Ignite Creation Date:
2025-12-24 @ 1:57 PM
Ignite Modification Date:
2026-01-02 @ 6:37 AM
Study NCT ID:
NCT05948995
Status:
COMPLETED
Last Update Posted:
2025-01-30
First Post:
2023-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between Abduction External Rotation Brace and Arm Sling After Arthroscopic Rotator Cuff
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'On the follow up date , both groups will be removed sling / brace before receiving by outcome assessor'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'The participants were randomly divided into two groups. The control group received arm sling post operative arthroscopic rotator cuff repair. The experimental group received abduction external rotation brace post operative arthroscopic rotator cuff repair.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-28', 'studyFirstSubmitDate': '2023-06-29', 'studyFirstSubmitQcDate': '2023-07-13', 'lastUpdatePostDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of range of motion of shoulders from baseline', 'timeFrame': 'At postoperative 3 weeks', 'description': 'Measurement by Goniometer into degrees (forward flexion, external rotation, internal rotation)'}, {'measure': 'Change of range of motion of shoulders from baseline', 'timeFrame': 'At postoperative 6 weeks', 'description': 'Measurement by Goniometer into degrees (forward flexion, external rotation, internal rotation)'}, {'measure': 'Change of range of motion of shoulders from baseline', 'timeFrame': 'At postoperative 3 months', 'description': 'Measurement by Goniometer into degrees (forward flexion, external rotation, internal rotation)'}, {'measure': 'Change of range of motion of shoulders from baseline', 'timeFrame': 'At postoperative 6 months', 'description': 'Measurement by Goniometer into degrees (forward flexion, external rotation, internal rotation)'}, {'measure': 'Change of range of motion of shoulder from baseline', 'timeFrame': 'At postoperative 1 year', 'description': 'Measurement by Goniometer into degrees (forward flexion, external rotation, internal rotation)'}], 'secondaryOutcomes': [{'measure': 'Change of visual analog scale for pain from baseline', 'timeFrame': 'Change from visual analog scale after 6 weeks postoperative', 'description': 'Range from 1-10 (1 = minimum pain, 10 = maximum pain)'}, {'measure': "Change of constant Murley's score from baseline", 'timeFrame': 'Change from visual analog scale after 6 weeks postoperative', 'description': 'Score 0-100 (Functional shoulder score), 0 = worst, 100 = best'}, {'measure': 'Change of the Thai version of the Shoulder Pain and Disability Index from baseline', 'timeFrame': 'Change from visual analog scale after 6 weeks postoperative', 'description': 'Thai functional shoulder score 0 = worst, 100 = best'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Arthroscopic Rotator Cuff Repair']}, 'descriptionModule': {'briefSummary': 'Comparison between Abduction External Rotation Brace and Arm Sling after Arthroscopic Rotator Cuff : A Randomized Controlled Trial Comparison of primary outcome : range of motion (at pre-operative , post-operative) , pain score , shoulder functional score', 'detailedDescription': 'Comparison between Abduction External Rotation Brace and Arm Sling after Arthroscopic Rotator Cuff : A Randomized Controlled Trial Comparison of primary outcome : range of motion (at pre-operative , post-operative) , pain score , shoulder functional score There are gaps of knowledge which sling/brace are the best for post operative arthroscopic rotator cuff repair Because patient who underwent arthroscopic rotator cuff repair have to wear these sling/brace for at least 1 month after operation , the better one could reduce post-operative shoulder stiffness , decrease pain and improve functional shoulder score'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with full thickness rotator cuff tear\n* Plan for arthroscopic rotator cuff repair\n\nExclusion Criteria:\n\n* Revision cuff surgery\n* Unable to answer question\n* Previous shoulder surgery\n* Full thickness subscapularis tear'}, 'identificationModule': {'nctId': 'NCT05948995', 'acronym': 'ARCR', 'briefTitle': 'Comparison Between Abduction External Rotation Brace and Arm Sling After Arthroscopic Rotator Cuff', 'organization': {'class': 'OTHER', 'fullName': 'Queen Savang Vadhana Memorial Hospital, Thailand'}, 'officialTitle': 'Comparison Between Abduction External Rotation Brace and Arm Sling After Arthroscopic Rotator Cuff : A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '022/2566'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Conventional arm sling', 'description': 'Conventional arm sling Arm position : Internal rotation , Adduction'}, {'type': 'EXPERIMENTAL', 'label': 'Abduction external rotational brace', 'description': 'Abduction external rotational brace Arm position : Abduction , External rotation', 'interventionNames': ['Device: Abduction external rotation brace']}], 'interventions': [{'name': 'Abduction external rotation brace', 'type': 'DEVICE', 'otherNames': ['Arm sling with abduction pillow'], 'description': 'Abduction external rotation brace Arm position : Abduction , External rotation', 'armGroupLabels': ['Abduction external rotational brace']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20110', 'city': 'Chon Buri', 'state': 'Si Racha', 'country': 'Thailand', 'facility': 'Queen Savang Vadhana Memorial Hospital', 'geoPoint': {'lat': 13.3622, 'lon': 100.98345}}], 'overallOfficials': [{'name': 'Chuenrutai Yeekian, Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'QSMVH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data was save in form of microsoft excel spreadsheet and SPSS file'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Queen Savang Vadhana Memorial Hospital, Thailand', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}