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Mind-body physical activity program for chronic pain with or without a digital-monitoring-device: proof-of-concept feasibility RCT
Greenberg J, Popok PJ, Lin A, Kulich R, James P, Macklin EA, Millstein RA, Edwards RR, Vranceanu AM
JMIR Formative Research 2020 Jun;4(6):e18703
clinical trial
5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: Chronic pain is associated with poor physical and emotional functioning. Nonpharmacological interventions can help but improvements are small and not sustained. Prior clinical trials do not follow recommendations to comprehensively target objective and performance-based physical function in addition to self-reported physical function. OBJECTIVE: To establish feasibility benchmarks and explore improvements in physical (self-report, performance based and objective) and emotional function, pain outcomes and coping through a pilot RCT of a mind-body physical activity program (GetActive) with and without a digital monitoring device (GetActive-Fitbit) which were iteratively refined through mixed methods. METHODS: Patients with chronic pain were randomized to GetActive (N = 41) or GetActive-Fitbit (N = 41) programs, which combine relaxation, cognitive-behavioral, and physical restoration skills and were delivered in person. They completed in-person assessments before and after the intervention. Performance based function was assessed with the 6-minute walk test and step-count was measured with an ActiGraph. RESULTS: Feasibility benchmarks (eg, recruitment, acceptability, credibility, therapist adherence, adherence to home-practice, ActiGraph wear, and client satisfaction) were good-to-excellent, and similar in both programs. Within each program, we observed improvement on the 6-minute walk test (+41 meters, p < 0.001, ES 0.99 for GetActive; +50 meters, p < 0.001, ES 0.85 for GetActive-Fitbit) and self-reported physical function (p = 0.001, ES 0.62 for GetActive; p = 0.024, ES 0.38 for GetActive-Fitbit). Mean step count increased only among sedentary patients (+874 steps GetActive; +867 steps for GetActive-Fitbit). Emotional function, pain intensity, pain coping and mindfulness also improved in both groups. Participants rated themselves as "much improved" at the end of the program, and those in GetActive-Fitbit noted that the Fitbit "greatly helped" with increasing their activity. CONCLUSIONS: These preliminary findings support a fully-powered efficacy trial of the two programs against an education control group. We present a model for successfully using IMMPACT criteria for comprehensive assessment of physical function and following evidence-based models to maximize feasibility prior to formal efficacy testing. CLINICAL TRIAL: NCT03412916.

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