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The purpose of this study is to determine whether relaxation (autogenic training of Schultz) is effective in treatment for migraine.
This randomized, multicenter study compares 2 parallel groups of patients with migraine :
Visit 1 : 1 month before randomization for patient's selection and baseline data
Visit 2 (J0): inclusion (randomization) During the first 2 months patients from group I benefit from relaxation consultations.
Visit 3 (2 months after randomization)and visit 4 (4 months after randomization) : evaluation of the efficacy of the two treatment strategies.
Primary endpoint :
- number of days with migraine per month from J0 to visit 4.
Secondary endpoints :
Each day, patients note in a notebook if a migraine appears and its intensity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Relaxation | Experimental | Relaxation (Schultz)+ medical treatment (beta-bloquant or Oxetorone)+ patient's education |
|
| without relaxation | No Intervention | Patients have no relaxation (only medical treatment+ education) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| relaxation (Schultz) | Behavioral | Patients have relaxation consultations during 2 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of reduction of migraine frequency between the 2 groups (with or without relaxation) | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison between the 2 groups of intensity of migraine, medication use and quality of life | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| LAURENT Bernard, MD PhD | Centre Hospitalier Universitaire de Saint Etienne | Study Director |
| PICKERING Gisèle, MD | Centre d'Investigation Clinique de Clermont-Ferrand | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Consultation de la douleur du CHU d'Amiens | Amiens | 80000 | France | |||
| UTCD - CHU Pellegrin |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Bordeaux |
| 33000 |
| France |
| CETD - CHU de Caen | Caen | 14033 | France |
| CETD du CHU Gabriel Montpied | Clermont-Ferrand | 63000 | France |
| CETD CHU de Grenoble | Grenoble | 38043 | France |
| Consultation de la douleur - CH Emile Roux | Le Puy-en-Velay | 43000 | France |
| CETD CH de Nemours | Nemours | 77140 | France |
| CETD du CHU de Saint-ETienne | Saint-Etienne | 42055 | France |
| CETD Hôpital Rangueil | Toulouse | 31403 | France |
| D009422 | Nervous System Diseases |