Interest of Relaxation From Patients With Pain Due to Migraine

Not Applicable

Completed

• Conditions: Migraine
• Interventions: Behavioral: relaxation (Schultz)

• Registration Number: NCT00904527
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

The purpose of this study is to determine whether relaxation (autogenic training of Schultz) is effective in treatment for migraine.

Detailed Description

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.

Study Timeline

• Study Start: 2006-06
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Study First Submitted: 2009-05-18
• Study First Submitted QC: 2009-05-18
• Study First Posted: 2009-05-19
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-27
• Last Update Posted: 2015-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• age > 18 years
• 5 to 14 days of migraines per month

Exclusion Criteria

• Headache by medication abuse
• Patients who already know relaxation technics
• Depression
• Contra indication of using beta-bloquant or Oxetorone

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Relaxation	relaxation (Schultz)	Relaxation (Schultz)+ medical treatment (beta-bloquant or Oxetorone)+ patient's education

Primary Outcome Measures

Name	Time	Method
Comparison of reduction of migraine frequency between the 2 groups (with or without relaxation)	4 months

Secondary Outcome Measures

Name	Time	Method
Comparison between the 2 groups of intensity of migraine, medication use and quality of life	4 months

Trial Locations

Locations (9)

UTCD - CHU Pellegrin; 🇫🇷 Bordeaux, France

CETD - CHU de Caen; 🇫🇷 Caen, France

CETD du CHU Gabriel Montpied; 🇫🇷 Clermont-Ferrand, France

CETD CHU de Grenoble; 🇫🇷 Grenoble, France

Consultation de la douleur - CH Emile Roux; 🇫🇷 Le Puy-en Velay, France

CETD du CHU de Saint-ETienne; 🇫🇷 Saint Etienne, France

CETD CH de Nemours; 🇫🇷 Nemours, France

CETD Hôpital Rangueil; 🇫🇷 Toulouse, France

Consultation de la douleur du CHU d'Amiens; 🇫🇷 Amiens, France