BJSM - 2026-09-17 - Journal Article
Digital therapeutic combining exercise and cognitive-behavioural therapy reduces pain in patients with chronic patellofemoral pain: a multicentre randomised controlled trial.
Park JY, Lee S, Kim JM, Lee SH, Chang MJ, Chung KS, Kim MS, Kim SH, Ryu DJ, Park TH, Choi CH, Yoon C, Chang CB, Kim JG
Topics
Key Takeaway
An 8-week smartphone-based digital therapeutic combining exercise and CBT reduced usual knee pain by 12.5 mm VAS (95% CI -17.1 to -7.8) versus education-plus-exercise-instruction in chronic PFP.
Summary Depth
Choose how much analysis to show on this article page.
Summary
This multicentre parallel-group RCT across 10 Korean orthopaedic outpatient clinics randomized 216 chronic PFP patients (≥3 months) to a smartphone-based DTx (MORA Cure PFP) combining personalised exercise and weekly CBT sessions versus education, one-time exercise instruction, and self-monitoring diaries. At 8 weeks, the DTx group demonstrated superior usual pain reduction (-12.5 mm VAS), worst pain reduction (-10.7 mm), AKPS improvement (+5.2 points), EQ VAS improvement (+10.7 points), and pain catastrophising reduction (PCS -1.8 points), all statistically significant. Exercise adherence exceeded 80% with no serious adverse events.
Key Limitation
The 12-week maximum follow-up cannot determine whether pain and functional gains are durable beyond the active intervention period, which is critical given the known chronicity and recurrence of PFP.
Original Abstract
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.