A Confirmatory Trial of Multidisciplinary Digital Therapeutics for Patellofemoral Pain Syndrome
- Conditions
- Patellofemoral Pain Syndrome
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 216
- Patients with peripatellar or posterior patellar pain in one or more knee joints for 3 months or longer
- Patients with peripatellar or posterior patellar pain provoked by squatting
- 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
- Patients who signed a written informed consent form
- Patients with osteoarthritis which scored 3 or higher grade of the Kellgren-Lawrence scale
- Patients diagnosed with a fracture or dislocation around the knee within the last 3 months
- Patients who had knee surgery within the last 3 months
- Patients diagnosed with patellar tendinitis based on imaging within 3 months
- Patients taking narcotic pain medications for pain control
- Patients taking or planning to take any medication that is a contraindication within the next 16 weeks at the time of screening
- Patients who are pregnant
- Patients currently participating in another clinical trial or have participated in another clinical trial within the past 3 months at the time of screening
- Patients deemed unsuitable for this study by the investigator
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- 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
Myongji Hospital🇰🇷Goyang-si, Gyeonggi-do, Korea, Republic of