Headache, Migraine
Conditions
Keywords
Auriculotherapy
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).
Interventions
PROCEDUREAuriculotherapy
3 sessions of auriculotherapy at one month intervals.
Sponsors
Hopital Foch
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Months to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of days with migraine and non-migraine headache post inclusion. | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of days with non migraine headache post inclusion. | 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. |
| Intensity of pain episodes (migraines and non-migraine headaches) post inclusion: numerical scale | 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 . |
| Number of days with migraine post inclusion. | 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. |
| Evaluation of the quality of life of the patient: MIDAS score | 3 months | Calculation of the MIDAS score during the inclusion visit and 3 months after the inclusion visit. |
| Tolerance of auriculotherapy treatment | 3 months | The presence or absence of adverse events attributed to the treatment of auriculotherapy by the patient. |
| Evolution of antalgic use (triptan and non-triptan) in migraine patients. | 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. |
Countries
France
Outcome results
None listed