Development of a Multicomponent Mindfulness and Movement Program for Lumbosacral Radicular Pain: A Mixed Methods Protocol

Abstract BACKGROUND Lumbosacral radicular pain (LRP) is a highly disabling condition frequently accompanied by pain-related fear, reduced physical activity, and difficulty engaging in daily activities. Although mindfulness-based and movement-based interventions are recommended for chronic low back pain, few programs have been specifically designed for individuals with LRP or developed using patient-centered, theory-informed methods. Before large-scale evaluation, early-phase work is needed to establish the feasibility and acceptability of such interventions and their associated study procedures. This protocol describes the development and pilot testing of Move-MORE, a multicomponent, digitally delivered mindfulness and movement intervention for adults with LRP and elevated kinesiophobia.

Methods: This study uses an iterative convergent mixed methods design comprising two sub-studies. Study 1 is a qualitative-dominant intervention development study involving patient focus groups ( n = 10) and clinician interviews ( n = 10) conducted using the Person-Based Approach to refine intervention content and delivery. Study 2 is a single-arm pilot feasibility trial ( n = 32) enrolling adults aged 18–75 with LRP and elevated kinesiophobia. Move-MORE will be delivered virtually in a group format with primary outcomes of feasibility and acceptability, including recruitment, retention, adherence, engagement, safety, and data completeness. Acceptability will be assessed using validated satisfaction and expectancy measures and qualitative exit interviews. A comprehensive set of patient-reported outcomes, ecological momentary assessment, actigraphy, quantitative sensory testing, and biomechanical assessments will be collected to characterize participants, evaluate data collection procedures, and inform outcome selection and design considerations for a future randomized controlled trial. Quantitative analyses of patient reported outcomes and objective assessments will be descriptive. Finally, patient partners were involved throughout the study using a patient-engaged research approach, including participation in focus groups to inform intervention development, review of participant-facing materials, and input on interpretation and dissemination of study findings.

Discussion: This protocol outlines a systematic, patient-engaged approach to developing and testing the feasibility of a novel multicomponent intervention tailored to individuals with LRP. Findings will inform refinement of the Move-MORE intervention, feasibility benchmarks, and methodological decisions needed to support subsequent efficacy testing in a randomized trial. TRIAL REGISTRATION : Clinicaltrials.gov #: NCT07125027