N/A
N=299
Aging Back Clinics
Chronic Low Back Pain
Bottom Line
View on ClinicalTrials.gov: NCT03564600 ↗Enrolled (actual)
299
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Oswestry Disability Index (ODI) Change — -0.4; 2.7; -0.8; 1.2 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Aging Back Clinics management (Other)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Mar 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Oswestry Disability Index (ODI) Change |
-0.4; 2.7; -0.8; 1.2; 1.3; -0.2 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03564600). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.