Optimizing Outcomes for Older Veterans With Chronic Low Back Pain Syndrome: Aging Back Clinics
Phase: NA
Conditions: Chronic Low Back Pain
Sponsor: VA Office of Research and Development

 
 
 
 
 
 
 
 
 
 
Title: Optimizing Outcomes for Older Veterans with Chronic Low Back Pain Syndrome: Aging Back Clinics  
NCT03564600 
September 2021 
 
 

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Abstract 
Degenerative disease of the lumbar spine is ubiquitous in older adults, but low back pain is not.  Treatments 
that focus exclusively on degenerative spine disease, such as spinal injection and surgery, have resulted in 
rising costs and exposure to potentially life-threatening morbidity but outcomes have not improved.  We posit 
that to improve treatment outcomes for older adults with chronic low back pain (CLBP – back pain that has 
been present on at least half the days for at least 6 months), the condition should be approached as a 
syndrome, that is, a final common pathway for the expression of many contributors, in the same way that 
geriatricians approach the evaluation and treatment of delirium and falls.  Using this model, the lumbar spine is 
considered a weak link, but is rarely the sole treatment target.  Conditions that commonly contribute to pain 
and disability in older adults with CLBP include hip osteoarthritis, fibromyalgia, anxiety, maladaptive coping, 
and myofascial pain, each of which is associated with specific evidence-based treatments.  Because such 
conditions are not routinely evaluated in patients with CLBP, it is perhaps not surprising that first line 
treatments that do not specifically target multiple contributors (e.g. spine-focused physical therapy and 
analgesics) often provide suboptimal treatment outcomes.  This often results in continued treatment-seeking 
including potentially toxic medications and invasive, expensive, and potentially life-threatening procedures 
such as complex spinal fusion. 
 
The central question that the proposed randomized trial is designed to answer is: What is the efficacy of caring 
for older adults with CLBP in Aging Back Clinics (ABC), where the patient is first treated as an older adult, and 
second as a patient with CLBP, compared with usual care (UC)?  We have developed evidence and expert-
opinion based guidelines for the evaluation and treatment of 12 key contributors to pain and disability in older 
adults with CLBP.  Our prior work also supports the commonplace nature of multiple contributors to CLBP in 
older Veterans and the feasibility of delivering patient-centered comprehensive care that follows our published 
guidelines.  We now wish to implement these guidelines in our ABC clinics and compare this approach to that 
of UC in older Veterans.  Proof of the hypotheses could significantly impact patient care by reducing pain and 
disability and identifying key conditions whose treatment could prevent the pursuit of invasive treatments and 
their associated potential morbidity and cost. 
 
About 450 Veterans age 65-89 with CLBP will be recruited from primary care provider practices at 3 VAs – VA 
Pittsburgh Healthcare System, VA Greater Los Angeles, and Richmond VA to meet a target randomization of 
310.  Individuals will be randomized to receive either ABC care or UC and they will be followed for one year. 
Those in ABC care will be referred to a generalist (e.g., geriatrician, physiatrist, rheumatologist) that has been 
identified and trained in a structured assessment to identify the conditions for which evidence and expert 
opinion-based algorithms have been created.  Usual care will not be constrained.  Outcomes will be assessed 
at baseline and over the telephone at up to three later time points: 3 months, 6 months, 9 months and 12 
months.  Health Care Utilization will be assessed monthly. Gait speed, a strong predictor of morbidity and 
mortality in older adults, will be measured at baseline.  The proposed clinical trial has the potential not only to 
improve pain-related disability, but also to reduce morbidity, increase quality of life, and limit healthcare 
utilization. 

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List of Abbreviations 
ABC- Aging Backs Clinic 
ACP- American College of Physicians 
CARF- Commission for Accreditation of Rehabilitation Facilities 
CBT- cognitive behavioral therapy 
cIRB- central Institutional Review Board 
CLBP- chronic low back pain 
co-I - co-Investigator 
COX2- cyclooxygenase-2 
CPRS- computerized patient record system 
CTC- Clinical Trial Center 
CVS- Concurrent Versions System 
Dr.- Doctor 
e.g.- exempli gratia or for example 
EP- Expert Panel 
FAB- Fear Avoidance Beliefs 
FES- Falls Efficacy Short Form 
FIPS- Federal Information Process Standards 
FMS- fibromyalgia syndrome 
G&EC- Geriatrics and Extended Care 
GAD-7 -General Anxiety Disorder-7 
GEM- Geriatric Evaluation and Management 
GH- Global Health 
GRECC- Geriatric Research, Education and Clinic Center 
i.e.- for example 
IRB- Institutional Review Board 
LA- Los Angeles 
LHP- lateral hip/thigh pain 
LLD- leg length discrepancy 
LSS- lumbar spinal stenosis 
LVCF- least-value-carried-forward 
MAR- missing at random 
MCI- mild cognitive impairment 
MCID- minimal clinically important difference 
M.D.- Medical Doctor 
MDS- Minimum Data Set 
MH-PH- Mental Health Physical Health 
MMSE- Mini Mental Status Exam 
MOS Social Support Survey- Medical Outcomes Study Social Support 
Survey 
MP- myofascial pain 
MR- multidisciplinary rehabilitation 
MRI- magnetic resonance imaging 
NIH- National Institutes of Health 
NNT- number needed to treat 
NSAID- nonsteroidal anti-inflammatory drugs 

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OA- osteoarthritis 
ODI- Oswestry Disability Index 
OEF- Operation Enduring Freedom 
OIF- Operation Iraqi Freedom 
PACT- Patient Aligned Care Team 
PCP- primary care provider 
PhD- Doctor of Philosophy 
PHQ-4 - Patient Health Questionnaire for Depression and Anxiety-4 
PHQ-9 - Patient Health Questionnaire-9 
PI- Principal Investigator 
PT- Physical therapist 
QMCI- Quick Mild Cognitive Impairment 
R&D- Research and Development 
RC- Research Coordinator 
Richmond, VA- Richmond Virginia 
RR&D- Rehab Research and Development 
Rx- medical prescription 
SAS- Statistical Analysis Machine 
SIJS- sacroiliac joint syndrome 
SPiRE- Small Projects in Rehabilitation Research  
SSN- Social Security Number 
SUD- Substance Use Disorders 
TBB- Take Back Your Back 
UC- Usual Care 
VA- Veterans Administration 
VAPHS- Veterans Administration of Pittsburgh Healthcare System 
VHA- Veterans Health Administration 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Contents 
Protocol Title: ............................................................................................................................. 6 
1.0 
Study Personnel............................................................................................................... 6 
2.0 
Introduction ...................................................................................................................... 7 
3.0 
Objectives ...................................................................................................................... 13 
4.0 
Resources and Personnel .............................................................................................. 14 
5.0 
Study Procedures .......................................................................................................... 16 
5.1 Study Design ................................................................................................................... 16 
5.2 Recruitment Methods ...................................................................................................... 17 
5.3 Informed Consent Procedures......................................................................................... 17 
5.4 Inclusion/Exclusion Criteria ............................................................................................. 18 
5.5 Study Evaluations ........................................................................................................... 18 
5.6 Data Analysis .................................................................................................................. 24 
5.7 Withdrawal of Subjects .................................................................................................... 26 
6.0 
Reporting ....................................................................................................................... 26 
7.0 
Privacy and Confidentiality ............................................................................................. 27 
8.0 
Communication Plan ...................................................................................................... 28 
9.0 
References ....................................................................... Error! Bookmark not defined. 
 

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Protocol Title:  Optimizing Outcomes for Older Veterans with Chronic Low Back Pain Syndrome: Aging 
Back Clinics 
 
1.0 Study Personnel 
Principal Investigator/Study Chair 
 
Debra Kaye Weiner, M.D. 
Debra.Weiner@va.gov 
Phone: 412-360-2920 
Veterans Administration of Pittsburgh Healthcare System 
University Drive C,  
Pittsburgh PA, 15240 
 
Co-Investigators: 
Denise Wei Duan- Porter, M.D. 
Wei.DuanPorter@va.gov 
Phone: 612-467-2158 
1 Veterans Drive 
Minneapolis, MN 55417 
 
Meika Fang, M.D. 
Meika Fang, M.D. 
Phone: 310-268-4503 
11301 Wilshire Blvd 
Los Angeles, CA 90073 
 
Edward Garay, M.D.  
Edward.Garay@va.gov 
Phone: 412-360-6359 
Veterans Administration of Pittsburgh Healthcare System 
University Drive C,  
Pittsburgh PA, 15240 
 
Angela Gentili, M.D. 
Angela.Gentili@va.gov 
Phone: 804-675-5428 
Hunter Holmes McGuire VA Medical Center 
1201 Broad Rock Blvd 
Richmond, Virginia 23224 
 
Subashan Perera, PhD 
ksp9@pitt.edu 
Phone: 412-692-2365 
University of Pittsburgh 
2471 Fifth Avenue 
Kaufman Medical Building, Suite 500 
Pittsburgh, PA 15213 

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Collaborators: 
Beverly Thorn, PhD, Professor Emeritus  
bthorn@ua.edu  
Phone: 205-348-5024 
University of Alabama 
417-D Gordon Palmer Hall  
Tuscaloosa, AL 35487 
2.0 Introduction 
 
