Background: Low back pain (LBP) is a common disabling condition in older adults which often limits physical function and diminishes quality of life. Two clinical trials in older adults have shown spinal manipulative therapy (SMT) results in similar or small improvements relative to medical care; however, the effectiveness of adding SMT or rehabilitative exercise to home exercise is unclear. Methods: We conducted a randomized clinical trial assessing the comparative effectiveness of adding SMT or supervised rehabilitative exercise to home exercise in adults 65 or older with sub-acute or chronic LBP. Treatments were provided over 12-weeks and self-report outcomes were collected at 4, 12, 26, and 52 weeks. The primary outcome was pain severity. Secondary outcomes included back disability, health status, medication use, satisfaction with care, and global improvement. Linear mixed models were used to analyze outcomes. The primary analysis included longitudinal outcomes in the short (week 4-12) and long-term (week 4-52). An omnibus test assessing differences across all groups over the year was used to control for multiplicity. Secondary analyses included outcomes at each time point and responder analyses. This study was funded by the US Department of Health and Human Services, Health Resources and Services Administration. Results: 241 participants were randomized and 230 (95%) provided complete primary outcome data. The primary analysis showed group differences in pain over the one-year were small and not statistically significant. Pain severity was reduced by 30 to 40% after treatment in all 3 groups with the largest difference (eight percentage points) favoring SMT and home exercise over home exercise alone. Group differences at other time points ranged from 0 to 6 percentage points with no consistent pattern favoring one treatment. One-year post-treatment pain reductions diminished in all three groups. Secondary self-report outcomes followed a similar pattern with no important group differences, except satisfaction with care, where the two combination groups were consistently superior to home exercise alone. Conclusions: Adding spinal manipulation or supervised rehabilitative exercise to home exercise alone does not appear to improve pain or disability in the short- or long-term for older adults with chronic low back pain, but did enhance satisfaction with care. Trial registration: NCT00269321.
|Original language||English (US)|
|Journal||Chiropractic and Manual Therapies|
|State||Published - May 15 2019|
Bibliographical noteFunding Information:
Ethical approval for the study was provided by the Institutional Review Boards at Northwestern Health Sciences University and the Minneapolis Medical Research Foundation. All participants provided written informed consent to participate.
A detailed description of the study protocol was published previously . The study was funded by the U.S. Department of Health and Human Services and registered at clinicaltrials.gov (NCT00269321). This study used a parallel-group randomized controlled trial design. Institutional Review Boards at participating institutions (Northwestern Health Sciences University, # 1–15– 02-04 and Minneapolis Medical Research Foundation, #04–2321) approved the study protocol, and all participants provided written consent.
The authors acknowledge the contributions of our independent statistical analysis team, dedicated project managers, research clinicians and staff, supporting institution (Northwestern Health Sciences University), as well as funding from the US Department of Health and Human Services (R18HP01425) and the National Institute of Health’s National Center for Complementary and Integrative Health (K01AT008965).
Research reported in this publication was supported by the Department of Health and. Human Services (HHS), Health Resources and Services Administration (HRSA), Bureau of Health Professions (BHPr), Division of Medicine and Dentistry (DMD) under award number R18HP01425 and the National Center For Complementary & Integrative Health of the National Institutes of Health (NIH) under Award Number K01AT008965. The content is solely the responsibility of the authors and does not necessarily represent the official views of HHS, HRSA, BHPr, DMD or the NIH.
© 2019 The Author(s).
PubMed: MeSH publication types
- Journal Article
- Research Support, N.I.H., Extramural
- Research Support, U.S. Gov't, P.H.S.
- Randomized Controlled Trial