NCT06260865

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 216 (estimated)
• Sponsor: EverEx Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Patellofemoral Pain Syndrome

Interventions

Type	Name	Description
DEVICE	MORA Cure	MORA Cure (ETH-01K), developed by EverEx, Inc., is a digital therapeutics (S/W medical device) designed to provide multidisciplinary rehabilitation treatment, a combination of graded exercise therapy and cognitive behavioural therapy for patients with patellofemoral pain syndrome.
OTHER	Treatment as Usual	In the control group, education is delivered and self-exercise is recommended.

Timeline

• Start date: 2024-04-26
• Primary completion: 2025-03-31
• Completion: 2025-03-31
• First posted: 2024-02-15
• Last updated: 2025-01-23

Locations

10 sites across 1 country: South Korea