Improving multimodal physical function in adults with heterogeneous chronic pain; Protocol for a multisite feasibility RCT

• Published in: Contemporary clinical trials Vol. 138; p. 107462
• Main Authors: Hooker, Julia E., Brewer, Julie R., McDermott, Katherine A., Kanaya, Millan, Somers, Tamara J., Keefe, Francis, Kelleher, Sarah, Fisher, Hannah M., Burns, John, Jeddi, Rebecca W., Kulich, Ronald, Polykoff, Gary, Parker, Robert A., Greenberg, Jonathan, Vranceanu, Ana-Maria
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.03.2024
• Subjects: Adult; Chronic pain; Chronic Pain - therapy; Feasibility; Feasibility Studies; Humans; Mind-body; Physical function; Randomized Controlled Trials as Topic; Self Report; Step count; Feasibility; Mind-body; Chronic pain; Physical function; Step count
• ISSN: 1551-7144; 1559-2030
• DOI: 10.1016/j.cct.2024.107462

Chronic pain is associated with substantial impairment in physical function, which has been identified as a top concern among persons with pain. GetActive-Fitbit, a mind-body activity program, is feasible, acceptable, and associated with improvement in physical function among primarily White, sedentary individuals with pain. In preparation for a multisite efficacy trial, we must examine feasibility across multiple sites with diverse patient populations. Here we describe the protocol of a multisite, feasibility RCT comparing GetActive-Fitbit with a time- and attention-matched educational comparison (Healthy Living for Pain). We aim to 1) test multisite fidelity of clinician training; 2) evaluate multisite feasibility benchmarks, including recruitment of chronic pain patients taking <5000 steps/day and racial and ethnic minorities; and 3) optimize fidelity and study protocol in preparation for a future multisite efficacy trial. Clinician training fidelity was assessed via roleplays and mock group sessions. Feasibility (i.e., recruitment, acceptability, credibility, adherence, satisfaction), multimodal physical function (e.g., self-report, 6-Minute Walk Test, step-count), and other psychosocial outcomes are assessed at baseline, posttest, and 6 months. Protocol optimization will be assessed using exit interviews and cross-site meetings. The trial is ongoing. Clinician training is complete. 87 participants have been recruited. 54 completed baseline assessments and randomization, 44 are mid-intervention, and 9 have completed the intervention and posttest. This study addresses the critical need for feasible, acceptable mind-body-activity interventions for chronic pain that follow evidence-based guidelines and improve all aspects of physical function across diverse populations. Results will inform a future fully-powered multisite efficacy trial. Clinical Trial Registration: NCT05700383