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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Headache, Migraine

Intervention / Treatment
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* Procedure: Auriculotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Months
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AUR+: Auriculotherapy<br>Patients benefit from 3 sessions of auriculotherapy at one month intervals. | Procedure: Auriculotherapy<br>* 3 sessions of auriculotherapy at one month intervals.<br>|
| No Intervention: AUR-: No auriculotherapy<br>Patients do not benefit from auriculotherapy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days with migraine and non-migraine headache post inclusion. | 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. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days with migraine post inclusion. | 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. | 3 months | 
| Number of days with non migraine headache post inclusion. | 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. | 3 months | 
| Intensity of pain episodes (migraines and non-migraine headaches) post inclusion: numerical scale | 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 . | 3 months | 
| Evolution of antalgic use (triptan and non-triptan) in migraine patients. | 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. | 3 months | 
| Evaluation of the quality of life of the patient: MIDAS score | Calculation of the MIDAS score during the inclusion visit and 3 months after the inclusion visit. | 3 months | 
| Tolerance of auriculotherapy treatment | The presence or absence of adverse events attributed to the treatment of auriculotherapy by the patient. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Auriculotherapy