement. These include:  
● BRLP related capabilities (e.g. knowledge, skills, physical capacity), opportunities 
(e.g. available resources), motivations (e.g. optimism) 51-53 for participants enrolled into 
supported self-management.  
● Beliefs related to self-efficacy as measured by confidence in ability to manage daily 
activities, symptoms, emotions, and social interactions (PROMIS self-efficacy for 
managing chronic conditions);130 the chronic pain acceptance questionnaire will also 
be administered.157 
● Fear-avoidance beliefs using the Fear-avoidance Beliefs Questionnaire 131  
● Catastrophizing measured using the 13-item Pain Catastrophizing Scale;132  it uses a 
5-item point scale (0=not at all, 4 all the time) and has internal consistency and validity. 
● Expectations about back pain treatments (HEAL items).135  
 
Qualitative measures 
Qualitative measures will be collected from enrolled subjects, as well as providers 
regarding their views of barriers, facilitators, affordability, practicality, effectiveness, 
acceptability, and equity. 
As part of the supplemental aims, qualitative information will be collected from other 
stakeholders with pain who are underrepresented in CIH LBP/BRLP research to explore 
their views of barriers and facilitators to care for LBP/BRLP. 
 
Randomization 
In the pilot study, randomization precedes intervention administration. Randomization will 
occur within 21 days of completing the first baseline screening visit. Participants who are 
not randomized within this time frame will repeat the in-person screening. Interventions 
will be initiated within 14 days of randomization/enrollment. 
 6.2.3. Blinding 
 
Blinding of treatment providers and participants is not feasible. However, the following 
steps will be taken to minimize potential bias and enhance study rigor: 
● Study personnel involved in screening and enrollment will be masked to upcoming 
randomization assignments 
● The statistician will be blinded to treatment group until the analysis is complete.  

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● Participants will be queried in self-report questionnaires as to whether or not anybody 
attempted to influence their responses. 
Blinded Personnel: Select investigators and the study statistician will be blinded until the 
database is locked and the analysis is complete. The study’s statistician will assign a 
member of his staff to create the random allocation tables according to the allocation 
plan, which will be administered using the randomization module in REDCap. 
 
Unblinded Personnel: The study coordinator, clinicians, data manager, and 
investigators participating in fidelity assessment will not be blinded to study 
interventions. 
 
Individuals authorized to break the blind: The PIs and their investigator designees are 
authorized to break the blind.  
Circumstances for breaking the blind: This will occur when it is in the participants’ safety- 
related interest. The primary example is a reportable adverse event. 
 
6.2.4 Follow-up Visits 
Intervention Visits (M0-M6) 
The following information will be collected at each intervention visit in the pilot study, 
which will occur as needed throughout the six months, as there is no set schedule of 
treatments: 
● Treatment administered – study providers will record treatment administered at each 
visit including required, allowed, and prohibited treatments.  
 
● Adverse events (AEs)- participants will be asked about the occurrence of AE/SAEs by 
their treatment provider at each visit. The AE protocol described in section 7, Safety 
and Assessments will be initiated and adhered to for all AEs identified.  
Weekly Follow-Up (∓ 3 DAYS) 
Weekly outcomes will be collected electronically via direct patient self-report for six 
months; participants who are unable to provide electronic data will be contacted directly 
by blinded study staff who will ascertain outcomes. Additional information related to data 
collection and quality assurance is described in section 10.  
Clinical Outcome Measures 
● BRLP and LBP frequency and intensity  
Monthly Follow-up (∓ 14 DAYS) 

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Monthly follow-up data (Months 1-6) will be collected electronically via direct patient self-
report. Participants who are unable to provide electronic data will be contacted directly by 
blinded study staff who will ascertain outcomes, or they will be mailed a paper copy of the 
questionnaire to complete and return to the study team. Additional information related to 
data collection and quality assurance is described in section 10. 
The following outcomes will be collected on a monthly basis for 6 months (± 14 days): 
Clinical Outcome Measures 
● Disability, PROMIS-29+2 measures, and productivity loss 
● Adverse Events - participants will be asked if they experienced any potential adverse 
events associated with study interventions (e.g. increased pain, neurological 
symptoms, nausea) 
Behavioral Outcome Measures 
● BRLP-related medication and healthcare use 
Month 2 Follow-up (∓ 14 DAYS) 
Mediating Outcome Measures 
● Satisfaction related to the patient-provider connection and healthcare environment 
(HEAL items).135 Treatment expectations for the assigned intervention will also be 
assessed. 
Month 3 Follow-up (∓ 14 DAYS) 
Clinical Outcome Measures 
● PROMIS/NIH Toolbox measures for social emotional support, domain-specific life 
satisfaction, and perceived stress. 
● Global improvement will be measured using a 9-point scale ranging from completely 
recovered to vastly worse.154 
Behavioral Outcome Measures 
● Chronic pain coping behaviors, physical activity levels 
Mediating Outcome Measures 
● BRLP related capabilities (e.g. knowledge, skills, physical capacity), opportunities 
(e.g. available resources), motivations (e.g. optimism) for participants enrolled in SSM 
51-53  
● Beliefs regarding self-efficacy, fear avoidance, and treatment. 
● Satisfaction related to the patient-provider connection, healthcare environment (HEAL 
items),135 specific components of the SBSM intervention, and overall treatment20 

