A “prescribable” mobile app for people with chronic back pain attending general practice: a feasibility randomized controlled trial (Preprint)

BACKGROUND Pain education and clinical hypnosis delivered in person have demonstrated promise in reducing pain and disability among individuals with chronic pain. However, their effectiveness when delivered digitally for chronic back pain and the feasibility of integrating this delivery within general practice remain uncertain. OBJECTIVE This trial aimed to assess the feasibility of conducting a randomized controlled trial comparing the effectiveness of a mobile app delivering pain education and clinical hypnosis, integrated into general practice through a digital consultation platform, with an online, guideline-based factsheet among individuals with chronic back pain. METHODS Two-arm, parallel, feasibility randomized controlled trial, conducted in Australian general practices between September 2024 and March 2025. This feasibility trial included individuals with chronic non-specific back pain (> 3 months in duration) attending general practice for back pain. The interventions consisted of a mobile app including daily 20-minute sessions of pain education and clinical hypnosis via reading and prerecorded audio sessions for 8 weeks, or a single-page digital education factsheet that summarises guideline-based information on back pain management. Feasibility outcomes included recruitment rates, follow-up completion rates, adverse events, adherence, acceptability, appropriateness of the interventions and delivery mode, and participants’ experiences with the app. RESULTS 60 participants were randomized to the mobile app (n=30) and digital factsheet (n=30) within 13 weeks. The mean age was 51.6 (SD = 13.5) years (61.7% women, n = 37), with an average back pain duration of 12.0 (SD = 11.9) years. The mean randomization rate was 5 participants per week and increased to 7 when active recruitment strategies (e.g., phone and email contacts) were implemented. The follow-up outcome completion rates were 92% (n = 55) at 8 weeks post-intervention for pain severity (on a 0-10 numeric pain rating scale) and disability (on a 0-24 Roland-Morris Disability Questionnaire). CONCLUSIONS Findings from this feasibility trial support progression to a full-scale randomized controlled trial to evaluate the effectiveness of a “prescribable” mobile app that delivers pain education and clinical hypnosis, compared with an online guideline-based factsheet, in individuals with chronic back pain following general practice consultation. CLINICALTRIAL This feasibility trial was prospectively registered onto ClinicalTrials.gov (NCT06605248).