Ignite Creation Date:
2025-12-24 @ 10:42 PM
Ignite Modification Date:
2025-12-25 @ 8:12 PM
Study NCT ID:
NCT03421535
Status:
COMPLETED
Last Update Posted:
2018-02-05
First Post:
2017-12-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Opposite SI Joint Stretching for GIRD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2018-09-28', 'releaseDate': '2018-02-11'}], 'estimatedResultsFirstSubmitDate': '2018-02-11'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D019534', 'term': 'Shoulder Impingement Syndrome'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Each player was randomly assigned to either a sleeper stretch group or an opposite SI joint stretch group. The investigators were blinded to the treatment groups.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All 23 players of a minor league baseball team voluntarily participated in the study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-05-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-29', 'studyFirstSubmitDate': '2017-12-30', 'studyFirstSubmitQcDate': '2018-01-29', 'lastUpdatePostDateStruct': {'date': '2018-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Shoulder internal ROM after stretching opposite SI joint', 'timeFrame': 'Measurement made within 30 minutes of stretching', 'description': 'Internal range of motion of dominant shoulder after stretching opposite SI joint'}], 'secondaryOutcomes': [{'measure': 'Shoulder Internal ROM after sleeper stretch', 'timeFrame': 'Measurement made with 30 minutes of stretching', 'description': 'Internal range of motion of dominant shoulder after sleeper stretch'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Glenohumeral internal rotational deficit', 'GIRD', 'Sleeper stretch', 'SI joint stretch'], 'conditions': ['Shoulder Impingement']}, 'referencesModule': {'references': [{'pmid': '12671624', 'type': 'BACKGROUND', 'citation': 'Burkhart SS, Morgan CD, Kibler WB. The disabled throwing shoulder: spectrum of pathology Part I: pathoanatomy and biomechanics. Arthroscopy. 2003 Apr;19(4):404-20. doi: 10.1053/jars.2003.50128.'}, {'pmid': '9302464', 'type': 'BACKGROUND', 'citation': 'Bigliani LU, Codd TP, Connor PM, Levine WN, Littlefield MA, Hershon SJ. Shoulder motion and laxity in the professional baseball player. Am J Sports Med. 1997 Sep-Oct;25(5):609-13. doi: 10.1177/036354659702500504.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate if stretching the contralateral sacroiliac (SI) joint improves GIRD in baseball players. Additionally, we aimed to compare our SI joint stretching regiment with a classically described sleeper stretch routine.', 'detailedDescription': "Abstract:\n\nBackground:\n\nGlenohumeral Internal Rotational Deficit (GIRD) is a well-documented finding in throwing athletes.\n\nHypothesis/Purpose:\n\nThe purpose of this study is to investigate if stretching the contralateral sacroiliac (SI) joint improves GIRD in baseball players. Additionally, the effect of the SI joint stretch will be compared to that of the classically described sleeper stretch.\n\nStudy Design:\n\nRandomized Controlled Clinical Trial\n\nMethods:\n\nWith the athlete supine and arm abducted 90o, internal rotation of both shoulders was measured in 23 minor league baseball players.\n\nNext, each player randomly was assigned to either a control (sleeper stretch of dominant shoulder) or experimental (stretch of the SI joint contralateral to the dominant shoulder) group supervised by a certified athletic trainer. The players performed their own stretches.\n\nFinally, the initial two investigators, unaware of to which group the player was assigned, re-measured the end-range internal rotation of each athlete's dominant shoulder."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '23 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All members a minor league baseball team\n\nExclusion Criteria:\n\n* Any active shoulder or back injury or history of shoulder or back injury'}, 'identificationModule': {'nctId': 'NCT03421535', 'briefTitle': 'Opposite SI Joint Stretching for GIRD', 'organization': {'class': 'OTHER', 'fullName': 'Romano Orthopaedic Center'}, 'officialTitle': 'Sacroiliac Stretching Improves Glenohumeral Internal Rotational Deficit of the Opposite Shoulder in Baseball Players in a Randomized Control Study', 'orgStudyIdInfo': {'id': 'IRB#2017-087'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sleeper stretch group', 'description': 'A certified athletic trainer supervised and observed the athlete as he performed the sleeper stretch on his dominant shoulder.', 'interventionNames': ['Procedure: Sleeper Stretch']}, {'type': 'EXPERIMENTAL', 'label': 'Opposite SI joint Stretch', 'description': 'A certified athletic trainer supervised and observed the athlete as he performed the SI joint stretch opposite his dominant shoulder.', 'interventionNames': ['Procedure: Opposite SI joint Stretch']}], 'interventions': [{'name': 'Sleeper Stretch', 'type': 'PROCEDURE', 'description': 'Internal Range of motion of dominant shoulder', 'armGroupLabels': ['Sleeper stretch group']}, {'name': 'Opposite SI joint Stretch', 'type': 'PROCEDURE', 'description': 'Internal range of motion of dominant shoulder', 'armGroupLabels': ['Opposite SI joint Stretch']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60302', 'city': 'Oak Park', 'state': 'Illinois', 'country': 'United States', 'facility': 'Romano Orthopaedic Center', 'geoPoint': {'lat': 41.88503, 'lon': -87.7845}}], 'overallOfficials': [{'name': 'Victor Romano', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Romano Orthopaedic Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Romano Orthopaedic Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Orthopaedic Surgeon', 'investigatorFullName': 'Victor Romano, MD', 'investigatorAffiliation': 'Romano Orthopaedic Center'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2018-02-11', 'type': 'RELEASE'}, {'date': '2018-09-28', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Victor Romano, MD, Orthopaedic Surgeon, Romano Orthopaedic Center'}}}}