Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03564600 |
| Other study ID # |
O2808-R |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 3, 2019 |
| Est. completion date |
September 30, 2024 |
Study information
| Verified date |
October 2023 |
| Source |
VA Office of Research and Development |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
