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.

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 treatment group will use the app, while the control group will perform self-guided exercises using educational materials. This trial aims to determine if the treatment group shows greater reduction in usual pain intensity scores at 8 weeks compared to the control group. Additional assessments include worst pain, knee function, depression, and pain catastrophizing levels.

Discussion: Key design elements of the clinical trial, such as control group selection, inclusion/exclusion criteria, number of patients, and primary endpoint, were designed with consideration for not only medical perspectives but also regulatory aspects of software as a medical device, including device approval and health technology assessment.

Trial Registration: ClinicalTrials.gov., NCT06260865, registered 15th February 2024.