Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2025-12-26 @ 1:43 AM
Study NCT ID:
NCT00438633
Status:
COMPLETED
Last Update Posted:
2019-06-21
First Post:
2007-02-20
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Comparison of Early and Late Therapy for Adults With Non-Operatively Treated Proximal Humerus Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012784', 'term': 'Shoulder Fractures'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nchen1@partners.org', 'phone': '6177264700', 'title': 'Dr. Neal Chen', 'organization': 'Massachusetts General Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Early Therapy', 'description': 'Subjects who begin therapy immediately after diagnosis of injury.', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 0, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Late Therapy', 'description': 'Subjects who delay therapy for 3 weeks after diagnosis of injury.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 0, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Shoulder Flexion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Therapy', 'description': 'Subjects who begin therapy immediately after diagnosis of injury.'}, {'id': 'OG001', 'title': 'Late Therapy', 'description': 'Subjects who delay therapy for 3 weeks after diagnosis of injury.'}], 'classes': [{'categories': [{'measurements': [{'value': '150', 'spread': '26', 'groupId': 'OG000'}, {'value': '146', 'spread': '22', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'We measured active forward flexion of the shoulder', 'unitOfMeasure': 'Degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All analysis conducted with those who completed 3-month follow-up. We used mean imputation for the 6-month evaluation for patients who did not attend a 6-month follow-up.'}, {'type': 'SECONDARY', 'title': 'Shoulder Pain Likert Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Therapy', 'description': 'Subjects who begin therapy immediately after diagnosis of injury.'}, {'id': 'OG001', 'title': 'Late Therapy', 'description': 'Subjects who delay therapy for 3 weeks after diagnosis of injury.'}], 'classes': [{'title': 'NRS Pain, 3 months', 'categories': [{'measurements': [{'value': '3', 'spread': '2', 'groupId': 'OG000'}, {'value': '3', 'spread': '1', 'groupId': 'OG001'}]}]}, {'title': 'NRS Pain, 6 months', 'categories': [{'measurements': [{'value': '2', 'spread': '1', 'groupId': 'OG000'}, {'value': '2', 'spread': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months, 6 months', 'description': 'Rated on a scale of 0-10, where 0 is no pain and 10 is severe pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All analysis conducted with those who completed 3-month follow-up. We used mean imputation for the 6-month evaluation for patients who did not attend a 6-month follow-up.'}, {'type': 'SECONDARY', 'title': 'External Rotation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Therapy', 'description': 'Subjects who begin therapy immediately after diagnosis of injury.'}, {'id': 'OG001', 'title': 'Late Therapy', 'description': 'Subjects who delay therapy for 3 weeks after diagnosis of injury.'}], 'classes': [{'title': 'External Rotation, 3 months', 'categories': [{'measurements': [{'value': '53', 'spread': '30', 'groupId': 'OG000'}, {'value': '51', 'spread': '21', 'groupId': 'OG001'}]}]}, {'title': 'External Rotation, 6 months', 'categories': [{'measurements': [{'value': '70', 'spread': '17', 'groupId': 'OG000'}, {'value': '66', 'spread': '26', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months, 6 months', 'unitOfMeasure': 'Degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All analysis conducted with those who completed 3-month follow-up. We used mean imputation for the 6-month evaluation for patients who did not attend a 6-month follow-up.'}, {'type': 'SECONDARY', 'title': 'Abduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Therapy', 'description': 'Subjects who begin therapy immediately after diagnosis of injury.'}, {'id': 'OG001', 'title': 'Late Therapy', 'description': 'Subjects who delay therapy for 3 weeks after diagnosis of injury.'}], 'classes': [{'title': 'Abduction, 3 months', 'categories': [{'measurements': [{'value': '115', 'spread': '43', 'groupId': 'OG000'}, {'value': '101', 'spread': '41', 'groupId': 'OG001'}]}]}, {'title': 'Abduction, 6 months', 'categories': [{'measurements': [{'value': '147', 'spread': '27', 'groupId': 'OG000'}, {'value': '136', 'spread': '33', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months, 6 months', 'unitOfMeasure': 'Degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All analysis conducted with those who completed 3-month follow-up. We used mean imputation for the 6-month evaluation for patients who did not attend a 6-month follow-up.'}, {'type': 'SECONDARY', 'title': 'Disability of the Hand, Shoulder, and Arm Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Therapy', 'description': 'Subjects who begin therapy immediately after diagnosis of injury.'}, {'id': 'OG001', 'title': 'Late Therapy', 'description': 'Subjects who delay therapy for 3 weeks after diagnosis of injury.'}], 'classes': [{'title': 'DASH, 3 months', 'categories': [{'measurements': [{'value': '33', 'spread': '25', 'groupId': 'OG000'}, {'value': '24', 'spread': '15', 'groupId': 'OG001'}]}]}, {'title': 'DASH, 6 months', 'categories': [{'measurements': [{'value': '18', 'spread': '12', 'groupId': 'OG000'}, {'value': '14', 'spread': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months, 6 months', 'description': 'Disability of the Hand, Shoulder, and Arm Score (DASH) is a measure of upper extremity physical function, with scores ranging from 0 to 100. A higher score indicates more physical impairment.