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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

NCT06260865•EverEx Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

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

Locations (10)

Myongji Hospital

Goyang-si, Gyeonggi-do, South Korea

Hanyang University Guri Hospital

Guri-si, Gyeonggi-do, South Korea

Seoul National University Bundang Hospital

Gyeonggi-do, Gyeonggi-do, South Korea

CHA Bundang Medical Center

Seongnam-si, Gyeonggi-do, South Korea

Inha University Hospital

Junggu, Incheon, South Korea

Chung-Ang University Hospital

Dongjak, Seoul, South Korea

Seoul Metropolitan Government-Seoul National University Boramae Medical Center

Dongjak, Seoul, South Korea

Kyung Hee University Hospital at Gangdong

Gangdong, Seoul, South Korea

The Catholic University of Korea Seoul St. Mary's Hospital

Seocho, Seoul, South Korea

Asan Medical Center

Seoul, Seoul, South Korea

Key Dates

Start Date

April 26, 2024

Primary Completion Date

March 31, 2025

Completion Date

March 31, 2025

Last Updated

January 23, 2025

Enrollment

216

ESTIMATED participants

Conditions

Patellofemoral Pain Syndrome

Interventions

MORA Cure

DEVICE

Treatment as Usual

OTHER

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 23, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Confirmatory Trial of Multidisciplinary Digital Therapeutics for Patellofemoral Pain Syndrome

Inclusion Criteria

Exclusion Criteria

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