A Confirmatory Trial of Multidisciplinary Digital Therapeutics for Patellofemoral Pain Syndrome

Patellofemoral Pain Syndrome Clinical Trial

Official title:

Prospective, Randomized, Controlled Confirmatory Clinical Investigation to Evaluate the Safety and Efficacy of a Multidisciplinary Digital Therapeutics in Patients With Patellofemoral Pain Syndrome

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06260865
• Other study ID #: E-ETH-01K-CI02
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 31, 2024
• Est. completion date: August 30, 2024

Study information

• Verified date: February 2024
• Source: EverEx Inc.
• Contact: Tae Hyun Park, MD
• Phone: 82-2-588-0812
• Email: bill[@]everex.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 216
• Est. completion date: August 30, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Patellofemoral Pain Syndrome
• Somatoform Disorders
• Syndrome

Intervention

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.

Other:
• Treatment as Usual
In the control group, education is delivered and self-exercise is recommended.

Locations

Country	Name	City	State
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	Myongji Hospital	Goyang-si	Gyeonggi-do
Korea, Republic of	Hanyang University Guri Hospital	Guri-si	Gyeonggi-do
Korea, Republic of	Seoul National University Bundang Hospital	Gyeonggi-do
Korea, Republic of	Inha University Hospital	Junggu	Incheon-si
Korea, Republic of	The Catholic University of Korea Seoul St. Mary's Hospital	Seocho	Seoul
Korea, Republic of	CHA Bundang Medical Center	Seongnam-si	Gyeonggi-do
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
EverEx Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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