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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
216
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.
In the control group, education is delivered and self-exercise is recommended.
Myongji Hospital
Goyang-si, Gyeonggi-do, South Korea
Hanyang University Guri Hospital
Guri-si, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Gyeonggi-do, Gyeonggi-do, South Korea
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).
Time frame: 8 weeks
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 4 weeks, 8 weeks, 12 weeks
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CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, South Korea
Inha University Hospital
Junggu, Incheon, South Korea
Chung-Ang University Hospital
Dongjak, Seoul, South Korea
Seoul Metropolitan Government-Seoul National University Boramae Medical Center
Dongjak, Seoul, South Korea
Kyung Hee University Hospital at Gangdong
Gangdong, Seoul, South Korea
The Catholic University of Korea Seoul St. Mary's Hospital
Seocho, Seoul, South Korea
Asan Medical Center
Seoul, Seoul, South Korea
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).
Time frame: 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).
Time frame: 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).
Time frame: 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
Time frame: 4 weeks, 8 weeks, 12 weeks