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All analysis conducted with those who completed 3-month follow-up. We used mean imputation for the 6-month evaluation for patients who did not attend a 6-month follow-up.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Early Therapy', 'description': 'Subjects who begin therapy immediately after diagnosis of injury.'}, {'id': 'FG001', 'title': 'Late Therapy', 'description': 'Subjects who delay therapy for 3 weeks after diagnosis of injury.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': '3-month Follow-up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '17'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '17'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Early Therapy', 'description': 'Subjects who begin therapy immediately after diagnosis of injury.'}, {'id': 'BG001', 'title': 'Late Therapy', 'description': 'Subjects who delay therapy for 3 weeks after diagnosis of injury.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63', 'spread': '13', 'groupId': 'BG000'}, {'value': '62', 'spread': '12', 'groupId': 'BG001'}, {'value': '63', 'spread': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Injured Hand', 'classes': [{'categories': [{'title': 'Dominant', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Non-dominant', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Non- or minimally displaced', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline characteristics are assessed for all subjects completing 3-month follow-up.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-19', 'studyFirstSubmitDate': '2007-02-20', 'resultsFirstSubmitDate': '2018-09-14', 'studyFirstSubmitQcDate': '2007-02-20', 'lastUpdatePostDateStruct': {'date': '2019-06-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-06-19', 'studyFirstPostDateStruct': {'date': '2007-02-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Shoulder Flexion', 'timeFrame': '6 months', 'description': 'We measured active forward flexion of the shoulder'}], 'secondaryOutcomes': [{'measure': 'Shoulder Pain Likert Scores', 'timeFrame': '3 months, 6 months', 'description': 'Rated on a scale of 0-10, where 0 is no pain and 10 is severe pain.'}, {'measure': 'External Rotation', 'timeFrame': '3 months, 6 months'}, {'measure': 'Abduction', 'timeFrame': '3 months, 6 months'}, {'measure': 'Disability of the Hand, Shoulder, and Arm Score', 'timeFrame': '3 months, 6 months', 'description': 'Disability of the Hand, Shoulder, and Arm Score (DASH) is a measure of upper extremity physical function, with scores ranging from 0 to 100. A higher score indicates more physical impairment.'}]}, 'conditionsModule': {'keywords': ['proximal humerus fracture', 'rehabilitation', 'non-operative treatment', 'DASH and Constant instruments'], 'conditions': ['Proximal Humeral Fractures']}, 'referencesModule': {'references': [{'pmid': '35727196', 'type': 'DERIVED', 'citation': 'Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to compare two common ways of rehabilitating after proximal humerus fractures treated non-operatively.', 'detailedDescription': 'Proximal humerus fractures with limited displacement and fractures that occur in older, less active or infirm patients are treated non-operatively. There is a general impression, supported by some data, that better function is obtained with immediate initiation of shoulder exercises. However, there is some concern that this may contribute to nonunion of the fracture and may be unnecessary. Some researchers have demonstrated better outcomes with immediate rehabilitation with pendulum movements. Others have shown similar functional outcomes when rehabilitation begins approximately a month after injury, or when radiographs show signs of bone healing, and this delay is associated with lower rates of non-union and malunion occurrence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients from the MGH Hand and Upper Extremity or Trauma service', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and Female patients.\n* Any race\n* Older than 18y\n* Diagnosed with proximal humeral fracture clinically and confirmed by imaging studies: X rays and/or CT Scans.\n* Any type of proximal humeral fracture according to the Neer or AO classification system.\n* Patient should have received non-operative treatment.\n\nExclusion Criteria:\n\n* Patients younger than 18 y.\n* Patients with multiple other fractures.\n* Patients that have received surgical treatment including closed reduction and percutaneous fixation, open reduction and internal fixation (plates, screws, pins, tension wire bands, cerclage wiring and/or intramedullary nailing) and/or articular shoulder prosthesis.'}, 'identificationModule': {'nctId': 'NCT00438633', 'briefTitle': 'Comparison of Early and Late Therapy for Adults With Non-Operatively Treated Proximal Humerus Fractures', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Early vs Delayed Physical Therapy (Exercises) for Non-Operatively-Treated Proximal Humerus Fractures: A Prospective Randomized Trial', 'orgStudyIdInfo': {'id': '2004-P-002235'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Early Therapy', 'description': 'Subjects who begin therapy immediately after diagnosis of injury.'}, {'label': 'Late Therapy', 'description': 'Subjects who delay therapy for 3 weeks after diagnosis of injury.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Neal Chen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator; Hand Service', 'investigatorFullName': 'Neal Chung-Jen Chen', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}