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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-18

Study Completion Date

2021-03-22

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

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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).

Conditions

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Headache, Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AUR+: Auriculotherapy

Patients benefit from 3 sessions of auriculotherapy at one month intervals.

Group Type EXPERIMENTAL

Auriculotherapy

Intervention Type PROCEDURE

3 sessions of auriculotherapy at one month intervals.

AUR-: No auriculotherapy

Patients do not benefit from auriculotherapy.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Auriculotherapy

3 sessions of auriculotherapy at one month intervals.

Intervention Type PROCEDURE

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.

* 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.