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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MORA Cure | Experimental | Participants randomly assigned to this arm will use the digital therapeutics, MORA Cure. |
|
| Treatment as Usual | Active Comparator | Participants randomly assigned to this arm will receive their treatment as usual only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MORA Cure | Device | 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. |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chong Bum Chang, MD, PhD | Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Myongji Hospital | Goyang-si | Gyeonggi-do | 10475 | South Korea | ||
| Hanyang University Guri Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40890852 | Derived | Park TH, Yoon C, Park JH, Lee S, Choi CH, Chang CB, Kim JG. Study protocol for a prospective, randomized controlled confirmatory clinical investigation to evaluate the safety and efficacy of a multidisciplinary digital therapeutics in patients with patellofemoral pain syndrome. Trials. 2025 Sep 1;26(1):328. doi: 10.1186/s13063-025-09030-2. |
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Multicenter randomized controlled trial
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| Treatment as Usual | Other | In the control group, education is delivered and self-exercise is recommended. |
|
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 |
| Guri-si |
| Gyeonggi-do |
| 11923 |
| South Korea |
| Seoul National University Bundang Hospital | Gyeonggi-do | Gyeonggi-do | 13620 | South Korea |
| CHA Bundang Medical Center | Seongnam-si | Gyeonggi-do | 13496 | South Korea |
| Inha University Hospital | Junggu | Incheon | 22332 | South Korea |
| Chung-Ang University Hospital | Dongjak | Seoul | 06973 | South Korea |
| Seoul Metropolitan Government-Seoul National University Boramae Medical Center | Dongjak | Seoul | 07061 | South Korea |
| Kyung Hee University Hospital at Gangdong | Gangdong | Seoul | 05278 | South Korea |
| The Catholic University of Korea Seoul St. Mary's Hospital | Seocho | Seoul | 06591 | South Korea |
| Asan Medical Center | Seoul | Seoul | 05505 | South Korea |
| ID | Term |
|---|---|
| D046788 | Patellofemoral Pain Syndrome |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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