BACKGROUND AND SIGNIFICANCE 
Statement of the Problem. Back and other musculoskeletal pains are the most common reasons that United 
States Veterans seek medical care,18 and approximately half of these patients are age 65 and older.19  The 
prevalence of low back pain in those 85+, the most vulnerable and fastest growing segment of society, is 
estimated at 44%.20  Chronic low back pain (CLBP, i.e., exists on at least half the days for at least 6 months4) 
is associated with the overwhelming majority of low back pain-associated healthcare resource utilization and 
personal suffering, including physical disability, depression, anxiety, insomnia, cognitive dysfunction, loss of 
sleep and appetite, and social isolation.21-23  In older Veterans (i.e., > age 65), physical and emotional suffering 
may be compounded by a heightened risk of iatrogenic adversity associated with commonly employed 
interventions such as spinal injections, surgery, and potentially toxic medications (e.g., gastrointestinal 
bleeding and renal failure with nonsteroidal anti-inflammatory drugs, falls and hip fractures with opioids24). And, 
while substantial resources continue to target treating patients with back pain, treatment outcomes have 
remained stagnant.3 What accounts for this healthcare crisis? 
Lumbar Spine-Targeted CLBP Treatment.  When evaluating patients with CLBP, spinal imaging such as x-
rays and magnetic resonance imaging (MRI) are not recommended because they have not improved care.25,26 
But the utilization of spinal imaging and procedures guided by this imaging (e.g., epidural corticosteroids, 
spinal surgery) for patients with CLBP has continued to skyrocket.3 This approach often is not helpful for older 
Veterans because degenerative disease of the lumbar spine (e.g., degenerative disc and facet disease, 
bulging discs) identified with imaging is nearly ubiquitous in people age 65 and older, even in those who are 
pain-free.1  An estimated 1 in 5 pain-free older adults also has moderate to severe lumbar spinal stenosis on 
MRI.2   
If we attempt to manage the older adult with CLBP solely using spinal imaging, there may be one of three 
results: 1) In the best-case scenario, the physical cause of pain is identified and the appropriately targeted 
treatment is prescribed (e.g., severe central canal stenosis is identified and decompressive laminectomy 
results in reduction of pain and disability); 2) Pathology is identified that may be incidental (e.g., asymptomatic 
central canal stenosis, bulging discs, degenerative disc disease) but the cause(s) of pain and disability lies 
outside of the lumbar spine (e.g., sacroiliac joint syndrome [SIJS], myofascial pain of the erector spinae or 
quadratus lumborum, hip OA), thus treatment may be misdirected; 3) Spinal pathology is identified that, when 
combined with biopsychosocial factors outside of the lumbar spine (e.g., anxiety, depression, fear avoidance 
beliefs, insomnia, fibromyalgia syndrome [FMS], hip OA), adds to CLBP and further disability results. If our 
treatment targets only degenerative spine disease in these patients, suboptimal outcomes are likely. That is, 
imaging-directed treatment failures in older Veterans with CLBP may relate to the treatments being spine-
centered rather than patient-centered. 
Non-specific CLBP Treatment.  Some providers practice at the opposite end of the spectrum.  Instead of 
prescribing treatment that targets spinal pathology, they approach CLBP as a generic condition.  As previously 
mentioned, “non-specific low back pain” is a commonly used term defined as low back pain that is not 
attributable to a recognizable, known specific spinal pathology (e.g., infection, tumor, spinal fracture, structural 
deformity, inflammatory disorder) or associated with radiculopathy/spinal stenosis.25,27  First line treatment 

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involves physical therapy and/or oral analgesics, an approach that typically results in modest improvement in 
pain and function.28 This approach fails to acknowledge the commonly occurring specific contributors to CLBP 
and back pain-related disability in older adults that cannot be detected on spinal imaging and respond to a 
variety of evidence-based treatments such as hip osteoarthritis29, fibromyalgia30, and depression.31 
The 2017 Clinical Practice Guideline on Acute, Subacute and Chronic Low Back Pain from the American 
College of Physicians (ACP) approach CLBP as a non-specific condition and recommend “treatment with 
nonsteroidal anti-inflammatory drugs (NSAIDs) as first-line therapy” for patients “who have had an inadequate 
response to nonpharmacologic therapy.”28  Even these recent guidelines fail to acknowledge that NSAIDs are 
very cautiously recommended for chronic use in older adults because these drugs risk causing renal 
insufficiency, gastrointestinal bleeding, and other adverse events.24 The guidelines also recommend initial 
treatment of CLBP with multidisciplinary rehabilitation (MR) as one non-pharmacological option based on 
moderate quality evidence28, even though these programs are characterized by high participant burden, 
making them inaccessible to many older Veterans, especially those who are physically and/or cognitively frail. 
Evidence indicates that while MR improves function, it is only modestly effective in reducing pain 
intensity 32, one of the key outcomes that our patients value.   As noted above, older adults with CLBP can 
have many physical contributors to their pain33 that have specific evidence-based pain treatments and may not 
be included in MR programs, as these programs tend to be group based, not individualized.  Thus, 
approaching CLBP as a non-specific condition is fraught with limitations that result in suboptimal outcomes for 
many older adults. 
How can we redirect the evaluation and treatment of older adults with CLBP to result in better 
outcomes? To answer this question, we started by convening an expert panel of three physical therapists 
(PTs) and a geriatrician/ rheumatologist whose practices focused on chronic pain management.  The panel’s 
task was to identify common categories of physical pathology in older adults with CLBP that were not 
being treated because they were overlooked or misdiagnosed by referring providers.  Four categories 
were identiﬁed: myofascial pain (MP), ﬁbromyalgia, sacroiliac joint syndrome (SIJS), and hip disease.33  We 
developed protocols to identify these conditions and established the feasibility of training providers in their 
recognition.33  We found that MP exists in 96% of older adults with CLBP, SIJS in 84%, hip disease in 24%, 
and fibromyalgia in 19%. Eighty-two percent had multiple conditions 33, none diagnosed with spinal imaging, 
but all detectable during a thorough history and physical exam.  
This work validated our clinical observations of the multiple physical contributors to CLBP in older 
adults that were being missed with spinal imaging.  We then took the next step toward facilitating practice 
change, recognizing the need to break down specialty silos.  We collaborated with 42 providers (9 PCPs and 
33 pain/pain-related experts [chiropractic, geriatric medicine, neuropsychology, occupational therapy, pain 
medicine, pharmacology, physiatry, physical therapy, psychiatry, psychology, rheumatology, sleep medicine]), 
to gather and evaluate the wealth of evidence scattered within specialty literature, often inaccessible to many 
providers.  The 42-member panel used a modified Delphi process to synthesize existing evidence and 
develop a set of 12 algorithms that guide the systematic evaluation and safe treatment of key physical and 
non-physical contributors to pain and disability in older adults with CLBP.  The 12                                                            
conditions are: a) those that cause CLBP directly (i.e., hip osteoarthritis66, fibromyalgia30, myofascial pain67, 
SIJS68, leg length discrepancy54, lumbar spinal stenosis [LSS]69); b) those that impair an individual’s ability to 
modulate pain and compound CLBP-associated disability (i.e., anxiety and/or depression21, insomnia23, 
maladaptive coping [i.e., fear avoidance beliefs70 and pain catastrophizing71], dementia72);  and c) those 
associated with leg pain not caused by degenerative spine disease and can mimic radiculopathy (i.e., greater 
trochanteric pain syndrome73, myofascial pain74). Each of these conditions, except LSS, cannot be detected 
on spinal imaging and respond to a variety of evidence-based treatments, per Table 1. Thus, evaluating 
and treating these conditions can prevent unnecessary and ineffective care.  The protocols we developed 
are the foundation of the Aging Backs Clinic (ABC) arm of the proposed trial (Appendix 5). ABC care 
approaches the older adult with CLBP, first as an older adult, and second as a patient with chronic 
pain.  CLBP is approached as a geriatric syndrome, i.e., a final common pathway for the expression of multiple 
contributors5 rather than a disease isolated to the spine or a non-specific condition.  That is, we conceptualize 
the lumbar spine as an area of vulnerability, but not the sole treatment target. 

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Figure 1. VA Stepped Pain Care75 
ABCs and the VA Stepped Pain Care Model.  In 1998 the Veterans Health Administration launched their 
Pain Management Strategy in response to the growing number of Veterans with pain and the associated 
personal and financial burden.  The overarching objective of the Strategy was to develop a “comprehensive, 
multicultural, integrated, systemwide approach to pain management that reduces pain and suffering for 
Veterans experiencing acute and chronic pain associated with a wide range of illnesses including pain at the 
end of life.”75 To guide implementation of the Strategy, in 2009 the VA Stepped Pain Care model was 
published, shown in Figure 1.75 This model calls for “assessment and management of health problems via low 
intensity interventions followed by the introduction of more intensive, specialized, and individually tailored 
approaches if persons do not maximally benefit from less intensive efforts.”75 ABC care aligns with the VA 
Stepped Pain Care model and is guided by our 
published stepped care algorithms targeting 
the Veteran’s individual pain contributors. It 
conceptually straddles Step 1 and Step 2 in 
Figure 1, and incorporates comprehensive 
screening, assessment and management of 
important conditions contributing to CLBP and 
disability, with as needed referrals to other 
specialists, depending on the patient’s 
individual pain contributors. Depending on the 
Veteran’s response to initial treatments and 
their physical/cognitive stamina, 
interdisciplinary pain clinic referral (Step 3) 
also may be offered.  The flexibility of the 
ABC approach affords truly patient-
centered care. Additional details about ABC 
operations are provided in the Research 
Design and Methods section. 
The Proposed Study.  The goal of the proposed clinical trial is to evaluate the efficacy of ABC care as 
compared with that of Usual Care (UC) for older Veterans with CLBP.  The preparatory work that we have 
conducted to establish the foundation for this trial is presented in the Preliminary Studies section below.   
 
PRELIMINARY STUDIES 
Standardization of ABC Clinic Treatments. Our first pilot study funded by VA Rehabilitation Research & 
Development (Pilot Study #1) resulted in the creation of the 12 CLBP algorithms referenced in the Background 
and Significance section.  An interdisciplinary expert panel (EP) created each algorithm and accompanying 
materials (i.e., tables outlining stepped care medication management and rationale for individual components 
of the algorithm with supportive references).  A 9-member panel of experienced PCPs, including VA providers, 
reviewed the materials, focusing on feasibility of implementation in the VA.  The EP modified the algorithms 
based on PCP feedback and the process continued until no revisions were recommended.  
All algorithms have these common elements: 1) supportive literature evidence and, when lacking, EP 
consensus; 2) imaging only to confirm pathology suspected on history and physical examination (e.g., 
American College of Rheumatology clinical criteria for hip OA required before ordering hip x-rays); 3) emphasis 
on self-management; 4) patient-provider collaborative decision making; 5) stepped-care management that 
acknowledges specific vulnerabilities in older adults (e.g., avoiding medications in Beers’ criteria for potentially 
inappropriate medications in older adults24, prescribing a walker instead of pain medications or an invasive 
procedure for the frail older adult with neurogenic claudication). As shown in Table 1, most of the conditions 
are associated with strong evidence-based treatments that have been incorporated into each of the algorithms.  
Dr. Rollin Gallagher, former Director of Pain Management for the Veterans Health Administration, endorsed the 
importance of our work (see letter of support); each algorithm has been published along with an illustrative 
case in Pain Medicine, the official journal of the American Academy of Pain Medicine (Appendix 5). 

