Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 11:45 PM
Study NCT ID:
NCT00326794
Status:
TERMINATED
Last Update Posted:
2006-05-17
First Post:
2006-05-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Shoulder Mobilisation Versus Conventional Immobilisation for Nonsurgically Proximal Humerus Fracture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012046', 'term': 'Rehabilitation'}], 'ancestors': [{'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 76}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2002-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-06', 'completionDateStruct': {'date': '2005-09'}, 'lastUpdateSubmitDate': '2006-05-15', 'studyFirstSubmitDate': '2006-05-15', 'studyFirstSubmitQcDate': '2006-05-15', 'lastUpdatePostDateStruct': {'date': '2006-05-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-05-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome was functional assessment of the shoulder (Constant score) at 3 months.'}], 'secondaryOutcomes': [{'measure': 'Functional assessment at 6 weeks and at 6 months'}, {'measure': 'Change in pain (on a visual analogue scale)at 6 weeks, 3 months and at 6 months'}, {'measure': 'Passive range of motion at 6 weeks, 3 months and at 6 months.'}]}, 'conditionsModule': {'keywords': ['Nonsurgical proximal humerus fracture', 'Rehabilitation', 'Physiotherapy', 'randomised controlled trial'], 'conditions': ['Shoulder Fracture']}, 'descriptionModule': {'briefSummary': "Background: Nonsurgical proximal humerus fracture is common, causing prolonged disability, for which the time to begin rehabilitation is not well determined. We assessed the feasibility and efficacy of early (within 3 days'after fracture) mobilisation of the shoulder compared with conventional 3-week immobilization followed by physiotherapy.", 'detailedDescription': 'Methods: We randomly assigned 74 patients with impacted nonsurgically treated proximal humerus fracture to receive early passive mobilisation or conventional-treatment. The primary outcome was functional assessment of the shoulder (Constant score) at 3 months. Secondary outcomes were functional assessment at 6 weeks and at 6 months, change in pain (on a visual analogue scale) and passive range of motion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Impacted nonsurgically treated proximal humerus fracture\n* Patients over the age 20\n\nExclusion Criteria:\n\n* Pre-existing shoulder pathology\n* Neurological disorders of the upper limbs\n* Indication for surgery of the shoulder\n* Combined polytrauma\n* Difficulties with language or comprehension to understand a rehabilitation program and information'}, 'identificationModule': {'nctId': 'NCT00326794', 'briefTitle': 'Efficacy of Shoulder Mobilisation Versus Conventional Immobilisation for Nonsurgically Proximal Humerus Fracture', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Effectiveness at 3 Months of Immediate Shoulder Mobilisation Versus Conventional Immobilisation for Impacted Nonsurgically Treated Proximal Humerus Fracture: a Randomised Controlled Trial.', 'orgStudyIdInfo': {'id': 'P011022'}}, 'armsInterventionsModule': {'interventions': [{'name': 'mobilisation (rehabilitation)', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Cochin', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Marie-Martine Lefevre-colau, MDPhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'APHP'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}}}}