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Qualitative Measures 
For the pilot study, qualitative data will be collected via open-ended questions in REDCap 
surveys, as well as semi-structured, audio-recorded interviews.106 Patient and provider 
views of barriers, facilitators, affordability, practicality, effectiveness, acceptability, equity 
will be collected.  
Month 6 Follow-Up & Final Close Out/Final Evaluation (-14 to +28 DAYS) 
Clinical Outcome Measures 
● PROMIS/NIH Toolbox measures for social emotional support, domain-specific life 
satisfaction, and perceived stress 
● Global improvement 
Behavioral Outcome Measures 
● Chronic pain coping behaviors, physical activity levels 
Mediating Outcome Measures 
● Beliefs regarding self-efficacy and fear avoidance. 
● Satisfaction related to the patient-provider connection, healthcare environment (HEAL 
items),135 specific components of study interventions, and overall treatment20 
Participant Close-out 
● Final participation will be used to record participant status. Participants will receive 
notice of their participation being complete (via email or mail). 
6.2.5. Compensation 
 
 
There is no cost for participation in the study. Participants and their insurers will not be 
billed for study screening and treatment visits. Participants in the pilot study will be 
compensated a total of $150.00 for time associated with participating in the study, in the 
form of a UMN ClinCard. Participants are not compensated for attending screening and/or 
intervention study visits. ClinCards will be administered at an in-person study visit or via 
mail following enrollment in the study. The following compensation scheduled will be 
used: 
80% of weekly surveys completed 
$40.00 
Month 1 follow-up completion 
$10.00 
Month 2 follow-up completion 
$10.00 
Month 3 follow-up completion 
$40.00 
Month 4 follow-up completion 
$10.00 

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Month 5 follow-up completion 
$10.00 
Month 6 follow-up completion 
$30.00 
In addition, prescription and over-the-counter medications recommended for participants 
in the MC group will be paid for by the study. Study staff will load cards with funds for 
participants to pay for their study medications. ClinCards will be administered at an in-
person study visit or via mail following enrollment in the study. 
For the supplemental aims qualitative interviews, participants will be compensated $50.00 
per interview. 
7. SAFETY ASSESSMENTS  
7.1. 
AEs and SAEs, Expectedness, and Relatedness- Definitions 
The Co-PIs are responsible for adjudicating AEs/SAEs.  
Adverse Event 
AE is generally defined as any unfavorable and unintended diagnosis, symptom, sign 
(including an abnormal laboratory finding), syndrome or disease which either occurs 
during the study, having been absent at baseline, or if present at baseline, appears to 
worsen. AEs are to be recorded regardless of their relationship to the study intervention.   
The following scale will be used to grade AEs: 
1.  Mild: no intervention required; no impact on activities of daily living (ADL). 
2.  Moderate: minimal, local, or non-invasive intervention indicated; moderate impact on 
ADL. 
3.  Severe: significant symptoms requiring invasive intervention; subject seeks medical 
attention, needs major assistance with ADL.  
We will measure and compare rates of AEs across the two treatment arms. We will 
specifically look for common treatment-related AEs that include: LBP, soreness at the 
treatment site, gastrointestinal symptoms, emotional discomfort, and other events. We 
will capture AEs prospectively from study participants through monthly surveys and at 
intervention visits. Each unique occurrence will receive a separate ID in order to avoid 
duplication in documentation. 
Serious Adverse Event 
SAE is generally defined as any untoward medical occurrence that  
● results in death 
● is life threatening 
● requires inpatient hospitalization or prolongation of existing hospitalization 

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SUPPORT Study Protocol V3 May 2022 
● results in persistent or significant disability/incapacity, or is  
● a congenital anomaly or birth defect.  
We will collect SAEs both passively through ad hoc reporting and through systematic 
evaluation at study visits. Given the nature of the interventions we do not anticipate any 
specific treatment-related SAEs and therefore focus on standard and BRLP-specific 
serious events: death; severe or permanent disabilities; life-threatening conditions; 
hospitalizations; other important medical events; progressive neurological deficits, or 
cauda equina syndrome.  
Expectedness:  
AEs and SAEs will be classified as expected if  
● They have been documented as a known adverse reaction (disclosed in the consent 
form) or are part of an existing comorbid disease process. The PI or designee is 
responsible for making this determination.  
Relatedness to Research Participation:  
AEs and SAEs will be classified as either unrelated, unlikely related, possibly related, 
probably related, or definitely related to participation in the research project. The PI or 
designee is responsible for making this determination. To assess relationship of an event 
to study intervention, the following guidelines are used: 
Related (Possible, Probable, Definite) 
● The event is known to occur with the study intervention. 
● There is a temporal relationship between the intervention and event onset. 
● The event abates when the intervention is discontinued. 
● The event reappears upon a re-challenge with the intervention. 
Not Related (Unlikely, Unrelated) 
● There is no temporal relationship between the intervention and event onset. 
● An alternate etiology has been established. 
 
7.2 
Adverse Event Identification           
 
Adverse events will be identified in the following ways: 
● Following enrollment, participants will be asked about the occurrence of AE/SAEs by 
their treatment provider at every visit.  
● Participants will be informed to report AE/SAEs directly to study staff throughout the 
study period  
● Participants will be asked if they experienced any AE/SAEs during their monthly self-
report questionnaires. 

