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

Morgan Justice; Annie Piccorelli; Andrew L Avins; Andrea J Cook; Carolyn M Eng; Arya Nielsen; Alice Pressman; Katie L Stone; Raymond Y Teets; Robert Wellman; Lynn L DeBar

doi:10.1016/j.cct.2025.107981

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

Contemp Clin Trials. 2025 Jun 6:107981. doi: 10.1016/j.cct.2025.107981. Online ahead of print.

Authors

Affiliations

¹ Kaiser Permanente Washington Health Research Institute, Seattle, WA, United States of America. Electronic address: morgan.j.fuoco@kp.org.
² Kaiser Permanente Washington Health Research Institute, Seattle, WA, United States of America.
³ Kaiser Permanente Northern California Division of Research, Oakland, CA, United States of America; University of California Department of Epidemiology and Biostatistics, San Francisco, CA.
⁴ Icahn School of Medicine at Mount Sinai, Department of Family Medicine & Community Health, New York, NY, United States of America.
⁵ University of California Department of Epidemiology and Biostatistics, San Francisco, CA; Kaiser Permanente Bernard J Tyson School of Medicine, Pasadena, CA, United States of America; Sutter Health Center for Health Systems Research, Walnut Creek, CA, United States of America.
⁶ University of California Department of Epidemiology and Biostatistics, San Francisco, CA; Sutter Health California Pacific Medical Center Research Institute, San Francisco, CA, United States of America.
⁷ Institute for Family Health, New York, NY, United States of America.
⁸ Kaiser Permanente Center for Health Research, Portland, OR, United States of America.

PMID: 40484274
DOI: 10.1016/j.cct.2025.107981

Abstract

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.

Keywords: Acupuncture; Chronic low back pain; Older adults; Pragmatic clinical trial.

Associated data

ClinicalTrials.gov/NCT04982315