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. Identifier: NCT03036761
Recruitment Status : Recruiting
First Posted : January 30, 2017
Last Update Posted : March 1, 2017
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
Migraine Procedure: Auriculotherapy Not Applicable

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 2017
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine

Arm Intervention/treatment
Experimental: Auriculotherapy Procedure: Auriculotherapy
No Intervention: No auriculotherapy

Primary Outcome Measures :
  1. Number of days with migraine and headache [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Number of days with migraine [ Time Frame: 3 months ]
  2. Number of days with non migrainous headache [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Months to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 prophylactic treatment or with a prophylactic treatment 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:

  • Men
  • patients 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 prophylactic 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 identifier (NCT number): NCT03036761

Contact: Mireille Michel-Cherqui, MD +33(0)146252985

Hopital Foch Recruiting
Suresnes, France, 92150
Contact: Mireille Miche-Cherqui, MD    +33(0)146252985   
Sponsors and Collaborators
Hopital Foch
Principal Investigator: Mireille Michel-Cherqui, MD Hopital Foch

Responsible Party: Hopital Foch 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: March 1, 2017
Last Verified: February 2017

Keywords provided by Hopital Foch:

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