Digital therapeutic combining exercise and cognitive-behavioural therapy reduces pain in patients with chronic patellofemoral pain: a multicentre randomised controlled trial.

OBJECTIVES: To evaluate whether an 8-week smartphone-based multidisciplinary digital therapeutic (DTx) combining exercise and cognitive-behavioural therapy reduced usual knee pain at 8 weeks compared with education and exercise instruction in chronic patellofemoral pain (PFP). METHODS: This multicentre, parallel-group randomised controlled trial included 216 participants with chronic PFP, defined as anterior or retropatellar pain lasting at least 3 months with activity-related provocation, recruited from orthopaedic outpatient clinics at 10 hospitals in the Republic of Korea. Participants were randomly assigned to the DTx group (MORA Cure PFP) or a control group receiving PFP-related education, one-time exercise instruction, printed materials and self-monitoring exercise diaries. The DTx intervention included personalised home-based exercises, weekly cognitive-behavioural sessions and self-reflective daily worksheets. Outcomes were assessed at baseline, 4, 8 and 12 weeks. The primary endpoint was usual pain at 8 weeks, measured using a 0-100 mm visual analogue scale (VAS). Secondary outcomes included worst pain, knee function (Anterior Knee Pain Scale; AKPS), health-related quality of life assessed using the 5-level EQ-5D version (EQ-5D-5L) and the EQ visual analogue scale (EQ VAS), and psychological distress (Patient Health Questionnaire-9 and Pain Catastrophizing Scale (PCS)). Longitudinal changes were analysed using linear mixed-effects models. RESULTS: For the primary endpoint, usual pain at week 8 favoured the DTx group (between-group mean difference -12.5 mm, 95% CI -17.1 to -7.8). Secondary outcomes at week 8 also favoured the DTx group, including worst pain (-10.7 mm, 95% CI -15.9 to -5.4), knee function (AKPS, 5.2 points, 95% CI 2.7 to 7.7), health-related quality of life (EQ VAS 10.7 points, 95% CI 7.1 to 14.4) and pain catastrophising (PCS, -1.8 points, 95% CI -3.3 to -0.3). Exercise adherence exceeded 80%, with no device-related or intervention-related serious adverse events reported. CONCLUSION: An 8-week smartphone-based multidisciplinary DTx programme reduced usual pain at 8 weeks compared with education and exercise instruction in patients with chronic PFP, with improvements in pain, knee function, health-related quality of life and psychological outcomes. These findings support the potential role of an integrated DTx package for delivering exercise and cognitive-behavioural support in PFP care. TRIAL REGISTRATION NUMBER: NCT06260865.