Multidisciplinary Digital Therapeutics of Patellofemoral Pain Syndrome Versus Usual Care

NCT05614583 | Completed

• 1 other identifier: E-ETH-01K-CTP-01
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

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.

Conditions

Patellofemoral Pain Syndrome

Outcome Measures

Primary Outcomes (3)

• Usual pain severity assessed by the Numeric Rating Scale (NRS )

  The primary outcome being measure is differences in usual pain severity between groups after the intervention. NRS score was measured from 0 (no pain) to 10 (worst pain imaginable).

  8 weeks

• Global rating of perceived recovery

  The primary outcome being measure is differences in global rating of perceived recovery between groups after the intervention. Global rating of perceived recovery score was measured from 1 (very bad) to 7 (very good).

  8 weeks

• Functional disability assessed by the Kujala Patellofemoral Scale

  The primary outcome being measure is differences in functional disability between groups after the intervention. Kujala Patellofemoral Scale, also known as Anterior Knee Pain Scale, is a patient reported assessment of patellofemoral pain syndrome-specific functional limitations. It has 13 questions, and total score ranges from 0 to 100 (higher scores meaning better outcomes).

  8 weeks

Secondary Outcomes (15)

• Usual pain severity assessed by the Numeric Rating Scale (NRS)

  4, 12 weeks

• Global rating of perceived recovery

  4, 12 weeks

• Functional disability assessed by the Kujala Patellofemoral Scale

  4, 12 weeks

• Worst pain severity, pain during specific activities (running, standing up from sitting, going up or down stairs, and sleeping) assessed by the Numeric Rating Scale (NRS)

  4, 8, 12 weeks

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

  4, 8, 12 weeks

Study Arms (2)

MORT-PFPS

EXPERIMENTAL

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

Device: MORT-PFPS app

treatment as usual (TAU)

ACTIVE COMPARATOR

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

Other: treatment as usual (TAU)

Interventions

MORT-PFPS app 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.

MORT-PFPS

treatment as usual (TAU) OTHER

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

treatment as usual (TAU)

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• long 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 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

Sponsors & Collaborators

• EverEx Inc.: lead

Study Sites (2)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

Seoul Metropolitan Government-Seoul National University Boramae Medical Center

Dongjak, Seoul, 07061, South Korea

Location

Related Publications (1)

• 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.

  PMID: 41105952 DERIVED

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Chong Bum Chang, Dr.

  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: Single site, randomized controlled trial research study

Study Record Dates

• First Submitted: October 30, 2022
• First Posted: November 14, 2022
• Study Start: November 16, 2022
• Primary Completion: October 19, 2023
• Study Completion: October 19, 2023
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)