Interest of Relaxation From Patients With Pain Due to Migraine (MIGREL)

July 27, 2015 updated by: Centre Hospitalier Universitaire de Saint Etienne
The purpose of this study is to determine whether relaxation (autogenic training of Schultz) is effective in treatment for migraine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80000
        • Consultation de la douleur du CHU d'Amiens
      • Bordeaux, France, 33000
        • UTCD - CHU Pellegrin
      • Caen, France, 14033
        • CETD - CHU de Caen
      • Clermont-Ferrand, France, 63000
        • CETD du CHU Gabriel Montpied
      • Grenoble, France, 38043
        • CETD CHU de Grenoble
      • Le Puy-en Velay, France, 43000
        • Consultation de la douleur - CH Emile Roux
      • Nemours, France, 77140
        • CETD CH de Nemours
      • Saint Etienne, France, 42055
        • CETD du CHU de Saint-ETienne
      • Toulouse, France, 31403
        • CETD Hôpital Rangueil

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Relaxation
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 have no relaxation (only medical treatment+ education)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparison of reduction of migraine frequency between the 2 groups (with or without relaxation)
Time Frame: 4 months
4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparison between the 2 groups of intensity of migraine, medication use and quality of life
Time Frame: 4 months
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Study Director: LAURENT Bernard, MD PhD, Centre Hospitalier Universitaire de Saint Etienne
  • Study Chair: PICKERING Gisèle, MD, Centre d'Investigation Clinique de Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

May 18, 2009

First Submitted That Met QC Criteria

May 18, 2009

First Posted (Estimate)

May 19, 2009

Study Record Updates

Last Update Posted (Estimate)

July 28, 2015

Last Update Submitted That Met QC Criteria

July 27, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0601001b

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Migraine

Clinical Trials on relaxation (Schultz)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kuwait

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe