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

H

Hopital Foch

Status

Completed

Conditions

Headache, Migraine

Treatments

Procedure: Auriculotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT03036761
2016-A01534-47 (Other Identifier)
2016/58

Details and patient eligibility

About

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

Full 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).

Enrollment

90 patients

Sex

Female

Ages

18 months to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

90 participants in 2 patient groups

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

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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