Interest of Auriculotherapy in Prophylaxis of Migraine and Headache in Patients With Migraines (Migauric)

April 20, 2021 updated by: Hopital Foch
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

Study Overview

Status

Completed

Conditions

Intervention / 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 Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Maisons-Alfort, France, 94700
        • Cabinet Medical
      • Montigny-le-Bretonneux, France, 78180
        • Centre Médical de L'Olivier
      • Paris, France, 75014
        • GHP Saint Joseph
      • Suresnes, France, 92150
        • Hôpital Foch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 76 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital Foch

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2017

Primary Completion (Actual)

December 14, 2020

Study Completion (Actual)

March 22, 2021

Study Registration Dates

First Submitted

January 27, 2017

First Submitted That Met QC Criteria

January 27, 2017

First Posted (Estimate)

January 30, 2017

Study Record Updates

Last Update Posted (Actual)

April 21, 2021

Last Update Submitted That Met QC Criteria

April 20, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016/58
  • 2016-A01534-47 (Other Identifier: ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Headache, Migraine

Clinical Trials on Auriculotherapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sri Lanka

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe