Multidisciplinary Digital Therapeutics of Patellofemoral Pain Syndrome Versus Usual Care

NCT ID: NCT05614583

Last Updated: 2024-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-16
• Study Completion Date: 2023-10-19

Brief Summary

This randomized controlled pilot study will be evaluating an app, MORT-PFPS app (ETH-01K), owned by EverEx, Inc., to examine safety and effectiveness in individuals with patellofemoral pain syndrome.

Detailed Description

This randomized controlled pilot study will enroll 40 participants, where half will be randomly assigned to the app, MORT-PFPS (n = 20), and half will be assigned to treatment as usual (TAU) (n = 20), 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 app provides multidisciplinary rehabilitation treatment, a combination of graded exercise therapy and cognitive behavioural therapy for patients with patellofemoral pain syndrome.

Conditions

Patellofemoral Pain Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MORT-PFPS

Participants randomly assigned to this arm will use the app, MORT-PFPS.

Group Type: EXPERIMENTAL

MORT-PFPS app

Intervention Type: DEVICE

The MORT-PFPS, developed by EverEx, Inc., is designed to provide multidisciplinary rehabilitation treatment, a combination of graded exercise therapy and cognitive behavioural therapy for patients with patellofemoral pain syndrome.

treatment as usual (TAU)

Participants randomly assigned to this arm will receive their TAU only (no use of the app, MORT-PFPS).

Group Type: ACTIVE_COMPARATOR

treatment as usual (TAU)

Intervention Type: OTHER

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

Interventions

MORT-PFPS app

The MORT-PFPS, developed by EverEx, Inc., is designed to provide multidisciplinary rehabilitation treatment, a combination of graded exercise therapy and cognitive behavioural therapy for patients with patellofemoral pain syndrome.

Intervention Type: DEVICE

treatment as usual (TAU)

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Male or female ≥ 19 and <50 years of age
• Patients who have a history of anterior knee pain in one or both knees, persisting for longer than 3months but not longer than 2 years
• Patients who have pain provoked by squatting
• Patients who have pain provoked by 2 or more following activities

1. long sitting

2. cycling

3. running

4. going up or down stairs

5. kneeling

6. compression of the patella

7. palpation of the patellar facets

• Patients who signed a written informed consent form

Exclusion Criteria

• Patients with osteoarthritis which scored 2 or higher grade of the Kellgren-Lawrence scale
• Patients who have a history of knee pathologies or injuries (fracture, tendon injury, cartilage injury, or patella dislocation)
• Patients who had previous knee surgeries
• Patients who have patellar tendinopathy
• Patients who have Osgood-Schlatter disease, or other defined pathological conditions of the knee
• Patients who are pregnant or breastfeeding
• Patients who are using anti-inflammatory medication
• Patients with known substance/alcohol use disorders
• Patients with known somatic symptom and related disorders
• Patients who are not able to participate in an exercise or strengthening program

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

EverEx Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chong Bum Chang, Dr.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Seoul Metropolitan Government-Seoul National University Boramae Medical Center

Dongjak, Seoul, South Korea

Countries

South Korea

References

Lee S, Yoon C, Choi CH, Park TH, Yang SJ, Cha HR, Kim TW, Park JH, Chang MJ, Chang CB. Efficacy of a Mobile Multidisciplinary Digital Therapeutics App for Patellofemoral Pain: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2025 Oct 17;13:e69627. doi: 10.2196/69627.

Reference Type: DERIVED

PMID: 41105952 (View on PubMed)

Other Identifiers

E-ETH-01K-CTP-01

Identifier Type: -

Identifier Source: org_study_id