Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT01096420
Status:
COMPLETED
Last Update Posted:
2013-08-14
First Post:
2010-03-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Acupuncture in Chronic Migraine: A Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015670', 'term': 'Acupuncture Therapy'}, {'id': 'D000077236', 'term': 'Topiramate'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D005632', 'term': 'Fructose'}, {'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D007661', 'term': 'Ketoses'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-12', 'studyFirstSubmitDate': '2010-03-29', 'studyFirstSubmitQcDate': '2010-03-30', 'lastUpdatePostDateStruct': {'date': '2013-08-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean monthly number of headache days with moderate or severe intensity', 'timeFrame': '3 months', 'description': 'a day with headache pain that lasts ≧ 4 h with peak severity of moderate or severe intensity, or any severity or duration if the subject takes and response to a triptan or ergot.'}], 'secondaryOutcomes': [{'measure': '≥ 30% or ≥ 50% reduction in mean monthly headache days with moderate or severe intensity', 'timeFrame': '3 months'}, {'measure': 'Mean monthly total headache days', 'timeFrame': '3 months'}, {'measure': 'Reduction from baseline in the use of acute headache medications', 'timeFrame': '3 months'}, {'measure': 'Short-Form 36-Item Health Survey(SF-36)', 'timeFrame': '3 months'}, {'measure': 'Beck Depression Inventory(BDI)', 'timeFrame': '3 months'}, {'measure': 'Migraine disability assessment questionnaire (MIDAS)', 'timeFrame': '3 months'}, {'measure': 'Plasma CGRP level', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['chronic migraine', 'acupuncture', 'Topiramate', 'Randomized trial'], 'conditions': ['Patients With Chronic Migraine']}, 'referencesModule': {'references': [{'pmid': '22019576', 'type': 'DERIVED', 'citation': 'Yang CP, Chang MH, Liu PE, Li TC, Hsieh CL, Hwang KL, Chang HH. Acupuncture versus topiramate in chronic migraine prophylaxis: a randomized clinical trial. Cephalalgia. 2011 Nov;31(15):1510-21. doi: 10.1177/0333102411420585. Epub 2011 Oct 21.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study was to investigate the efficacy and tolerance of acupuncture treatment compared with pharmacologic treatment in patients with chronic migraines.Besides, the investigators tested whether the clinical effects of acupuncture in chronic migraine prophylaxis are mediated by changes of the plasma CGRP (Calcitonin gene-related peptide).', 'detailedDescription': 'Subjects who completed the prospective baseline periods and meet met the prespecified entry criteria will be randomized into 2 groups: acupuncture treatment, and topiramate treatment group.\n\nSubjects will be allowed to continue taking acute migraine medications for the treatment of breakthrough attacks during the trial, but any migraine preventive medications will be prohibited.\n\nWritten informed consent was obtained from all participants before entering the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 18 to 75 years old\n* Patients were required to have a diagnosis of chronic migraine with or without medication overuse that satisfied the ICHD-2 criteria during the last 3 months prior to trial entry, with an established migraine history for at least 1 year.\n\nExclusion Criteria:\n\n* Patients did not fulfill the criteria of ≧ 15 days or response to triptans or ergots on at least 8 days in prospective baseline periods .\n* The presence of headaches other than chronic migraine (such as another primary chronic headache or any secondary headache).\n* Migraine prophylaxis agents during last 3 months including β-blockers, anti-depressants, calcium channel blockers, anti-epileptic agents or cycle-modulating hormonal drugs.\n* Migraine onset after age 50 or the age at onset of CM \\> 60 years.\n* History of hepatic disorder, nephrolithiasis or other severe illness.\n* Cognitive impairment interfering with the subject's ability to follow instructions and describe symptoms.\n* Prior fearful experience of acupuncture.\n* Bleeding diathesis or anticoagulation.\n* Pregnant or nursing."}, 'identificationModule': {'nctId': 'NCT01096420', 'briefTitle': 'Acupuncture in Chronic Migraine: A Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Kuang Tien General Hospital'}, 'officialTitle': 'Acupuncture in Chronic Migraine: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '9713'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'acupuncture', 'interventionNames': ['Procedure: acupuncture']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'topiramate', 'interventionNames': ['Drug: topiramate']}], 'interventions': [{'name': 'acupuncture', 'type': 'PROCEDURE', 'description': 'Each patient had a fixed and classic acupuncture points Ex-HN-3,BL-2,GB-20,EX-HN-5 bilaterally in their 24 sessions.\n\nAcupuncture consisted of 24 sessions of 30 min duration, administrated over 12 weeks (two sessions per week).\n\nSterile disposable and steel needle (3210) were used .\n\nThe needles were manipulated by rotation methods to produce a characteristic sensation know as De Qi.', 'armGroupLabels': ['acupuncture']}, {'name': 'topiramate', 'type': 'DRUG', 'description': 'The patients were submitted to the topiramate treatment also for 12 consecutive weeks.\n\nThe study phase consists of a 4-week titration and a 8-week maintenance period.\n\nAll dosages of topiramate will be initiated at 25 mg/d hs and increased by 25 mg/d weekly to a maximum of 100 mg/day (or to the maximal tolerated dose).\n\nStudy drug was administered daily in equally divided twice daily doses.', 'armGroupLabels': ['topiramate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '433', 'city': 'Taichung', 'state': 'Taiwan', 'country': 'Taiwan', 'facility': 'Kuang Tien General Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kuang Tien General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Chun-pai Yang', 'investigatorAffiliation': 'Kuang Tien General Hospital'}}}}