Ignite Creation Date:
2025-12-24 @ 2:08 PM
Ignite Modification Date:
2026-01-10 @ 11:27 AM
Study NCT ID:
NCT02787395
Status:
UNKNOWN
Last Update Posted:
2016-06-03
First Post:
2016-05-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Self Reduction of Shoulder Dislocation
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': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-06-01', 'studyFirstSubmitDate': '2016-05-22', 'studyFirstSubmitQcDate': '2016-05-25', 'lastUpdatePostDateStruct': {'date': '2016-06-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'rate of successfull self reduction', 'timeFrame': '10 minutes', 'description': 'the number/rate of successful reductions using each technique will be calculated'}], 'secondaryOutcomes': [{'measure': 'pain using VAS during reduction', 'timeFrame': '10 minutes', 'description': 'patients will be asked to report pain levels using VAS during the self reduction procedure'}, {'measure': 'patient satisfaction from self reduction process using VAS', 'timeFrame': '10 minutes', 'description': 'patients will be asked to report their satisfaction from self reduction process using VAS'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Anterior Shoulder Dislocation']}, 'descriptionModule': {'briefSummary': 'Anterior dislocation of the shoulder (glenohumeral joint) is one of the most prevalent dislocations. Following a first dislocation recurrence rates of up to 80% have been reported. Many patients will seek medical assistance for reduction of the shoulder after each of these recurrent dislocations. The investigators describe the results of reduction of anterior glenohumeral dislocation using a modified self manipulated Milch technique that can be performed by the patients themselves after simple guidance and demonstration. This method is directed to patients who are not willing or cannot have surgical stabilization and may be in a place where medical assistance is not available.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* anterior shoulder dislocation\n* acute (24 hours) shoulder dislocation\n\nExclusion Criteria:\n\n* shoulder fracture\n* non-cooperative patient'}, 'identificationModule': {'nctId': 'NCT02787395', 'acronym': 'SR-SD', 'briefTitle': 'Self Reduction of Shoulder Dislocation', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Tel-Aviv Sourasky Medical Center'}, 'officialTitle': 'Patients Education of a Self-reduction Technique for Anterior Dislocation of Shoulder', 'orgStudyIdInfo': {'id': 'TASMC-15-OC-0612-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Milch', 'description': 'modified Milch technique for self reduction', 'interventionNames': ['Procedure: shoulder dislocation self reduction']}, {'type': 'EXPERIMENTAL', 'label': 'Boss Holtzach', 'description': 'Boss Holtzach technique for self reduction', 'interventionNames': ['Procedure: shoulder dislocation self reduction']}, {'type': 'EXPERIMENTAL', 'label': 'Stimson', 'description': 'Stimson technique for self reduction', 'interventionNames': ['Procedure: shoulder dislocation self reduction']}], 'interventions': [{'name': 'shoulder dislocation self reduction', 'type': 'PROCEDURE', 'description': 'shoulder dislocation self reduction using one of three methods in the study', 'armGroupLabels': ['Boss Holtzach', 'Milch', 'Stimson']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tel-Aviv Sourasky Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}