Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-04-08 @ 2:39 PM
Study NCT ID:
NCT00986505
Status:
COMPLETED
Last Update Posted:
2009-09-30
First Post:
2009-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intravenous Lidocaine for Fibromyalgia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-09-29', 'studyFirstSubmitDate': '2009-08-03', 'studyFirstSubmitQcDate': '2009-09-29', 'lastUpdatePostDateStruct': {'date': '2009-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain', 'timeFrame': '1day'}], 'secondaryOutcomes': [{'measure': 'other signs', 'timeFrame': '1day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['lidocaine', 'fibromyalgia', 'intravenous lidocaine', 'manifestations'], 'conditions': ['Fibromyalgia']}, 'descriptionModule': {'briefSummary': 'The effect of intravenous lidocaine infusion on manifestations of fibromyalgia manifestations were recorded before and 4 weeks after treatment. Pain intensity was rated on a numerical scale.The combination of 240 mg intravenous lidocaine (once a week) and 25 mg amitriptyline for 4 weeks did not modify pain intensity or manifestations in patients with fibromyalgia.', 'detailedDescription': 'Thirty patients ranging in age from 18 to 60 years, with fibromyalgia (American College of Rheumatology criteria: pain in the four quadrants of the body for at least 3 months and a minimum of 11 out of 18 tender points) were studied. Other manifestations were also recorded: sleep disorders, fatigue, subjective edema, depression, and paresthesia.\n\nCriteria for exclusion were alterations in thyroid, rheumatological, renal and hepatic function; trauma; rheumatic, neuromuscular or psychiatric disease; infectious arthropathy; other pain syndromes; drug hypersensitivity, and pregnancy.\n\nAll patients received amitriptyline at a dose of 12.5 mg in the first week and 25 mg over the subsequent 4 weeks. Patients of group 1 (n = 15) received 125 mL 0.9% saline and patients of group 2 (n = 15) received 240 mg lidocaine diluted in 125 mL 0.9% saline. The solutions were infused over a period of 1 h, once a week, for 4 weeks (T1, T2, T3 and T4).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 60 years, with fibromyalgia (American College of Rheumatology criteria: pain in the four quadrants of the body for at least 3 months and a minimum of 11 out of 18 tender points\n\nExclusion Criteria:\n\n* Thyroid, rheumatological, renal and hepatic function\n* Trauma\n* Rheumatic, neuromuscular or psychiatric disease\n* Infectious arthropathy\n* Other pain syndromes\n* Drug hypersensitivity; AND\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT00986505', 'briefTitle': 'Intravenous Lidocaine for Fibromyalgia', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of São Paulo'}, 'officialTitle': 'Effect of Intravenous Lidocaine on Manifestations of Fibromyalgia', 'orgStudyIdInfo': {'id': 'IV lidocaine'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lidocaine', 'description': 'Comparison between intravenous lidocaine and saline infusion', 'interventionNames': ['Drug: Lidocaine']}], 'interventions': [{'name': 'Lidocaine', 'type': 'DRUG', 'otherNames': ['Lidocaine infusion', 'Saline infusion'], 'description': 'Intravenous lidocaine once a week', 'armGroupLabels': ['Lidocaine']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Rioko K Sakata, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universidade Federal de São Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of São Paulo', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Roberto Vlainich', 'oldOrganization': 'Federal University of São Paulo'}}}}