Efficacy of a Mobile Multidisciplinary Digital Therapeutics App for Patellofemoral Pain: Randomized Controlled Trial

Patellofemoral pain (PFP) is a common musculoskeletal disorder characterized by persistent knee pain, often without any structural abnormalities. Conservative treatments, particularly exercise therapy, are widely recommended; however, adherence remains generally low, and full recovery is often not achieved. Psychological interventions can aid in symptom management; however, studies integrating cognitive behavioral therapy (CBT), which is known to be effective for chronic pain, with exercise therapy for patients with PFP are limited. This study examined the impact of MORA Cure (PFP), a multidisciplinary digital therapeutics (DTx) app that integrates exercise and CBT, in comparison with conventional treatments for PFP management.

This study aimed to evaluate the efficacy and safety of an 8-week DTx intervention incorporating exercise and CBT compared with in-person exercise education in patients with PFP.

A parallel-group randomized controlled trial was conducted with 35 patients diagnosed with PFP recruited from orthopedic outpatient clinics. Participants were randomly assigned to either the DTx group (n=18, 51%) or the control group (n=17, 49%). The DTx group received an 8-week intervention via the MORA Cure (PFP) app incorporating home-based exercises and weekly CBT modules with daily worksheets. The control group received conventional treatment, including disease education, a single in-person exercise education session conducted by a medical professional, and encouragement to continue self-exercising throughout the study period. The outcome measures included pain severity (usual and worst, assessed using the numeric pain rating scale), functional disability (Anterior Knee Pain Scale), knee extension strength (measured using an isokinetic dynamometer), health-related quality of life (EQ-5D), and mental health status (9-item Patient Health Questionnaire). Assessments were conducted from baseline at 4-week intervals for up to 12 weeks.

The DTx group showed significant reductions in usual pain at each time point (4 weeks: mean score 2.2, SD 1.5, and P=.006; 8 weeks: mean 2.3, SD 1.7, and P=.003; 12 weeks: mean 1.2, SD 1.8, and P=.008), whereas the control group exhibited no changes. The knee extension strength in the DTx group increased significantly at both 8 and 12 weeks (P<.001), with greater improvement than that in the control group at 8 weeks (P=.04). Both groups showed significant improvements in functional disability at 12 weeks (DTx: mean score 85.2, SD 12.7, and P=.006; control: mean 84.5, SD 13.0, and P=.01). Health-related quality of life (EQ-5D) also improved in the DTx group at 8 and 12 weeks, whereas the control group showed improvement only at 12 weeks.

This multidisciplinary DTx intervention was associated with significant pain reduction, improved functional disability, and increased knee extension strength in patients with PFP. These findings underscore the promise of DTx in PFP management and their potential to enhance patient outcomes.

ClinicalTrials.gov NCT05614583; https://clinicaltrials.gov/study/NCT05614583.