Abstract
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.