Efficacy of a Mobile Multidisciplinary Digital Therapeutic Application for Patellofemoral Pain: A Randomized Controlled Trial (Preprint)
Authors: Lee Sanghee , Yoon Chan , Choi Chi-Hyun , Park Tae Hyun , Yang Sangjin , Cha Ha Ri , Kim Tae Woo , Park Jae Hyeon , Chang Moon Jong , Chang Chong Bum 
Published: December 2024

BACKGROUND

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 therapeutic device that integrates exercise and CBT, in comparison with conventional treatments for PFP management.

OBJECTIVE

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

METHODS

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 digital therapeutics (DT) group (n = 18) or the control group (n = 17). The DT group received an 8-week intervention via the MORA Cure (PFP) application, incorporating home-based exercises and weekly CBT modules. 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 with an isokinetic dynamometer), health-related quality of life (EQ-5D), and mental health status (Patient Health Questionnaire-9). Assessments were conducted from baseline at 4-week intervals for up to 12 weeks.

RESULTS

The DT group showed significant reductions in usual pain at each time point: 4 (2.2 ± 1.5, p = 0.006), 8 (2.3 ± 1.7, p = 0.003), and 12 (1.2 ± 1.8, p = 0.008) weeks, whereas the control group demonstrated no changes. However, between-group differences in pain reduction were not statistically significant. The knee extension strength in the DT group increased significantly at both 8 and 12 weeks (p < 0.001), with greater improvement than that in the control group at 8 weeks (p = 0.039). Both groups showed significant improvements in functional disability at 12 weeks (DT: 85.2 ± 12.7, p = 0.006; Control: 84.5 ± 13.0, p = 0.010). Health-related quality of life (EQ-5D) also improved in the DT group at 8 and 12 weeks, whereas the control group showed improvement only at 12 weeks.

CONCLUSIONS

This multidisciplinary digital therapeutic 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 digital therapeutics in PFP management and their potential to enhance patient outcomes.

CLINICALTRIAL

ClinicalTrials.gov (NCT05614583).