Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT06677320
Status:
RECRUITING
Last Update Posted:
2025-03-04
First Post:
2024-11-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Establishing Clinical Significance in Rotator Cuff Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 69}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-03', 'studyFirstSubmitDate': '2024-11-04', 'studyFirstSubmitQcDate': '2024-11-05', 'lastUpdatePostDateStruct': {'date': '2025-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional level', 'timeFrame': 'before the treatment and within 1 week after 2 months of treatment', 'description': 'Shoulder Disability Questionnaire (total score between 0-100) (higher values indicate higher disability)'}, {'measure': 'Functional level', 'timeFrame': 'before the treatment and within 1 week after 2 months of treatment', 'description': 'The short version of the Western Ontario Rotator Cuff Index (total score between 0-100) (higher values indicate higher functional level)'}, {'measure': 'Functional level', 'timeFrame': 'before the treatment and within 1 week after 2 months of treatment', 'description': 'Shoulder Rating Questionnaire (total score between 17-100) (higher values indicate higher functional level)'}, {'measure': 'Functional level', 'timeFrame': 'before the treatment and within 1 week after 2 months of treatment', 'description': 'The University of California-Los Angeles Shoulder Scale (total score between 0-100) (higher values indicate higher functional level)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['rotator cuff', 'clinical significance', 'minimal important chance', 'substantial clinical benefit', 'patient acceptable symptomatic state', 'maximal outcome improvement', 'Shoulder Disability Questionnaire', 'Western Ontario Rotator Cuff Index', 'Shoulder Rating Questionnaire', 'University of California-Los Angeles Shoulder Scale'], 'conditions': ['Rotator Cuff Disease']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to learn about rotator cuff patients. The main questions it aims to answer are:\n\n* What is the minimal clinically important difference value of the Shoulder Disability Questionnaire, the short version of the Western Ontario Rotator Cuff Index, the Shoulder Rating Questionnaire, and the University of California-Los Angeles Shoulder Scale?\n* What is the substantial clinical benefit value of the Shoulder Disability Questionnaire, the short version of the Western Ontario Rotator Cuff Index, the Shoulder Rating Questionnaire, and the University of California-Los Angeles Shoulder Scale?\n* What is the patient-acceptable symptomatic state value of the Shoulder Disability Questionnaire, the short version of the Western Ontario Rotator Cuff Index, the Shoulder Rating Questionnaire, and the University of California-Los Angeles Shoulder Scale?\n* What is the maximal outcome improvement value of the Shoulder Disability Questionnaire, the short version of the Western Ontario Rotator Cuff Index, the Shoulder Rating Questionnaire, and the University of California-Los Angeles Shoulder Scale?\n* What are the risk factors that prevent rotator cuff patients from reaching the minimal clinically important difference value?\n* What are the risk factors that prevent rotator cuff patients from reaching the substantial clinical benefit value?\n* What are the risk factors that prevent rotator cuff patients from reaching the patient-acceptable symptomatic state value?\n* What are the risk factors that prevent rotator cuff patients from reaching the maximal outcome improvement value?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "The study will be conducted with rotator cuff patients who will have physical therapy at Kırklareli Training and Research Hospital's physical therapy unit.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* to be over 18 years old\n* to be a rotator cuff patient\n\nExclusion Criteria:\n\n* to have another pathology in the affected shoulder area\n* to have a neurological, rheumatological, or oncological disease\n* to have radiculopathy\n* to have had a previous fracture or operation in the affected shoulder area\n* to be not cooperative enough for what will be done within the scope of the study'}, 'identificationModule': {'nctId': 'NCT06677320', 'briefTitle': 'Establishing Clinical Significance in Rotator Cuff Disease', 'organization': {'class': 'OTHER', 'fullName': 'Kırklareli University'}, 'officialTitle': 'Establishing the Clinical Significance Values of Scales Used in Rotator Cuff Disease', 'orgStudyIdInfo': {'id': '2024-1636'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Rotator cuff patients', 'description': 'Patients with rotator cuff disease who will receive conservative treatment.', 'interventionNames': ['Other: Exercise']}], 'interventions': [{'name': 'Exercise', 'type': 'OTHER', 'description': 'Patients with rotator cuff disease will receive exercise treatment for two months.', 'armGroupLabels': ['Rotator cuff patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '39000', 'city': 'Kırklareli', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'facility': 'Kırklareli Eğitim ve Araştırma Hastanesi', 'geoPoint': {'lat': 41.73508, 'lon': 27.22521}}], 'centralContacts': [{'name': 'Ozan Gür, MSc', 'role': 'CONTACT', 'email': 'ozan.gur94@gmail.com', 'phone': '506 338 38 49', 'phoneExt': '90'}], 'overallOfficials': [{'name': 'Ozan Gür, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kırklareli University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kırklareli University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant', 'investigatorFullName': 'Ozan Gür, PT', 'investigatorAffiliation': 'Kırklareli University'}}}}