Patient-Centered Versus Imaging-Directed Care for Older Veterans With Chronic LBP
Phase: NA
Conditions: Chronic Low Back Pain, Hip Ostearthritis, Myofascial Pain Syndrome, Fibromyalgia, Depression, Maladaptive Coping, Lumbar Spinal Stenosis, Insomnia, Sacroiliac Joint Pain, Lateral Hip and Thigh Pain, Anxiety, Dementia, Recent Leg Length Discrepancy
Sponsor: VA Office of Research and Development

1 
 
Study Title:     Patient-Centered Versus Imaging-Directed Care for Older Veterans 
With Chronic LBP   
 
NCT02697435 
 
July 11, 2019 
 
NOTE:  
The manuscript that starts on the following page has been 
accepted for publication in Pain Medicine. 
 
 

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Aging Back Clinics - A Geriatric Syndrome Approach to Treating Chronic Low 
Back Pain in Older Adults: Results of a Preliminary Randomized Controlled Trial 
(Running Title: Chronic Low Back Pain Syndrome Treatment) 
 
Debra K. Weiner, M.D.1-5, Angela Gentili, M.D.6,7, Michelle Rossi, M.D.1,2, Katherine 
Coffey-Vega, M.D.8, Keri L. Rodriguez, PhD9,10; Kristina L. Hruska, MS9, Leslie 
Hausmann, PhD9,10, Subashan Perera, Ph.D.2,11 
From the 1) Geriatric Research, Education and Clinical Center, VA Pittsburgh 
Healthcare System – Pittsburgh PA; 2) Department of Medicine (Geriatric Medicine), 
University of Pittsburgh, 3) Department of Psychiatry, University of Pittsburgh, 4) 
Department of Anesthesiology, University of Pittsburgh, 5) Clinical and Translational 
Sciences Institute, University of Pittsburgh, 6) Hunter Holmes McGuire VA Medical 
Center, Richmond VA; 7) Department of Medicine (Geriatric Medicine), Virginia 
Commonwealth University, Richmond VA; 8) Department of Medicine (Geriatric 
Medicine), University of Virginia, Charlottesville VA, 9) Center for Health Equity 
Research and Promotion, VA Pittsburgh Healthcare System, Pittsburgh, PA; 10) 
Division of General Internal Medicine, Department of Medicine, University of Pittsburgh; 
11) Department of Biostatistics, University of Pittsburgh. 
Corresponding Author: Debra K. Weiner, M.D.; VA Pittsburgh Healthcare System, 
University Drive; Building 30, 00GR; Pittsburgh PA 15240; telephone: 412-360-2920; 
FAX: 412-360-2922; e-mail: debra.weiner@va.gov 
 
 

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ABSTRACT 
Objective: Treating chronic low back pain (CLBP) with spine-focused interventions is 
common, potentially dangerous, and often ineffective. This preliminary trial tests the 
feasibility and efficacy of caring for CLBP in older adults as a geriatric syndrome in 
Aging Back Clinics (ABC). 
Design: Randomized controlled trial 
Setting: Outpatient clinics of two VA Medical Centers  
Subjects: Fifty-five English-speaking Veterans age 60-89 with CLBP and no red flags 
for serious underlying illness, prior back surgery, dementia, impaired communication, or 
uncontrolled psychiatric illness. 
Methods: Participants were randomized to ABC care or usual care (UC) and followed 
for 6 months. ABC care included: 1) a structured history and physical examination to 
identify pain contributors, 2) structured participant education, 3) collaborative decision 
making, and 4) care guided by condition-specific algorithms.  Primary outcomes were 
low back pain severity (0 to 10 current, and 7-day average/worst pain) and pain-related 
disability (Roland Morris). Secondary outcomes included the SF-12 and health care 
utilization. 
Results: ABC participants experienced significantly greater reduction in 7-day average 
(-1.22 points; p=0.023) and worst pain (-1.70 points; p=0.003), and SF-12 interference 
with social activities (50.0 vs 11.5%; p=0.0030) at 6 months.  ABC participants were 
less likely to take muscle relaxants (16.7 vs. 42.3%, p=0.0481). Descriptively, UC 
participants were more likely to experience pain-related emergency room visits (45.8 vs 
30.8%) and be exposed to non-COX2 nonsteroidal anti-inflammatory drugs (73.1% vs. 
54.2).   

4 
 
Conclusion: These preliminary data suggest that ABC care for older Veterans with 
CLBP is feasible and may reduce pain and exposure to other potential morbidity. 
 
KEY WORDS: chronic low back pain, function, disability, treatment,  aging 
ClinicalTrials.gov ID: NCT02697435; unique protocol ID: F2021-P 
 

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INTRODUCTION 
Low back pain is the most common cause of pain in older adults (1).  Providers are 
advised to approach low back pain as a non-specific condition, one that is associated 
with sciatica, or one caused by a specific disorder such as vertebral compression 
fractures, infection, or malignancy (2).  More than 85% of patients that present to their 
primary care provider with low back pain are said to have non-specific causes (2).  
When low back pain becomes chronic (i.e., pain at least half the days for at least 6 
months (3)) in older adults, a number of deleterious consequences may result including 
falls and fractures (4); impaired physical function (1, 5, 6); depression/anxiety and 
suicide (7-9); social isolation (10); impaired sleep, appetite, and cognitive functioning 
(11-14); and caregiver stress (15). 
 
Rundell and colleagues recently demonstrated that greater than 75% of older adults 
with low back pain in the primary care setting suffer from the chronic variety (16).  
Nearly two-thirds of these patients continue to experience significant pain-related 
functional impairment a year after initial onset (16).  Further, non-invasive treatments for 
chronic low back pain (CLBP) recommended by the American College of Physicians 
have typically been associated with only modest efficacy (17). These data suggest that 
alternative approaches to treatment are needed. 
 
We posit that CLBP in older adults is a geriatric syndrome, that is, a final common 
pathway for the expression of multiple contributors (18). In this model, degenerative 
disease of the lumbar spine is the weakest link rather than the sole treatment target 
(19). This notion is supported by several observations. First, degenerative pathology is 

6 
 
nearly as common and severe in older adults who are pain-free as compared with those 
that have CLBP (20).  Second, extra-spinal disorders such as hip osteoarthritis (OA), 
fibromyalgia and depression often co-exist in older adults with CLBP (21-24) and may 
be associated with pain-associated disability (25-27).  Third, exclusively spine-focused 
treatments often are ineffective (28). 
 
We recently validated the prevalence and functional correlates of a number of these 
disorders in community-dwelling older Veterans with CLBP (26). We also have 
published a series of clinical algorithms that resulted from modified Delphi interactions 
between a panel of interdisciplinary pain experts and PCPs (29-40).  The purpose of 
these algorithms is to guide the evaluation and treatment of common contributors to 
pain and disability in older adults with CLBP.   
 
The algorithms guide evaluation and treatment of the following conditions: 1) hip OA 
(29), 2) myofascial pain (30), 3) fibromyalgia (31), 4) depression (32), 5) maladaptive 
coping (33), 6) lumbar spinal stenosis (34), 7) insomnia (35), 8) lateral hip and thigh 
pain (36), 9) anxiety (37), 10) sacroiliac joint syndrome (38), 11) dementia (39), and 12) 
leg length inequality (40).  All algorithms have the following common elements: 1) 
supportive literature evidence and when lacking, expert panel consensus; 2) imaging 
only to confirm pathology suspected based on history and physical examination (e.g., 
patient must have American College of Rheumatology clinical criteria for hip OA 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 

7 
 
inappropriate medications in older adults (41), prescribing a walker instead of pain 
medications or an invasive procedure for the frail older adult with neurogenic 
claudication).  Although these algorithms were carefully developed from evidence and 
expert consensus, their effects, when used collectively in practice, have not been 
tested.   
 
We now conduct a randomized controlled pilot clinical trial evaluating the feasibility and 
preliminary evidence of the efficacy of implementing care guided by these algorithms.  
We hypothesize that older adults with CLBP that undergo comprehensive structured 
evaluation and algorithms-guided treatment in Aging Back Clinics (ABCs) will 
experience significantly greater reduction of pain and improvement in function after 6 
months as compared with those randomized to usual care (UC). 
 