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Table 2. Prevalence of CLBP Contributors (n=51) 
Condition 
Prevalence 
n (%) 
Hip OA 
15 (29) 
Myofascial pain 
38 (74.5) 
Sacroiliac joint syndrome 
34 (67) 
Lumbar spinal stenosis 
16 (31) 
Leg length discrepancy 
13 (25.5) 
Lateral hip/thigh pain 
8 (15.7) 
Fibromyalgia 
12 (23.5) 
Depression 
17 (34) 
Anxiety 
14 (28) 
Maladaptive coping 
33 (61) 
Insomnia 
30 (63.8) 
Only 1 CLBP contributor 
1 (2) 
>1 physical contributor 
45 (88) 
>1 non-physical contributor 
30 (60) 
>1 physical AND >1 non-
physical contributor 
44 (86.3) 
Feasibility of Training Providers in Evaluating CLBP Conditions. In Pilot Study #1, four providers (2 at 
VAPHS and 2 at Richmond VA - 3 geriatricians and one general internist with a large older adult patient panel) 
were trained in the structured physical assessment (Appendix 6) to ascertain the presence of hip OA, leg 
length discrepancy (LLD), myofascial pain (MP), sacroiliac joint syndrome (SIJS), and lateral hip/thigh pain 
(LHP – e.g., greater trochanteric pain syndrome), and a 
structured history to screen for lumbar spinal stenosis. After 
two training sessions (separated in time by ~ 1 month), all 
providers were confident in their ability to perform the 
physical assessment for the conditions listed above (hip OA, 
LLD, MP, SIJS, LHP) and immediately began incorporating 
their newfound skills into the care of their own patients.  
Providers uniformly felt empowered in their ability to educate 
their patients about the contributors to their CLBP and felt 
that patients were more satisfied with their encounter than 
they had been previously.  Specific provider comments 
included, “I find seeing these patients fun now!” “I was so 
excited that I was able to identify the cause of the patient’s 
pain!” “These protocols have given me a way to offer my 
patients options other than sending them for potentially 
harmful procedures…Many of them are getting better!”   
These data, although associated with a small sample size, 
underscore the feasibility and potential value of training 
providers in the structured CLBP physical exam that helps to 
guide ABC care.  
Clinical Profile of Older Veterans with CLBP. In Pilot 
Study #1, a research coordinator at each site administered 
questionnaires to screen for non-musculoskeletal CLBP 
contributors, specifically, the PHQ-9 for depression 76, the 
GAD-7 for anxiety 77, the Insomnia Severity Index for 
insomnia 78, the catastrophizing scale of the cognitive 
strategies questionnaire 79, and the fear avoidance beliefs 
questionnaire.80 The prevalence of conditions among 
participants is summarized in Table 2.  Most participants, 
88%, had at least one physical contributor; 60% had at least 
one non-physical contributor (i.e., depression, anxiety, 
maladaptive coping [either catastrophizing or fear avoidance 
beliefs], or insomnia); and the majority (86.3%) had both physical and non-physical contributors.  These data 
highlight the validity of the comprehensive approach that will be applied in the ABC arm of the proposed trial. 

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Table 3. Annual Recruitment: Potential Enrollees 
Number of Veterans… 
VAPHS 
Los 
Angeles 
Richmond 
Available for pre-screening 
4,739 
7,486 
5,010 
Eligible for telephone screening 
2,890 
  4,491 
2,505 
Eligible for on-site assessment 
1,600 
  2,470 
1,387 
Eligible after on-site assessment 
1,194 
  1,828 
1,035 
Table 4. Value of ABC Care: Veteran Quotes 
• I am sleeping better, having less pain, and able to 
do things I couldn’t do before, like cut the grass. 
• My pain is tolerable now. 
• Before the study I was getting one hour of sleep; 
now I am doing much better. 
• I can stand longer and the pain is not as intense.  
Before the study I could only walk 20 yards and my 
back felt like it was on fire.  I no longer feel that. 
• I wouldn’t trade [being in the study] for a million 
dollars.  I am fortunate to be a veteran and to be 
able to get this kind of care.  I’m sincere about it. 
 
Figure 2. Status of Pilot Study #2
Feasibility of Recruitment and Implementation 
of ABC Care:  Pilot Study #2 funded by VA 
Rehabilitation Research & Development is being 
conducted to evaluate the feasibility of 
recruitment and implementation of ABC care. 
Electronic medical records of Veterans age 65-89 
who had undergone a lumbar MRI during the 
prior 30 days or were scheduled to have an MRI 
within 30 days, were reviewed for eligibility 
(absence of red flags/need for urgent and 
specialized treatment; no prior lumbar surgery; 
cognitively intact) at VAPHS and the Richmond 
VA.  The results are summarized in Figure 2. All 
50 participants have been enrolled. They are 
96% male, age 68.7 + 8.2, 28% black, with an 
average back pain intensity 6.4 + 1.6 and 
average pain duration 5.7 + 0.7 years. The follow 
up time points that have been collected thus far 
are shown in Figure 2.  There have been no 
dropouts and no adverse events. Data on CLBP 
contributors were collected using methods 
identical to that of Pilot Study #1.  The clinical 
profile of participants was: 4.2% had only one contributor to their CLBP, 79.2% had two or more physical 
contributors, 20.8% had two or more non-physical contributors, and 66.7% had at least one physical and at 
least one non-physical contributor. In this Pilot, we recruited Veterans with a recent lumbar MRI because such 
imaging can lead to a cascade of events that do not result in improved outcomes.81  As per Figure 2, this 
strategy resulted in excluding the majority of potential older Veteran participants with CLBP.  To optimize the 
generalizability of findings associated with the proposed clinical trial, we do not require imaging as a 
prerequisite to participating.  This revised strategy is also consistent with clinical guidelines, as highlighted in 
Background and Significance. 
To ascertain the feasibility of the revised (no 
imaging required) recruitment strategy, we 
reviewed 100 randomly selected charts at each 
site from among the total available pool (i.e., 
those available for pre-screening).  As shown in 
Table 3, data pulled from our 3 participating 
sites over the past 12 months revealed 17,235 
Veterans age 65-89 with a diagnosis of low 
back pain and who had seen their PCP within 
the prior 6 months (7,486 from Los Angeles, 
4,739 from Pittsburgh and 5,010 from 
Richmond). Pre-screening excluded 40% at Los 
Angeles, 50% at Richmond, and 39% at VAPHS.  The most 
common reason for ineligibility across sites was prior spine 
surgery (60% of those excluded at Los Angeles, 34% of 
those excluded at Richmond, and 38% of those excluded at 
VAPHS).  Total numbers available for on-site assessment 
following telephone screening and those eligible following 
on-site assessment were calculated based on Pilot Study #2 
(Figure 2) and the results are shown in Table 3. Thus, we 
expect to easily meet our recruitment goals of 55 participants 
per site per year. 
Perceived Value of ABC Care. Pilot Study #2 is ongoing 

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Figure 3. Take Back Your Back: Catastrophizing pop-up  
thus we have not broken the study blind. As per our study protocol, an unmasked research coordinator has 
conducted exit interviews at study completion (6 months follow up) for participants that were randomized to 
PCC care. Noteworthy feedback is in Table 4.   
Educating and Screening Older Veterans for CLBP Contributors.  Pilot Study #3 was funded by an award 
from the VA Pittsburgh Healthcare System (VAPHS) Geriatric Research, Education and Clinical Center.  This 
funding supported the development of Take Back Your Back (TBB), an interactive tablet-based tool for older 
adults with CLBP.  This tool takes ~7-10 minutes to complete and is designed to be self-administered prior to 
the patient undergoing CLBP evaluation by their healthcare provider (e.g., in the waiting room or waiting in the 
physical exam room).  Specifically, the tool:   
1) Educates patients about realistic treatment expectations; the multifactorial biopsychosocial nature of 
CLBP; the role of imaging, injections, and analgesics in managing CLBP; and the risks associated with 
opioids, muscle relaxants and NSAIDs.24 
2) Screens for key CLBP contributors – Anxiety and 
depression are screened with the PHQ482 and 
insomnia is screened with a single item:   In the past 7 
days, my sleep quality was: very poor/ poor/ fair/ 
good/very good.4  Fibromyalgia is screened with the 
fibromyalgia survey83; fear avoidance beliefs (FAB) 
and/or catastrophizing4, as indicators of maladaptive 
coping, by asking the following questions from the NIH 
Minimal Data Set: Do you agree with the following 
statements? – ‘I feel that my back pain is terrible and 
it’s never going to get any better (an affirmative 
response suggests catastrophizing);’ ‘It’s not really 
safe for a person with my back problem to be physically active (an affirmative response suggests FAB).  
We screen for possible hip OA with the question, ‘Do you have pain in one or both of your hips?’ The 
presence of leg symptoms precipitated by walking and relieved by rest as a possible indicator of lumbar 
spinal stenosis also is included in TBB.  
3) Encourages the patient to communicate with their healthcare provider.  For example, if the patient 
screens positive for fear-avoidance beliefs by responding “yes” to the question: Do you agree with the 
following statement? - ‘I feel that my back pain is 
terrible and it’s never going to get any better,’ a 
pop-up will appear, per Figure 3, encouraging the 
patient to discuss this concern with their 
healthcare provider.  As described in the Research 
Design and Methods section, a summary screen of 
the Veteran’s responses will be given to the 
healthcare provider and this will facilitate targeting 
of their history and physical examination.  That is, 
while TBB will screen for key conditions, its 
purpose is not to diagnose.  Additional details 
about TBB that relate to its incorporation into the 
proposed trial are provided in the Research 
Design and Methods section. 
We have conducted three rounds of usability testing with 
TBB in 15 older adults (mean age 71.7, range 60-88 + 
7.9) with CLBP (81% Veterans). Each round had 5 or 
more participants. In rounds 2 and 3, one to two 
participants from the prior round participated, as per 
standard iterative usability testing methods.84  The 
reading level of TBB is at a Flesch-Kincaid Grade level 
of 6.9.  All participants voiced that the material was 
Table 5. Participant Feedback on “Take Back Your Back” 
Veteran Quotes 
• Starts you thinking what you can and can’t do 
• Very straightforward 
• Helpful because it’s a “holistic approach; included a wide 
variety of problems” 
• Liked the ipad over a booklet [like a pamphlet in the doctor’s 
office]; more fun! 
• Helped me realize things I already knew but forgot 
• Opened my mind to different options 
• It was helpful that the questions were even asked 
• It tries to get to the source of the problems (and it gets to the 
point!) 
• I feel empowered by the app (from an 88 y.o. participant) 
• Better prepared to talk to my doctor. 
• Good starting point; something to build on 
 
Non-Veteran Quotes 
• Would have been really helpful to have (wish I would have 
had this) when I first started seeking treatment for my low 
back pain 
• Great refresher 

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presented in a clear manner.  In the third round of testing, no suggestions for modifications were 
recommended.  A round of beta-testing (mean age 75.1, range 60-86) was performed on an additional 30 
participants, 14 Veterans and 16 non-Veterans. Noteworthy feedback from participants is shown in Table 5. 
Thus, this tool was very well received by Veterans.  Further, by removing the need for dedicated staff (e.g., the 
research coordinator in Pilot Study #1) to screen for non-musculoskeletal CLBP contributors, it has the 
potential to efficiently facilitate translation of our research findings into clinical practice. 
 
