Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2026-02-24 @ 9:57 PM
Study NCT ID:
NCT01687660
Status:
COMPLETED
Last Update Posted:
2020-02-17
First Post:
2012-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acupuncture for Migraine Prophylaxis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020326', 'term': 'Migraine without Aura'}, {'id': 'D006261', 'term': 'Headache'}], 'ancestors': [{'id': 'D008881', 'term': 'Migraine Disorders'}, {'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015670', 'term': 'Acupuncture Therapy'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 249}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-13', 'studyFirstSubmitDate': '2012-08-31', 'studyFirstSubmitQcDate': '2012-09-18', 'lastUpdatePostDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'MSQ(Migraine Specific Quality of Life Questionnaire MSQ Version2.1)', 'timeFrame': 'the day of inclusion and 4th week after inclusion', 'description': 'to observe the change of MSQ'}, {'measure': 'acupuncture expectation scale', 'timeFrame': '1 day', 'description': 'an outcome to indicate the expectation of patient towards acupuncture treatment for migraine'}], 'primaryOutcomes': [{'measure': 'frequency of migraine attacks', 'timeFrame': '16th week after inclusion', 'description': 'to assess the frequency of migraine attacks at the 16th week after inclusion'}], 'secondaryOutcomes': [{'measure': 'frequency of migraine attacks', 'timeFrame': '4th and 24th week after inclusion', 'description': 'to assess the frequency of migraine attacks at the 4th and 24th week respectively'}, {'measure': 'headache severity', 'timeFrame': '0 day, 4th, 8th, 12th, 16th, 20th, 24th week after inclusion', 'description': 'to evaluate the change of severity of headache'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['acupuncture', 'migraine prophylaxis'], 'conditions': ['Migraine Without Aura', 'Unilateral Headache']}, 'referencesModule': {'references': [{'pmid': '28241154', 'type': 'DERIVED', 'citation': 'Zhao L, Chen J, Li Y, Sun X, Chang X, Zheng H, Gong B, Huang Y, Yang M, Wu X, Li X, Liang F. The Long-term Effect of Acupuncture for Migraine Prophylaxis: A Randomized Clinical Trial. JAMA Intern Med. 2017 Apr 1;177(4):508-515. doi: 10.1001/jamainternmed.2016.9378.'}, {'pmid': '24171782', 'type': 'DERIVED', 'citation': 'Chen J, Zhao L, Zheng H, Li Y, Yang M, Chang X, Gong B, Huang Y, Liu Y, Liang F. Evaluating the prophylaxis and long-term effectiveness of acupuncture for migraine without aura: study protocol for a randomized controlled trial. Trials. 2013 Oct 30;14:361. doi: 10.1186/1745-6215-14-361.'}]}, 'descriptionModule': {'briefSummary': 'Hypothesis: Acupuncture obtains an abiding effect on migraine prophylaxis Design: A open-label randomized controlled trial. 249 participants will be included. Three arms: acupuncture in acupoint-meridian， non-acupoint-meridian group, and waiting list.', 'detailedDescription': 'Aim: to attest the abiding efficacy and safety of acupuncture for migraine prophylaxis Design: A open-label randomized controlled trial will be performed in Chengdu, Hunan and Chongqing province. Two hundred and forty-three participants will be randomly assign to acupoint-meridian group, non-acupoint-meridian group, and wait-and-see group. Each participants will receive 20 sessions of acupuncture in 4 weeks, with a duration of 30 minutes in a session. After all the treatments was accomplished, there will be 5 times follow-ups in the impending every 4 weeks. The primary outcome is frequency of migraine attacks 16 weeks after inclusion. Secondary outcomes include frequency of migraine attacks at the 4th and 24th week, headache severity, MSQ(Migraine Specific Quality of Life Questionnaire MSQ Version2.1), etc.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age of a subject is between 18 and 65 years old(initially occured beneath the age of 50), male or female;\n* in accordance with diagnosis of migraine without aura in International Classification of Headache Disorders, ICHD-2, by IHS;\n* 2 to 8 times attack per month in recent 3 months, with each period beyond 15 days;\n* with migraine history for over 1 year;\n* be able and willing to finish the headache diary in baseline ;\n* informed consent form must be signed by patient or lineal relative;\n\nExclusion Criteria：\n\n* Patients who are unconscious, psychotic.\n* Patients with aggravating tumor and other serious consumptive disease, and who are subject to infection and bleeding.\n* With serious primary illness or disease of cardiovascular, liver, renal, gastrointestinal, hematological systems and so on.\n* Pregnant women or women in lactation.'}, 'identificationModule': {'nctId': 'NCT01687660', 'acronym': 'AMP', 'briefTitle': 'Acupuncture for Migraine Prophylaxis', 'organization': {'class': 'OTHER', 'fullName': 'Chengdu University of Traditional Chinese Medicine'}, 'officialTitle': 'A Continuous Study on Abiding Effect of Acupuncture for Migraine Treatment', 'orgStudyIdInfo': {'id': '2012CB518501-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'acupoint-meridian group', 'description': 'Apply traditional acupuncture to prevent the migraine attack according to TCM theory', 'interventionNames': ['Other: acupuncture']}, {'type': 'OTHER', 'label': 'sham-acupoint group', 'description': 'sham-acupoint will be penetrated for migraine prophylaxis.', 'interventionNames': ['Other: acupuncture']}, {'type': 'NO_INTERVENTION', 'label': 'waiting list', 'description': 'No acupuncture nor other methods will be conducted in this group.'}], 'interventions': [{'name': 'acupuncture', 'type': 'OTHER', 'description': 'apply acupuncture to prevent the migraine attack', 'armGroupLabels': ['acupoint-meridian group', 'sham-acupoint group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '610075', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'Chengdu University of TCM', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'overallOfficials': [{'name': 'Fanrong Liang, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chengdu University of Traditional Chinese Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Li ying', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hunan University of Traditional Chinese Medicine', 'class': 'OTHER'}, {'name': 'Chongqing Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chengdu University of Traditional Chinese Medicine', 'investigatorFullName': 'Li ying', 'investigatorAffiliation': 'Chengdu University of Traditional Chinese Medicine'}}}}