A Confirmatory Trial of Multidisciplinary Digital Therapeutics for Patellofemoral Pain Syndrome

Prospective, Randomized, Controlled Confirmatory Clinical Investigation to Evaluate the Safety and Efficacy of a Multidisciplinary Digital Therapeutics in Patients with Patellofemoral Pain Syndrome

This randomized controlled confirmatory study will be evaluating an mobile application, MORA Cure (ETH-01K), owned by EverEx, Inc., to examine safety and effectiveness in individuals with patellofemoral pain syndrome.

This randomized controlled confirmatory study will enroll 216 participants, where half will be randomly assigned to the digital therapeutics (S/W medical device), MORA Cure (n = 108), and half will be assigned to treatment as usual (TAU) (n = 108), to examine safety and effectiveness in individuals with patellofemoral pain syndrome. All subjects will be followed up in the study for a total of 12 weeks, 8-week courses of treatment with additional 4-week observation. The application provides multidisciplinary rehabilitation treatment, a combination of graded exercise therapy and cognitive behavioural therapy for patients with patellofemoral pain syndrome.

Inclusion Criteria:

1. Patients with peripatellar or posterior patellar pain in one or more knee joints for 3 months or longer
2. Patients with peripatellar or posterior patellar pain provoked by squatting
3. Patients who have pain provoked by 2 or more following activities: prolonged sitting, cycling, running, going up or down stairs, kneeling, compression of the patella, palpation of the patellar facets
4. Patients who signed a written informed consent form

Exclusion Criteria:

1. Patients with osteoarthritis which scored 3 or higher grade of the Kellgren-Lawrence scale
2. Patients diagnosed with a fracture or dislocation around the knee within the last 3 months
3. Patients who had knee surgery within the last 3 months
4. Patients diagnosed with patellar tendinitis based on imaging within 3 months
5. Patients taking narcotic pain medications for pain control
6. Patients taking or planning to take any medication that is a contraindication within the next 16 weeks at the time of screening
7. Patients who are pregnant
8. Patients currently participating in another clinical trial or have participated in another clinical trial within the past 3 months at the time of screening
9. Patients deemed unsuitable for this study by the investigator