My Back Exercise app: an automated exercise intervention supported by educational notifications, a sleep programme and diet advice to improve function in people with chronic non-specific low back pain – protocol for a superiority, adaptive multi-arm multi-stage randomised controlled trial

Introduction: As chronic low back pain (LBP) remains one of the most pressing global health challenges, digital health emerges as an opportunity to deliver evidence-based care at scale. In this context, the My Back Exercise app has been developed to support people with LBP in self-managing their condition. This study aims to determine the effectiveness of the My Back Exercise app to improve physical function in people with chronic non-specific LBP.

Methods and analysis: A single-blind, superiority, adaptive randomised controlled trial encompassing a multi-arm multi-stage design will be conducted and reported according to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT), Template for the Intervention Description and Replication for telehealth (TIDieR-telehealth), and the Consolidated Standards of Reporting Trials (CONSORT) Extension for Adaptive Designs. Informed consent will be obtained from all participants. Eligible participants will be randomly assigned in a 1:1:1:1:1 ratio to either the control group, receiving education alone, or one of four intervention groups ((1) education, notifications and exercise modules; (2) education, notifications, exercise and sleep modules; (3) education, notifications, exercise and diet modules; and (4) education, notifications, exercise, sleep and diet modules) through the app. The study consists of two stages with the possibility of dropping arms for futility using pre-specified decision rules at the end of the first stage. A total of 370 participants aged 18 years or older, with chronic non-specific LBP, will be recruited Australia-wide from the general community. The primary outcome will be self-reported physical function measured by the Patient-Specific Functional Scale at 6 weeks post-randomisation. Data will be analysed using the Student’s t-test or the non-parametric Mann-Whitney U test.

Ethics and dissemination: This trial was approved by the Human Research Ethics Committee (HREC) of The University of Sydney (HREC Approval No. 2023/HE000772). The findings of this study will be disseminated via scientific publications, reports and conference presentations, and strategically disseminated to the wider community and relevant policymakers.

Trial registration number: Australian New Zealand Clinical Trials Registry (ACTRN12624000319572).