protocolSection identificationModule nctId: NCT06260865, orgStudyIdInfo id: E-ETH-01K-CI02, briefTitle: A Confirmatory Trial of Multidisciplinary Digital Therapeutics for Patellofemoral Pain Syndrome, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-31, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-08-30, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: EverEx Inc., class: INDUSTRY, descriptionModule briefSummary: 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., conditionsModule conditions: Patellofemoral Pain Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Multicenter randomized controlled trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 216, type: ESTIMATED, armsInterventionsModule interventions name: MORA Cure, interventions name: Treatment as Usual, outcomesModule primaryOutcomes measure: Usual pain severity assessed by the Visual Analogue Scale (VAS), secondaryOutcomes measure: Usual pain severity assessed by the Visual Analogue Scale (VAS), secondaryOutcomes measure: Worst pain severity assessed by the Visual Analogue Scale (VAS), secondaryOutcomes measure: Functional disability assessed by the Kujala Patellofemoral Scale, secondaryOutcomes measure: Health-related quality of life assessed by EuroQol five-dimensional (EQ-5D), secondaryOutcomes measure: Assessment of mental health symptoms specific to depression as assessed by the Patient Health Questionnaire-9 (PHQ-9), secondaryOutcomes measure: Assessment of catastrophic thinking measured by Pain Catastrophizing Scale (PCS), secondaryOutcomes measure: Flexion and extension strength of knee, secondaryOutcomes measure: Treatment adherence, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Myongji Hospital, city: Goyang-si, state: Gyeonggi-do, zip: 10475, country: Korea, Republic of, geoPoint lat: 37.65639, lon: 126.835, locations facility: Hanyang University Guri Hospital, city: Guri-si, state: Gyeonggi-do, zip: 11923, country: Korea, Republic of, geoPoint lat: 37.5986, lon: 127.1394, locations facility: CHA Bundang Medical Center, city: Seongnam-si, state: Gyeonggi-do, zip: 13496, country: Korea, Republic of, geoPoint lat: 37.43861, lon: 127.13778, locations facility: Inha University Hospital, city: Junggu, state: Incheon-si, zip: 22332, country: Korea, Republic of, geoPoint lat: 37.69175, lon: 126.60024, locations facility: Chung-Ang University Hospital, city: Dongjak, state: Seoul, zip: 06973, country: Korea, Republic of, geoPoint lat: 35.15713, lon: 126.8166, locations facility: Seoul Metropolitan Government-Seoul National University Boramae Medical Center, city: Dongjak, state: Seoul, zip: 07061, country: Korea, Republic of, geoPoint lat: 35.15713, lon: 126.8166, locations facility: Kyung Hee University Hospital at Gangdong, city: Gangdong, state: Seoul, zip: 05278, country: Korea, Republic of, locations facility: The Catholic University of Korea Seoul St. Mary's Hospital, city: Seocho, state: Seoul, zip: 06591, country: Korea, Republic of, geoPoint lat: 37.49056, lon: 127.02, locations facility: Seoul National University Bundang Hospital, city: Gyeonggi-do, zip: 13620, country: Korea, Republic of, geoPoint lat: 37.58944, lon: 126.76917, locations facility: Asan Medical Center, city: Seoul, zip: 05505, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, hasResults: False