METHODS 
Participants and Setting 
The study protocol was approved by the Institutional Review Boards (IRBs) and the 
Research and Development (R&D) Offices of the two participating sites - Veterans 
Administration (VA) Pittsburgh Healthcare System (Pittsburgh, PA) and the Hunter 
Holmes McGuire VA Medical Center (Richmond, VA). Participants were initially 
identified through the VA’s data warehouse. Using an IRB-approved waiver of consent, 
research coordinators (RCs) at each site screened the electronic medical records of 
Veterans age 60 and older who carried a diagnosis of low back pain and were actively 
receiving care from a VA PCP. Records were screened for potential study eligibility. 
Those eligible were mailed a study brochure via US mail and a letter signed by the chief 

8 
 
of Primary Care. Those interested in participating telephoned the RC who performed 
additional eligibility screening. Those found to be eligible after the telephone screening 
procedure were then invited to come on site at the VA for additional study participation.   
 
Inclusion/exclusion criteria were: 1) CLBP, defined as pain in the lower back of at least 
moderate severity (assessed with a verbal rating scale (42)), every day or almost every 
day, for at least 3 months; 2) lumbar MRI within the past 30 days that is without 
evidence of infection, malignancy, or acute fracture; 3) no 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); 4) no prior lumbar surgery; 5) pain in other body locations must be less 
severe than CLBP; 6) cognitively intact (based on Mini-Mental State Examination 
[MMSE] score, as described below); 7) no psychotic symptoms; 8) no acute illness; 9) 
no prohibitive communication impairment (e.g., severe hearing or visual impairment);  
and 10) able to commit to 6 months of study participation.  We required a recent MRI 
because the literature indicates that advanced spinal imaging is the start of a slippery 
slope of potentially unnecessary and ineffective healthcare utilization (43). By starting 
with a recent MRI, and limiting participants to those with negative findings, we targeted 
patients whom were at risk for unnecessary care and could, therefore, benefit from the 
algorithm-based care being tested in this intervention. 
 
After providing written informed consent, participants underwent the MMSE and those 
scoring < 24 were excluded.   
 

9 
 
 
Baseline Data 
All participants were administered the following measures by the research coordinator 
(RC) at each site: 
1. Outcome measures – Primary outcomes were low back pain severity (0 to 10 
current, and 7-day average/worst pain) and pain-related disability (Roland Morris 
(42). Secondary outcomes were measured with the SF-12® Health Survey (44) 
and health care utilization. 
2. Key participant characteristics : 
a. The Minimum Dataset (MD) recommended by the NIH Task Force on 
Research Standards for CLBP was administered (3).  In addition to 
measuring pain severity and interference with daily activities, the MD 
assesses 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.   
b. Medical comorbidity was measured with the Duke comorbidity index (45). 
c. Pain medications (regularly scheduled and as-needed) were 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, and g) adjunctive agents (e.g., corticosteroids, 

10 
 
capsaicin).  Regularly scheduled opioid analgesics were converted to daily 
oral morphine equivalents (46).  
d. Treatment expectancy/credibility (47) was assessed using validated 
methods of Borkovec (48). 
e. Social support was measured with the MOS Social Support Scale (49). 
f. Mild Cognitive Impairment (MCI) was assessed (for participants not already 
excluded based on the MMSE) using the Quick MCI Questionnaire (50). 
 
Randomization and Blinding 
Following baseline data collection, participants were randomized to Aging Back Clinic 
Care (ABC) or UC.  Within each site, we used a blocked randomization scheme to force 
continued approximate balance between the numbers of subjects in each arm during 
recruitment. The block size was randomly chosen to be 2 or 4 to prevent personnel from 
predicting treatment arm. The study statistician created separate randomization 
schedules for the two sites that contained a randomization sequence number (different 
from a participant's study identification number) and assigned arm. Then he created 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, research personnel opened the next available envelope, and 
record the randomization sequence number, subject identification number and group 
assignment in a dedicated database, different from the main study database. Personnel 
assessing follow-up outcomes were blinded to intervention assignment (see Follow-Up 
Data below), and the technical details of the randomization scheme described here 
were not revealed to the research staff. 

11 
 
 
Interventions 
Those participants randomized to UC underwent no further baseline data collection or 
additional intervention beyond standard clinical care. They were not allowed to be seen 
by ABC providers during their study participation.  Participants randomized to ABC care 
were administered the following questionnaires in addition to the baseline assessment 
described above, as they constitute additional evaluations required for ABC care: 
1. PHQ-4, that combines the PHQ-2 screening for depression and the GAD-2 
screening for anxiety (51). 
2. Insomnia Severity Index, that screens for insomnia.  A score of 11 was used as 
the criterion as a positive screen (52). 
3. Fibromyalgia Survey, that screens for fibromyalgia (53). 
 
A geriatrician trained by the PI in structured history and physical examination 
procedures described elsewhere (26) reviewed the results of the above screening 
questionnaires and tailored their history-taking accordingly. For example, if the 
participant screened positive for anxiety, the provider asked additional questions to 
determine the next step(s) as outlined in the anxiety algorithm.  If (s)he screened 
positive for insomnia, the provider asked a variety of questions to hone in on the cause 
of the insomnia (e.g., restless legs, urinary frequency, sleep apnea) and determine the 
appropriate path to follow within the insomnia algorithm. Symptoms of neurogenic 
claudication also were queried to identify possible lumbar spinal stenosis.  A structured 
physical examination also was performed to evaluate for key conditions that included 

12 
 
hip OA, sacroiliac joint syndrome, myofascial pain, leg length discrepancy, and lateral 
hip/thigh pain syndrome.   
 
After completing the assessment, the provider educated the participant about their 
CLBP contributors, gave them a booklet summarizing their findings, and discussed a 
multifaceted approach to treatment that was guided by our published algorithms (29-
40).  ABC providers collaborated with patient participants in devising a treatment plan 
and patients were permitted to refuse treatments that were recommended without being 
withdrawn from the study.  Additional appointments with the ABC research clinic 
provider were scheduled as needed.   
 
Follow-up Data: Quantitative  
Monthly telephone calls were made for 6 months during the intervention phase to collect 
data on the main outcome measures of pain severity and pain disability, as well as SF-
12®.  Pain medication use and pain provider/other health care utilization (e.g., 
emergency room visits, hospitalizations) also were collected at each time point using 
established methods (54).  To ensure the research coordinator (RC) collecting these 
measures was masked to randomization group, the RC at the Pittsburgh site collected 
data on participants from the Richmond site and vice versa. 
 
Follow-up Data: Qualitative  
Qualitative data were collected to gain a deeper understanding of patient and provider 
perspectives on ABC care, including feasibility and acceptability.  ABC patient 
participant perspectives were collected through telephone calls made at the time of 6-

13 
 
months follow-up.  Calls were made by two RCs (trained by the experienced qualitative 
researcher on the study team, KLR) and 23 study subjects were queried through audio 
recorded semi-structured one-on-one telephone interviews.  One participant could not 
be reached.  The patient interview guide was developed by the study PI tor and the 
multidisciplinary study team, including experts in geriatrics and management of CLBP.  
Interviews included open-ended questions and probes designed to elicit patient 
feedback on the ABC process, with an emphasis on identifying elements that were 
particularly useful or burdensome.  For the providers’ perspectives, calls were made 
within 2 months after all participant 6-month calls had been completed.  KR conducted 
1-on-1 interviews with the 3 ABC providers.  All interviews were telephone-based, audio 
recorded, and semi-structured. The provider interview guide was also developed by the 
PI and multidisciplinary study team. Interviews included open-ended questions and 
probes designed to elucidate ways to improve the delivery of ABC care to maximize 
benefits to patients and minimize burden to both patients and providers.   
 
Statistical Analysis (Quantitative): In this pilot trial, we descriptively interpreted 
magnitudes of intervention effects in addition to their statistical significance. We also 
employed graphical techniques such as needle to depict individual-level changes in 
addition to average changes, as done in other pilot studies (55, 56).  All analyses were 
performed as intention-to-treat and using SAS® version 9.3 (SAS Institute, Inc., Cary, 
North Carolina).  First, appropriate descriptive statistics were computed for all variables 
for each treatment group for each time point as well as change scores from baseline to 
follow-up. Second, the pre-intervention values of the variables and participant 
characteristics were compared between the treatments using independent samples t-, 

14 
 
Wilcoxon rank sum, chi-square or Fisher’s exact tests, as appropriate.  Third, for 
continuous variables such as pain, disability and scored SF-12® domains, we fitted a 
series of linear mixed models using the SAS® MIXED procedure with baseline to follow-
up change in each outcome as the dependent variable; intervention group (ABC/UC), 
month of follow-up (1/2/3/4/5/6) and their interaction as fixed effects of interest; with and 
without baseline value of the dependent variable as a fixed effect covariate; and a 
Toeplitz correlation structure to account for multiple measurements from the same 
participants and allow for greater correlations between proximal measurements in time.  
Appropriately constructed means contrasts were used to compare intervention effect at 
each month. For dichotomized outcomes such as any improvement (yes/no) in 
interference with social activities rating and utilization of services or medications, we 
performed chi square and Fisher’s exact tests but base our interpretations mostly on 
descriptive comparisons of proportions due to small sample size. Within each group, we 
correlated (r) baseline treatment expectations with change in outcomes.  
 
Qualitative Analysis: Interviewers and the coder knew that each participant interviewed 
had been randomized to ABC care but were otherwise blinded to participant data. All 
data were analyzed using rapid identification of themes from audio recordings (RITA) 
that allows for data analysis and coding without transcribing the interviews (57). 
Because the traditional RITA methodology does not account for the use of qualitative 
data analysis computer software (i.e., NVivo), we replaced the original “coding form” 
with a supplemental coding document (see below). 
 
Participant interview data were coded using deductive and inductive approaches. The 

15 
 
deductive approach started with reviewing specific foci from the qualitative study aims to 
guide preliminary codebook development, including elements of the ABC process that 
were particularly useful (e.g., in terms of pain management) or burdensome (from 
patient interviews), and potential ways to improve the delivery of ABC care to maximize 
benefits to patients and minimize burden on both patients and providers (from provider 
interviews). The deductive approach also included pre-identified codes based on the 
interview guide topics regarding 11 contributors to CLBP (i.e., the algorithm conditions 
listed in the Introduction, except dementia, as those with dementia were excluded from 
the study). The interview guide questions included: whether each contributor was 
discussed with their doctor; whether they were aware of each contributor to CLBP prior 
to seeing their doctor; what other things (besides the aforementioned 11 contributors to 
CLBP) contribute to their CLBP; what treatments they received; did they find that 
treatment helpful, and whether they engaged in pain self-management. An inductive 
approach was also used during the codebook development and coding phases in the 
event of identification of sub-codes for each of the aforementioned codes, as well as 
contributors to CLBP not included in the pre-identified deductive codes. 
 
The finalized patient and provider codebooks were entered in NVivo 11 Pro for 
Windows (QSR International, Doncaster, Australia) used for audio coding. To record 
more detailed information about the coded audio segments throughout the coding 
process, a supplementary coding document was created in Microsoft Excel. The 
codebook and coding form were tested and subsequently refined using a small subset 
of interview audio files before formal coding began.  An experienced qualitative 
researcher (KLR) ensured consistency during codebook development and coding by 

16 
 
assisting in resolution of coder uncertainties. She also reviewed the codebook prior to 
the completion of the coding process as well as a 20% (i.e., 5 patient audio files, 1 
provider audio file) sample of coded audio files to ensure the transparency and 
comprehensibility in code application.  
 
RESULTS 
Quantitative 
The CONSORT diagram for this pilot randomized controlled trial is shown in Figure 1 
and participant characteristics in Table 2. No adverse effects were reported. 
 
In the ABC group, participants were on average approximately 4 years older and more 
often had diabetes mellitus and lung disease than those randomized to UC.  The two 
groups otherwise were comparable in other demographic characteristics and medical 
comorbidities. Similarly, there were no significant between-groups differences in 
parameters recommended by the NIH task force on research standards for chronic low 
back pain (i.e., Minimal Data Set (3)) that include pain duration/frequency/intensity, leg 
symptoms, pain in other locations, pain interference, physical functioning, prior 
treatments for CLBP, sleep quality, depressive symptoms, coping self-statements, and 
ethanol use.  Descriptively, there were between-group differences in smoking history, 
with 8 (32.0%) never smokers in the ABC group versus 4 (13.3%) in UC, and 1 (4.0%) 
current smoker in the ABC group versus 7 (23.3%) in UC. There was a statistically 
significant difference in MMSE scores, although the one-point difference (28 vs. 29) is 
not clinically meaningful.  Fewer veterans in ABC than UC group were on gabapentin 

17 
 
(8.0 vs 30.0%; p=0.0423), but there was no between-groups difference in the use of 
other pain medications, baseline physical function or treatment expectancy. 
 
Of the various conditions only evaluated in the ABC group, insomnia was the most 
common central nervous system condition, with 14 (56%) participants screening 
positive.  Myofascial pain (n=20; 80%) and sacroiliac joint pain (n=13; 52%) were the 
most common physical conditions identified. 
 
Participants’ CLBP contributors and further evaluations/treatments recommended are 
listed in Table 2. 
 
Table 3 shows the change in continuous outcomes variables by month following 
baseline.  All pain intensity measures (current pain, average pain over prior week, worst 
pain over prior week) improved in the ABC group as compared to UC at 6 months, with 
the greatest magnitude of improvement and statistical significance in worst pain.  A 30% 
pain reduction over 6 months was seen in 21% and 15% of ABC and UC participants, 
respectively, in average pain during prior week; and 29% and 8% in worst pain prior 
week. Roland Morris and SF-12® physical component summary improvement was 
greater in the ABC based on descriptive statistics and magnitudes of estimates, but 
these differences did not reach statistical significance. Sensitivity analysis additionally 
controlling for age slightly reduced magnitudes of adjusted differences for pain but not 
materially (<15%). 
 

18 
 
In addition to the results based on averages and model-based estimates in Table 3, 
Figures 2 and 3 shows the changes experienced in participants at the individual level.  
We note that a greater number of participants in ABC care experienced a reduction in 7-
day average pain than those in UC group, and in greater magnitudes.  Moreover, there 
is a suggestion that those with the highest baseline levels of pain experienced the 
greatest benefit.  Findings for the worst pain is similar but more pronounced. 
Interference with social activities also reduced in more participants in ABC care (50.0 vs 
11.5%; p=0.0030). 
 
Based on descriptive statistics, there was greater improvement in some of the other 
dichotomous outcomes (data not shown in tables or figures) in the ABC group as 
compared with UC.  Specifically, during the 6-month follow up period, there were more 
pain-related emergency room visits in the UC group as compared with the ABC group 
(45.8 vs 30.8%; p=0.5136), and fewer ABC participants took non-COX2 non-steroidal 
anti-inflammatory drugs (54.2 vs. 73.1%; p=0.1640), opioids (20.8 vs. 38.5%; p=0.1742) 
and skeletal muscle relaxants (16.7 vs. 42.3%; p=0.0481). While fewer participants 
randomized to ABC care were exposed to opioids, this difference also was apparent at 
baseline. 
 
Regarding treatment expectations at baseline, there were no significant associations 
with pain reduction.   
 
Qualitative 

19 
 
Patient participants mostly said they already knew about the majority of their 
conditions contributing to their low back pain and creating difficulty doing the things they 
would like to do before they saw the MD. Also, they said that they discussed almost all 
of these conditions with their MD. For those currently receiving treatment, they identified 
the most common as physical therapy, self-management, acupuncture, and 
medications.  Of all the treatment strategies pursued since their initial visit with the MD, 
those perceived as most helpful were the combination of all the treatments they 
received, as well as physical therapy and independent exercises, acupuncture, back 
injections, transcutaneous electrical nerve stimulation (TENS) unit, and medications.  
Other participants said the least helpful treatments were physical therapy, independent 
exercises, acupuncture, and epidural.  Most participants said that all aspects of their 
pain and functioning had been adequately addressed since their initial visit with the MD; 
a few noted that they had upper leg or iliotibial (IT) band pain, knee pain, and spinal 
stenosis that were not adequately addressed. Patient participant suggestions for 
improving VA management of CLBP included more check-ins or follow ups with more 
consistent/frequent treatment, listening to the patient, treatment closer to the patient’s 
home, consulting with private doctors, explaining management versus eliminating pain, 
not pushing for surgery, more communication between departments, staying up-to-date 
on research, stop prescribing pain medications, VA gym or gym access, and continuing 
programs and research for pain. 
Provider participants said they liked that ABC care provided holistic and individualized 
patient care and that Veterans appreciated ABC care. Some were concerned that ABC 
care required a large time commitment (e.g., provider training, long clinic visits and 
follow ups) and felt that it could be difficult to institute more broadly across the VA.  