Summary of Preliminary Studies. The studies described above lay the essential foundation for the 
proposed clinical trial. We have: 1) used a rigorous process to develop and publish 12 evaluation and 
treatment protocols for key conditions that contribute to CLBP and disability in older adults and these 
will be implemented in the ABC arm; 2) established the feasibility of training providers in the evaluation 
of musculoskeletal contributors; 3) validated the importance of comprehensive biopsychosocial 
assessment in older Veterans; 4) developed an interactive patient self-report and education tool usable 
in the clinical setting; 5) examined the feasibility of conducting the trial (i.e., participant recruitment and 
intervention implementation).  These studies have prepared us to take the next important step, that is, 
to conduct a randomized controlled clinical trial to test the efficacy of a new approach to CLBP care for 
older Veterans – Aging Back Clinics (ABCs). 
 
Inclusion of Vulnerable Subjects and Special Populations. Vulnerable subjects will not be enrolled. 
Neither pregnant subjects nor women of childbearing potential will be included because we are 
targeting older adults with low back pain. Neither children nor prisoners will be included.  
3.0 Objectives 
 
SPECIFIC AIMS 
Degenerative disease of the lumbar spine (e.g., degenerative discs and facets, bulging discs) is ubiquitous 
in older adults, but low back pain is not.1,2  Treatment that focuses exclusively on degenerative spine 
disease such as spinal injection and surgery, therefore, has resulted in rising costs and exposure to 
potentially life-threatening morbidity but not improved outcomes.3  We posit that to improve treatment 
outcomes for older adults with chronic low back pain (CLBP – back pain that has been present on at least 
half the days for at least 6 months4), the condition should be approached as a syndrome, that is, a final 
common pathway for the expression of many contributors.  Geriatricians evaluate and treat other 
syndromes, such as delirium and falls similarly, with good outcomes.5  When an older patient experiences 
delirium, a geriatrician doesn’t recommend brain surgery. Using this model, the lumbar spine is considered 
a weak link, but is rarely the sole treatment target.   Conditions that commonly contribute to pain and 
disability in older adults with CLBP such as hip osteoarthritis (OA), fibromyalgia, and depression, are 
associated with specific evidence-based treatments.   
 
PURPOSE AND HYPOTHESES 
The central question that the proposed randomized trial is designed to answer is: What is the efficacy of 
comprehensive patient-centered care of CLBP as a syndrome that is delivered in Aging Back 
Clinics (ABC), compared with usual care (UC)?  Through prior VA Rehabilitation Research & 
Development support, we have developed and published evidence and expert-opinion based guidelines for 
the evaluation and treatment of 12 key contributors to pain and disability in older adults with CLBP – hip 
OA, fibromyalgia, myofascial pain, lumbar spinal stenosis, sacroiliac joint syndrome (SIJS), leg length 
discrepancy, lateral hip/thigh pain, insomnia, depression, anxiety, maladaptive coping, and dementia.6-11  
Our prior work also supports the commonplace nature of multiple contributors to CLBP in older Veterans 
and the feasibility of delivering ABC care that follows our published guidelines.  We now wish to compare 
this approach to that of UC in older Veterans.  Proof of the hypotheses that we will test could significantly 

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impact patient care by reducing pain and disability and avoiding costly and potentially morbid treatments. 
The proposed trial is designed to address the following aims: 
Aim 1: Establish the efficacy of ABC care compared to usual care. 
We hypothesize that those randomized to ABC care will have: 
H1.1: Greater 6-month reductions in pain-related disability as measured by Oswestry Disability Index (ODI; 
primary outcome and endpoint); 
H1.2: Greater 12-month reductions in ODI; and greater 6- and 12-month reductions in pain severity (by 
PROMIS 29), quality of life (by PROMIS Global Health [GH]); depressive and anxiety symptoms (by 
PROMIS 29); and greater improvement in falls efficacy (by Falls Efficacy Scale-International short form);  
H1.3: Less healthcare utilization between 6 and 12 months with respect to emergency room visits, 
hospitalizations, opioids prescribed, and invasive procedures performed (secondary outcomes and 
endpoints). 
Aim 2: Explore the heterogeneity of treatment efficacy of ABC care. 
H2.1: Those with greater baseline CLBP-associated disability, anxiety/depression, mild cognitive 
impairment, and/or obesity will reap greater benefits from ABC compared to UC (exploratory subgroup 
discovery). 
 
Four hundred fifty Veterans age 65-89 with CLBP, (for a targeted enrollment of 310), will be recruited from 
primary care provider (PCP) practices at 3 VAs – VA Pittsburgh Healthcare System, VA Greater Los 
Angeles, and Hunter Holmes McGuire (Richmond) VA.  Individuals will be randomized to receive either 
ABC care or UC, and they will be followed for one year.  Aging Back Clinics will be staffed by consultants 
(e.g., geriatrics, pain medicine, rheumatology) that have been trained in evaluating and treating key CLBP 
conditions associated with our published evidence-based algorithms.  Usual care will not be constrained.  
Baseline measures will be assessed on site or on the telephone and include: Minimal Data Set 
recommended by the NIH Task Force on research standards for CLBP4; Oswestry Disability Index (ODI; 
main outcome)12; cognitive function (QMCI)13; PROMIS-29 that includes pain severity, pain-related activity 
interference, physical function, sleep disturbance, depressive symptoms, leg symptoms14; quality of life with 
the PROMIS-GH scale15, participant opioids-related concerns with the Prescribed Opioids Difficulties 
Scale16, gait speed, balance confidence with the Falls Efficacy Scale-International short form17; healthcare 
utilization over the prior month (e.g., pain medications, emergency room visits, hospitalizations) will be 
assessed on site.  We will also be utilizing the Life Space Assessment106 to measure the spatial extent of a 
participant’s mobility. Three, 6-, up to 9-, and 12-months outcomes (ODI, PROMIS 29 and GH, balance 
confidence, healthcare utilization, life space assessment and VR-12) will be assessed over the telephone 
by individuals masked to group assignment. While monthly, the 0-10 Numerical Pain Rating Scale, 
Medications (pain medications monthly and all medications at baseline and final follow-up), and Health 
Care Utilization will be measured. The Global Impression of Change data measure will be administered 
only at the final phone follow up. The proposed clinical trial has the potential not only to improve pain-
related disability, but also to reduce morbidity, increase quality of life, and limit healthcare utilization.   
 
4.0 Resources and Personnel 
 
The Overall PI (Dr. Debra Kaye Weiner) and the Overall RC (Kimberly Hayes Clemens) will oversee all study 
related activities to ensure the protocol is followed.  
 
This research study will be conducted at three VA facilities. 
  
Site One: VA Pittsburgh Healthcare System (VAPHS; Pittsburgh, PA) 
 
Pittsburgh LSI: Dr. Edward Garay 
Pittsburgh Local Site RC: David Newman 
 

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Site Two: VA Greater Los Angeles Healthcare System  
Dallas LSI: Dr. Meika Fang 
Dallas Local Site RC: David Segovia 
 
Site Three: Hunter Holmes McGuire VA Medical Center (Richmond, VA) 
Richmond LSI: Dr. Angela Gentili 
Richmond Local Site RC: Judy Pulliam 
 
The Local Site Investigator and Research Coordinator at each of the three sites will be responsible for site 
specific daily operations. They will have access to PHI.  
 
All RCs will be responsible for recruiting subjects, obtaining informed consent, administering survey/interview 
procedures, among other responsibilities.  
 
The study Statistician, Dr. Subashan Perera will be in charge of data analysis along with the PI. He will remain 
at the University of Pittsburgh to analyze data and will do so on time allocated for the VA grant through his IPA. 
They will work together along with LSIs in writing papers and manuscripts that are a result of this study. 
 
Dr. Wei Duan Porter will serve as a co-Investigator on the overall study analysis. She works out of the 
Minneapolis VAMC. She will not have access to identifiable data nor any patient interaction. She will work with 
the PI in data interpretation and preparation of manuscripts that result from this research. 
 
Contractor:  
All patients in the intervention group will be provided with a copy of the pain self-management workbook 
(“Learning about Chronic Pain”) developed by consultant and pain psychologist Dr. Beverly Thorn.95 The 
workbook, “Learning About My Pain (LAMP),” has been successfully implemented in the context of a trial that 
specifically targets patients of low literacy and was funded by the Patient-Centered Outcomes Research 
Institute.  The workbook was developed to be used in a group setting and will be modified during the startup 
phase of the proposed trial for use by individuals not in a group setting, under the guidance of Dr. Thorn. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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5.0 Study Procedures 
 
5.1 Study Design 
 
RESEARCH DESIGN AND METHODS  
The proposed clinical trial is designed to 
evaluate the efficacy of Aging Back Clinics 
(ABCs) that approach CLBP in older 
Veterans as a geriatric syndrome, that is, a 
final common pathway for the expression of 
multiple contributors, as compared with Usual 
Care (UC). In the context of the research 
proposed, ABCs are virtual 
interdisciplinary clinics that are inserted 
within the stepped care model shown in 
Figure 4.  Veterans without red flags 
requiring urgent attention are referred for 
ABC care that will be delivered by a 
specialist provider that has been trained in 
use of the algorithms. Both ABC care and UC 
will be provided for up to12 months. Those 
with refractory symptoms may be referred for 
intensive interdisciplinary pain rehabilitation, 
depending on their availability and the Veteran’s capacity to participate. Interventions for ABC care participants 
are numerous and vary depending on participants’ needs. These interventions include but are not limited to 
CBT, pharmacotherapy, physical therapy (PT), exercise therapy, analgesia, orthotics, injections, and 
acupuncture. One of the primary goals of ABC care is to avoid unnecessary and costly imaging and the risks 
associate with it, including unnecessary, ineffective, and potentially morbid surgeries. 
  
