In a descriptive analysis of the study population in the BackInAction trial, researchers found that participants enrolled from federally qualified health centers (FQHCs) had higher than average clinical and social risks at baseline, potentially complicating intervention delivery for these patients while adding to the generalizability of the trial’s results.
The report was published in Contemporary Clinical Trials.
BackInAction, an NIH Collaboratory Trial, is a pragmatic clinical trial testing the effectiveness of acupuncture for improving back pain–related disability among older adults with chronic low back pain. The trial is being conducted in 4 healthcare systems in California, New York, and Washington, including a network of FQHCs in an urban setting, 2 integrated health insurance and care delivery systems serving broad geographic regions, and a fee-for-service system serving a relatively urban and suburban population.
The FQHC site in BackInAction had the highest proportion of participants with disability, pain that limited work, comorbid medical conditions, mental health conditions, dysfunction related to back pain, and heightened pain intensity. This site also had the highest proportion of participants with cognitive-behavioral predictors of adverse pain outcomes, such as fear avoidance and pain catastrophizing. The site’s study population was also younger, more diverse, and more socioeconomically disadvantaged than the population at the other BackInAction sites.
The authors of the report, led by Morgan Justice of the Kaiser Permanente Washington Health Research Institute under the guidance of principal investigator Lynn DeBar, noted that the research team’s success in enrolling a representative study population of older adults and including a broad range of healthcare system types should enhance the generalizability of BackInAction’s results and inform treatment policy.
BackInAction is supported within the NIH Pragmatic Trials Collaboratory by a grant from the National Center for Complementary and Integrative Health. Learn more about BackInAction.