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.
Subject(s)
Chronic Pain , Adult , Humans , Chronic Pain/therapy , Feasibility Studies , Self Report , Randomized Controlled Trials as TopicABSTRACT
Over the past ten years, we have tested and helped develop a multi-electrode array for chronic cortical recordings in behaving non-human primates. We have found that it is feasible to record from dozens of single units in the motor cortex for extended periods of time and that these signals can be decoded in a closedloop, real-time system to generate goal-directed behavior of external devices. This work has culminated in a FDA clinical trial that has demonstrated that a tetraplegic patient can voluntarily modulate motor cortical activity in order to move a computer cursor to visual targets. Further advances in BMI technology using non-human primates have focused on using multiple modes of control from signals in different cortical areas. We demonstrate that primary motor cortical activity may be optimized for continuous movement control whereas signals from the premotor cortex may be better suited for discrete target selection. We propose a hybrid BMI whereby decoding can be voluntarily switched from discrete to continuous control modes.
