Effectiveness of an artificial intelligence-based self-management intervention to support sick-listed individuals with musculoskeletal disorders in Norway: rationale and protocol for the SmaRTWork randomised controlled trial.

INTRODUCTION: Long-term sickness absence represents a major public health challenge with far-reaching consequences for both individuals and society. Musculoskeletal disorders (MSDs) are among the leading causes of sickness absence. Although mobile apps show promise for supporting self-management of MSDs, high-quality evidence remains limited, and outcomes related to work participation are rarely examined. This trial aims to evaluate whether an individually tailored, app-based self-management intervention (SmaRTWork), provided in addition to usual care, improves return-to-work compared with usual care alone among individuals on sick leave due to MSDs. METHODS AND ANALYSIS: We will conduct a randomised controlled trial with two parallel arms: 1) SmaRTWork in addition to usual care and 2) usual care alone. Individuals 20-59 years old who have been sick-listed for <12 weeks due to back, neck or widespread pain will be recruited through clinicians in primary health care. Eligible participants are randomised 1:1 to one of the two arms. We aim to include 298 participants, 149 in each arm. The primary outcome is time to sustainable return-to-work, defined as one consecutive month without receiving medical benefits, assessed over a 12-month period using registry data. Secondary outcomes include health-related measures assessed at baseline, 3, 6 and 12 months. The trial will also incorporate qualitative studies, a process evaluation and a health economic evaluation. ETHICS AND DISSEMINATION: The trial is approved by the Committees for Clinical Trials of Pharmaceuticals and Medical Devices (Ref. 563919). Results will be published in peer-reviewed journals and presented at national and international conferences. TRIAL REGISTRATION: NCT07034040.