20 
 
They identified a number of processes and factors that facilitate the implementation of 
ABC care including provider training in screening exam techniques, having patient 
educational materials, the straightforward structure of ABC care steps, having additional 
support staff, Veterans being open to ABC care, and resources being available to 
Veterans (e.g., VA pays for chiropractor and acupuncture). Perceived barriers to 
implementing ABC care for CLBP noted by providers included patients living far from 
the VA, time required to train providers, lack of patient follow through (e.g., patients do 
not continue PT), and patients with maladaptive coping. Provider participants stated that 
ABC care could be improved by educating other healthcare providers about the 
contributors to CLBP (including those who do not deliver PCCET, such as primary care 
providers), training specialists about PCCET for CLBP (e.g., physical therapists, 
psychologists), integrating patients’ self-report data into their electronic medical record, 
excluding patients who live an hour or more away from the VA, and broadening the list 
of possible contributors to CLBP. 
 
DISCUSSION 
This pilot randomized controlled trial suggests that a comprehensive patient-centered 
approach for the treatment of CLBP in older Veterans is feasible, well-tolerated, and 
associated with preliminary evidence of greater pain reduction and lesser exposure to 
potentially harmful medications as compared with UC. The greatest magnitude of 
improvement was in worst pain intensity over the past 7 days.  Participants in ABC had 
significantly less exposure to skeletal muscle relaxants (medications on Beers’ list) and 
reported reduced frequency of interference with social activities.   Participants 
randomized to ABC on average descriptively experienced less exposure to nonsteroidal 

21 
 
anti-inflammatory drugs (also on Beer’ list), fewer emergency room visits and more 
improvement in low back pain associated disability (i.e. Roland Morris score), although 
these differences were not statistically significant.   
 
We deemed our intervention as feasible according to the feasibility domains outlined by 
Bowen and colleagues (58). These include: 1) acceptability – Our qualitative data 
support the acceptability of the intervention to providers and participants, and the fact 
that we had only one dropout with complete data collection on all other participants 
further supports acceptability; 2) demand (for the intervention) – Our ease of recruiting 
patients support the demand for alternate strategies to treat chronic low back pain in 
older veterans; 3) implementation – Our intervention utilizes resources that are routinely 
available in VA settings; 4) practicality – Our qualitative data support that ABC care is 
practical when delivered in specialty clinics but perhaps not in primary care clinics; we 
used this feedback in the design of our ongoing RCT in which the ABC clinics is a 
specialty clinic that is not embedded in primary care; 5) adaptation – Our pilot study did 
not highlight any areas that required adaptation; 6) integration – No organizational 
change was required to implement our intervention; 7) expansion – If we determine that 
the intervention is efficacious in the context of the RCT, we plan a large comparative 
effectiveness study; 8) limited-efficacy testing – This was accomplished and the results 
are presented in this manuscript. 
 
We tested our hypotheses by examining the between-groups mean change in 
outcomes, an analytical approach that is traditionally used to evaluate intervention 
efficacy.  Additional insight can be gained by examining participant level data.  

22 
 
Examining individual-level change revealed that 50% more people in ABC as compared 
with UC experienced a reduction in average pain intensity. Moreover, there was more 
than a twofold reduction in the number of people in the ABC group as compared with 
UC who experienced worse pain during the 6-months study period. Between-groups 
differences in 7-day worst pain intensity was even more striking. Our pain intensity data 
suggest that most people who receive ABC care may benefit.  We are in the process of 
testing this hypothesis in the context of a recently funded, ongoing, full scale clinical trial 
to more definitively establish the efficacy of our Aging Back Clinics approach. 
 
Our clinical experience in caring for older adults with CLBP resonates with several of 
our study findings, specifically those related to pain intensity, social function, and the 
trends in reduction of emergency room visits and certain analgesics.  There was no 
significant between-groups difference in current pain intensity, although magnitudes 
tended to favor ABC care.  We find that asking patients with CLBP to rate their current 
pain on a scale of 0 to 10 is not likely to be clinically useful, as symptoms are most often 
precipitated during standing-associated activities, not when sitting during typical clinic 
check-in procedures.  Consistent with the observed reduction in 7-day worst pain 
intensity, one of the first things that clinic patients report after starting effective 
treatments is a significant reduction in the frequency and intensity of pain flares, and, 
therefore, a lesser need for emergency treatment seeking and analgesic use. Further, 
the observed reduction of interference with social function reflects our clinical 
experience that engagement in social activities is highly valued by older adults and is 
one of the first functional improvements to return after severe pain flares have been 
ameliorated. 

23 
 
 
It has been demonstrated that contextual factors that occur between the patient and 
provider are associated with significant placebo effects in patients with musculoskeletal 
pain (59).  Several of the contextual components of ABC care may have contributed to 
improvement.  First, participants received a thorough hands-on assessment designed to 
identify the physical contributors to the CLBP, and the touch-intensive aspect of the 
evaluation may have in and of itself been therapeutic.  Second, participants received 
positive communication from the healthcare provider designed to educate the 
participant about the multi-faceted nature of CLBP and the multiple potential 
interventions that can reduce pain interference and improve quality of life.  Third, the 
ABC provider and participant engaged in respectful and collaborative decision making 
about how to approach treatment.  
 
It is worth highlighting that the three ABC providers in this preliminary study were 
geriatricians, and none had received official training in pain medicine.  They only had 
been trained in the structured physical examination procedures and used the published 
treatment algorithms to guide their discussions with participants.  Qualitative findings 
indicate that providers found the physical exam training to be both a benefit and at the 
same time a barrier to broad dissemination.  Given the limited education that medical 
trainees receive on pain management in general (60) and for CLBP in particular (61), it 
would be a daunting task to teach all PCPs the requisite advanced knowledge and skills 
used in ABCs. Restructuring PCP visits to afford the time to spend with these complex 
patients would also be a challenge. Clinical settings that focus on older adults and/or 
pain management may be more appropriate targets than primary care for future 

24 
 
dissemination of ABCs. 
 
In contrast to clinical trials that require adherence to a strict intervention protocol, the 
interventions for the participants’ CLBP contributors were guided by collaborative 
decision making, as noted earlier.  As highlighted by our qualitative data, the very same 
treatments that some patients valued highly were those that others found least helpful, 
reinforcing the importance of patient-centered care.  The magnitude of pain reduction 
we observed is comparable to that found in trials that have tested single intensive 
interventions (62).  If we replicate and expand our findings in the context of a full-scale 
trial, we will be well-positioned to propose broad dissemination of ABC as a model of 
care. 
 
That ABC care did not result in a statistically significant reduction in pain-associated 
disability as compared with UC warrants reflection.  Foremost, we did find greater 
magnitudes of improvements based on estimates and descriptive statistics, and 
statistical power to reach significance was low in our pilot study with a small sample 
size. But also, as noted above, participants were not required to engage in a rigorous 
intervention such as weekly physical therapy, yoga, cognitive behavioral therapy, or 
meditation.  Studies that have tested these types of interventions typically have shown 
more modest reduction in pain-associated disability than in pain intensity (62).  Further, 
we followed participants for only 6 months.  Most participants reported having 
experienced low back pain for at least 5 years, thus 6 months may be inadequate to 
afford the intensive provider-participant interaction and educational reinforcement 
needed to change behavior.  Our large clinical trial includes 12 months follow up.   

25 
 
 
The reduction in exposure to nonsteroidal anti-inflammatory drugs and muscle relaxants 
is noteworthy.  Both of these medication classes are included in Beers’ list of 
inappropriate medications for older adults because of the potential for these 
medications to cause significant morbidity either due to direct adverse effects or drug-
disease interactions (63).  Muscle relaxants are associated with potential anticholinergic 
side effects, sedation, risk of falls and fractures (63).  Nonsteroidal anti-inflammatory 
drugs have a host of potential adverse consequences including gastrointestinal 
bleeding, renal insufficiency and exacerbation of hypertension and congestive heart 
failure (63).  Thus, ABC care may have important benefits above and beyond pain 
reduction. 
 
Pain at the present moment is a more dynamic and volatile outcome with day-to-day 
variability which happened to be somewhat less at baseline in the ABC group. That may 
have played a role in our ability to find significant differences with respect to current 
pain, although a pattern appears to be emerging in the later months signaling a greater 
benefit at later months. 
 
While our study had a number of strengths, its limitations should be highlighted. First, 
ABC care was not conducted according to a stringent protocol.  The baseline history 
and physical examination were structured, as was the education provided about each 
participant’s pain contributors, but the treatments provided were not.  Thus, we cannot 
be definitive about the most effective components of ABC care. Now that we have 
established feasibility and preliminary evidence of efficacy in the context of this pilot 

26 
 
study, we will track all interventions administered and ABC providers’ perceived 
participant compliance in the context of our ongoing large randomized controlled clinical 
trial, enabling us to ascertain the most effective ABC components.  Another study 
limitation is that all participants in our study were Veterans and they received care in the 
Veterans healthcare system.  Thus, our findings may not be broadly applicable.  If our 
larger ongoing clinical trial corroborates and extends the findings, a similar model of 
care should be examined in other settings.  
 
