Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2025-12-25 @ 10:08 PM
Study NCT ID:
NCT00184158
Status:
COMPLETED
Last Update Posted:
2017-08-22
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment for Cubital Tunnel Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020430', 'term': 'Cubital Tunnel Syndrome'}, {'id': 'D009463', 'term': 'Neuroma'}], 'ancestors': [{'id': 'D020424', 'term': 'Ulnar Neuropathies'}, {'id': 'D020422', 'term': 'Mononeuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D017769', 'term': 'Ulnar Nerve Compression Syndromes'}, {'id': 'D009408', 'term': 'Nerve Compression Syndromes'}, {'id': 'D012090', 'term': 'Cumulative Trauma Disorders'}, {'id': 'D013180', 'term': 'Sprains and Strains'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D018317', 'term': 'Nerve Sheath Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003664', 'term': 'Decompression'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011312', 'term': 'Pressure'}, {'id': 'D055595', 'term': 'Mechanical Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-17', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2017-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain'}], 'secondaryOutcomes': [{'measure': 'electroneurography (ENG', 'description': 'electroneurography (ENG) before and after the operation and to see if it is consistent with the patient evaluation.'}, {'measure': 'paresthesia'}, {'measure': 'weakness'}, {'measure': 'patient satisfaction'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cubital tunnel', 'treatment', 'nerve compression'], 'conditions': ['Cubital Tunnel Syndrome']}, 'descriptionModule': {'briefSummary': 'The researchers want to find out the best treatment for cubital tunnel. The researchers establish the degree of nerve compression and then the patients are randomised to different treatment alternatives, ranging from conservative to operative treatments.\n\nThe study is performed at 5 different hospitals in Norway.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with cubital tunnel syndrome\n\nExclusion Criteria:\n\n* Rheumatoid arthritis (RA)\n* Osteoarthrosis\n* Varus or valgus deformities at elbow'}, 'identificationModule': {'nctId': 'NCT00184158', 'briefTitle': 'Treatment for Cubital Tunnel Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Norwegian University of Science and Technology'}, 'officialTitle': 'Cubital Tunnel Treatment, Evaluation of Conservative and Operative Alternatives', 'orgStudyIdInfo': {'id': '056-02'}}, 'armsInterventionsModule': {'interventions': [{'name': 'decompression', 'type': 'PROCEDURE', 'description': 'Conservative, simple decompression and nerve transfer'}]}, 'contactsLocationsModule': {'locations': [{'zip': '7006', 'city': 'Trondheim', 'country': 'Norway', 'facility': 'St Olavs Hospital', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Vilhjalmur Finsen, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'National Taiwan Normal University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}