Interest of Relaxation From Patients With Pain Due to Migraine (MIGREL)
The purpose of this study is to determine whether relaxation (autogenic training of Schultz) is effective in treatment for migraine.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Interest of Relaxation From Patients With Pain Due to Migraine|
- Comparison of reduction of migraine frequency between the 2 groups (with or without relaxation) [ Time Frame: 4 months ] [ Designated as safety issue: No ]
- Comparison between the 2 groups of intensity of migraine, medication use and quality of life [ Time Frame: 4 months ] [ Designated as safety issue: No ]
|Study Start Date:||June 2006|
|Study Completion Date:||April 2009|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
Relaxation (Schultz)+ medical treatment (beta-bloquant or Oxetorone)+ patient's education
Behavioral: relaxation (Schultz)
Patients have relaxation consultations during 2 months
No Intervention: without relaxation
Patients receive medical treatment only (beta-bloquant or Oxetorone)+ education but no relaxation.
Behavioral: without relaxation
patient receive the usual treatment only (beta-bloquant or oxetorone)+ education
This randomized, multicenter study compares 2 parallel groups of patients with migraine :
- I: patients are treated with relaxation + medical treatment (beta-bloquant or Oxetorone)+ patients' education
- II: patients are treated only with medical treatment + patients' education.
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 :
- monthly drug consumption
- percentage of patients who respond (50 % frequency reduction)
- quality of life (SF 36)
Each day, patients note in a notebook if a migraine appears and its intensity.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00904527
|Consultation de la douleur du CHU d'Amiens|
|Amiens, France, 80000|
|UTCD - CHU Pellegrin|
|Bordeaux, France, 33000|
|CETD - CHU de Caen|
|Caen, France, 14033|
|CETD du CHU Gabriel Montpied|
|Clermont-Ferrand, France, 63000|
|CETD CHU de Grenoble|
|Grenoble, France, 38043|
|Consultation de la douleur - CH Emile Roux|
|Le Puy-en Velay, France, 43000|
|CETD CH de Nemours|
|Nemours, France, 77140|
|CETD du CHU de Saint-ETienne|
|Saint Etienne, France, 42055|
|CETD Hôpital Rangueil|
|Toulouse, France, 31403|
|Study Director:||LAURENT Bernard, MD PhD||Centre Hospitalier Universitaire de Saint Etienne|
|Study Chair:||PICKERING Gisèle, MD||Centre d'Investigation Clinique de Clermont-Ferrand|