Background: Despite somewhat limited evidence, non-pharmacological, self-management interventions are often recommended for general practice patients with persistent pain. StudyU is an open-source digital platform designed to help patients undertake self-experiments, using a single case experimental design, to test whether these interventions are personally effective. Aim: To investigate the feasibility and acceptability of integrating digitally-enabled self-experiments in the general practice care of patients with persistent pain. Design and setting: We will recruit 50 patients from a large Australian general practice. Participants trial a self-selected, self-management intervention (such as a physical activity, mindfulness practice, or online, self-guided cognitive behavioural 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 mean difference in pain interference (measured using the modified Brief Pain Inventory) between baseline (usual routine) and intervention conditions. Clinical reports are generated for the patient and their GP. Method: We use validated measures of app usability and acceptance, pre/post measures of patient self-efficacy, quality of life, health service use and self-reported health, individual interviews informed by Normalisation 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. Conclusion: Digitally-enabled self-experiments testing non-pharmacological treatment effectiveness may empower patients to self-manage persistent pain, in partnership with their GPs, and provide a model for integrating other new technology for patients with other chronic conditions.

Jane Nikles has a commercial interest in N-of-1 Hub Pty Ltd consultancy company.

Australia and New Zealand Clinical Trials Registry: ACTRN12624000459527

Royal Australian College of General Practitioners Foundation, Medibank Better Health Foundation and Motor Accident Insurance Commission Qld have generously funded this study.

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Ethical approval: The University of Queensland Human Research Ethics Committee 2023/HE000039.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

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I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

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I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

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All trial data collected in the study will be made publicly available at https://studyu.health after completion of the study.