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7.3 
Follow-up for Adverse Events            
Events will be followed until resolution or stabilization, whichever occurs first; resolution 
and stabilization will be determined by the PI with input from the study clinician when 
appropriate. 
AEs During the Intervention Phase  
If an AE/SAE occurs during the intervention phase, the study clinician or designee will 
obtain information about the event, which will be used by the PI to assess the severity, 
expectedness and relatedness to the study. The study clinician will monitor the AE/SAE 
while the participant is under their care; this will include a medical evaluation and 
treatment, or modifications to treatment as necessary to protect the participant and 
minimize harm. If warranted, referral to an outside provider will be made. Participants who 
cannot continue with the study intervention due to safety concerns will be removed from 
the intervention and/or study when warranted. See Study Discontinuation.  
The rescue medication protocol may apply. See Rescue Medication.  
AEs During the Monthly Follow-Up (M1-M6) 
If an AE/SAE occurs during the follow-up phase, study staff (clinician, coordinator, PI or 
designee) will contact the participant (or their emergency contact with the participant’s 
permission), to obtain information about the event, including but not limited to what 
happened, when the event occurred, and treatment rendered. This information will be 
used by the PI to assess the severity, expectedness and relatedness to the study.  
Events will be followed for outcome information until resolution or stabilization. Resolution 
and stabilization will be determined by a PI with input from the study clinician when 
appropriate.  
The PI or designee will record all reportable events with start dates occurring any time 
after enrollment until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of 
study participation. 
7.4 
Reporting Procedures           
 
AEs/SAEs/Unanticipated problems will be reported to NCCIH and the UMN IRB. 
“Awareness” or “Aware” is defined as the date on which the research team is able to 
discuss the event with the participant (or their designee) to gather additional information 
about the event for adjudication. See AEs and SAEs, Expectedness, and Relatedness- 
Definitions for information related to how decisions will be made regarding determining 
relatedness and severity.  
NCCIH 
Unexpected fatal or life-threatening AEs related to the intervention will be reported to 
the NCCIH Program Officer within 3 days of the investigator becoming aware of the 
event.  

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Other serious, unexpected AEs related to the intervention will be reported within 7 
business days.  
 
UPIRTSOs will be reported within 7 business days.  
 
All other AEs documented during the course of the trial will be summarized and reported 
to NCCIH on an annual basis by way of inclusion in the annual report and in the annual 
AE summary which will be provided to NCCIH. 
 
UMN IRB 
The UMN IRB will be notified via a Report of New Information (RNI) of any harm (e.g. AE 
or SAE) experienced by a participant or other individual that, in the opinion of the PI or 
designee, is unexpected and at least probably related to the research procedures within 
5 business days of the study team becoming aware of the event.  
Unexpected death: Unexpected death of a locally enrolled participant whether considered 
related to the research or not will be reported to the UMN IRB via a RNI within 5 business 
days of the study team being made aware of the event. Death is considered unexpected 
if the risk of death is not listed in the consent form.  
If new information becomes available to the research team that suggests a new or 
increased risk to study participants, a safety issue or a reduction in benefit, this 
information will be reported to the UMN IRB via a RNI within 5 business days of the study 
team being made aware of the new information.  
Effective March 27, 2017, submitting logs of events at continuing review is not required. 
See Protocol Deviations for reporting information related to deviations and participant 
harm. 
7.5. 
Known Expected Risks  
  
Supported Biopsychosocial Self-Management 
The risks associated with SSM are considered low for subjects who meet the 
inclusion/exclusion criteria. To further minimize risks, licensed doctors of chiropractic 
(DC) and physical therapists (PT) will be trained and certified by investigators, and 
monitored for fidelity to ensure they are implementing SSM in a manner that optimizes 
patient safety. Experienced investigators and consultants will be available as needed to 
assist DCs and PTs in managing adverse events if needed. The core elements of SSM 
include 
physical, 
psychological 
and 
social 
strategies.  
 
Physical: Side effects associated with manual treatment and exercise are common and 
benign. Approximately 35% of participants in our previous BRLP trial reported expected 
self-limiting adverse events that were mild to moderate in severity (e.g. increased pain, 
soreness).20 

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Serious adverse events following manual treatment to the lower back are rare and are 
estimated to occur once per million to several million visits.  
Psychological and social: Subjects may experience some short-lasting emotional 
discomfort during and outside the sessions when practicing the psychological and social 
exercises and strategies (e.g. of relaxed breathing, guided imagery, pacing, relaxation, 
pacing, problem solving, cognitive restructuring, interpersonal communication, etc.). 
Expected risks include  
● Cauda equina syndrome 
● Disc herniation 
● Emotional discomfort 
● Exacerbation of low back pain/back related leg pain, soreness or stiffness in the region 
treated 
● Fracture 
● Hematomas or hemorrhagic cysts.31, 146 
Medical Care 
The risks associated vary depending on the medications prescribed. Choice of first and 
second-line medications for the study protocol was informed by the current evidence and 
the American College of Physicians guidelines on noninvasive treatment for LBP which 
balances evidence for risks and benefits when making recommendations. Licensed 
medical providers will care for participants randomized to medical care. Pharmacological 
therapies are associated with increased adverse events compared to placebo.31 Study 
providers will discuss risk/benefit profiles for specific medications with participants before 
making a shared decision on what medication to prescribe. 
Expected risks include: 
● Non-steroidal anti-inflammatory drugs (First-Line Medications) 
○ Serious risks include cardiovascular events (heart attack, stroke, heart failure, high 
blood pressure), gastrointestinal bleeding, allergic reaction (hives, skin irritation, 
respiratory distress, edema), kidney failure, skin reactions, liver failure, and asthma 
attacks.  
○ Other side effects include stomach pain, constipation, diarrhea, gas, heartburn, 
nausea, vomiting and dizziness.  
● Second-line medications  
○ Serious risks with these medications include allergic reaction, seizures, infection, 
hyperglycemia, bone fracture, liver or kidney damage, and addiction or abuse. 
○ Other risks include sedation, drowsiness, fatigue, sleep problems, headache, 
weight gain, muscle weakness, mental/physical impairment, dry mouth, abdominal 
pain, anorexia, nausea, vomiting, gastritis, occult bleeding, dizziness, vertigo, 
tremor, syncope, and leukopenia. 
 

