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

This study has been completed.
Sponsor:
Information provided by:
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT00904527
First received: May 18, 2009
Last updated: May 19, 2009
Last verified: May 2009
  Purpose

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


Condition Intervention
Migraine
Behavioral: relaxation (Schultz)
Behavioral: without relaxation

Study Type: Interventional
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

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison between the 2 groups of intensity of migraine, medication use and quality of life [ Time Frame: 4 months ] [ Designated as safety issue: No ]

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 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00904527

Locations
France
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
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
  More Information

No publications provided

Responsible Party: Pr Bernard LAURENT, Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT00904527     History of Changes
Other Study ID Numbers: 0601001b
Study First Received: May 18, 2009
Last Updated: May 19, 2009
Health Authority: France: French Data Protection Authority

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

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 16, 2014