IMPORTANCE: The study was carried out to inform Medicare acupuncture coverage decisions addressing the gap in evidence on acupuncture effectiveness, specifically for older adults with chronic low back pain (CLBP).
OBJECTIVE: To determine the effectiveness of standard acupuncture (SA) or SA plus maintenance (enhanced acupuncture [EA]) to improve CLBP-related disability relative to usual medical care (UMC) at 3, 6, and 12 months after randomization.
DESIGN, SETTING, AND PARTICIPANTS: This multisite, 3-arm, parallel-group randomized clinical trial of older adults with CLBP collected data from 4 US health care systems in 3 geographic areas and compared SA and EA treatment with UMC only. Study enrollment was conducted from August 12, 2021, to October 27, 2022; follow-up concluded on November 7, 2023.
INTERVENTIONS: Both SA (8-15 treatment sessions over 12 weeks plus UMC) and EA (SA plus 4-6 maintenance sessions during the next 12 weeks) were provided by experienced, community-based licensed acupuncturists. Participants were randomized 1:1:1 to the 3 groups.
MAIN OUTCOMES AND MEASURES: The primary outcome was CLBP-related disability measured by a baseline-to-6-month change in the Roland-Morris Disability Questionnaire (RMDQ) score. Secondary outcomes included pain intensity and the percentage of participants with clinically meaningful (=30%) improvements.
RESULTS: The trial identified 800 individuals who were randomized to 3 groups (mean [SD] age, 73.6 [6.0] years; 496 females [62.0%]). At 6 months, RMDQ change scores were significantly better in both the SA and EA groups compared with the UMC only group (SA vs UMC: adjusted mean difference, -1.0 [95% CI, -1.9 to -0.1] and EA vs UMC: adjusted mean difference, -1.5 [95% CI, -2.5 to -0.6]). SA and EA change scores did not differ significantly from one another. The relative benefit of acupuncture compared with UMC on disability persisted at 12 months. Pain intensity exhibited a relative benefit of EA over SA at 6 months, and both acupuncture groups had significant improvement over UMC. The adjusted percentage with clinically meaningful improvements in RMDQ at 6 months was greater for SA (39.1% [95% CI, 33.1%-46.1%]; adjusted relative risk, 1.33 [95% CI, 1.04-1.70]) and for EA (43.8% [95% CI, 38.0%-50.4%]; adjusted relative risk, 1.49 [95% CI, 1.19-1.86]) compared with UMC (29.4% [95% CI, 24.3%-35.5%]) and persisted at 12 months. Rates of serious adverse events were low and similar among groups, with less than 1% that was possibly acupuncture-intervention related.
CONCLUSIONS AND RELEVANCE: The findings of this randomized clinical trial of older adults with CLBP suggest that acupuncture needling provided greater improvements in back pain-related disability at 6 months and at 12 months compared with UMC alone. These findings support acupuncture needling as an effective and safe treatment option for older adults with CLBP.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04982315.
| Discipline Area | Score |
|---|---|
| Rehab Clinician (OT/PT) |  |
Rehab Clinician (OT/PT) rater
The placebo effects of acupuncture are well known and is increased by the belief of the practitioner. Perhaps this doesn't matter as long as the patient improves. I personally would like to see treatments that have a plausible mechanism.
Rehab Clinician (OT/PT) rater
Statistical significance is not the same as clinical significance. "Clinical improvement is shown if RMDQ score is reduced by 30% from baseline and back pain is rated as better on a global rating scale." (Jordan et al. 2006; J Clin Epidemiology: Volume 59, Issue 1) At 6 months, RMDQ change scores were 'significantly' better in both the SA and EA groups compared with the UMC-only group (SA vs UMC: adjusted mean difference, -1.0, and EA vs UMC: -1.5. Note: Blinding was discontinued at 10 weeks. The chronic low back pain population is a very heterogeneous group for whom generalisation is, by definition, thwarted. Consequently, while statistically significant, the clinical findings do not necessarily support acupuncture needling as an "effective" intervention for older adults with CLBP, although they suggest that standard acupuncture may be superior to 'usual medical care.' The 'bourbon' or 'scotch' debate: which appears less effective or better?
Rehab Clinician (OT/PT) rater
There was a lot of variability in approaches and a vague description of the treatment/acupuncture protocols. This is a weakness in the study and hinders practitioners from being able to reproduce the treatment approach.
, McMaster University