The conditions targeted by ABCs include those that cause CLBP directly (hip OA66, SIJS68, myofascial pain67, 
lumbar spinal stenosis69, leg length discrepancy54); those that impair pain modulation, compound CLBP-
associated disability and that themselves can cause disability (fibromyalgia30, depression21, anxiety21, 
maladaptive coping [i.e., pain catastrophizing71 and/or fear avoidance beliefs70], insomnia23, dementia72); and 
those that can mimic radiculopathy (greater trochanteric pain syndrome73, myofascial pain74).  While our 
screening procedures exclude Veterans with possible dementia (based on the Mini Mental State Examination), 
those with possible mild cognitive impairment (MCI) will be included.  As MCI and dementia are on a 
continuum, providers may wish to apply elements of the published Dementia protocol to those that screened 
positive for MCI.    
Participants:   
About 450 Veterans (150 from each site), age 65-89 with chronic low back pain (CLBP) will be recruited, (to 
target randomizing 310 participants), from the VA Pittsburgh Healthcare System (VAPHS), the VA Greater Los 
Angeles Healthcare System (Los Angeles, CA), and the Hunter Holmes McGuire VA Medical Center 
(Richmond VA). We anticipate the need to telephone screen ~1050 (i.e., ~175 per site per year) to obtain 450 
participants who meet all inclusion and exclusion criteria. No one will be excluded on the basis of race, gender 
or ethnicity. Based upon the data from each of the three sites, we anticipate that our overall participant sample 
will be 97% male, 3% female, 2% Hispanic or Latino, 98% Not Hispanic or Latino, 1% American Indian/Alaskan 
Native, 0% Asian, 2% Native Hawaiian or Pacific Islander, 18% Black or African American, and 79% White or 
Caucasian. Non-Veterans will not be recruited to participate. Vulnerable subjects will not be enrolled, including 
children and prisoners. Neither pregnant subjects nor women of childbearing potential will be included because 
we are targeting older adults with chronic LBP. 
 
 
 
Figure 4.  The ABC Stepped Care Approach 

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Costs and Payment:   
In order to compensate participants for their time, they will be paid $100 in total, with payments spaced out 
over 12 months. They will be paid $40 for their baseline visit and $30 for their final follow-up visit. An additional 
$30 will be paid after their 6-month follow-up call.  
Participants will be paid by check or electronic bank deposit, $100 in total, with payments spaced out over up 
to 12 months. They will be paid $40 for their baseline visit and $30 for their final follow-up visit. An additional 
$30 will be paid after their 6-month follow-up call. Participants may drop out of the study at any time without 
forfeiting the payments they have already received. Payments typically take between 10 days and two weeks 
to reach Veterans.  
 
 
5.2 Recruitment Methods 
 
Recruitment Procedures:  We will recruit 450 participants with methods that we have used successfully for 
other VA clinical trials: 
1. We will request a waiver of informed consent to review the CPRS records of Veterans age 65-89 with a 
documented diagnosis of low back pain.  The research coordinator (RC) at each site will review records of 
potentially eligible Veterans to ensure the veteran has a primary care provider within the VA system and that 
they have seen their PCP within the past 6 months for low back pain. This pull of potential eligible 
participants will initially be extracted from the Corporate Data Warehouse by a study staff member.   
Potentially eligible Veterans will be mailed a letter signed by the site PI and a flyer or brochure describing 
the study (both of which will be IRB-approved).  If (s)he is interested in participating, (s)he will call the study 
research coordinator (RC), whose name and contact information will be provided in the brochure. In 
addition, 14 days after we have mailed letters, if we have not been contacted, we will call potential 
participants to ascertain their interest in participation. We have successfully adopted this strategy in the 
context of our ongoing pilot study. 
2. We will recruit directly from clinics, at each local VA site, using the following approaches: a) Site PIs will 
send email to the Providers in clinics at their site to introduce the study.  b) Brochures will be delivered to 
clinic waiting rooms and to the Providers themselves including those associated with Women’s Health 
Clinics. We will suggest that Providers keep brochures in their exam rooms for distribution to potentially 
eligible Veterans.  c) IRB-approved posters will be placed in exam rooms. d) Site PIs will deliver an 
educational presentation on CLBP for PCPs and/or Providers in the context of an existing conference, and 
study information with be provided at that time.  
3. The IRB-approved brochures will also be placed in waiting rooms of specialty clinics that commonly care for 
Veterans with CLBP (e.g., orthopedics, neurosurgery, neurology, pain medicine). Interested Veterans will 
call the RC to complete screening procedures.  
 
5.3 Informed Consent Procedures 
 
In order to meet the timeline demands of this extremely low-risk study, we will request both a waiver of HIPAA 
authorization and a waiver of Informed Consent so Research Coordinators (RC) may review CPRS records for 
potentially eligible participants. The information collected will have no PHI attached to it.  
At baseline, the RC at each site will administer the Informed Consent and HIPAA prior to study procedures. 
Ample time will be provided for questions and discussion. Subjects will be considered enrolled once they have 
provided written informed consent, and a copy of the signed Informed Consent document will be provided to 
the participant. Before data collection begins, the RC will screen the participant for cognitive impairment with 

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the Mini Mental State Examination (MMSE). Participants who score less than 24 will be excluded, and their 
PCP will be alerted. Excluded participants will still be paid $40. Baseline data collection will begin at this time 
for eligible participants. Baseline data beyond the screening for cognitive impairment and gait speed test may 
be collected over the phone or on site.  
 
A progress note documenting consent will be placed in CPRS after completion of baseline. The signed 
Informed Consent will be kept under double lock and key in the research staff members’ office and only the 
research staff will have access to these documents. 
Local site study personnel will be required to maintain active training in CITI for their Human Subjects 
Protections training courses. They will also be required to be listed as administers of informed consent 
at their local site.  
 
5.4 Inclusion/Exclusion Criteria 
 
We are targeting older Veterans with CLBP, defined as pain in the lower back of at least moderate severity 
(assessed with a verbal rating scale), on > half the days for > 6 months. Veterans must be age 65-89 and 
English speaking. They must be able to commit to up to 12 months of study participation. The Quick Mild 
Cognitive Impairment Screen (QMCI) will be administered on site to screen for mild cognitive impairment 
(MCI). Those with MCI will not be excluded, but their PCP will be alerted.   
 
Exclusion Criteria include:  
• 
Positive screen for dementia (score <23 on the MMSE) 
• 
Pain in other body locations that is more severe than their low back pain 
• 
Red flags indicative of serious underlying illness requiring urgent care (e.g., fever, change in 
bowel/bladder function, sudden severe change in pain, unintentional weight loss, new lower 
extremity weakness) 
• 
Previous lumbar surgery  
• 
Acute illness 
• 
Psychotic symptoms  
• 
Prohibitive communication impairment (e.g., severe hearing or visual impairment)   
• 
Evidence of illicit substance abuse on urine drug screen at anytime in the past 6 months or 
active drug abuse documented by provider 
• 
Other (e.g. have moved out of state, are homebound, terminal illness, etc.) 
 
Neither pregnant subjects nor women of childbearing potential will be included due to the age requirements of 
the study. Vulnerable subjects will not be enrolled, nor children and prisoners.  
 
Research staff will recruit all participants. They will not use coercion of any kind.  
 
5.5 Study Evaluations 
 
Screening Procedures (Appendix 7):  Telephone screening by the RC (approved via a waiver of consent) 
using a structured questionnaire will determine participant eligibility, i.e., CLBP, ability to participate for up to 12 
months, no red flags or prohibitive communication impairment, and no acute medical or psychiatric illness.  If 
the screening procedures indicate that the Veteran is eligible, (s)he will be invited to come in for on-site 
baseline testing. After the participant has signed the HIPAA and Informed Consent documents they are 
considered enrolled. Then, the RC will administer the MMSE and those who fail (i.e., screen positive for 
dementia with a score <24) will be excluded and their PCP notified. We use the MMSE because it has been 

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studied extensively, has good diagnostic accuracy (sensitivity 0.85, specificity 0.9) and it takes only 5 to 7 min 
to administer.85 Then a doctor who is part of this study will perform a Red Flags Screening. After this is 
complete, participants will be considered active participants in this study. Beyond the data measures that must 
be collected on site (MMSE, gait speed, and Red Flags Screening by provider), the remaining may be 
collected over the telephone or on site.  
Baseline Testing (Appendix 8) - On all enrolled participants, RCs will collect a set of established measures 
that assess constructs relevant to older adults and have low participant burden, as shown in Table 6.  
1. The Oswestry Disability Index (ODI):  Our main outcomes measure, the ODI assesses interference of 
pain with function.12  
2. The Minimal Data Set (MDS), recommended by the NIH Task Force on research standards for CLBP, 
measures pain severity and interference with daily activities, widespread pain, prior CLBP treatments, 
overall physical function, depressive symptoms, sleep, psychological maladaptation (i.e., fear-avoidance 
beliefs and catastrophizing), alcohol/drug use, cigarette smoking, demographics (age, race, ethnicity, 
gender, education, marital status), height and weight.4 
3. The PROMIS 29 collects items not already included in the MDS - anxiety symptoms, fatigue, and 
participation in social roles and activities.14  The full PROMIS 29 will be administered during follow-up. 
4. Other key cofactors that may impact outcomes, and are relevant to older Veterans: 
a. Medical comorbidity will be measured by self-report with the Duke comorbidity index.86 
b. Pain medications (regularly scheduled and as-needed) will be categorized into sub-classes:  a) 
salicylates (aspirin > 1200 mg/day, salsalate), b) non-aspirin, non-COX2 selective non-steroidal anti-
inflammatory drugs (NSAIDs), c) COX2 selective NSAIDs, d) acetaminophen, e) opioids, f) skeletal 
muscle relaxants, g) adjunctive agents (e.g., corticosteroids, capsaicin).  Regularly scheduled opioid 
analgesics will be converted to daily oral morphine equivalents.87  
c. Medications other than pain will be collected as well. 
d. Social support will be measured with the well-validated MOS Social Support Scale.88  
e. Opioid difficulties will be measured (in those taking opioids) with the Prescribed Opioids Difficulties 
Scale, a patient-centric instrument that assesses patient problems and concerns attributed to use of 
opioids.16 
f. Suicidality will be measured with a question from the PHQ 9: “Over the last 2 weeks, have you had 
thoughts that you would be better off dead or of hurting yourself?” If the veteran responds affirmatively 
and the assessment is being conducted in person, the RC will immediately notify the  site’s PI who will 
contact the Veteran’s primary care provider and proceed with the VA suicide hotline protocol that 
includes a warm transfer to a VA mental health provider. If the assessment is being conducted over 
the telephone, the RC will ask the Veteran to hold on and (s)he will immediately contact the site PI 
using another telephone and the facilitiy’s Suicide Threat Call Protocol will be followed.   
5. Quality of life will be measured with the PROMIS-Global Health scale  (36) and the Veterans Rand 12 
Item Health Survey (VR-12) [ref]. 
6. Balance confidence (i.e., confidence in avoiding falling) will be measured because of data supporting 
the relationship between pain and falls in older adults.89  We will measure this with the Falls Efficacy 
Scale-International short form.17  
7. Falls during the prior 3 months will be queried because of the relationship between pain and falls in older 
adults.89 We also will collect data on falls history during the quarterly follow-up calls (see below). 
8. Quick Mild Cognitive Impairment (QMCI) screen, a validated measure that screens for the presence of 
mild cognitive impairment, will be administered.13,90  Evidence supports the impact of MCI on physical 
functioning in older adults in general and specifically in those with pain.91 The RC will upload the results 
of the QMCI to CPRS. 
9. Gait speed, a well-validated measure of physical frailty in older adults, will be measured over 4 meters 
using standard methods.92 That is, participants will be asked to walk at their usual pace and from a 
standing start.  This will be measured twice and results expressed as the average over two trials.    
10. Life Space Assessment106 will be utilized to measure the spatial extent of a participant’s mobility. 
11. 0-10 Numerical Pain Rating Scale will be utilized to measure pain at the moment, on average during the 
last week and the worst pain of the last week. 
12. Treatment History will be collected on all patients using the Treatment History form to gain an 
understanding of treatments participants have already received or are receiving to try and aid their CLBP.  

