Clinical trial NCT03036761: Interest of Auriculotherapy in Prophylaxis of Migraine and Headache in Patients With Migraines
Official title: Interest of Auriculotherapy in Prophylaxis of Migraine and Headache in Patients With Migraines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Headache, Migraine
Keywords: Auriculotherapy
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2017-01-30
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Number of days with migraine and non-migraine headache post inclusion.
timeFrame: 3 months
Secondary outcomes:
measure: Number of days with migraine post inclusion.
timeFrame: 3 months
measure: Number of days with non migraine headache post inclusion.
timeFrame: 3 months
measure: Intensity of pain episodes (migraines and non-migraine headaches) post inclusion: numerical scale
timeFrame: 3 months
measure: Evolution of antalgic use (triptan and non-triptan) in migraine patients.
timeFrame: 3 months
measure: Evaluation of the quality of life of the patient: MIDAS score
timeFrame: 3 months
measure: Tolerance of auriculotherapy treatment
timeFrame: 3 months
Other outcomes:
Locations:
city: Maisons-Alfort
country: France
facility: Cabinet Médical
city: Montigny-le-Bretonneux
country: France
facility: Centre Médical de L'Olivier
city: Paris
country: France
facility: GHP Saint Joseph
city: Suresnes
country: France
facility: Hopital Foch
Study officials:
affiliation: Hopital Foch
name: Mireille Michel-Cherqui, MD
role: PRINCIPAL_INVESTIGATOR
References: