Evaluating the Effectiveness of Nonpharmacological Self-Management Interventions for Persistent Pain: Protocol for Single-Case Experimental Designs

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Abstract
Background: Nonpharmacological self-management interventions are often recommended for general practice patients with persistent pain—a distressing, costly, and heterogeneous condition with variable responses to treatment interventions. Single-case experimental designs (“self-experiments”) evaluate intervention effectiveness at the individual level. StudyU is an open-source digital platform designed to help patients undertake these self-experiments. Objective: This study aims to investigate the feasibility and acceptability (for patients, practitioners, and other practice staff) of integrating digitally enabled, withdrawal/reversal self-experiments in the general practice care of patients with persistent pain. Methods: We will recruit 50 patients from a large Australian general practice. Participants will trial a self-selected, self-management intervention (such as physical activity, mindfulness practice, or online self-guided cognitive behavioral therapy) approved by their general practitioner (GP) and use the StudyU app to rate the daily impact of their pain over the 10-week study period. The primary clinical outcome of the self-experiments is pain interference (measured using the modified Brief Pain Inventory), testing for its mean difference between usual routine and intervention conditions. Clinical reports will be generated for the patient and their GP. We will use validated measures of app usability and acceptance, pre-post measures of patient self-efficacy, quality of life, health service use, self-reported health; individual interviews informed by the Normalization Process Theory; and a nested process evaluation to examine the feasibility and acceptability for patients and practice staff of embedding these self-experiments in general practice care. Results: The research was funded in September 2023, funding and other agreements were completed by December 2024, patient recruitment commenced in January 2025, and publication of results is anticipated by January 2027. Conclusions: Digitally enabled self-experiments testing nonpharmacological treatment effectiveness may empower patients to self-manage persistent pain and adopt personally effective nonpharmacological interventions in partnership with their GPs and provide a model for integrating other new technologies into the general practice care of patients with other chronic conditions. Trial Registration: Australia and New Zealand Clinical Trials Registry ACTRN12624000459527; https://tinyurl.com/bdhabjd2 International Registered Report Identifier (IRRID): DERR1-10.2196/79810

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