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13. The Pain Self Efficacy Questionnaire (PSEQ) will measure participants’ confidence in their ability to do 
things despite their pain. 
 
Randomization and Blinding: Following baseline testing, we will use the high quality pseudo-random deviate 
generator in SAS® (SAS Institute, Inc., Cary, North Carolina) to randomize participants to ABC care or UC in a 
1:1 ratio, stratified by recruitment site. Within each site, we plan a blocked randomization scheme to force 
continued approximate balance between the numbers of subjects in each arm during recruitment. The block 
size will be randomly chosen to be one of two small even numbers to prevent personnel from predicting 
treatment arm, and exact block sizes will be revealed at the study conclusion.  The study statistician will create 
separate randomization schedules for the 3 strata that contains a randomization sequence number (different 
from a participant's study identification number) and assigned arm.  Then he will create a series of sealed 
envelopes for each of the sites containing the treatment assignment but conspicuously labeled on the outside 
with only the randomization sequence number.  At the time of randomization, the overall RC based at the 
coordinating site will open the next available envelope specific for the participant’s site, and record the 
randomization sequence number, subject identification number and group assignment in a dedicated 
database, different from the main study database. She will then inform the RC at the participant’s site of their 
randomization group and the local RC will inform the participant of next steps.  Personnel assessing follow-up 
outcomes will be masked to intervention assignment (see Follow-Up below). The study statistician has 
successfully employed the same process in other clinical trials.  
Intervention  
UC will not be constrained.  As a courtesy, participants who are randomized to UC will be offered the ability to 
see an ABC provider at their site (in person or virtually) after their completion of all study related procedures 
and the end of their up to12 month participation. The RCs will track the components and location of care with 
monthly telephone calls using methods that we and others have used successfully in older adults (see below). 
We considered other control group designs, but chose not to for the following reasons: 1) Our clinical 
experience in delivering care to older Veterans with CLBP in our pain clinics highlights that most patients with 
CLBP already have had and failed a trial of physical therapy; thus, while we considered a control condition of 
physical therapy and analgesics, patients’ prior participation in physical therapy would threaten recruitment 
feasibility. 2) We considered physical therapy and analgesics for the control group, and altering our inclusion 
criteria; specifically, we considered including only Veterans with “new onset” CLBP, e.g., back pain on most 
days for no more than the prior 12 months to reduce the likelihood of prior physical therapy; had we used these 
criteria in our previously described pilot work, however, only 4 of 50 participants would have qualified.  3) We 
considered recruiting patients from pain clinics, i.e., randomizing participants to either ABC care or Pain Clinic 
care, but the numbers of Veterans referred to Pain Clinics is considerably smaller than those available with our 
strategy.  Comparing ABC care to standard Pain Clinic care could be the focus of a much larger, future trial.  
ABCs will be staffed by a minimum of 3 non-surgical consultants at each site who have been trained in the 
published evaluation and treatment protocols. The PI will train providers at VAPHS and the Greater Los 
Angeles VA on site. Those at the Richmond VA site will be trained by co-I Dr. Gentili (Richmond site PI) who 
has been trained in the context of the VA Rehab R&D-funded pilot studies that form the foundation of the 
proposed clinical trial.  Training at all sites will occur over one day and will use effective adult learning 
principles that we have successfully employed in our pilot studies (see Preliminary Studies).  Learning will be 
interactive and characterized by goal-directed practice coupled with targeted feedback93,94 as follows: 
1. The trainers (Drs. Weiner and Gentili) will teach the structured examination (Appendix 6) to providers on 3-
4 patients.  They will demonstrate the examination on the first patient, then observe the provider perform 
the exam on 2 to 3 additional patients, provide immediate feedback and answer any questions.  This will 
occur during the first half of the day. 
2. During the second half of the day, the trainers and the providers will perform the structured exam on a 
separate group of 5-6 patients using the same goal-directed model with targeted feedback.   
3. Because of the importance of content reinforcement for adult learners94, the PI also will conduct a weekly 
teleconference during the start-up period with all participating providers to review the algorithms and 
accompanying materials using illustrative case examples, and to answer any questions.  Two to three 
algorithms will be reviewed once a week for 4-5 weeks.   

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Figure 5. Take Back Your Back: Summary Screen 
Figure 6. Portion of Insomnia algorithm 
4. The materials will be housed on a SharePoint site dedicated specifically to this study and to which the 
participating providers will have ready access for the duration of the study period.  
5. Reinforcement training sessions will be scheduled as 
needed prior to the start of participant enrollment.   
As in the UC group, RCs will track the components and 
location of care with monthly telephone calls. 
Care in the ABCs will proceed as follows: 
1. Usual clinical staff will check the Veteran into the 
clinic using standard procedures (i.e., confirm his/her 
name and SSN, and purpose of the visit). 
2. The Veteran will complete Take Back Your Back, an 
interactive tablet-based questionnaire described in 
Preliminary Studies (Appendix 9).  This will take ~7-10 
minutes. As noted previously, 
the purpose of this tool is to 
educate the Veteran, screen 
him/her for key component 
conditions (e.g., fibromyalgia, 
depression, anxiety, 
maladaptive coping [i.e., fear 
avoidance believes and 
catastrophizing], and 
insomnia), and encourage the 
Veteran to discuss these 
potential contributors with the 
ABC provider. This can all be 
administered via verbally by 
research staff, over the phone.  
3. The Summary Screen from 
Take Back Your Back 
(example shown in Figure 5) 
will be revealed to the provider 
in the ABC clinic who will 
review it with the Veteran and 
tailor their history-taking accordingly.  This can be done virtually. Also, the history can be attained virtually, 
or in person, by the Provider. The participant whose results are shown in Figure 5 screened positive for 
unrealistic treatment expectations, insomnia, possible hip arthritis and spinal stenosis, and maladaptive 
coping. Armed with this knowledge, the ABC provider will tailor his history accordingly.  As per the first 
portion of the Insomnia algorithm shown in Figure 6, the provider would want to evaluate this Veteran’s 
mood, even though his PHQ4 was negative.  The provider also will want to evaluate this Veteran’s history 
of substance use, and review the medication list to determine if there are any that can negatively impact 
sleep.  
4. The ABC provider also will check the results of the QMCI so that the pace and implementation of treatment 
can be modified accordingly.  As MCI and dementia are part of a continuum, the published Dementia 
algorithm can be applied to those with MCI. 
5. The provider will perform the previously learned structured physical examination to identify the other CLBP 
contributors listed in Table 1 (hip OA, SI joint syndrome, myofascial pain, leg length discrepancy, lateral 
hip/thigh pain syndrome). 

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Figure 8.  Portion of Lumbar Spinal Stenosis algorithm 
 
Figure 7. Excerpt from “Making Better Lives: Patient-
Focused Care for Low Back Pain” 
6. The provider will educate the Veteran about the contributors to their CLBP and functional impairment. This 
will be facilitated by a brief educational booklet that will be given to the Veteran to take home and keep.  
The booklet, “Making Better Lives: Patient-Focused Care for Low Back Pain (Appendix 10),” was created 
for our ongoing SPiRE trial (Pilot Study #2) and provides a brief overview of the Veteran’s contributing 
conditions, using simple language, as shown in Figure 7. In this Figure, the ABC provider determined, 
based on their evaluation, that the Veteran has maladaptive coping (i.e., fear avoidance beliefs and/or 
catastrophizing) as one potential contributor to CLBP/disability.  
7. The provider will use the algorithms (Appendix 5) to 
direct next steps (e.g., referral for insomnia 
consultation to consider behavioral treatment50; 
obtaining an x-ray of the hip to confirm a diagnosis of 
hip OA; referral to physical therapy for treatment of 
lumbar spinal stenosis).  All patients, regardless of 
pain contributors, will be provided with a copy of the 
pain self-management workbook developed by 
consultant and pain psychologist Dr. Beverly Thorn 
(Appendix 11).95 The workbook, “Learning About My 
Pain (LAMP),” has been successfully implemented in 
the context of a trial that specifically targets patients 
of low literacy and was funded by the Patient-
Centered Outcomes Research Institute.  The 
workbook was developed to be used in a group 
setting and will be modified during the startup phase of the proposed trial for use by individuals not in a 
group setting, under the guidance of Dr. Thorn (see letter of support). We will refer to it as “Learning About 
Chronic Pain” book. Participants will be encouraged to revisit Learning About Chronic Pain book 
periodically to determine how they perceive themselves to be coping. 
8. To facilitate communication with other providers involved in the algorithms-guided care, the ABC provider 
will document their baseline assessment results using a standardized template in CPRS.  This assessment  
will include a list of the participant’s contributing conditions and the treatments recommended (See 
Appendix 12) in a data measure 
called the Post H&P Rx.  The ABC 
provider also will complete 
templated follow-up visits notes 
(Appendix 12).  
9. The frequency of ABC care visits 
will not be constrained.  
Suggestions for frequency of 
patient monitoring are provided 
within the algorithms. At follow-up 
visits (which can be in person or 
virtual), the ABC Provider will 
collect data measures to capture 
the participant’s main conditions. 
This study focuses on 11 main 
conditions related to CLBP, and a 
data measure will be provided for 
each condition so that the ABC 
Provider may capture all the 
necessary data. For each of the 
participant’s contributing 
conditions, the provider will record 
current treatment, perceived 
compliance (full, partial, none), treatment response (complete, partial, none, did not tolerate), method of 