CONCLUSIONS 
This preliminary trial demonstrates that treating older adults with CLBP using a 
comprehensive geriatric syndrome approach is feasible, received positively by patients 
and providers, and may be efficacious.  If supported by a larger randomized controlled 
trial, the proposed approach could improve quality of life and reduce morbidity and 
misdirected health care utilization for millions of older adults. 
 
 

27 
 
ACKNOWLEDGEMENTS 
This material is based on work supported by the Department of Veterans Affairs, 
Veterans Health Administration, Office of Research and Development, grant # 
RX002021-01.  The contents of this report do not represent the views of the Department 
of Veterans Affairs or the United States government. 
 
The authors wish to thank Kimberly Clemens for her conscientious oversight of the 
study. They also wish to thank Dave Newman, Rachel Samuels, and Christopher 
Godschalk for their efforts in participant recruitment and data collection. 
 
CONFLICTS OF INTEREST 
None of the authors has any conflicts of interest to report. 
 
 

28 
 
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37 
 
Table 1: Participant characteristics at baseline [mean ± standard deviation or N (%)] 
 
ABC 
N=25 
UC 
N=30 
p-Value 
Age 
71.3±7.5 
67.2±5.5 
0.0227 
Gender 
 
Female 
 
Male 
 
1 (4.0) 
24 (96.0) 
 
1 (3.3) 
29 (96.7) 
1.0000 
Ethnicity 
 
Hispanic/Latino 
 
Not Hispanic/Latino 
 
Unknown 
 
Not reported 
 
0 (0.0) 
25 (100) 
0 (0.0) 
0 (0.0) 
 
0 (0.0) 
26 (86.7) 
1 (3.3) 
3 (10.0) 
0.2424 
Race 
 
Black 
 
White 
 
Unknown 
 
8 (32.0) 
17 (68.0) 
0 (0.0) 
 
9 (30.0) 
20 (66.7) 
1 (3.3) 
1.0000 
Employment status 
 
Working now 
 
Looking for work 
 
Disabled due to back pain 
 
Disabled for other reason 
 
Retired 
 
Other 
 
2 (8.0) 
1 (4.0) 
2 (8.0) 
1 (4.0) 
18 (72.0) 
1 (4.0) 
 
2 (6.7) 
1 (3.3) 
6 (20.0) 
2 (6.7) 
19 (63.3) 
0 (0.0) 
 
0.7919 
Education 
 
No high school diploma 
 
High school/GED 
 
Some college no degree 
 
Occupational/technical/vocational 
 
3 (12.0) 
9 (36.0) 
6 (24.0) 
1 (4.0) 
 
1 (3.3) 
8 (26.7) 
8 (26.7) 
3 (10.0) 
0.5274 

38 
 
 
Associate degree 
 
Bachelor’s degree 
 
Professional school degree 
 
Doctoral degree 
2 (8.0) 
2 (8.0) 
1 (4.0) 
1 (4.0) 
4 (13.3) 
6 (20.0) 
0 (0.0) 
0 (0.0) 
Height (cm) 
176.3±5.4 
178.1±6.0 
0.2579 
Weight (kg) 
96.2±24.8 
94.5±22.1 
0.7923 
 
Comorbidities 
Cardiovascular 
9 (36.0) 
6 (20.0) 
0.1846 
Neurological 
4 (16.0) 
2 (6.7) 
0.3943 
Musculoskeletal 
25 (100) 
30 (100) 
NE 
General 
19 (76.0) 
19 (63.3) 
0.3115 
Visual/hearing 
16 (64.0) 
22 (73.3) 
0.4558 
Diabetes 
11 (44.0) 
5 (16.7) 
0.0263 
Cancer 
3 (12.0) 
7 (23.3) 
0.3184 
Lung 
11 (44.4) 
5 (16.7) 
0.0263 
Duke comorbidity index 
3.9±1.4 
3.2±1.5 
0.0689 
 
Pain 
Current pain 
4.5±2.8 
5.3±2.4 
0.2482 
Average pain prior week 
6.6±1.7 
6.5±1.4 
0.8725 
Worst pain prior week 
8.8±1.5 
8.5±1.9 
0.5132 
 
Cognitive Function 
MMSE 
28.1±1.6 
29.0±1.1 
0.0159 
QMCI 
72.2±8.5 
72.7±9.9 
0.8556 
 
Medications 
Salicylate 
1 (4.0) 
0 (0.0) 
0.4545 

39 
 
Non-aspirin, non-COX2 selective NSAID 
9 (36.0) 
10 (33.3) 
0.8359 
COX2 selective NSAID 
0 (0.0) 
3 (10.0) 
0.2424 
Acetaminophen 
3 (12.0) 
4 (13.3) 
1.0000 
Opioid analgesic 
5 (20.0) 
10 (33.3) 
0.2689 
Skeletal muscle relaxant 
2 (8.0) 
5 (16.7) 
0.4363 
Topical 
2 (8.0) 
1 (33.3) 
0.5855 
Corticosteroid 
0 (0.0) 
0 (0.0) 
NE 
Gabapentin 
2 (8.0) 
9 (30.0) 
0.0423 
Pregabalin 
0 (0.0) 
0 (0.0) 
NE 
Antidepressant, non-tricyclic 
1 (4.0) 
0 (0.0) 
0.4545 
Antidepressant, tricyclic 
0 (0.0) 
1 (3.3) 
1.0000 
Other 
1 (4.0) 
1 (3.3) 
1.0000 
 
Roland-Morris Disability Index 
14.8±5.1 
15.1±5.3 
0.7912 
 
Treatment Credibility & Expectations 
 
 
 
How logical 
6.1±2.7 
6.2±2.6 
0.8683 
Expectation of success 
4.8±2.4 
5.0±2.7 
0.8135 
Confidence in recommending to others 
4.4±3.1 
5.4±2.8 
0.2158 
Expected percent improvement 
50.4±30.3 
45.7±32.6 
0.5822 
Feeling of expected symptom reduction 
5.4±2.8 
5.4±2.5 
0.9178 
Feeling of percent symptom reduction 
55.6±33.9 
50.0±31.9 
0.5318 
 
History & Physical Exam (n=25) 
Fibromyalgia 
4 (16.0) 
NA 
NE 
Insomnia 
14 (56.0) 
NA 
NE 
Anxiety 
2 (8.0) 
NA 
NE 
Depression 
4 (16.0) 
NA 
NE 

40 
 
Maladaptive Coping: Fear Avoidance 
Beliefs 
5 (20.0) 
NA 
NE 
Maladaptive Coping: Catastrophizing 
 
5 (20.0) 
NA 
NE 
Mild Cognitive Impairment 
1 (4.0) 
NA 
NE 
Myofascial Pain 
20 (80.0) 
NA 
NE 
 
Erector Spinae 
10 (40.0) 
NA 
NE 
 
Quadratus Lumborum 
8 (32.0) 
NA 
NE 
 
Gluteus Medius 
4 (16.0) 
NA 
NE 
 
Piriformis 
10 (40.0) 
NA 
NE 
 
Perpetuating factors: Scoliosis   
14 (56.0) 
NA 
NE 
 
Kyphosis 
4 (16.0) 
NA 
NE 
 
Mood disorder 
4 (16.0) 
NA 
NE 
 
Maladaptive coping 
6 (24.0) 
NA 
NE 
 
Abnormal gait 
6 (24.0) 
NA 
NE 
 
Leg length   discrepancy 
3 (12.0) 
NA 
NE 
 
            Other 
6 (24.0) 
NA 
NE 
Leg Length Discrepancy   
5 (20.0) 
NA 
NE 
Hip Osteoarthritis 
8 (32.0) 
NA 
NE 
Sacroiliac Joint Pain 
13 (52.0) 
NA 
NE 
IT Band Pain 
6 (24.0) 
NA 
NE 
Greater Trochanteric Pain 
1 (4.0) 
NA 
NE 
Lumbar spinal stenosis 
5 (20.0) 
NA 
NE 
Radiculopathy 
3 (12.0) 
NA 
NE 
 
MOS Social Support 
Emotional 
67.9±21.7 
68.1±30.3 
0.9726 
Tangible 
70.5±26.2 
68.1±32.1 
0.7681 
Affectionate 
79.0±26.1 
77.2±31.5 
0.8229 
Interaction 
75.0±23.1 
75.6±30.6 
0.9407 

