A Confirmatory Trial of Multidisciplinary Digital Therapeutics for Patellofemoral Pain Syndrome

Not Applicable

Active, not recruiting

• Conditions: Patellofemoral Pain Syndrome
• Interventions: Device: MORA Cure; Other: Treatment as Usual

• Registration Number: NCT06260865
• Lead Sponsor: EverEx Inc.

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.

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.

Study Timeline

• Study First Submitted: 2024-02-07
• Study First Submitted QC: 2024-02-07
• Study First Posted: 2024-02-15
• Study Start: 2024-04-26
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-21
• Last Update Posted: 2025-01-23
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 216

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MORA Cure	MORA Cure	Participants randomly assigned to this arm will use the digital therapeutics, MORA Cure.
Treatment as Usual	Treatment as Usual	Participants randomly assigned to this arm will receive their treatment as usual only.

Primary Outcome Measures

Name	Time	Method
Usual pain severity assessed by the Visual Analogue Scale (VAS)	8 weeks	Differences in usual pain severity between groups after the intervention. VAS score will be measured from 0 (no pain) to 100 (worst pain imaginable).

Secondary Outcome Measures

Name	Time	Method
Treatment adherence	4 weeks, 8 weeks, 12 weeks	Treatment adherence of each group, defined as percentage of days taking treament properly out of all days
Usual pain severity assessed by the Visual Analogue Scale (VAS)	4 weeks, 12 weeks	Differences in usual pain severity between groups after the intervention. VAS score will be measured from 0 (no pain) to 100 (worst pain imaginable).
Worst pain severity assessed by the Visual Analogue Scale (VAS)	4 weeks, 8 weeks, 12 weeks	Differences in worst pain severity between groups after the intervention. VAS score will be measured from 0 (no pain) to 100 (worst pain imaginable).
Functional disability assessed by the Kujala Patellofemoral Scale	4 weeks, 8 weeks, 12 weeks	Differences in functional disability between groups. 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).
Health-related quality of life assessed by EuroQol five-dimensional (EQ-5D)	4 weeks, 8 weeks, 12 weeks	Differences in health-related quality of life between groups. It measures five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with three possible answers for each dimension (1=no problem, 2=moderate problem, 3=severe problem). The instrument also includes a visual analogue scale, which is numbered from 0 (the worst health you can imagine) to 100 (the best health you can imagine).
Assessment of mental health symptoms specific to depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)	4 weeks, 8 weeks, 12 weeks	Differences in mental health symptoms between groups. The Patient Health Questionnaire-9 (PHQ-9) total score for the nine items ranges from 0 to 27 (higher scores indicating greater severity of depression).
Assessment of catastrophic thinking measured by Pain Catastrophizing Scale (PCS)	4 weeks, 8 weeks, 12 weeks	Differences in levels of catastrophic thinking between groups at 8, 12 weeks. The Pain Catastrophizing Scale (PCS) is a 13-item scale, with a total range of 0 to 52 (higher scores indicating higher amounts of pain catastrophizing).
Flexion and extension strength of knee	4 weeks, 8 weeks, 12 weeks	Flexion and extension strength of knee are measured using a Biodex isokinetic dynamometer (peak torque (Nm) and % decrease in torque).

Trial Locations

Locations (10)

Myongji Hospital; 🇰🇷 Goyang-si, Gyeonggi-do, Korea, Republic of

Hanyang University Guri Hospital; 🇰🇷 Guri-si, Gyeonggi-do, Korea, Republic of

CHA Bundang Medical Center; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of

Inha University Hospital; 🇰🇷 Junggu, Incheon-si, Korea, Republic of

Chung-Ang University Hospital; 🇰🇷 Dongjak, Seoul, Korea, Republic of

Seoul Metropolitan Government-Seoul National University Boramae Medical Center; 🇰🇷 Dongjak, Seoul, Korea, Republic of

Kyung Hee University Hospital at Gangdong; 🇰🇷 Gangdong, Seoul, Korea, Republic of

The Catholic University of Korea Seoul St. Mary's Hospital; 🇰🇷 Seocho, Seoul, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Gyeonggi-do, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of