Baseline sample characteristics for the BackInAction pragmatic trial of acupuncture for chronic low back pain in older adults

Background: Chronic low back pain (cLBP) is a leading cause of disability, particularly among older adults. Despite this, effective nonpharmacologic treatments such as acupuncture have not been adequately studied in older adults. The “BackInAction” pragmatic clinical trial aims to address this gap by evaluating the effectiveness of acupuncture in reducing back pain-related disability among adults aged ≥65. The purpose of this manuscript is to compare sample characteristics across sites and across waves of COVID-19. Methods: We describe participant baseline characteristics for the BackInAction trial, a three-arm randomized trial conducted across four U.S. healthcare systems: two integrated care delivery, a fee-for-service (FFS) system, and an urban federally qualified health center (FQHC). Participants (N = 800) with cLBP were randomized to receive standard acupuncture, standard acupuncture plus maintenance sessions, or usual medical care. Baseline data were collected through self-reported measures and electronic health records. Recruitment trends are evaluated during COVID waves. Results: The sample was predominantly female (61.9 %) and non-Hispanic white (64.6 %), with an average age of 73.6 years. The FQHC enrolled a younger, more diverse and socioeconomically disadvantaged population with higher levels of back pain-related dysfunction. The FFS enrolled an older population but had similar rates of back pain-related dysfunction and pain intensity as in the integrated care delivery systems. There were no differences by site corresponding to the circulation of COVID-19 strains. Conclusion: Findings suggest that FQHC populations have higher-than-average social and clinical risks, illustrating the complexity of delivering treatment for cLBP and the urgency to ensure such clinical environments are included in trials. Trial registration: ClinicalTrials.gov Identifier: NCT04982315. Clinical trial registration date: July 29, 2021.