Improving Multimodal Physical Function in Adults with Heterogeneous Chronic Pain; Protocol for a Multisite Feasibility RCT

Overview

Journal Contemp Clin Trials

Publisher Elsevier

Date 2024 Jan 29

PMID 38286223

Authors

Julia E Hooker

Julie R Brewer

Katherine A McDermott

Millan Kanaya

Tamara J Somers

Francis Keefe

Sarah Kelleher

Hannah M Fisher

John Burns

Rebecca W Jeddi

Ronald Kulich

Gary Polykoff

Robert A Parker

Jonathan Greenberg

Ana-Maria Vranceanu

Affiliations

Soon will be listed here.

Abstract

Background: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Citing Articles

A Mindfulness-Based Lifestyle Intervention for Dementia Risk Reduction: Protocol for the My Healthy Brain Feasibility Randomized Controlled Trial.

Mace R, Law M, Cohen J, Ritchie C, Okereke O, Hoeppner B JMIR Res Protoc. 2024; 13:e64149.

PMID: 39571150 PMC: 11621724. DOI: 10.2196/64149.

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