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

Headache, Migraine Clinical Trial

— Migauric  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03036761
• Other study ID #: 2016/58
• Secondary ID: 2016-A01534-47
• Status: Completed
• Phase: N/A
• Start date: January 18, 2017
• Est. completion date: March 22, 2021

Study information

• Verified date: April 2021
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 22, 2021
• Est. primary completion date: December 14, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Months to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Headache
• Headache, Migraine
• Migraine Disorders

Intervention

Procedure:
• Auriculotherapy
3 sessions of auriculotherapy at one month intervals.

Locations

Country	Name	City	State
France	Cabinet Médical	Maisons-Alfort
France	Centre Médical de L'Olivier	Montigny-le-Bretonneux
France	GHP Saint Joseph	Paris
France	Hopital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Tolerance of auriculotherapy treatment	The presence or absence of adverse events attributed to the treatment of auriculotherapy by the patient.	3 months