Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-25 @ 7:34 PM
Study NCT ID:
NCT00272532
Status:
COMPLETED
Last Update Posted:
2008-02-20
First Post:
2006-01-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
EMINEM: Efficacy of Muscoril In NEck Myofascial Syndromes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009209', 'term': 'Myofascial Pain Syndromes'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C004280', 'term': 'thiocolchicoside'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-02', 'lastUpdateSubmitDate': '2008-02-18', 'studyFirstSubmitDate': '2006-01-04', 'studyFirstSubmitQcDate': '2006-01-04', 'lastUpdatePostDateStruct': {'date': '2008-02-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain relief (Visual Analog Scale and sensitometer) and increase in mobility of neck. Patient and physician satisfaction'}]}, 'conditionsModule': {'conditions': ['Myofascial Pain Syndromes']}, 'descriptionModule': {'briefSummary': 'Study objective:\n\n* To demonstrate, in patients with myofascial pain syndrome in cervical region, the degree of efficacy of thiocolchicoside ointment administered to trigger point regions compared with the trigger point injection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Submitted to clinic with a complaint of head and neck pain\n* Be diagnosed as having myofascial pain syndrome by determining the active trigger points in trapezius and/or interscapular region according to criteria of Simons and Travel\n* Have 1 to 8 active trigger point(s)\n\nExclusion Criteria:\n\n* Have evident cervical discopathy and signs of osteoarthritis\n* Have bleeding diathesis or using anticoagulant medication which hinders injection\n* Have known malignity, being used steroids, have immunodepressive disorders and/or being taken immunodepressive drugs\n* Be pregnant or have the possibility of being pregnant or not being used a regular contraceptive method\n* Have known allergic reaction against Thiocolchicoside'}, 'identificationModule': {'nctId': 'NCT00272532', 'briefTitle': 'EMINEM: Efficacy of Muscoril In NEck Myofascial Syndromes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'The Efficacy of Topical Thiocolchicoside in Cervical Myofascial Pain Syndrome: Triple-Arm, Single-Blind, Randomized, Prospective, Phase IV Clinical Study', 'orgStudyIdInfo': {'id': 'L_9892'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Thiocolchicoside', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Edibe Taylan', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}}}}