41 
 
Overall 
71.5±20.3 
71.0±26.1 
0.9304 
 
SF-12® Health Survey 
Physical component summary 
31.2±8.1 
32.5±9.4 
0.5998 
Mental component summary 
51.7±11.4 
51.3±10.8 
0.8874 
Frequency of physical health/emotional 
problems interfering with social 
activities 
 
 
0.4635 
 
All of the time 
2 (8.0) 
2 (6.7) 
 
 
Most of the time 
6 (24.0) 
4 (13.3) 
 
 
A good bit of the time 
0 (0.0) 
1 (3.3) 
 
 
Some of the time 
3 (12.0) 
6 (20.0) 
 
 
A little of the time 
7 (28.0) 
6 (16.7) 
 
 
None of the time 
7 (28.0) 
12 (40.0) 
 
ABC=Aging Back Clinic; COX = cyclooxygenase; IT = iliotibial band; MMSE = Mini 
Mental State Examination; NSAID = nonsteroidal anti-inflammatory; QMCI = Quick 
Mild Cognitive Impairment screen; NE = not estimable; NA = not applicable; UC = 
usual care 
 
 
 

42 
 
Table 2. CLBP Syndrome Conditions and Interventions Recommended for Participants 
Randomized to ABC Care 
Participant CLBP Syndrome 
Conditions 
Intervention(s) Recommended 
1 
• Insomnia 
• Hip osteoarthritis (OA) 
• Lumbar spinal 
stenosis 
• Physical therapy (PT) 
• Lumbar brace 
• Hip x-ray 
 
2 
• Insomnia 
• Depression 
• Hip OA 
• Sacroiliac joint (SIJ) 
pain 
• Insomnia clinic referral 
• Chiropractic 
• Acupuncture 
• Hip x-ray 
 
3 
• Insomnia 
• Myofascial pain 
• SIJ pain 
• IT band pain 
 
• Insomnia clinic referral 
• Acupuncture 
• Chiropractic 
4 
• Fibromyalgia 
• Insomnia 
• Anxiety 
• Depression 
• Maladaptive Coping 
• Hip OA 
 
• Insomnia clinic referral 
• Interdisciplinary Pain 
Management Program referral 
• Hip x-ray 
 
5 
• Insomnia 
• Myofascial pain 
• Lumbar spinal 
stenosis 
• PT 
• Epidural corticosteroid 
• Acupuncture 
 

43 
 
6 
• Myofascial pain 
• Leg length Inequality 
• SIJ pain 
 
• PT 
7 
• Depression 
• Myofascial pain 
• Hip OA 
• SIJ pain 
 
• Titrate sertraline 
• Hip x-ray 
 
8 
• Myofascial pain 
• Leg length inequality 
• Lumbar spinal 
stenosis 
 
• PT 
• Acupuncture 
• Statin holiday 
9 
• Myofascial pain 
• SIJ pain 
• IT band pain 
 
• Titrate acetaminophen 
• PT 
10 
• Maladaptive coping 
• Myofascial pain 
• Leg length inequality 
• SIJ pain 
• IT band pain 
• Lumbar spinal 
stenosis 
 
• PT 
• Chiropractic 
• Massage 
• Maintain spiritual support for 
coping; consider psychology in 
future 
11 
• Depression 
• Maladaptive coping 
• Myofascial pain 
• Regularly scheduled 
acetaminophen 
• PT 
• Epidural corticosteroid 

44 
 
• Lumbar spinal 
stenosis 
 
• Psychology referral 
12 
• Insomnia 
• Anxiety 
• Maladaptive coping 
• Myofascial pain 
• Leg length inequality 
• SIJ pain 
 
• Chiropractic 
• Lidocaine patch 
• Regularly scheduled 
acetaminophen 
• Discontinue muscle relaxant 
• PT 
13 
• Myofascial pain 
• SIJ pain 
 
• Lidocaine ointment 
• PT 
14 
• Myofascial pain 
• Hip OA 
• SIJ pain 
• IT band pain 
• Lumbar spinal 
stenosis 
 
• PT 
• Lidocaine patch 
• Discontinue muscle relaxant 
• Hip x-ray 
15 
• Myofascial pain 
• SIJ pain 
• Regularly scheduled 
acetaminophen 
• PT 
 
16 
• Myofascial pain 
• PT 
• Referred to MOVE program (for 
obesity management) 
 
17 
• Myofascial pain 
• Maladaptive coping 
• PT 
• Acupuncture 

45 
 
• Yoga for self-management 
• CBT (participant declined) 
 
18 
• Myofascial pain 
• SIJ pain 
• Lumbar spinal 
stenosis 
• Insomnia 
 
• PT 
• Tramadol prn 
• SIJ injection 
• Follow up with sleep clinic for 
management of sleep apnea 
 
19 
• Insomnia 
• Myofascial pain 
 
• PT 
• Sleep clinic (participant declined) 
• Sleep hygiene education 
 
20 
• Myofascial pain 
• IT band pain 
• Insomnia 
 
• PT 
• “Acupuncture” (dry needling and 
gua sha) 
• Sleep clinic (participant declined) 
• Sleep hygiene education 
 
21 
• Insomnia 
• Depression 
• Maladaptive coping 
• Myofascial pain 
• SIJ pain 
• IT band pain 
 
• PT 
• Psychology for cognitive 
behavioral therapy 
• Switch bupropion to duloxetine 
(approved by Psychiatry) 
• Sleep hygiene education 
22 
• Fibromyalgia 
• Insomnia 
• Anxiety 
• Rheumatology referral 
• Psychology referral 
• PT 

46 
 
• Maladaptive coping 
• Myofascial pain 
• Hip OA 
• Lateral thigh pain (IT 
band pain and greater 
trochanteric pain) 
• SIJ pain 
 
• Acupuncture 
• Aquatherapy 
• Acetaminophen  
• Sleep clinic referral with 
diagnosis and treatment of sleep 
apnea 
• Continue T’ai Chi for self-
management 
• Continue Psychiatry follow up 
• D/C methacarbamol (participant 
refused) 
 
23 
• Myofascial pain 
• Hip OA 
• Insomnia 
 
• Hip x-ray 
• PT 
• Acupuncture 
• MOVE referral (participant 
refused) 
• Sleep hygiene education 
 
24 
• Myofascial pain 
• Hip osteoarthritis 
 
• PT 
• Single point cane 
• Acupuncture 
• MOVE referral (participant 
refused) 
• Reduce cyclobenzaprine dose 
(participant refused 
discontinuation) 
 
25 
• Fibromyalgia 
• Insomnia 
• Maladaptive coping 
• Hip OA 
• PT 
• Sleep hygiene education 
• Continue psychotherapy 
• Aquatherapy 

47 
 
• SIJ pain 
 

48 
 
Table 3: Changes in main outcomes in the two intervention arms  
 
Baseline to Follow-up Change 
Mean ± Standard Deviation 
ABC vs UC 
Difference ± Standard Error [p-Value*] 
ABC 
UC 
Unadjusted 
Adjusted for Baseline 
Current pain at the moment after: 
 
 
 
 
 
1 Month 
0.76±2.73 
0.38±1.83 
0.38±0.72 [0.6015] 
-0.23±0.59 [0.6938] 
 
2 Months 
0.13±2.56 
0.12±1.90 
0.06±0.72 [0.9315] 
-0.53±0.59 [0.3743] 
 
3 Months 
0.41±2.63 
0.28±2.37 
0.07±0.73 [0.9225] 
-0.49±0.60 [0.4110] 
 
4 Months 
-0.13±3.13 
0.56±2.14 
-0.80±0.72 [0.2709] 
-1.38±0.59 [0.0202] 
 
5 Months 
0.09±3.36 
0.19±2.81 
-0.14±0.72 [0.8432] 
-0.76±0.59 [0.2000] 
 
6 Months 
0.46±2.99 
0.96±2.18 
-0.46±0.72 [0.5261] 
-1.07±0.59 [0.0702] 
Average pain over prior week after: 
 
 
 
 
 
1 Month 
-0.68±2.27 
-0.27±1.76 
-0.41±0.61 [0.5046] 
-0.39±0.53 [0.4597] 
 
2 Months 
-1.13±2.33 
-0.80±1.78 
-0.25±0.62 [0.6820] 
-0.22±0.54 [0.6759] 
 
3 Months 
-1.05±2.13 
-0.32±1.93 
-0.97±0.62 [0.1199] 
-0.95±0.54 [0.0822] 
 
4 Months 
-1.33±2.06 
-0.44±1.85 
-1.21±0.62 [0.0525] 
-1.18±0.54 [0.0283] 
 
5 Months 
-1.61±2.59 
-1.00±2.26 
-0.58±0.62 [0.3466] 
-0.57±0.54 [0.2903] 
 
6 Months 
-1.38±2.46 
-0.08±2.02 
-1.24±0.62 [0.0456] 
-1.22±0.54 [0.0230] 
Worst pain over prior week after: 
 
 
 
 
 
1 Month 
-1.12±2.45 
-0.50±1.63 
-0.62±0.60 [0.2992] 
-0.59±0.57 [0.3015] 

49 
 
 
2 Months 
-1.42±2.26 
-0.84±1.99 
-0.51±0.60 [0.3935] 
-0.47±0.57 [0.4093] 
 
3 Months 
-1.55±2.86 
-0.60±1.53 
-1.15±0.61 [0.0586] 
-1.11±0.58 [0.0562] 
 
4 Months 
-1.79±1.84 
-0.48±1.42 
-1.64±0.60 [0.0069] 
-1.60±0.57 [0.0054] 
 
5 Months 
-2.35±2.55 
-1.08±1.67 
-1.19±0.60 [0.0484] 
-1.15±0.57 [0.0453] 
 
6 Months 
-2.25±2.44 
-0.42±1.42 
-1.74±0.60 [0.0040] 
-1.70±0.57 [0.0032] 
Roland-Morris Disability Index after: 
 
 
 
 
 
1 Month 
-1.12±4.96 
-0.58±2.77 
-0.54±1.28 [0.6711] 
-0.72±1.25 [0.5665] 
 
2 Months 
-1.46±5.40 
-0.40±3.79 
-1.12±1.28 [0.3856] 
-1.28±1.25 [0.3069] 
 
3 Months 
-1.27±3.18 
-0.36±3.33 
-1.50±1.29 [0.2452] 
-1.68±1.26 [0.1851] 
 
4 Months 
-1.80±5.42 
0.16±4.25 
-1.96±1.28 [0.1266] 
-2.13±1.25 [0.0894] 
 
5 Months 
-2.30±5.23 
-0.69±3.95 
-1.44±1.28 [0.2635] 
-1.62±1.26 [0.1994] 
 
6 Months 
-1.29±6.05 
0.08±4.12 
-1.24±1.28 [0.3336] 
-1.42±1.25 [0.2581] 
SF-12® Physical Component 
Summary: 
 
 
 
 
 
1 Month 
1.09±7.58 
1.05±8.02 
-0.11±2.22 [0.9615] 
-0.30±2.12 [0.8886] 
 
2 Months 
0.81±6.74 
0.70±7.36 
0.04±2.23 [0.9858] 
-0.19±2.13 [0.9286] 
 
3 Months 
3.77±7.44 
0.89±8.20 
2.93±2.27 [0.1983] 
2.71±2.17 [0.2125] 
 
4 Months 
3.39±7.71 
1.09±7.93 
2.45±2.22 [0.2720] 
2.23±2.12 [0.2935] 
 
5 Months 
2.47±8.22 
-0.03±7.93 
2.37±2.24 [0.2894] 
2.18±2.13 [0.3084] 
 
6 Months 
1.46±8.38 
-1.08±8.84 
2.36±2.23 [0.2906] 
2.17±2.12 [0.3068] 

50 
 
SF-12® Mental Component 
Summary: 
 
 
 
 
 
1 Month 
-2.09±9.05 
-3.98±9.53 
2.05±2.60 [0.4325] 
2.39±2.46 [0.3325] 
 
2 Months 
-0.64±8.31 
-3.61±9.80 
2.79±2.61 [0.2876] 
3.05±2.47 [0.2191] 
 
3 Months 
-1.73±7.97 
-1.54±9.23 
0.01±2.65 [0.9958] 
0.34±2.52 [0.8927] 
 
4 Months 
-1.09±7.49 
-2.57±8.48 
1.45±2.60 [0.5781] 
1.75±2.46 [0.4779] 
 
5 Months 
-1.65±8.97 
-2.11±10.47 
0.76±2.62 [0.7718] 
1.11±2.48 [0.6556] 
 
6 Months 
-1.14±9.55 
-3.12±10.59 
2.12±2.60 [0.4161] 
2.47±2.46 [0.3182] 
* Using a linear mixed model  
 

51 
 
Figure Legends 
Figure 1. CONSORT diagram 
Figure 2. Six months of individual participant level data in Aging Back Clinic care (ABC) 
and Usual Care (UC) for 7-day average 0 to 10 pain score (top diagram) and 7-day 
worst pain score (bottom diagram) 
Figure 3. Six months of individual participant level data in Aging Back Clinic care (ABC) 
and Usual Care (UC) for SF-12® frequency of health/emotional problems 
interference with social activities item. 
 
 

52 
 
 
  
 
                      
 
 
 
 
Figure 1.  

53 
 
Figure 2. 
 

54 
 
Figure 3. 
 
 
 
 
 

55 
 
APPENDIX: NIH Minimal Data Set Participant Baseline Characteristics [mean ± standard 
deviation or N (%)] 
Characteristic 
ABC 
N=25 
UC 
N=30 
p-Value 
Pain duration 
 
3-6 Months 
 
6 Months-1 Year 
 
1-5 Years 
 
>5 Years 
 
1 (4.0) 
2 (8.0) 
6 (24.0) 
16 (64.0) 
 
1 (3.3) 
0 (0.0) 
4 (13.3) 
25 (83.3) 
0.2366 
Pain frequency 
 
Every/nearly every day 
 
At least half the days 
 
Less than half the days 
 
23 (92.0) 
2 (8.0) 
0 (0.0) 
 
27 (90.0) 
2 (6.7) 
1 (3.3) 
1.0000 
Average pain prior week 
6.5±1.4 
6.4±1.8 
0.8582 
Pain spread to legs prior 2 weeks 
 
No 
 
Yes 
 
Not sure 
 
11 (44.0) 
14 (56.0) 
0 (0.0) 
 
10 (33.3) 
18 (60.0) 
2 (6.7) 
0.5039 
Bothered prior month by 
 
 
 
 
Stomach pain 
 
 
Not at all 
 
 
A little 
 
 
A lot 
 
18 (72.0) 
6 (24.0) 
1 (4.0) 
 
18 (60.0) 
6 (20.0) 
6 (20.0) 
0.2236 
 
Other joints 
 
 
Missing 
 
0 (0.0) 
 
1 (3.3) 
0.3986 

56 
 
 
 
Not at all 
 
 
A little 
 
 
A lot 
6 (24.0) 
10 (40.0) 
9 (36.0) 
3 (10.0) 
11 (36.7) 
15 (50.0) 
 
 
Headaches 
 
 
Not at all 
 
 
A little 
 
 
A lot 
 
13 (52.0) 
8 (32.0) 
4 (16.0) 
 
22 (73.3) 
4 (13.3) 
4 (13.3) 
0.2060 
 
Widespread pain 
 
 
Not at all 
 
 
A little 
 
 
A lot 
 
13 (52.0) 
5 (20.0) 
7 (28.0) 
 
15 (50.0) 
3 (10.0) 
12 (40.0) 
0.5347 
Had surgery 
0 (0.0) 
0 (0.0) 
NE 
In the prior week pain interference with 
 
 
 
 
Day-to-day activities 
 
 
Not at all 
 
 
A little bit 
 
 
Somewhat 
 
 
Quite a bit 
 
 
Very much 
 
1 (4.0) 
4 (16.0) 
10 (40.0) 
5 (20.0) 
5 (20.0) 
 
2 (6.7) 
3 (10.0) 
12 (40.0) 
10 (33.3) 
3 (10.0) 
0.6827 
 
Work around the home 
 
 
Not at all 
 
 
A little bit 
 
 
Somewhat 
 
 
Quite a bit 
 
1 (4.0) 
3 (12.0) 
11 (44.0) 
7 (28.0) 
 
5 (16.7) 
5 (16.7) 
7 (23.3) 
10 (33.3) 
0.4029 

57 
 
 
 
Very much 
3 (12.0) 
3 (10.0) 
 
Social activities 
 
 
Not at all 
 
 
A little bit 
 
 
Somewhat 
 
 
Quite a bit 
 
 
Very much 
 
5 (20.0) 
6 (24.0) 
6 (24.0) 
6 (24.0) 
2 (8.0) 
 
8 (26.7) 
5 (16.7) 
7 (23.3) 
7 (23.3) 
3 (10.0) 
0.9924 
 
Household chores 
 
 
Not at all 
 
 
A little bit 
 
 
Somewhat 
 
 
Quite a bit 
 
 
Very much 
 
3 (12.0) 
5 (20.0) 
7 (28.0) 
7 (28.0) 
3 (12.0) 
 
4 (13.3) 
7 (23.3) 
8 (26.7) 
7 (23.3) 
4 (13.3) 
0.9929 
Opioid painkillers (ever) 
 
No 
 
Yes 
 
Not sure 
 
11 (44.0) 
13 (52.0) 
1 (4.0) 
 
13 (43.3) 
17 (56.7) 
0 (0.0) 
0.6788 
Current use 
 
Missing 
 
No 
 
Yes 
 
4 (16.0) 
16 (64.0) 
5 (20.0) 
 
6 (20.0) 
14 (46.7) 
10 (33.3) 
0.4148 
Injections   
 
No 
 
Yes 
 
13 (52.0) 
12 (48.0) 
 
19 (63.3) 
11 (36.7) 
0.3962 
Exercise therapy 
 
 
0.1568 

58 
 
 
Missing 
 
No 
 
Yes 
 
Not sure 
0 (0.0) 
7 (28.0) 
16 (64.0) 
2 (8.0) 
1 (3.3) 
5 (16.7) 
24 (80.0) 
0 (0.0) 
Psychological counseling 
 
No 
 
Yes 
 
22 (88.0) 
3 (12.0) 
 
21 (70.0) 
9 (30.0) 
0.1075 
Off work prior month 
 
Disagree 
 
Agree 
 
Not applicable 
 
5 (20.0) 
0 (0.0) 
20 (80.0) 
 
6 (20.0) 
2 (6.7) 
22 (73.3) 
0.6504 
Workers’ Comp/Disability 
 
Disagree 
 
Agree 
 
Not applicable 
 
5 (20.0) 
0 (0.0) 
20 (80.0) 
 
3 (10.0) 
4 (13.3) 
23 (76.7) 
0.1364 
Physical function 
 
 
 
 
Chores 
 
 
W/o any difficulty 
 
 
W/ a little difficulty 
 
 
W/ some difficulty 
 
 
W/ much difficulty 
 
 
Unable to do 
 
0 (0.0) 
3 (12.0) 
11 (44.0) 
5 (20.0) 
6 (24.0) 
 
2 (6.7) 
8 (26.7) 
14 (46.7) 
4 (13.3) 
2 (6.7) 
0.1912 
 
Up/down stairs 
 
 
W/o any difficulty 
 
 
W/ a little difficulty 
 
1 (4.0) 
9 (36.0) 
 
3 (10.0) 
4 (13.3) 
0.3416 

59 
 
 
 
W/ some difficulty 
 
 
W/ much difficulty 
 
 
Unable to do 
6 (24.0) 
1 (4.0) 
8 (32.0) 
7 (23.3) 
3 (10.0) 
13 (43.3) 
 
Walk 15 minutes 
 
 
W/o any difficulty 
 
 
W/ a little difficulty 
 
 
W/ some difficulty 
 
 
W/ much difficulty 
 
 
Unable to do 
 
3 (12.0) 
6 (24.0) 
5 (20.0) 
5 (20.0) 
6 (24.0) 
 
6 (20.0) 
4 (13.3) 
5 (16.7) 
4 (13.3) 
11 (36.7) 
0.6610 
 
Run errands 
 
 
W/o any difficulty 
 
 
W/ a little difficulty 
 
 
W/ some difficulty 
 
 
W/ much difficulty 
 
 
Unable to do 
 
7 (28.0) 
5 (20.0) 
8 (32.0) 
5 (20.0) 
0 (0.0) 
 
5 (16.7) 
5 (16.7) 
11 (36.7) 
4 (13.3) 
5 (16.7) 
0.2460 
Prior week felt 
 
 
 
 
Worthless 
 
 
Never 
 
 
Rarely 
 
 
Sometimes 
 
 
Often 
 
 
Always 
 
14 (56.0) 
2 (8.0) 
8 (32.0) 
1 (4.0) 
0 (0.0) 
 
18 (60.0) 
3 (10.0) 
4 (13.3) 
4 (13.3) 
1 (3.33) 
0.3717 
 
Helpless 
 
 
Never 
 
 
Rarely 
 
17 (68.0) 
2 (8.0) 
 
21 (70.0) 
3 (10.0) 
0.8443 

60 
 
 
 
Sometimes 
 
 
Often 
 
 
Always 
5 (20.0) 
1 (4.0) 
0 (0.0) 
3 (10.0) 
2 (6.7) 
1 (3.3) 
 
Depressed 
 
 
Never 
 
 
Rarely 
 
 
Sometimes 
 
 
Often 
 
 
Always 
 
16 (64.0) 
2 (8.0) 
3 (12.0) 
3 (12.0) 
1 (4.0) 
 
17 (56.7) 
2 (6.7) 
9 (30.0) 
1 (3.3) 
1 (3.3) 
0.4410 
 
Hopeless 
 
 
Never 
 
 
Rarely 
 
 
Sometimes 
 
 
Often 
 
 
Always 
 
18 (72.0) 
3 (12.0) 
2 (8.0) 
1 (4.0) 
1 (4.0) 
 
21 (70.0) 
4 (13.3) 
3 (10.0) 
1 (3.3) 
1 (3.3) 
1.0000 
Sleep quality prior week 
 
Very poor 
 
Poor 
 
Fair 
 
Good 
 
4 (16.0) 
7 (28.0) 
9 (36.0) 
5 (20.0) 
 
6 (20.0) 
8 (26.7) 
10 (33.3) 
6 (20.0) 
0.9842 
Prior week sleep was 
 
 
 
 
Refreshing 
 
 
Not at all 
 
 
A little bit 
 
 
Somewhat 
 
5 (20.0) 
7 (28.0) 
9 (36.0) 
 
8 (26.7) 
4 (13.3) 
10 (33.3) 
0.5904 

61 
 
 
 
Quite a bit 
 
 
Very much 
3 (12.0) 
1 (4.0) 
4 (13.3) 
4 (13.3) 
 
Had problems 
 
 
Not at all 
 
 
A little bit 
 
 
Somewhat 
 
 
Quite a bit 
 
 
Very much 
 
5 (20.0) 
4 (16.0) 
8 (32.0) 
3 (12.0) 
5 (20.0) 
 
4 (13.3) 
6 (20.0) 
6 (20.0) 
6 (20.0) 
8 (26.7) 
0.7678 
 
Difficulty falling asleep 
 
 
Not at all 
 
 
A little bit 
 
 
Somewhat 
 
 
Quite a bit 
 
 
Very much 
 
8 (32.0) 
6 (24.0) 
4 (16.0) 
2 (8.0) 
5 (20.0) 
 
11 (36.7) 
3 (10.0) 
7 (23.3) 
3 (10.0) 
6 (20.0) 
0.7590 
Not safe to be physically active 
 
Disagree 
 
Agree 
 
14 (56.0) 
11 (44.0) 
 
23 (76.7) 
7 (23.3) 
0.1039 
Terrible and not going to get better 
 
Disagree 
 
Agree 
 
14 (56.0) 
11 (44.0) 
 
23 (76.7) 
7 (23.3) 
0.1039 
Involved in lawsuit 
 
No 
 
Yes 
 
Unsure 
 
22 (88.0) 
2 (8.0) 
1 (4.0) 
 
29 (96.7) 
1 (3.3) 
0 (0.0) 
0.3942 
Past year 
 
 
 

62 
 
 
Drunk/used drugs 
 
  
Never 
 
 
Rarely 
 
 
Sometimes 
 
 
Often 
 
22 (88.0) 
3 (12.0) 
0 (0.0) 
0 (0.0) 
 
24 (80.0) 
2 (6.7) 
3 (10.0) 
1 (3.3) 
0.3124 
 
Wanted to cut down 
 
  
Never 
 
 
Rarely 
 
 
Sometimes 
 
 
Often 
 
24 (96.0) 
0 (0.0) 
1 (4.0) 
0 (0.0) 
 
26 (86.7) 
3 (10.0) 
0 (0.0) 
1 (3.3) 
0.2015 
Smoking status 
 
Missing 
 
Never smoked 
 
Current smoker 
 
Former smoker 
 
1 (4.0) 
8 (32.0) 
1 (4.0) 
15 (60.0) 
 
0 (0.0) 
4 (13.3) 
7 (23.3) 
19 (63.3) 
0.0536