Summary

This randomized controlled trial demonstrates that a novel digital therapeutic intervention, combining exercise therapy with cognitive-behavioral therapy, significantly reduces pain intensity and improves knee function, quality of life, and cognitive distortion in patients with patellofemoral pain, highlighting the potential of digital therapeutics to transform conventional care.

Abstract

Objective

Patellofemoral pain (PFP) is a common yet multifactorial condition often requiring both physical and psychological interventions. However, real-world access to such comprehensive care is frequently limited by logistical and socioeconomic barriers. This study aimed to evaluate the efficacy of a digital therapeutic (DT) intervention combining exercise therapy and cognitive-behavioral therapy (CBT) for managing PFP in a more accessible and integrative manner.

Methods

A total of 216 participants with chronic PFP (≥3 months) were enrolled in a randomized controlled trial and assigned equally to either the DT group or the control group. The DT group received an 8-week mobile app–based program (MORA Cure PFP) integrating personalized exercise therapy and structured CBT modules, followed by a 4-week observation period. The control group received one face-to-face exercise education session (≥15 minutes), standardized educational materials, and recorded self-directed exercises in daily logs. Pain was required to be provoked by squatting and at least two of the following: prolonged sitting, cycling, running, stair use, kneeling, compression test, or palpation tenderness. Exclusion criteria included osteoarthritis (K-L grade >2), recent surgery or trauma, patellar tendinopathy, pregnancy, or narcotic use. Assessments were conducted at baseline, 4, 8, and 12 weeks, and included usual and worst pain (visual analogue scale, 0–100), functional disability (Anterior Knee Pain Scale; AKPS), quality of life (EQ-5D-5L), pain catastrophizing (Pain Catastrophizing Scale; PCS), and depressive symptoms (Patient Health Questionnaire-9). This abstract reports interim findings prior to database lock; however, all participant data collection has been completed.

Results

There were no significant differences in baseline characteristics between the DT and control groups, including usual pain scores (52.3 ± 19.9 vs. 49.4 ± 19.8, p = 0.290). At weeks 8 and 12, the DT group demonstrated significantly greater reductions in both usual pain (week 8: 26.9 ± 20.8 vs. 36.7 ± 20.7; week 12: 22.2 ± 20.6 vs. 36.2 ± 21.1; both p < 0.001) and worst pain (week 8: 40.5 ± 25.7 vs. 49.1 ± 21.5, p = 0.008; week 12: 31.9 ± 24.2 vs. 47.0 ± 23.6, p < 0.001) compared to the control group. Improvements in functional disability (AKPS) and quality of life (EQ-5D-5L) were also significantly greater in the DT group at both time points. At week 12, the DT group showed significantly lower PCS compared to the control group (p = 0.016). Exercise adherence over the 8-week intervention period was significantly higher in the DT group than in the control group (80.5% vs. 70.7%, p < 0.001). Additionally, CBT adherence in the DT group reached 82.7%, reflecting strong engagement with both the physical and psychological components of the digital intervention.

Conclusions

This interim analysis suggests that digital delivery of a combined exercise and CBT program results in greater improvements in pain, function, and psychological outcomes compared to usual care. High adherence rates further support the feasibility and acceptability of digital therapeutics for PFP. The scalable nature of this approach offers potential clinical utility in broader settings, including remote or underserved populations.