Improving multimodal physical function in adults with heterogeneous chronic pain; Multi-site feasibility RCT
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PROJECT SUMMARY Chronic pain is costly, challenging to treat, and associated with substantial impairment in physical function. Mild physical activity such as walking is safe but engagement and adherence are problematic. IMMPACT criteria and the ICF frameworks recommend that all chronic pain clinical trials assess and target physical function comprehensively using not only self- report, but also performance based and ambulatory monitoring of activity (e.g., objective). No clinical trials to date have followed these recommendations. A mind body program adapted for the unique needs of individuals with chronic musculoskeletal pain that incorporates activity skills to help individuals increase step count using a Fitbit to provide accountability to goals may be efficacious in improving all aspects of physical function. To begin testing these hypotheses we completed an R34 NCCIH funded project, in which we: 1) adapted a multimodal, theory grounded mind body program (The Relaxation Response Resilience Program; 3RP) for the unique needs of patients with chronic non-malignant, musculoskeletal pain and to specifically target increased walking (their preferred activity) through time goals (GetActive) or step count goals measured and reinforced by a Fitbit (GetActive-Fitbit); 2) completed an open pilot with exit interviews of the 2 programs; and 3) conducted an RCT of the 2 programs and established single site feasibility, acceptability and fidelity benchmarks including similar signal of improvement in physical function measurements. Directly building upon this successful trial, we now propose a multisite pilot RCT implemented at MGH and 2 additional geographically diverse sites (Rush and Duke) of GetActive-Fitbit (with evidence of superiority over GetActive from quantitative and qualitative data) vs a Health Enhancement Program (HEP). We will establish: 1) multi-site fidelity to training and protocol; and 2) multi-site feasibility and acceptability of study procedures including recruitment of sedentary individuals who benefit the most from this program and a sample of racial and ethnic minorities that is representative of the USA (38%, 2020 numbers) .We will also refine our protocols using qualitative information from staff and participants to set the stage for a large, multi-site efficacy RCT and subsequent implementation of GetActive-Fitbit in routine care of chronic pain patients.
