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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Patellofemoral Pain Syndrome
• Intervention / Treatment: Device: MORA Cure; Other: Treatment as Usual

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 Type: Interventional
• Enrollment (Estimated): 216
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tae Hyun Park, MD; Phone Number: 82-2-588-0812; Email: bill@everex.co.kr

Study Locations

• Korea, Republic of
  • Gyeonggi-do, Korea, Republic of, 13620
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Gyeonggi-do
    • Goyang-si, Gyeonggi-do, Korea, Republic of, 10475
      • Myongji Hospital
    • Guri-si, Gyeonggi-do, Korea, Republic of, 11923
      • Hanyang University GURI Hospital
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13496
      • Cha Bundang Medical Center
  • Incheon-si
    • Junggu, Incheon-si, Korea, Republic of, 22332
      • Inha University Hospital
  • Seoul
    • Dongjak, Seoul, Korea, Republic of, 07061
      • Seoul Metropolitan Government-Seoul National University Boramae Medical Center
    • Dongjak, Seoul, Korea, Republic of, 06973
      • Chung-Ang University Hospital
    • Gangdong, Seoul, Korea, Republic of, 05278
      • Kyung Hee University Hospital at Gangdong
    • Seocho, Seoul, Korea, Republic of, 06591
      • The Catholic University of Korea Seoul St. Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MORA Cure; Participants randomly assigned to this arm will use the digital therapeutics, MORA Cure.	Device: MORA Cure; 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.
Active Comparator: Treatment as Usual; Participants randomly assigned to this arm will receive their treatment as usual only.	Other: Treatment as Usual; In the control group, education is delivered and self-exercise is recommended.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	4 weeks, 12 weeks
Worst pain severity assessed by the Visual Analogue Scale (VAS)	Differences in worst pain severity between groups after the intervention. VAS score will be measured from 0 (no pain) to 100 (worst pain imaginable).	4 weeks, 8 weeks, 12 weeks
Functional disability assessed by the Kujala Patellofemoral Scale	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).	4 weeks, 8 weeks, 12 weeks
Health-related quality of life assessed by EuroQol five-dimensional (EQ-5D)	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).	4 weeks, 8 weeks, 12 weeks
Assessment of mental health symptoms specific to depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)	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).	4 weeks, 8 weeks, 12 weeks
Assessment of catastrophic thinking measured by Pain Catastrophizing Scale (PCS)	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).	4 weeks, 8 weeks, 12 weeks
Flexion and extension strength of knee	Flexion and extension strength of knee are measured using a Biodex isokinetic dynamometer (peak torque (Nm) and % decrease in torque).	4 weeks, 8 weeks, 12 weeks
Treatment adherence	Treatment adherence of each group, defined as percentage of days taking treament properly out of all days	4 weeks, 8 weeks, 12 weeks

Collaborators and Investigators

• Sponsor: EverEx Inc.
• Investigators: Principal Investigator: Chong Bum Chang, MD, PhD, Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 31, 2024
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): August 30, 2024

Study Registration Dates

• First Submitted: February 7, 2024
• First Submitted That Met QC Criteria: February 7, 2024
• First Posted (Actual): February 15, 2024

Study Record Updates

• Last Update Posted (Actual): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: PFPS; MSK; SaMD; DTx
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Disease; Joint Diseases; Musculoskeletal Diseases; Syndrome; Somatoform Disorders; Patellofemoral Pain Syndrome
• Other Study ID Numbers: E-ETH-01K-CI02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No