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Pilot study and supplemental aims qualitative data collection: there are few risks 
associated with this data collection. Risks include feeling uncomfortable answering 
certain questions; to minimize this, participants can decline responding to questions 
 
7.6. 
Safety Monitoring            
The Independent Monitoring Committee (IMC) for this study will review accruing data on 
a semi-annual basis to ensure: 
1. The study is adequately enrolling to meet targeted goals 
2. Data collection and protocol adherence rates are acceptable 
3. There are no serious safety concerns 
7.7. 
Potential Benefits  
 
There may be no direct benefit to participants. Some participants may experience an 
improvement or resolution of their BRLP or associated signs and symptoms. Some 
participants may learn new ways to manage their BRLP on their own.  
8. INTERVENTION DISCONTINUATION 
Criteria for Discontinuation 
Participants will be discontinued from their assigned intervention if the study interventions 
become contraindicated, for example: 
● A serious adverse event related to treatment occurs and thus makes it unsafe to 
continue with the assigned intervention. 
● The participant has a specific cause of BRLP and was erroneously diagnosed during 
screening. 
● New evidence emerges and suggests it is unsafe for the participant to proceed with 
the intervention. 
  
Criteria for discontinuation are met when the event is classified as serious and it is 
determined by the provider and/or the PI that it is unsafe to continue with the study 
intervention, or when a diagnosis for a specific cause of BRLP is made. 
  
Reasons for Discontinuation 
All efforts will be taken to facilitate participant’s completion of the study interventions. 
Potential reasons for early termination include: 
 
● Participant develops a competing comorbid health condition that precludes adherence 
or makes it unsafe for them to proceed with their assigned treatment. 
● A change in the participant’s life (e.g., participant moves, dies, has other personal 
matters to attend). 
● Participant chooses to discontinue on their own for any reason (e.g., participant is not 
responding to care or getting worse). 
● Study closure by institute or oversight body.  

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With their permission, participants will continue to be followed if the study intervention is 
discontinued. Participants who have discontinued treatment will be asked to complete 
weekly questionnaires and monthly questionnaires, if possible. Efforts will be made to 
accommodate participant compliance. 
   
Temporary Discontinuation of the Intervention 
Potential reasons for temporary intervention discontinuation include: 
● An acute health problem arises and prohibits their ability to attend the intervention 
(e.g., hospitalization). The length of discontinuation will be addressed on a case-by-
case basis. All attempts will be made to minimize this discontinuation. 
● Participant has a scheduled vacation. Participants will be asked to limit their vacation 
time during the active intervention phase of the study. 
 
Withdrawal Procedures 
Participants will be asked to submit a letter or email in writing to the PI (signed and dated 
when possible) if they want to withdraw from the study. For reporting purposes, research 
staff will inquire about reasons for their withdrawal. Participants may also be asked if 
they’re willing to complete self-report questionnaires as a means of collecting primary and 
secondary outcomes. If they refuse, participants will not be contacted by the study team. 
A formal letter will be sent by the PI, or designee, indicating receipt of their request for 
withdrawal and additional provisions around data collection, if applicable. The letter will 
reiterate our appreciation for their participation to date and remind participants that their 
withdrawal will not affect their relationship with the university. Further, regulatory bodies 
will be provided summary information related to attrition (e.g., losses to follow-up, 
withdrawals etc.). Individual participants will not be named. 
 
Termination Procedures 
This research may be discontinued at any time by the UMN IRB, the NIH, OHRP, UMN, 
or other government agencies as part of their duties to ensure research participants are 
protected.  
9. STATISTICAL CONSIDERATIONS 
9.1. 
General Design Issues            
We will conduct a parallel, two-group randomized pilot study in preparation for a future 
phase II multi-site randomized clinical trial. A total of 40-50 participants with chronic back-
related leg pain (BRLP) will be randomly assigned to either 12 weeks of: 1) Supported 
Self-Management (SSM) or 2) Medical Care. The pilot study will assess the feasibility of 
key methods and procedures to be used in the larger randomized trial. The aims of the 
pilot study are to:  
1. To conduct a Planning Phase to develop detailed protocols and procedures, train 
project personnel, and secure necessary oversight approvals.  
2. To assess future trial feasibility through achievement of pre-specified targets for:  

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a. Recruiting and enrolling individuals with chronic BRLP by assessing recruitment 
rates; enrollment rates; and screened participants’ views and perspectives 
b. Delivering experimental and comparison interventions by assessing acceptability 
and adherence; provider intervention fidelity rates; and participant and provider 
views 
c. Data collection by assessing follow up rates of future clinical trial outcome 
measures 
9.2. 
Sample Size 
 
The sample size for this pilot study has been informed by previous pilot studies by the 
investigators, who have found approximately 15-20 participants per group sufficient for 
informing the feasibility of larger, randomized clinical trials. The feasibility of recruitment, 
enrollment, intervention acceptability and credibility, participant adherence, provider 
fidelity, and data collection activities will be assessed using designated feasibility 
measures and targets. Protocol refinement measures will be collected using qualitative 
and quantitative methods to identify areas for modification in the future trial. Because of 
the relatively small number of providers needed for a pilot study, and budget restrictions, 
we will also engage our consultants and The Clinician Advisory Panel to provide input to 
the development and subsequent revisions of the intervention and training protocols. 
9.3. 
Treatment Assignment Procedures  
Enrolled subjects will be randomized using blocked randomization (with varying block 
sizes) following stratification for back-related leg pain classification (QTF classification 2, 
3, or 4).95 Computer generated random treatment assignments will be generated by an 
independent study statistician and conveyed electronically through REDCap (the 
electronic study database) at the time of enrollment to preserve allocation concealment. 
Screening clinicians and study staff will be blinded to upcoming treatment assignments.  
 
