Study protocol for a prospective, randomized controlled confirmatory clinical investigation to evaluate the safety and efficacy of a multidisciplinary digital therapeutics in patients with patellofemoral pain syndrome.

ABSTRACT:

Background

Patellofemoral pain is a prevalent knee condition affecting up to 40% of individuals, especially females aged teens to 50 s. Standard treatments, including exercise therapy, often yield insufficient long-term results, partly due to low compliance and psychological factors like depression and catastrophizing of pain. A digital therapeutics "MORA Cure PFP," which combines structured progressive exercise and cognitive behavioral therapy via an app, offers a solution to overcome the limitations of conventional treatment for patellofemoral pain patients.

Methods

To evaluate the safety and efficacy of MORA Cure PFP, a two-arm controlled trial will enroll 216 patients diagnosed with patellofemoral pain randomly assigned in a 1:1 ratio to treatment and control groups. The

SUBMITTER: Park TH 

PROVIDER: S-EPMC12403444 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature