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

Primary Purpose

Headache, Migraine

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Auriculotherapy
Sponsored by
Hopital Foch
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Headache, Migraine focused on measuring Auriculotherapy

Eligibility Criteria

18 Months - 80 Years (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Cabinet Médical
  • Centre Médical de L'Olivier
  • GHP Saint Joseph
  • Hopital Foch

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

AUR+: Auriculotherapy

AUR-: No auriculotherapy

Arm Description

Patients benefit from 3 sessions of auriculotherapy at one month intervals.

Patients do not benefit from auriculotherapy.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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 .
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.
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.
Tolerance of auriculotherapy treatment
The presence or absence of adverse events attributed to the treatment of auriculotherapy by the patient.

Full Information

First Posted
January 27, 2017
Last Updated
April 20, 2021
Sponsor
Hopital Foch
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1. Study Identification

Unique Protocol Identification Number
NCT03036761
Brief Title
Interest of Auriculotherapy in Prophylaxis of Migraine and Headache in Patients With Migraines
Acronym
Migauric
Official Title
Interest of Auriculotherapy in Prophylaxis of Migraine and Headache in Patients With Migraines
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
January 18, 2017 (Actual)
Primary Completion Date
December 14, 2020 (Actual)
Study Completion Date
March 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Foch

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache, Migraine
Keywords
Auriculotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AUR+: Auriculotherapy
Arm Type
Experimental
Arm Description
Patients benefit from 3 sessions of auriculotherapy at one month intervals.
Arm Title
AUR-: No auriculotherapy
Arm Type
No Intervention
Arm Description
Patients do not benefit from auriculotherapy.
Intervention Type
Procedure
Intervention Name(s)
Auriculotherapy
Intervention Description
3 sessions of auriculotherapy at one month intervals.
Primary Outcome Measure Information:
Title
Number of days with migraine and non-migraine headache post inclusion.
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Number of days with migraine post inclusion.
Description
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.
Time Frame
3 months
Title
Number of days with non migraine headache post inclusion.
Description
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.
Time Frame
3 months
Title
Intensity of pain episodes (migraines and non-migraine headaches) post inclusion: numerical scale
Description
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 .
Time Frame
3 months
Title
Evolution of antalgic use (triptan and non-triptan) in migraine patients.
Description
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.
Time Frame
3 months
Title
Evaluation of the quality of life of the patient: MIDAS score
Description
Calculation of the MIDAS score during the inclusion visit and 3 months after the inclusion visit.
Time Frame
3 months
Title
Tolerance of auriculotherapy treatment
Description
The presence or absence of adverse events attributed to the treatment of auriculotherapy by the patient.
Time Frame
3 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Woman
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mireille Michel-Cherqui, MD
Organizational Affiliation
Hopital Foch
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cabinet Médical
City
Maisons-Alfort
ZIP/Postal Code
94700
Country
France
Facility Name
Centre Médical de L'Olivier
City
Montigny-le-Bretonneux
ZIP/Postal Code
78180
Country
France
Facility Name
GHP Saint Joseph
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Hopital Foch
City
Suresnes
ZIP/Postal Code
92150
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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