9.4. 
Outcomes 
9.4.1. Primary Outcomes   
Primary outcomes for the pilot study are feasibility measures for the larger randomized 
trial including: 
● Recruitment feasibility - Number of participants screened per month; percentage of 
screened participants who are female; percentage of screened participants who are 
minorities; participant views and perspectives on research participation 
● Enrollment feasibility - Number of participants enrolled per month; percentage of 
enrolled participants who are female; percentage of enrolled participants who are 
minorities; participant views and perspectives on research participation 
● Intervention acceptability and credibility feasibility - Percentage of enrollees not 
receiving any treatment; percentage of enrollees receiving prohibited treatments 
during the 12-week intervention phase (contamination); percentage of enrollees 
satisfied with treatment 

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● Participant treatment adherence feasibility - Percentage of enrollees attending 
required sessions; percentage of enrollees in the supported biopsychosocial self-
management group reporting participation in home practice; percentage of enrollees 
in medical care group reporting taking medications as prescribed  
● Provider fidelity feasibility - Percentage of provider visits where 100% of required 
intervention activities were delivered 
● Data collection feasibility - Percentage of enrollees completing the month 3 
assessment; percentage of enrollees completing the month 6 assessment; 
percentage of weekly pain severity and frequency assessments completed 
 
 
 
 
Table 6. Feasibility Measures & Targets 
Recruitment 
≥40 screened/month (50% women, 25% minorities) 
Enrollment 
≥8 enrolled/month (50% women, 25% minorities) 
Intervention 
acceptability, 
credibility 
≤10% never receive any treatment; ≤10% receive prohibited 
treatments during 12-week intervention phase (contamination) 
 ≥80% satisfied with treatment 
Participant 
adherence 
≥80% participants attend required sessions (SSM=4; MC=2) 
≥70% of SSM participants report participation in home practices 
≥70% of MC participants report taking medications as prescribed  
Provider fidelity 
Providers deliver 100% of required intervention activities on 
≥70% of visits 
Data collection 
≥85% of participants complete 12 weeks follow up 
 ≥80% of participants complete 25-week follow up 
 ≥80% of weekly pain severity and frequency surveys completed 
 
9.4.2. Secondary Outcomes 
  
Secondary outcomes for the pilot study are protocol refinement measures for the larger 
randomized trial including:  
● Recruitment protocol refinement - Percentage of participants screened per month by 
recruitment method; percentage of screened participants who are female by 
recruitment method; percentage of screened participants who are minorities by 
recruitment method 
● Enrollment protocol refinement - Percentage of participants excluded by eligibility 
criterion; percentage of participants declining participation; main reasons for declined 
participation; average time to enrollment from initial screening 
● Intervention protocol refinement - Percentage of enrollees withdrawing from 
treatment; reasons for withdrawal from treatment; Enrollee and provider views of 
intervention including affordability, practicality, effectiveness, acceptability, and equity; 
percentage of required intervention activities not performed by provider; frequency of 
required intervention activities not performed by provider with reasons; provider beliefs 

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regarding back-related leg pain (also assessed pre and post-training in intervention 
protocols) 
● Data collection protocol refinement - Percentage of missing variables by data 
collection instrument; reasons for missed assessments; average duration of 
assessments 
 
9.4.3. Qualitative Data 
 
Qualitative information will provide important context and understanding to facilitate refinement 
for the future trial. These include: enrollee and provider views of intervention including 
affordability, practicality, effectiveness, acceptability, and equity; percentage of required 
intervention activities not performed by provider; frequency of required intervention activities 
not performed by provider with reasons; provider beliefs regarding back-related leg pain (also 
assessed pre and post-training in intervention protocols).  
 
As part of the supplemental aims we will also seek qualitative information from other stakeholders 
who are traditionally underrepresented in CIH LBP/BRLP research, regarding their views. 
 
Table 7 Protocol Refinement Measures (Examples) 
Recruitment 
 
-% screened/month per recruitment method;  
-% women and minorities screened/month per recruitment 
method 
Enrollment 
-% excluded by criterion 
-% declining participation, reasons 
-average time to enroll 
Intervention 
acceptability, 
credibility 
 
-% dropouts from intervention, reasons 
-Patient and provider views of barriers, facilitators, 
affordability, practicality, effectiveness, acceptability, equity* 
Provider 
fidelity 
-% of required intervention activities per session not 
performed, reasons 
- provider BRLP beliefs (pre-/post training)** 
Data 
collection 
- % of missing variables 
-reasons for missed assessments 
-average duration of assessments 
*Collected via qualitative data collection (open-ended survey questions, 
interviews and focus groups) 
**Collected via survey pre-/post-training 
9.5. 
Data Analyses           
 
