Ignite Creation Date:
2025-12-24 @ 11:49 AM
Ignite Modification Date:
2026-01-04 @ 12:38 PM
Study NCT ID:
NCT03036761
Status:
COMPLETED
Last Update Posted:
2021-04-21
First Post:
2017-01-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interest of Auriculotherapy in Prophylaxis of Migraine and Headache in Patients With Migraines
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055097', 'term': 'Auriculotherapy'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-03-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-20', 'studyFirstSubmitDate': '2017-01-27', 'studyFirstSubmitQcDate': '2017-01-27', 'lastUpdatePostDateStruct': {'date': '2021-04-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of days with migraine and non-migraine headache post inclusion.', 'timeFrame': '3 months', 'description': "Evaluated with the patient's migraine/headache/treatment diary of the last 3 months after inclusion.\n\nOne day with painful episodes of migraines and non-migraines headaches is a day when:\n\n* the pain episode lasts more than 4 hours,\n* or the pain episode is suppressed by a specific treatment known to the patient."}], 'secondaryOutcomes': [{'measure': 'Number of days with migraine post inclusion.', 'timeFrame': '3 months', 'description': "Evaluated with the patient's migraine/headache/treatment diay of the last 3 months after inclusion.\n\nOne day with painful episodes of migraines is a day when:\n\n* the pain episode lasts more than 4 hours,\n* or the pain episode is suppressed by a specific treatment known to the patient."}, {'measure': 'Number of days with non migraine headache post inclusion.', 'timeFrame': '3 months', 'description': "Evaluated with the patient's migraine/headache/treatment diary of the last 3 months after inclusion.\n\nOne day with painful episodes of non-migraines headaches is a day when:\n\n* the pain episode lasts more than 4 hours,\n* or the pain episode is suppressed by a specific treatment known to the patient."}, {'measure': 'Intensity of pain episodes (migraines and non-migraine headaches) post inclusion: numerical scale', 'timeFrame': '3 months', 'description': "The intensity of the pain episodes is evaluated by the patient on a numerical scale of 1 to 3 (1 = low, 2 = moderate, 3 = intense) which is in the patient's migraine/headache/treatment diary of the 3 months after inclusion.\n\nThe outcome is evaluated by the calculation of the sum of the pain intensities of migraines and non-migraine headaches ."}, {'measure': 'Evolution of antalgic use (triptan and non-triptan) in migraine patients.', 'timeFrame': '3 months', 'description': "Evaluated with the patient's migraine/headache/treatment diary of the last 3 months after inclusion.\n\nThe sum of antalgic use (triptan and non-triptan):\n\n* total number of triptan taken;\n* number of days with triptan;\n* total number of non-triptan analgesics taken;\n* number of days with non-triptan analgesics."}, {'measure': 'Evaluation of the quality of life of the patient: MIDAS score', 'timeFrame': '3 months', 'description': 'Calculation of the MIDAS score during the inclusion visit and 3 months after the inclusion visit.'}, {'measure': 'Tolerance of auriculotherapy treatment', 'timeFrame': '3 months', 'description': 'The presence or absence of adverse events attributed to the treatment of auriculotherapy by the patient.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Auriculotherapy'], 'conditions': ['Headache, Migraine']}, 'referencesModule': {'references': [{'pmid': '37284181', 'type': 'DERIVED', 'citation': "Michel-Cherqui M, Ma S, d'Ussel M, Ebbo D, Spassova A, Chaix-Couturier C, Szekely B, Fischler M, Lemaire N, Le Guen M. Auriculotherapy in prevention of migraine attacks: an open randomized trial. Front Neurol. 2023 May 22;14:1193752. doi: 10.3389/fneur.2023.1193752. eCollection 2023."}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to show that auriculotherapy decreases the number of days with painful episodes of migraine and headache after 3 months of treatment', 'detailedDescription': 'Prospective, multicenter, controlled and randomized study.\n\nAt the inclusion:\n\n* initial assessment of migraine and headache attacks of the last 3 months with the migraine/headache/treatment diary;\n* quality of life assessment (MIDAS questionnaire).\n\nPatients are randomized in 2 groups (distribution 2/3 AUR+, 1/3 AUR-):\n\n* AUR+: experimental group "Auriculotherapy". Patients benefit from 3 sessions of auriculotherapy at one month intervals.\n* AUR-: control group. Patients do not benefit from auriculotherapy.\n\nAfter 3 months, a visit of Algology is carried out :\n\n* final assessment of migraine and headache attacks of the last 3 months with the migraine/headache/treatment diary;\n* quality of life assessment (MIDAS questionnaire).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Months', 'genderBased': True, 'genderDescription': 'Woman', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Woman;\n* Aged from 18 to 80;\n* Benefiting from social security scheme or legal successor;\n* Having given their non-opposition to the study; ·\n* Diagnosis of chronical migraine for more than 6 months;\n* Without background treatment or with stable background therapy for more than 1 month;\n* Presenting a calendar of migraines and headaches mentioning the number of days with pain, intensity of pain and treatments for at least 3 months.\n\nNon inclusion Criteria:\n\n* Man;\n* Patient with less than 6 painful episodes in 3 months;\n* History or actual mental health disorder;\n* Dependence on opioids or tranquillizers;\n* Secondary headaches;\n* Incapacitated to keep a diary of the migraines / headaches / treatments;\n* Contraindications for the use of auriculotherapy (scheduled Magnetic resonance imaging examination, declared pregnancy, breastfeeding, artificial heart valves, Haemophilia, effective anticoagulation treatment);\n* Having received auriculotherapy treatment in the indication of the study in the last 12 months before inclusion;\n* Scheduled to start a new drug or non-drug therapy which could interfere with the study (antidepressant, opioids, anticonvulsant psychological therapy, physiotherapy, deep brain stimulation, etc..);\n* Modification of background treatment during the month before inclusion.\n\nExclusion criteria\n\n* Allergy or infection of the auricle\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT03036761', 'acronym': 'Migauric', 'briefTitle': 'Interest of Auriculotherapy in Prophylaxis of Migraine and Headache in Patients With Migraines', 'organization': {'class': 'OTHER', 'fullName': 'Hopital Foch'}, 'officialTitle': 'Interest of Auriculotherapy in Prophylaxis of Migraine and Headache in Patients With Migraines', 'orgStudyIdInfo': {'id': '2016/58'}, 'secondaryIdInfos': [{'id': '2016-A01534-47', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AUR+: Auriculotherapy', 'description': 'Patients benefit from 3 sessions of auriculotherapy at one month intervals.', 'interventionNames': ['Procedure: Auriculotherapy']}, {'type': 'NO_INTERVENTION', 'label': 'AUR-: No auriculotherapy', 'description': 'Patients do not benefit from auriculotherapy.'}], 'interventions': [{'name': 'Auriculotherapy', 'type': 'PROCEDURE', 'description': '3 sessions of auriculotherapy at one month intervals.', 'armGroupLabels': ['AUR+: Auriculotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94700', 'city': 'Maisons-Alfort', 'country': 'France', 'facility': 'Cabinet Médical', 'geoPoint': {'lat': 48.81171, 'lon': 2.43945}}, {'zip': '78180', 'city': 'Montigny-le-Bretonneux', 'country': 'France', 'facility': "Centre Médical de L'Olivier", 'geoPoint': {'lat': 48.76636, 'lon': 2.03405}}, {'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'GHP Saint Joseph', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '92150', 'city': 'Suresnes', 'country': 'France', 'facility': 'Hopital Foch', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}], 'overallOfficials': [{'name': 'Mireille Michel-Cherqui, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hopital Foch'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hopital Foch', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}