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

This study is currently recruiting participants.
See Contacts and Locations
Verified February 2017 by Hopital Foch
Sponsor:
Information provided by (Responsible Party):
Hopital Foch
ClinicalTrials.gov Identifier:
NCT03036761
First received: January 27, 2017
Last updated: February 28, 2017
Last verified: February 2017
  Purpose
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 Intervention
Migraine Procedure: Auriculotherapy

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Hopital Foch:

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

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

Estimated Enrollment: 90
Actual Study Start Date: January 2017
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: May 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Auriculotherapy Procedure: Auriculotherapy
No Intervention: No auriculotherapy

  Eligibility

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

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03036761

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

Locations
France
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
  More Information

Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT03036761     History of Changes
Other Study ID Numbers: 2016/58
2016-A01534-47 ( Other Identifier: ANSM )
Study First Received: January 27, 2017
Last Updated: February 28, 2017

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

ClinicalTrials.gov processed this record on September 19, 2017