Feasibility outcomes (Aims 2a-2c) will be assessed using a combination of descriptive 
statistics and qualitative analyses (described under Protocol refinement measures). For 
AIM 2a, we will determine the mean number of participants screened/month and 
enrolled/month in addition to the percentage of women and minorities screened and 
enrolled. For AIM 2b, we will report the percentage of enrolled participants compliant with 
treatment protocols by group (visit attendance, home practice, contamination) and 

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percentage of treatment visits delivered according to protocol (provider fidelity). For AIM 
2c, percentage of outcome assessments completed at 12 weeks and 6 months will be 
described, in addition to the percentage of weekly pain severity and frequency 
assessments completed. 
Protocol refinement measures will be analyzed and presented descriptively in a similar 
fashion as described above. Qualitative data (collected via open-ended questions in 
REDCap surveys, and transcribed interviews), will be analyzed using template style 
qualitative content analysis informed by the conceptual framework for the study (see 
Figure 
2).89,106,137-139 
 
by 
study 
team 
members 
with 
qualitative 
research 
experience.21,89,90,136 Representative quotations will be identified during the coding 
process, and coded themes will be quantified by categorizing them as present or absent 
for each case, and presented as frequencies.139   
10. DATA COLLECTION AND QUALITY ASSURANCE 
10.1. Data Collection Forms         
 
Initial screening data will be directly entered by potential study participants via a web-
based survey. Phone-based screening data, in-person, and virtual video/teleconference 
screening data will be entered directly into the study REDCap database by research staff 
to confirm study eligibility. A procedure/visit case report form will be filled out by research 
staff for every study-related visit and electronically entered directly into the study REDCap 
database. Electronic web-based surveys will be sent to study participants as indicated in 
section 6, with computer-assisted telephone interviewing or mailed surveys used as a 
back-up in cases where follow-up may be challenging. 
10.2. Data Management          
The Principal Investigators, Data Manager and Project Director are responsible for 
ensuring the accuracy, completeness and timeliness of study data. All source documents 
will be completed in a neat, legible manner to ensure accurate interpretation of data.  
10.2.1. Data security and storage  
CRFs for this study will be entered into a REDCap database, which uses a MySQL 
database via a secure web interface with data checks used during data entry to ensure 
data quality. REDCap includes a complete suite of features to support HIPAA compliance, 
including a full audit trail, user-based privileges, and integration with the institutional LDAP 
server. The MySQL database and the web server will both be housed on secure servers 
operated by the University of Minnesota Academic Health Center’s Information Systems 
group (AHC-IS). The servers are in a physically secure location on campus and are 
backed up nightly, with the backups stored in accordance with the AHC-IS retention 
schedule of daily, weekly, and monthly tapes retained for 1 month, 3 months, and 6 
months, respectively. Weekly backup tapes are stored offsite. The AHC-IS servers 
provide a stable, secure, well-maintained, and high-capacity data storage environment, 
and both REDCap and MySQL are widely-used, powerful, reliable, well-supported 

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systems. Access to the study's data in REDCap will be restricted to the members of the 
study team by username and password. Electronic communication with outside 
collaborators will involve only non-identifiable information and investigators will be blinded 
to group assignment until after the analysis by the study statistician is complete. 
Electronic source documents will be stored on password protected computers issued by 
the University of Minnesota. University-issued computers are supported and maintained 
by the UMN Academic Health Center-Information system. Participant ID numbers will be 
used to protect participants’ confidentiality. All paper source documents (e.g. combined 
signed consent forms & HIPAA forms) will be stored in a locked file cabinet, in a locked 
office at the University of Minnesota maintained by the Project Director and her 
designees. 
10.3. Quality Assurance and Control 
10.3.1. 
Quality Assurance  
The primary method of data collection for participant self-reported outcomes will be direct 
electronic entry through a survey interface with REDCap. Logic rules specifying the type 
and range of acceptable responses will be programmed into REDCap. Participants will 
receive an error message if they enter an invalid response.  
10.3.2. 
Training   
Training for study staff responsible for data collection will be conducted prior to study 
recruitment. Certification by the principal investigator (or designee) requires adherence 
to standard operating procedures for data collection outlined in the study protocol. Staff 
will be required to demonstrate proficiency in key data management steps (screening, 
randomization, data entry, documentation of AEs, data management protocol 
compliance, etc.).  
10.3.3. 
Quality Control Committee   
The Study Steering Committee will review reports on data capture and quality on a 
monthly basis. Missing data reporting and other customized reports will be developed in 
order to facilitate efficient workflow and high-quality data capture. CRF-specific follow-up 
rates will be tabulated on a nightly basis and reviewed during the weekly check-in 
meetings between the PIs and study staff.   
10.3.4. 
Metrics   
For each follow-up survey, we aim to achieve an 85% or higher follow-up rate. We will 
utilize a combination of web-based survey, telephone and text-based outreach, and 
mailed surveys to achieve maximal survey response. Survey completion rates will be 
primarily based upon the completion of pain and functional outcome measures, but we 
will additionally tabulate follow-up by each instrument to monitor and evaluate survey 
burden. Data on other key feasibility measures and targets will also be reviewed weekly 