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response assessment, and plan. The 3 Question Follow Up Data Measure will be administered at each 
follow up visit. As shown in Figure 8, for example, if the provider’s evaluation reveals symptoms consistent 
with lumbar spinal stenosis and the patient is neurologically stable, conservative treatment is 
recommended for 4-6 weeks followed by reassessment.  Each algorithm has multiple steps and 
recommendations conditional upon response.  The goal of treatment across all algorithms is reduction of 
pain-associated functional interference/disability.  
10. 
The participants randomized to the ABC Care group will be contacted either by phone, or if they would 
like to come on site, by an ABC Provider at their local site. No data measures will be collected. The 
purpose of this interaction would be to help discuss and guide the participant on care after study 
completion.  
11. 
ABC Providers will complete a “ Final  MD ABC Participant Assessment” for each of the participants 
upon completion of their finalmonth of participation.  
Rationale for Specialists Delivering ABC Care:  The investigative team discussed whether ABC care should be 
delivered by PCPs or specialists.  The study proposed is an explanatory clinical trial, thus we chose 
specialists because: 1) CLBP is a complex multifaceted condition that requires time to evaluate thoroughly.  
Patients typically are referred to specialty consultants to evaluate and recommend management for a single 
condition.  Primary care providers, on the other hand, must manage a host of conditions in each patient and 
their appointment duration is brief (e.g., 15 minutes for a follow-up patient), thus pragmatism played a 
significant role in our decision for specialist consultants to provide ABC care. 2) The background and training of 
many pain medicine consultants (i.e., anesthesiology96) and the desire of many patients for a “quick fix” often 
leads to pain clinics delivering spine-focused, procedure-oriented care (i.e., spinal injections).  Such care often 
is not associated with salient functional improvement, the outcome of critical relevance for older adults.  Since 
PCPs often do not have time to address chronic pain adequately, pain specialist referral occurs commonly, as 
recommended by the VA stepped care model (see Figure 1 in the Background and Significance section).  
Thus, expanding the expertise of consultants to address the needs of frail older adults has the potential not 
only to reduce pain and improve function, but to avoid unnecessary care and morbidity. 
 
Follow-up (Appendix 13):  Quarterly telephone calls for up to12 months following randomization will collect 
data on the main outcomes measure (the ODI) as well as the PROMIS 29, PROMIS-GH, VR-12, falls and falls 
efficacy (Falls Efficacy Scale-international short form), and the Life Space Assessment.106  Health care 
utilization that includes pain medication use (oral morphine equivalents87), emergency room visits, 
hospitalizations, and pain provider/other health care utilization  as well as the 0-10 Numerical Pain Rating 
Scale will be collected monthly using established methods.97 Monthly collection of data on health care 
utilization will facilitate comparison of key components of ABC care and Usual Care. During the final call at 12 
months, the Perceived Intervention Value data measure will be administered as well as the Global Impression 
of Change data measure. Also, during the final call, all medications will be collected. To ensure the RC 
collecting these measures is masked to randomization group we will employ methodology that we have used 
successfully with other VA trials.  For Example: the RC at the Pittsburgh site will collect follow up data on 
participants from the Los Angeles site, the RC from the Richmond site will collect follow up data on participants 
from the Pittsburgh site, and the RC from the Los Angeles VA will collect follow up data on participants from 
the Richmond site.  Participants who were randomized to the UC group will be made aware that they may see 
an ABC provider at their site, outside of the context of this study, for one visit after completion of participation. 
Participants who were randomized to the ABC Care group will be contacted at their final month of particpiation, 
whether by phone, or if they choose on site, to discuss care after their participation. No data measures will be 
collected and no study related procedures performed. The ABC Providers will fill out a Final MD ABC 
Participant Assessment for each ABC Participant upon completion of their up to 12-month participation. The 
purpose of this data measure is for the provider to comment on each condition for which the participant was 
treated, and if the condition was in fact treated, and if not the rationale for not treating the condition. If during 
telephone-based follow up data collection (for a participant based at the sister site) the Veteran expresses 
suicidal ideations, the RC will ask the Veteran to hold on and (s)he will immediately call the site PI at the sister 
site (i.e., the site of the Veteran’s home VA) who will call the Veteran and follow the facility’s Suicide Threat 
Call Protocol. If the sister site PI is not immediately available, the RC will call the PI at their own site who will 

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Table 7. Baseline and Follow-up Data 
Measure 
Timepoint 
Baseline 
Q3 
month* 
Q month 
Oswestry Disability Index (Primary Outcome) 
X 
X 
 
NIH Task Force Minimum Data Set 
X 
 
 
Quick Mild Cognitive Impairment (QMCI) screen 
X 
 
 
Medical Comorbidity (Duke Comorbidity Index) 
X 
 
 
Social Support (MOS Social Support Scale) 
X 
 
 
Prescribed Opioids Difficulties Scale 
X 
 
 
Pain Self Efficacy Questionnaire 
x 
 
 
Gait Speed 
X 
 
 
Life Space Assessment 
X 
X 
 
0-10 Numerical Rating Pain Scale 
X 
X 
X 
PROMIS-29 
X 
X 
 
Falls Efficacy Scale-international Short Form 
X 
X 
 
PROMIS Global Health Scale 
X 
X 
 
Veterans RAND 12 Item Health Survey (VR-12) 
X 
X 
 
Treatment History 
X 
 
 
Healthcare Utilization (pain medication, 
emergency room use, hospitalization) 
X 
X 
X 
Medications 
X 
 
final 
month 
Perceived Intervention Value 
 
 
final 
month 
Global Impression of Change 
 
 
final 
month 
*Collected at 3 months, 6 months, 9 months, 12 months follow up
talk with the Veteran, assess risk and follow procedures according the Veteran’s home VA’s Suicide Threat 
Call Protocol. 
 
Retention Strategies: We will employ methods to minimize dropout that we have used successfully for our 
other VA clinical trials.  Specifically, we will: 1) Provide $40 compensation following the completion of baseline 
data collection, and $30 each following the completion of 6 and final month of data collection.  Thus, each 
participant can receive up to $100 for their participation.  2) If we are unable to reach participants during the 
quarterly telephone calls (3 X over 2 weeks), we will send a reminder letter requesting that they call the RC for 
data collection.  3) Those randomized to the UC group will be offered ABC care after they have completed final 
month data collection. 
Tracking Intervention Adherence:  Following their baseline visits, participants from both the ABC and UC 
groups will be followed for adherence to their treatment plans.  An RC will query CPRS records beginning 30 
days following baseline testing to determine whether participants have attended their scheduled visits.  Results 
will be recorded in a secure tracker.  All RCs will query CPRS records a minimum of every 30 days for the 
duration of the study.  Participants in the Choice program will be asked to confirm their appointments with 
check-in calls. 
 
5.6 Data Analysis 
Data Management:  A summary of the baseline and follow-up data is provided in Table 7.  Data will be 
collected using paper forms. Completed data forms will be entered into a secure electronic database on a VA 
network server with regular server backup. The PI will work with the VAPHS research team to oversee all 
aspects of data management in accordance with policies and procedures outlined in VHA Handbook 1200.12. 
Only research team members at participating sites will have access to personal information needed for 
conducting informed consent procedures and participant tracking. Data collected on paper forms and any 
identifiable information will be stored in the Research Coordinator’s office at each site, under double lock and 
key.  All participants will be assigned unique synthetic identifiers that will appear on forms, files and serve as a 
non-identifiable index in database tables.  Only de-identified data will be entered into the secure electronic 
database. There will be no data fields in which to enter individually identifiable information electronically, 
except the synthetic participant 
study IDs. Data entry will include 
double data entry checks. All 
research desktop computers will be 
encrypted. The encryption software 
will be Federal Information Process 
Standards (FIPS) 140-1,2 
compliant. Data collected for this 
study will be kept in compliance 
with VHA regulations forbidding the 
destruction of research records. 
Data Analysis:                                                 
 
Overview: 
The study Statistician, Dr. 
Subashan Perera will be in charge 
of data analysis along with the PI.  
Dr. Perera will be sent only de-
identified data as described above. 
We will perform all main analysis 
based on intention-to-treat 
following the a priori plans outlined 

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below.  All statistical analyses will be performed using SAS® version 9 (SAS Institute, Inc., Cary, North 
Carolina) by the study statistician Dr. Perera.  Participant flow will be summarized using a CONSORT 
diagram.98  Data will be summarized by intervention arm and time point as well as baseline to follow-up change 
using appropriate descriptive statistics.  First, the baseline participant characteristics will be compared between 
the two arms.  Any significant differences will be noted and accounted for as covariates in the sensitivity 
analyses.  Second, primary and secondary analyses to address the aims will be performed as outlined below 
using multiple imputation for missing data.  The primary analysis will be performed to test the primary 
hypotheses H1.1 about the ODI.  Secondary analyses will be performed for remaining hypotheses, secondary 
outcomes and other exploratory analyses.  Third, we describe below our primary approach to missing data and 
a set of sensitivity analyses by including additional covariates, ignoring missing data, and reasonable 
alternative statistical modeling strategies to assess the robustness of our findings. 
Baseline Comparison: 
Due to the large sample size and the randomization scheme balanced with respect to site, it is highly unlikely 
that baseline participant characteristics will be significantly different between the arms.  If we do find any, they 
will be included as covariates in the sensitivity analyses.  We will not alter the primary analysis to preserve its a 
priori nature and predictability.  We will use independent samples t- or Wilcoxon rank sum tests, as appropriate 
based on distributional properties, to compare continuous baseline characteristics between the intervention 
arms.  For categorical baseline participant characteristics, we will use chi-square and Fisher’s exact tests, as 
appropriate.  Statistical significance of the intervention term will be interpreted as indicating the need to include 
them as covariates in sensitivity analyses. 
Aim 1 Primary Analysis: 
We will fit a linear mixed model with baseline to follow-up change in ODI score as the dependent variable; 
intervention arm (ABC/UC), follow-up time point (6/12 months) and their interaction as fixed effect of main 
interest; baseline ODI as a fixed effect covariate; and a participant random effect to account for multiple 
repeated assessments of the same participant over time.  The statistical significance at α=0.05 of the ABC vs 
UC means contrast at the 6-month point will serve as the formal test of the primary hypothesis H1.1.  Upon 
confirming the H1.1 primary hypothesis, we will compute the number-needed-to-treat (NNT) as the reciprocal 
of the between-intervention difference in percentages of those showing a meaningful ODI improvement above 
its MCID. 
Aim 1 Secondary Analyses:  
To characterize the intervention actually received under ABC care, we will describe the conditions identified, 
further evaluations/initiated treatments and their responses recorded in the form that tracks response to 
treatment and additional management plans (see Appendix 12). We will employ the same analytic strategy 
described above for ODI (under primary analysis) for our secondary continuous outcomes pain severity, quality 
of life and falls efficacy.  The statistical significance of the ABC vs UC means contrast at the 6- and 12-month 
points will serve as the formal tests of the secondary hypotheses H1.2.   
Measures of healthcare utilization between 6 and 12 months in H1.3 (prescriptions/refills of opioids and 
inappropriate medications for elderly, invasive procedures, emergency room/hospital visits) are mostly in the 
form of counts.  As such, we will fit a series of generalized linear models with each count utilization outcome as 
the dependent variable, a negative binomial distribution to account for any over dispersion and a logarithmic 
link function for the count outcome, actual person-time of exposure with opportunity for reporting utilization 
outcome as an offset, and intervention arm (ABC/UC) as the independent factor of interest.  Intervention arm 
incident rate ratios and their statistical significances will constitute tests of H1.3. 
Aim 2 Analyses: 
The goal is to explore whether ABC vs UC differences in improvement vary across participant subgroups of 
interest (effect modification). We will add each of the subgroups (based on baseline CLBP-associated 
disability, anxiety/ depression, mild cognitive impairment and obesity) and associated subgroup × intervention 
group interaction effects as additional fixed effects in the above statistical models.  Rigorous methodological 
guidelines for subgroup analyses require significant interaction effects for making conclusions of differential 
intervention effects in subgroups.99  As such, we will first construct difference-in-difference type means 
contrasts representing the difference in ABC vs UC effects in different subgroups at each of the follow-up time 
points.  If and only if the said interaction contrast is significant, we will estimate ABC vs UC differences and 

