ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03036761
Recruitment Status : Recruiting
First Posted : January 30, 2017
Last Update Posted : November 1, 2018
Sponsor:
Information provided by (Responsible Party):
Hopital Foch

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

Condition or disease Intervention/treatment Phase
Headache, Migraine Procedure: Auriculotherapy Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Interest of Auriculotherapy in Prophylaxis of Migraine and Headache in Patients With Migraines
Actual Study Start Date : January 18, 2017
Estimated Primary Completion Date : January 18, 2019
Estimated Study Completion Date : April 18, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine

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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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. 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 .


  4. 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.

  5. 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.

  6. Tolerance of auriculotherapy treatment [ Time Frame: 3 months ]
    The presence or absence of adverse events attributed to the treatment of auriculotherapy by the patient.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Months to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Woman
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03036761


Contacts
Contact: Mireille Michel-Cherqui, MD +33(0)146252985 m.michel-cherqui@hopital-foch.org

Locations
France
Cabinet Médical Recruiting
Maisons-Alfort, France, 94700
Contact: Antoinette Spassova, MD    +33(0)143681410    antoinette.spassova@gmail.com   
GHP Saint Joseph Recruiting
Paris, France, 75014
Contact: Marguerite D'Ussel, MD    +33(0)144127147    mdussel@hpsj.fr   
Hopital Foch Recruiting
Suresnes, France, 92150
Contact: Mireille Miche-Cherqui, MD    +33(0)146252985    m.michel-cherqui@hopital-foch.org   
Sponsors and Collaborators
Hopital Foch
Investigators
Principal Investigator: Mireille Michel-Cherqui, MD Hopital Foch

Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT03036761     History of Changes
Other Study ID Numbers: 2016/58
2016-A01534-47 ( Other Identifier: ANSM )
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hopital Foch:
Auriculotherapy

Additional relevant MeSH terms:
Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms