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Aging Back Clinics

Optimizing Outcomes for Older Veterans With Chronic Low Back Pain Syndrome: Aging Back Clinics

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03564600
Enrollment
299
Registered
2018-06-21
Start date
2019-01-03
Completion date
2024-03-29
Last updated
2025-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Low Back Pain

Keywords

low back pain

Brief summary

The purpose of this study is to compare two different ways to treat chronic low back pain. The two types of treatment that the investigators will compare are called Usual Care and ABC Care. Usual Care tends to focus on the spine. ABC Care focuses on the entire body and the mind. With Usual Care, participants will work with their own doctor to come up with a treatment plan. With ABC Care, participants will work with the investigators' ABC providers and their team. The investigators believe ABC Care will help reduce pain, lower costs, and increase participants' ability to do the things they enjoy doing better than Usual Care. In ABC Care the investigators hope to avoid treatments like surgeries where participants get metal rods put in their back. This research is being done at three Veterans Hospitals: the Veterans Administration of Pittsburgh Healthcare System (VAPHS) in Pittsburgh, PA; the North Texas VA Medical Center in Dallas, TX; and the Hunter Holmes McGuire VA Medical Center in Richmond, VA. This research study is being paid for by the Rehabilitation Research and Development section of the Veterans Health Administration. The investigators will be enrolling about 450 participants at 3 sites or around 150 at each site.

Detailed description

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. The investigators 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)? The investigators 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. The investigators' 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 the investigators' published guidelines. The investigators now wish to implement these guidelines in the investigators' 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, Dallas VA, and Richmond VA to meet a target randomization of 330. 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 three later time points: 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.

Interventions

OTHERAging Back Clinics management

Personalized care is delivered that is guided by published algorithms for each component condition identified by a trained provider.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to 89 Years
Healthy volunteers
Yes

Inclusion criteria

* 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 English speaking. * Must be able to commit 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

* 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. * 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.

Design outcomes

Primary

MeasureTime frameDescription
Oswestry Disability Index (ODI) ChangeBaseline visit, every three months for up to one yearThe ODI assesses interference of pain with function. This questionnaire is used by clinicians and researchers to quantify disability for low back pain. Range 0 to 100 with higher score indicating greater disability.

Countries

United States

Participant flow

Participants by arm

ArmCount
ABC Group
Veterans with back pain for at least the past 6 months receive personalized care by providers trained based on a published set of algorithms that guide care for conditions that contribute to disability in older adults with chronic low back pain Aging Back Clinics management: Personalized care is delivered that is guided by published algorithms for each component condition identified by a trained provider.
150
UC Group
Veterans with back pain for at least the past 6 months who receive usual care as directed by their primary care physician.
149
Total299

Baseline characteristics

CharacteristicABC GroupTotalUC Group
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
150 Participants299 Participants149 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Age, Continuous73.5 years
STANDARD_DEVIATION 5.1
73.39 years
STANDARD_DEVIATION 5.04
73.3 years
STANDARD_DEVIATION 5
Ethnicity (NIH/OMB)
Hispanic or Latino
11 Participants25 Participants14 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
139 Participants274 Participants135 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Oswestry Disability Index30.5 units on a scale
STANDARD_DEVIATION 14.7
31.8 units on a scale
STANDARD_DEVIATION 15.02
33.1 units on a scale
STANDARD_DEVIATION 15.3
Race (NIH/OMB)
American Indian or Alaska Native
2 Participants4 Participants2 Participants
Race (NIH/OMB)
Asian
0 Participants3 Participants3 Participants
Race (NIH/OMB)
Black or African American
41 Participants82 Participants41 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants2 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants4 Participants3 Participants
Race (NIH/OMB)
White
105 Participants204 Participants99 Participants
Region of Enrollment
United States
150 Participants299 Participants149 Participants
Sex: Female, Male
Female
14 Participants20 Participants6 Participants
Sex: Female, Male
Male
136 Participants279 Participants143 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1500 / 149
other
Total, other adverse events
0 / 1500 / 149
serious
Total, serious adverse events
0 / 1500 / 149

Outcome results

Primary

Oswestry Disability Index (ODI) Change

The ODI assesses interference of pain with function. This questionnaire is used by clinicians and researchers to quantify disability for low back pain. Range 0 to 100 with higher score indicating greater disability.

Time frame: Baseline visit, every three months for up to one year

ArmMeasureGroupValue (MEAN)Dispersion
ABC GroupOswestry Disability Index (ODI) Change3 months-0.4 units on a scaleStandard Deviation 13
ABC GroupOswestry Disability Index (ODI) Change6 months-0.8 units on a scaleStandard Deviation 12
ABC GroupOswestry Disability Index (ODI) Change9 months1.3 units on a scaleStandard Deviation 14.7
ABC GroupOswestry Disability Index (ODI) Change12 months0.2 units on a scaleStandard Deviation 14
UC GroupOswestry Disability Index (ODI) Change12 months2.8 units on a scaleStandard Deviation 12.1
UC GroupOswestry Disability Index (ODI) Change3 months2.7 units on a scaleStandard Deviation 11.3
UC GroupOswestry Disability Index (ODI) Change9 months-0.2 units on a scaleStandard Deviation 12.6
UC GroupOswestry Disability Index (ODI) Change6 months1.2 units on a scaleStandard Deviation 11.5

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026