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their statistical significance within those subgroups. 
Missing Data: 
The best approach for handling missing data is to prevent it.  We will use the methods described earlier to 
retain participants and prevent missing data. Despite our best efforts, missing data will occur.  We will clearly 
document those with missing data and reasons in the CONSORT diagram, and compare those with missing 
data to complete data with respect to available data.  Statistical guidelines for handling missing data 
recommend methods such as multiple imputation, which considers the uncertainty involved in imputing missing 
data.100  Multiple imputation is arguably the best available objective method to analytically account for missing 
data under the ignorable or missing-at-random (MAR) assumption.  Specifically, we will generate M=5 imputed 
values for each missing value, analyze the 5 datasets as though complete, and finally combine the results 
appropriately so that they reflect the uncertainty involved in imputation. SAS® MI and MIANALYZE procedures 
will be used. Other approaches to missing data, including the naïve approaches of ignoring the missing values 
and last-value-carried-forward (LVCF) will also be considered in sensitivity analyses and robustness of the 
results to using these approaches will be examined. 
Sensitivity Analyses:  
We will perform a series of sensitivity analyses to ensure the robustness of our results against various 
assumptions.  One such analysis will involve inclusions of baseline participant characteristics significantly 
different between groups as additional covariates in the linear mixed and generalized linear models above.  
Another will involve sensitivity of results to missing data handling techniques.  In addition, if analyses of 
residuals from the models show violations of statistical assumptions, we will consider fitting models after Box-
Cox transforming101 the continuous variables.  Finally, a reasonable alternative to the proposed negative 
binomial models for count data representing healthcare utilization measures is the zero-inflated Poisson 
model.102  We will examine the sensitivity of our findings for utilization outcomes against this alternative 
modeling strategy. 
Sample Size Justification and Statistical Power:   
Planned sample size is 310 participants. Prior data and assumptions include a between-subject standard 
deviation of 18 points for pre- to post-intervention change in the primary outcome ODI103; a conservative 
estimate of a minimally clinically important difference (MCID) of 7 points104; a conservative dropout rate of 15% 
from other back pain trials105; using published methods implemented in commercial software (PASS 2012®, 
Number Cruncher Statistical Systems, Kaysville, Utah), with 310 patients and 280 anticipated completers, we 
will be able to detect an observed primary outcome difference as small as 7 points with 90% power in a 2-tailed 
test at the α=0.05 level. 
 
5.7 Withdrawal of Subjects 
After participants sign both the HIPAA and Informed Consent documents, officially enrolling them in the 
study, they will be screened for cognitive impairment with the MMSE questionnaire before starting 
baseline data collection. Those who score <23 will immediately be withdrawn from the study, and their 
PCPs will be alerted.  
Participants are able to withdrawal at any time without consequence by either alerting the RC or the 
investigator. They will be able to keep the payment(s) they have already received but will not receive 
additional payment. UC participants can continue or discontinue care at their discretion. ABC care 
participants will no longer be treated as part of the study but can be referred to an ABC clinic by their 
PCP to re-engage treatment. Follow-up calls will be terminated, discontinuing data collection. 
Previously collected data will still be analyzed.  
 6  Reporting 
The overall PI and the overall RC will be available on a daily basis to take calls and emails from all 
study-site personnel. In addition, teleconferences will be scheduled at the site PI’s discretion to discuss 
goals, progress, modifications, documentation, recruitment, retention, data analysis, and confidentiality. 
Any instances of adverse events, protocol deviations, or other problems identified during the meetings 

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will be reported as soon as possible within the required reporting timeframes using the standard forms 
and/or procedures set forth by the IRB.  In addition, clinical coordinators may review study 
documentation and/or consent forms to ensure that subject’s confidentiality is maintained. 
7 Privacy and Confidentiality 
Protected Health Information (PHI) will be used for the purposes of contacting the subject via telephone 
and mail, as well as to screen their CPRS records. PHI will not be used outside of these few functions, 
nor will it be disclosed or used on any data collection measures.  
 
All data will be collected on hard copies and stored under double lock and key in the research team 
members’ office and/or file cabinets. No members outside of the research team will have access to this 
information. Data will be entered into an electronic database created in Microsoft Access, specifically 
for the purposes of this study. No PHI will be kept in this database. All electronic data and information 
will be kept on a protected VA shared drive that only research team members will have access to. Also, 
a master list of all subjects who have signed Informed Consent documents will be kept electronically on 
the VA Shared Drive.  
 
Study subjects will be assigned unique identifiers that will appear on all files used in the statistical analyses; all 
data will be de-identified.  Only limited team members at participating VAs will have access to personal 
information needed for tracking and informed consent.  Several steps will be taken to ensure data quality and 
data integrity: 1) use of standard methods of data collection and recording specified in a manual of operations 
2) required viewing of a webcast staff workshop on research integrity and data entry at the beginning of the 
study and when new personnel are hired, and 3) audits on a random sample of participants to verify 
completion of interviews and data accuracy. A code number will be the only identifier on the electronic data 
that is stored on a protected VA Shared Drive.  There will be no data fields in which to enter PHI electronically. 
 
All research desktop computers will be encrypted.  The encryption software will be Federal Information 
Processing Standards (FIPS) 140-1,2 compliant.  Data will be kept on the protected VA Shared Drive at least 3 
years following completion of the study and will be archived to ensure compliance with VHA regulations 
forbidding the destruction of research records.  
 
 
 
 
 
 
 
 
 
 
 

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Within and Between Sites Communication Structure 
8 Communication Plan 
 
The within and between site communication structure is shown in the diagram below.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The Overall PI and Overall RC, located at VAPHS, will have ongoing communication throughout the duration of 
the study.  The Overall PI and the Local Site PIs also will maintain an open line of communication for the 
duration of the study, as will the Overall RC and the Local Site RCs, and the Local Site PIs and the Local Site 
RCs.   We expect site personnel to respond to each other within 24 hours, preferably with the same day.  
The ABC Clinic operations will be overseen by the Local Site PI and the Local Site RC.  The RC will be 
responsible for maintaining the clinic schedule (i.e., scheduling all appointments and any changes to the 
schedule).  The Local Site PI will be the ABC Clinic Director.  The RC will schedule appointments with the ABC 
clinic providers and ensure that those assigned to UC do not have appointments with the ABC providers for the 
duration of the study.  Day to day procedures for operationalizing this process will be finalized during the study 
start-up period at each site.  
Communication also will occur between ABC Clinic Providers and other relevant clinic providers that are 
consulted in the context of the algorithms.  This will occur in the same manner as per standard VA care.  That 
is, consultations will be ordered through CPRS and all patient-related communications will occur securely 
through CPRS.   
Recurring Meetings 
The Overall PI and the Overall RC will meet weekly to discuss overall and site-specific activities, including 
recruitment, enrollment, retention, and any additional study activities or concerns. Additional meetings will be 
conducted as the need arises. The RC will take notes and keep those records for the duration of the study. 
 

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The Overall PI, Overall RC, Local Site PIs and RCs will meet weekly via teleconference during project start-up 
and the first six weeks of recruitment.  Then, meeting frequency will be monthly or as needed for the duration 
of the project. During the first three months of recruitment, they will discuss recruitment strategies, progress, 
and ensure adherence to the protocol. For the duration of the study, the calls will focus on responding to local 
site PI/RC questions, discussing recruitment goals and actual recruitment, as well as retention, enrollment, and 
follow-up progress.  Notes will be taken by the Overall RC and kept for the duration of the study.  
The Overall PI, the Local Site PIs, and all ABC clinic providers will communicate during regularly scheduled 
meetings.  During project start-up, the Overall PI will meet with the Local Site PIs and ABC clinical providers to 
review 2-3 algorithms per week. During the first 6 weeks of participant enrollment, weekly meetings will 
continue, and specific participant cases will be discussed.  Providers will present cases which allow for 
discussion on adherence to and reinforcement of the published algorithms. Subsequently these meetings will 
occur monthly or on an ad hoc basis.   
Local Site PI, the local site ABC Clinic Providers, and the Site RC will meet weekly or as needed to ensure that 
the procedures discussed during the meetings with the Overall PI and Overall RC are followed. They will 
discuss any site-specific clinical and administrative issues that arise, including but not limited to recruitment, 
enrollment, retention, follow up, flow of the study, and adherence to the protocol. Local RCs will take notes and 
keep them for the duration of the study. 
Any instances of adverse events, protocol deviations, or other problems identified during the above meetings 
will be reported as soon as possible within the required reporting timeframes using the standard forms and/or 
procedures set forth by the IRB. 
A summary of the project meetings is provided in the table below. 
Within and Between Site Communication 
Communication Level and 
Participating Staff 
Communication Frequency 
Meeting Focus 
Start-up period Post-startup and 
following 
Overall: PI and RC 
Weekly 
Weekly 
Track overall study 
progress and procedures 
Overall with Local Sites: 
Overall PI/RC, site PIs and 
site RCs 
Weekly 
Monthly or as 
needed 
Track site-specific study 
progress and procedures 
Overall with Local Sites: 
Overall PI, Site PIs, and ABC 
clinic providers 
Weekly 
Monthly or as 
needed 
Discuss active cases in 
ABC arm 
Within Site: Site PI/RC and 
ABC Clinic Providers 
Weekly 
Weekly or as 
needed 
Team discusses site-
specific study activities, 
both clinical and 
administrative 

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