Session-dose adequacy of acupuncture therapy for low back pain in adults 65 and older: A secondary analysis of the BackInAction trial

Acupuncture has been shown to be an effective treatment for chronic low back pain (cLBP). The BackInAction trial was conducted to inform CMS/Medicare acupuncture coverage decision specifically for older adults with cLBP. CMS coverage of acupuncture for cLBP among older adults specifies dose parameters despite gaps in research of optimal session-dose for such treatment. This is a secondary analysis of data from the BackInAction trial to report fidelity of the acupuncture intervention and to explore the association between the number of acupuncture sessions received (session-dose) and reductions in functional disability (RMDQ), pain intensity, and on a composite pain interference/intensity measure (PEG) at 3-months post-randomization. The majority of acupuncture recipients (82%) received the minimum clinical threshold of ≥8 sessions in the first three months with almost half meeting or exceeding the CMS 12-session threshold. Higher session-dose was associated with significant disability-related reductions and improvements on other pain outcomes. Pain intensity was better reduced with 12 or more sessions than with 8-11 sessions. These positive outcomes were found to increase monotonically with increasing session-dose. These findings provide support for 12-sessions within three months being more effective for reducing pain and functional disability than a dose of less than 8 sessions. Overall, study findings suggest that for those 65 and older with cLBP optimal outcomes may require at least 8 but preferably 12 or more acupuncture sessions. ClinicalTrials.gov Identifier: NCT04982315