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.