A Confirmatory Trial of Multidisciplinary Digital Therapeutics for Patellofemoral Pain Syndrome

NCT06260865 | Active Not Recruiting

• 1 other identifier: E-ETH-01K-CI02
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Patellofemoral Pain Syndrome

Keywords

PFPS; DTx; SaMD; MSK

Outcome Measures

Primary Outcomes (1)

• Usual pain severity assessed by the Visual Analogue Scale (VAS)

  Differences in usual pain severity between groups after the intervention. VAS score will be measured from 0 (no pain) to 100 (worst pain imaginable).

  8 weeks

Secondary Outcomes (8)

• Usual pain severity assessed by the Visual Analogue Scale (VAS)

  4 weeks, 12 weeks

• Worst pain severity assessed by the Visual Analogue Scale (VAS)

  4 weeks, 8 weeks, 12 weeks

• Functional disability assessed by the Kujala Patellofemoral Scale

  4 weeks, 8 weeks, 12 weeks

• Health-related quality of life assessed by EuroQol five-dimensional (EQ-5D)

  4 weeks, 8 weeks, 12 weeks

• Assessment of mental health symptoms specific to depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)

  4 weeks, 8 weeks, 12 weeks

Study Arms (2)

MORA Cure

EXPERIMENTAL

Participants randomly assigned to this arm will use the digital therapeutics, MORA Cure.

Device: MORA Cure

Treatment as Usual

ACTIVE COMPARATOR

Participants randomly assigned to this arm will receive their treatment as usual only.

Other: Treatment as Usual

Interventions

MORA Cure DEVICE

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.

MORA Cure

Treatment as Usual OTHER

In the control group, education is delivered and self-exercise is recommended.

Treatment as Usual

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with peripatellar or posterior patellar pain in one or more knee joints for 3 months or longer
• Patients with peripatellar or posterior patellar pain provoked by squatting
• 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
• Patients who signed a written informed consent form

You may not qualify if:

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

Sponsors & Collaborators

• EverEx Inc.: lead

Study Sites (10)

Myongji Hospital

Goyang-si, Gyeonggi-do, 10475, South Korea

Location

Hanyang University Guri Hospital

Guri-si, Gyeonggi-do, 11923, South Korea

Location

Seoul National University Bundang Hospital

Gyeonggi-do, Gyeonggi-do, 13620, South Korea

Location

CHA Bundang Medical Center

Seongnam-si, Gyeonggi-do, 13496, South Korea

Location

Inha University Hospital

Junggu, Incheon, 22332, South Korea

Location

Chung-Ang University Hospital

Dongjak, Seoul, 06973, South Korea

Location

Seoul Metropolitan Government-Seoul National University Boramae Medical Center

Dongjak, Seoul, 07061, South Korea

Location

Kyung Hee University Hospital at Gangdong

Gangdong, Seoul, 05278, South Korea

Location

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

Seocho, Seoul, 06591, South Korea

Location

Asan Medical Center

Seoul, Seoul, 05505, South Korea

Location

Related Publications (1)

• Park TH, Yoon C, Park JH, Lee S, Choi CH, Chang CB, Kim JG. 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. Trials. 2025 Sep 1;26(1):328. doi: 10.1186/s13063-025-09030-2.

  PMID: 40890852 DERIVED

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Chong Bum Chang, MD, PhD

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multicenter randomized controlled trial

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: February 15, 2024
• Study Start: April 26, 2024
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: January 23, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (10)