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by the PIs and monthly by the Study Steering Committee (e.g. recruitment rates, 
enrollment rates, intervention acceptability, credibility, and adherence, provider fidelity, 
adverse event reporting).  
Loss to Follow-Up: Participants are considered loss to follow-up if any of the criteria below 
are met: 
1. Participant dies 
2. Participant formally withdraws from the study 
3. Participant misses 3 consecutive monthly and 8 consecutive weekly surveys without 
responding to reminders by email (at least 3) or phone (at least 3). 
Participant’s meeting criteria 3 can have their loss to follow up status removed if they 
contact the study and request continuation of data collection activities. 
10.3.5. 
Protocol Deviations   
A protocol deviation occurs when activities on this study diverge from the UMN IRB 
approved protocol. Examples include divergence(s), that 
● Reduce the quality or completeness of the data, 
● Make the Informed Consent Form inaccurate, or 
● Impacts a subject's safety, rights, or welfare. 
Protocol deviations include, but are not limited to the following: 
● Failure to keep IRB approval up to date 
● Outcome assessment and/or measurement not performed 
● Implementing protocol modifications without obtaining prospective IRB approval; 
● Conducting research during a lapse in IRB approval; 
● Enrolling more subjects than what’s approved in the protocol; 
● Performing research procedures outside the protocol specified window; 
● Failure on the part of any individual involved in research review or oversight to abide 
by applicable laws or regulations, or the University of Minnesota IRB policies. 
● Randomization of an ineligible participant; not-adhering to inclusion/exclusion criteria; 
● Failure to obtain Informed Consent or altering from the informed consent process as 
described in the IRB approved protocol; 
● Obtaining consent using an outdated consent form; 
● Performing non-exempt human subject research without obtaining prospective 
University IRB approval; 
● Failure to report an SAE 
● Wrong intervention administered to a participant 
Protocol deviations will be logged by research staff in REDCap. Details regarding the 
protocol deviation including whether it resulted in an adverse event will be included in the 
log. Reports on protocol deviations will be reviewed by the PIs and study team on a 
regular basis. Corrective action plans will be implemented when relevant. Study operating 

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procedures will be modified as necessary based on review of protocol deviation 
summaries. 
Protocol deviations that result in harm to a research participant will be reported to the 
UMN IRB via a RNI within 5 business days of the study team being made aware of the 
harm and/or deviation.  
 
10.3.6. 
Monitoring   
Automated queries will be used to assess protocol deviations (e.g. missing evaluations 
or evaluations performed outside of allowed timeframe, non- compliance with assigned 
interventions). In addition, 100% of enrolled participants' records will be reviewed to 
ensure proper recording of screening data, informed consent documentation, and 
treatment fidelity. The PIs and the Study Steering Committee will review findings from the 
monitoring reports and other measures of trial progress and quality on a monthly basis. 
Table 8: Monitoring Schedule 
Data type 
Frequency of review 
Reviewer 
Subject accrual (including 
compliance with protocol 
enrollment criteria) 
Monthly 
PI,  Steering Committee 
Semi-annually 
Independent Monitor(s) 
Status of all enrolled subjects, as 
of date of reporting  
Monthly 
PI,  Steering Committee 
Semi-annually 
Independent Monitor(s) 
Findings from ongoing quality 
assurance and quality control 
procedures 
Monthly 
PI,  Steering Committee 
Semi-annually 
Independent Monitor(s) 
 
 
 
Adherence data regarding study 
visits and intervention 
Monthly 
PI,  Steering Committee 
Semi-annually 
Independent Monitor(s) 
AEs and rates 
Monthly 
PI,  Steering Committee 
Semi-annually 
 
Independent Monitor(s) 
Annually 
NCCIH 
SAEs (unexpected and related) 
Per occurrence 
PI, Independent  Monitor (s) 
NIH/NCCIH, IRB 
SAEs (expected or unrelated) 
Per Occurrence 
PI,  Steering Committee 
Per Policy 
Independent Monitor (s), 
NIH/NCCIH, IRB 
Unanticipated Problems 
Per occurrence 
PI,  Steering Committee 
Per Policy 
Independent Monitor (s), 
NIH/NCCIH, IRB 

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11. PARTICIPANT RIGHTS AND CONFIDENTIALITY 
11.1. Institutional Review Board (IRB) Review         
 
This protocol, informed consent document, participant facing CRFs and any subsequent 
modifications will be reviewed and approved by the UMN IRB  
11.2 Informed Consent Forms          
This study will use the combined HIPAA Authorization / Consent document (UMN HRP-
593). 
PIs or designees (research staff, investigators) will conduct the informed consent process. 
Participants will be given an electronic or hard copy of the consent form to review on their 
own, with ample time. The consent form will provide information regarding the study 
purpose and research design, procedures, potential risks and benefits, alternatives to 
participation, voluntary nature of participation, privacy and confidentiality, research-
related injury, and disclosure of new information regarding participation. Contact 
information for the PIs and study coordinator will also be provided.  
Research staff will meet one-on-one with the participant in a private space and review 
each section of the form. Informational materials will be used to facilitate understanding. 
Participants will be invited to ask questions section by section.  
Only individuals who demonstrate comprehension will be considered eligible to 
participate. Persons who are not able to read and write in English or consent for 
themselves are ineligible. Persons under 18 years old are not eligible.  
A signed consent form will be obtained from each participant. All participants will receive 
a copy of the signed form for their personal records. Original signed consent forms will be 
secured in the participant’s research file. E-consent forms will be secured in the 
participant’s research file in REDCap.  
Changes to the consent form may be initiated by research staff, investigators, or 
regulatory oversight boards as needed. Any changes will be approved by the co-Principal 
Investigators and submitted to the IRB of record for approval.  
11.3 Participant Confidentiality          
Procedures are in place for maintaining the confidentiality of all information collected.  All 
staff receive HIPAA and data safety training as well as intensive orientation on the 
confidentiality of the research record and maintaining the security of clinical information. 
Data are managed by study number and analyzed anonymously. Electronic data will be 
housed on password protected, HIPAA compliant databases stored on secure servers 
also operated by the UMN Academic Health Center-Information System (AHC-IS). The 
servers are in a physically secure location on campus and are backed up nightly, with the 

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SUPPORT Study Protocol V3 May 2022 
backups stored in accordance with the AHC-IS. All hard copy study files will be stored in 
locked filing cabinets located in secured, access restricted offices. Identifiable information 
will be accessible to study related personnel who have met the UMN’s training 
requirements for the Responsible Conduct of Research, HIPAA and data security.  
 
