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Completed

NCT Number: NCT03036761

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

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

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Key information

Age range

18 month–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cabinet Médical, Maisons-Alfort, France

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Auriculotherapy

Procedure

3 sessions of auriculotherapy at one month intervals.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Acronym: Migauric

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Jan 30, 2017
Registry last updated
Apr 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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