Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
Study NCT ID:
NCT07113912
Status:
COMPLETED
Last Update Posted:
2025-09-23
First Post:
2025-08-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Thoracic Mobilization Versus Counterforce Forearm Brace in Treatment of Lateral Elbow Tendinopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-20', 'studyFirstSubmitDate': '2025-08-03', 'studyFirstSubmitQcDate': '2025-08-03', 'lastUpdatePostDateStruct': {'date': '2025-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Scale (VAS)', 'timeFrame': '4 weeks', 'description': 'consists of a 10 cm (or 100 mm) horizontal or vertical line, where 0 indicates no pain, and 10 (or 100 mm) represent the worst imaginable pain'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lateral Elbow Tendinopathy']}, 'descriptionModule': {'briefSummary': 'The study aim to compare the effect of thoracic mobilization versus counterforce forearm brace in treatment of LET.\n\nDetailed Description:\n\nConditions: Lateral elbow tendinopathy Keywords: LET, Tennis elbow, Thoracic mobilization \\& counterforce forearm brace.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients clinically diagnosed as lateral elbow tendinopathy.\n* Positive clinical sign on the following: Cozen's test Mill's test and Maudsley's test\n* Pain involving in age group of 18-55 years\n* Patients complaining from unilateral elbow pain, more than 3 months\n\nExclusion Criteria:\n\n* Previous Surgery or Intervention (e.g., tendon release, debridement, or joint replacement) in the affected shoulder/elbow are excluded\n* Presence of systemic conditions affecting tendon healing like rheumatoid arthritis, diabetes, or other systemic diseases that impair tendon healing or exacerbate pain can confound results\n* Severe Comorbidities Such as Severe cardiovascular, neurological, or musculoskeletal disorders"}, 'identificationModule': {'nctId': 'NCT07113912', 'briefTitle': 'Thoracic Mobilization Versus Counterforce Forearm Brace in Treatment of Lateral Elbow Tendinopathy', 'organization': {'class': 'OTHER', 'fullName': 'Deraya University'}, 'officialTitle': 'Thoracic Mobilization Versus Counterforce Forearm Brace in Treatment of Lateral Elbow Tendinopathy (Randomized Control Trail)', 'orgStudyIdInfo': {'id': 'physio 7 2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'Received counterforce forearm brace and conventional therapy.', 'interventionNames': ['Device: counterforce forearm brace']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Received thoracic mobilization and conventional therapy.', 'interventionNames': ['Procedure: thoracic immobilization']}], 'interventions': [{'name': 'counterforce forearm brace', 'type': 'DEVICE', 'description': 'a flexible band that fits around the proximal forearm, applying pressure to underlying tissues during activity to potentially reduce acceleration forces and alleviate pain associated with conditions like lateral epicondylitis.', 'armGroupLabels': ['Experimental group']}, {'name': 'thoracic immobilization', 'type': 'PROCEDURE', 'description': 'the methods and devices used to restrict movement of the thoracic spine, which is the upper and middle part of the back.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Minya', 'country': 'Egypt', 'facility': 'Deraya universuty', 'geoPoint': {'lat': 28.09193, 'lon': 30.75813}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Deraya University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}