All published reports will be summary in nature and no individual participants will be 
identified.   
Information will not be released without written permission of the participant, except as 
necessary for monitoring by the IRB, the NCCIH, the OHRP, or other regulatory oversight 
agencies. 
11.4. Study Discontinuation         
 
The study may be discontinued at any time by the UMN, the IRB, NCCIH, the OHRP, or 
other government agencies as part of their duties to ensure that research participants are 
protected.  
12. COMMITTEES 
Leadership team: Dr. Brent Leininger will serve as the contact PI and Dr. Gert Bronfort 
will serve as a Co-PI; together they will provide oversight to the entire project and 
development and implementation of all policies, procedures, and processes. Additional 
details can be found in the Multiple PI Leadership Plan. The PIs will meet weekly to 
collaborate on the overall planning, administration, implementation, management, and 
oversight of the study. 
 
Study steering committee: The steering committee is comprised of the PIs, the Co-Is, and 
the Project Coordinator. They will convene to review and monitor study activities (see 
Project Timeline) including regulatory approvals, protocol and operations development, 
recruitment, enrollment, intervention implementation and fidelity, data collection, and 
reporting. Other study staff will be invited as needed to participate. 
 
Clinic team: The clinic team is comprised of one of the PIs (Leininger), the Project 
Coordinator, and the Co-I Evans and Greco; they will coordinate training, clinic resources 
and staff, and fidelity monitoring. The Clinic Team will also convene meetings between 
study clinicians and Co-Is Greco and Evans to review and discuss the SSM intervention 
implementation. 
 
Data Team: The data team is comprised of at least one of the PIs, the Statistician, and 
Co-I Schulz; they will coordinate data management and collection activities, including 
required reports. 
 
Clinician Advisory Team: In the Planning Phase, we will assemble a group of physical 
therapists and chiropractors to take part on a Clinician Advisory Team. The role of this 
group will be to provide review of study protocols, procedures, and materials, particularly 
related to the Biopsychosocial Supported Self-Management Intervention. 

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13. STUDY TIMELINE 
Planning phase. This project has a 6 month planning phase during which time the study 
team will develop and obtain the necessary regulatory approvals for the protocol, the 
Study Accrual and Retention Plan (SARP), Data Safety and Monitoring Plan (DSMP) if 
required, and case report forms (CRFs). Qualitative data collection will also be conducted 
with physical therapists (PT) and doctors of chiropractic (DCs) to inform development and 
refinement of the supported self-management (SSM) intervention. Qualitative data will 
also be collected from community members to provide feedback on patient-facing 
materials. Training of providers will also take place prior to commencing the pilot study 
clinical phase.  
 
Clinical phase. This pilot study will take place over the course of one year (last 6 months 
of year 1, and first 6 months of year 2).  We project enrolling 40-50 participants over a 6 
month period.  
 
Data collection & analyses. Data collection will begin from the first screening, through 
the 6 month follow up (quarter 3 of year 2). Data preparation and analyses will take place 
in the final 2 quarters of year 2.  
 
Table 9. Project Timeline  
Year One 
Year Two 
Q1 
Q2 
Q3 
Q4 
Q1 
Q2 
Q3 
Q4 
Planning 
IRB Approval 
X 
 
 
 
 
 
 
 
Protocol, SARP, DSMP, CRF Approval 
X 
X 
 
 
 
 
 
 
MOP Development 
 
X 
X 
 
 
 
 
 
Training 
 
X 
X 
 
 
 
 
 
Qualitative data collection and analyses 
(Providers, patient representatives, other 
stakeholders) 
X 
X 
X 
X 
X 
X 
X 
 
Clinical 
 
 
 
 
 
 
 
 
Recruitment 
 
 
X 
X 
X 
 
 
 
Screening & Enrollment 
 
 
 
X 
X 
 
 
 
Intervention Application 
 
 
 
X 
X 
X 
 
 
Fidelity Monitoring 
 
 
 
X 
X 
X 
 
 
Data Collection & Analysis (Pilot
Study & Supplemental Aims) 
 
 
 
 
 
 
 
 
Data Collection 
 
 
X 
X 
X 
X 
X 
 
Data Preparation & Analysis 
 
 
 
 
 
 
X 
X 
Dissemination 
 
 
 
 
 
 
 
X 
Preparation of proposal for phase II trial 
 
 
 
 
 
 
 
X 
 
Enrollment of First Subject 
First enrolled subject anticipated in the last quarter of Year 1.  
14. PUBLICATION OF RESEARCH FINDINGS & FUTURE 
RESEARCH 
Individual participant results (e.g, pre and post results) will not be shared with participants.  

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Future Research. After establishing feasibility (Table 6), we will use refinement data 
(Table 7) to further optimize study methods. This work will lead to a phase II multi-site 
randomized trial with team members from the University of Pittsburgh, to determine the 
short and long-term relative effectiveness of supported biopsychosocial self-management 
compared to medical care for BRLP.  
 
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