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

This study has been completed.
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne Identifier:
First received: May 18, 2009
Last updated: July 27, 2015
Last verified: July 2015
The purpose of this study is to determine whether relaxation (autogenic training of Schultz) is effective in treatment for migraine.

Condition Intervention
Behavioral: relaxation (Schultz)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Interest of Relaxation From Patients With Pain Due to Migraine

Resource links provided by NLM:

Further study details as provided by Centre Hospitalier Universitaire de Saint Etienne:

Primary Outcome Measures:
  • Comparison of reduction of migraine frequency between the 2 groups (with or without relaxation) [ Time Frame: 4 months ]

Secondary Outcome Measures:
  • Comparison between the 2 groups of intensity of migraine, medication use and quality of life [ Time Frame: 4 months ]

Enrollment: 60
Study Start Date: June 2006
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its 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
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Study Director: LAURENT Bernard, MD PhD Centre Hospitalier Universitaire de Saint Etienne
Study Chair: PICKERING Gisèle, MD Centre d'Investigation Clinique de Clermont-Ferrand
  More Information

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne Identifier: NCT00904527     History of Changes
Other Study ID Numbers: 0601001b
Study First Received: May 18, 2009
Last Updated: July 27, 2015

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Relaxation (Schultz)
antipain center

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases processed this record on April 26, 2017