Evaluation of the impact of a smartphone application on adherence to home exercise program for people with chronic low back pain: research protocol for a pilot randomised controlled trial

INTRODUCTION: Multidisciplinary rehabilitation programmes are highly recommended for individuals with the most disabling low back pain (LBP). However, the long-term adherence to regular home exercise is often poor. We aim to perform a prospective, controlled, pilot, randomised study that will evaluate the impact of a smartphone application on adherence to exercise programme for people with chronic LBP (CLBP). METHODS AND ANALYSIS: 120 participants with non-specific CLBP aged 18–65 years will be recruited and randomised in two groups: an experimental group benefitting from education in the application’s use in addition to a conventional multidisciplinary rehabilitation programme (exercises and self-management education) and a control group who will only participate in the multidisciplinary rehabilitation programme. Both groups will undergo the programme 5 days a week for 3 weeks. The primary outcome will be a change in patient’s adherence to physical exercise (Exercise Adherence Rating Scale) at 6 months. Secondary outcomes will be function (Oswestry Disability Index), beliefs concerning physical activity (Evaluation of Physical Activity Perception), pain (Numeric Rating Scale), and physical capacity and qualitative adherence (video). Statistical analyses will be performed according to intention to treat. A linear mixed model will be used to compare the primary endpoint between groups at 6 months post-randomisation. The study could demonstrate the impact of using a smartphone application on adherence to exercise programme in people with CLBP. We hypothesise that the application’s use will improve outcomes through improved exercise adherence. ETHICS AND DISSEMINATION: The study was approved by the medical ethics committee of Ile de France 3. The results of this study will be disseminated in peer-reviewed publications and presentations at international scientific meetings and will also be disseminated to the participants. TRIAL REGISTRATION NUMBER: NCT04264949.