Interest of Auriculotherapy in Prophylaxis of Migraine and Headache in Patients With Migraines

Not Applicable

Completed

• Conditions: Headache, Migraine
• Interventions: Procedure: Auriculotherapy

• Registration Number: NCT03036761
• Lead Sponsor: Hopital Foch

Brief Summary

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

Detailed Description

Prospective, multicenter, controlled and randomized study.

At the inclusion:

* initial assessment of migraine and headache attacks of the last 3 months with the migraine/headache/treatment diary;

* quality of life assessment (MIDAS questionnaire).

Patients are randomized in 2 groups (distribution 2/3 AUR+, 1/3 AUR-):

* AUR+: experimental group "Auriculotherapy". Patients benefit from 3 sessions of auriculotherapy at one month intervals.

* AUR-: control group. Patients do not benefit from auriculotherapy.

After 3 months, a visit of Algology is carried out :

* final assessment of migraine and headache attacks of the last 3 months with the migraine/headache/treatment diary;

* quality of life assessment (MIDAS questionnaire).

Study Timeline

• Study Start: 2017-01-18
• Study First Submitted: 2017-01-27
• Study First Submitted QC: 2017-01-27
• Study First Posted: 2017-01-30
• Primary Completion: 2020-12-14
• Study Completion: 2021-03-22
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-20
• Last Update Posted: 2021-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

• Woman;
• Aged from 18 to 80;
• Benefiting from social security scheme or legal successor;
• Having given their non-opposition to the study; ·
• Diagnosis of chronical migraine for more than 6 months;
• Without background treatment or with stable background therapy for more than 1 month;
• Presenting a calendar of migraines and headaches mentioning the number of days with pain, intensity of pain and treatments for at least 3 months.

Non inclusion Criteria:

• Man;
• Patient with less than 6 painful episodes in 3 months;
• History or actual mental health disorder;
• Dependence on opioids or tranquillizers;
• Secondary headaches;
• Incapacitated to keep a diary of the migraines / headaches / treatments;
• Contraindications for the use of auriculotherapy (scheduled Magnetic resonance imaging examination, declared pregnancy, breastfeeding, artificial heart valves, Haemophilia, effective anticoagulation treatment);
• Having received auriculotherapy treatment in the indication of the study in the last 12 months before inclusion;
• 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..);
• Modification of background treatment during the month before inclusion.

Exclusion criteria

• Allergy or infection of the auricle
• Pregnancy

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AUR+: Auriculotherapy	Auriculotherapy	Patients benefit from 3 sessions of auriculotherapy at one month intervals.

Primary Outcome Measures

Name	Time	Method
Number of days with migraine and non-migraine headache post inclusion.	3 months	Evaluated with the patient's migraine/headache/treatment diary of the last 3 months after inclusion.; One day with painful episodes of migraines and non-migraines headaches is a day when: * the pain episode lasts more than 4 hours,; * or the pain episode is suppressed by a specific treatment known to the patient.

Secondary Outcome Measures

Name	Time	Method
Intensity of pain episodes (migraines and non-migraine headaches) post inclusion: numerical scale	3 months	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.; The outcome is evaluated by the calculation of the sum of the pain intensities of migraines and non-migraine headaches .
Evaluation of the quality of life of the patient: MIDAS score	3 months	Calculation of the MIDAS score during the inclusion visit and 3 months after the inclusion visit.
Tolerance of auriculotherapy treatment	3 months	The presence or absence of adverse events attributed to the treatment of auriculotherapy by the patient.
Number of days with migraine post inclusion.	3 months	Evaluated with the patient's migraine/headache/treatment diay of the last 3 months after inclusion.; One day with painful episodes of migraines is a day when: * the pain episode lasts more than 4 hours,; * or the pain episode is suppressed by a specific treatment known to the patient.
Number of days with non migraine headache post inclusion.	3 months	Evaluated with the patient's migraine/headache/treatment diary of the last 3 months after inclusion.; One day with painful episodes of non-migraines headaches is a day when: * the pain episode lasts more than 4 hours,; * or the pain episode is suppressed by a specific treatment known to the patient.
Evolution of antalgic use (triptan and non-triptan) in migraine patients.	3 months	Evaluated with the patient's migraine/headache/treatment diary of the last 3 months after inclusion.; The sum of antalgic use (triptan and non-triptan): * total number of triptan taken; * number of days with triptan; * total number of non-triptan analgesics taken; * number of days with non-triptan analgesics.

Trial Locations

Locations (4)

Cabinet Médical; 🇫🇷 Maisons-Alfort, France

Centre Médical de L'Olivier; 🇫🇷 Montigny-le-Bretonneux, France

GHP Saint Joseph; 🇫🇷 Paris, France

Hopital Foch; 🇫🇷 Suresnes, France