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

Primary Purpose

Migraine

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
relaxation (Schultz)
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine focused on measuring Relaxation (Schultz), Migraine, antipain center

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Consultation de la douleur du CHU d'Amiens
  • UTCD - CHU Pellegrin
  • CETD - CHU de Caen
  • CETD du CHU Gabriel Montpied
  • CETD CHU de Grenoble
  • Consultation de la douleur - CH Emile Roux
  • CETD CH de Nemours
  • CETD du CHU de Saint-ETienne
  • CETD Hôpital Rangueil

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Relaxation

without relaxation

Arm Description

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

Patients have no relaxation (only medical treatment+ education)

Outcomes

Primary Outcome Measures

Comparison of reduction of migraine frequency between the 2 groups (with or without relaxation)

Secondary Outcome Measures

Comparison between the 2 groups of intensity of migraine, medication use and quality of life

Full Information

First Posted
May 18, 2009
Last Updated
July 27, 2015
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
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1. Study Identification

Unique Protocol Identification Number
NCT00904527
Brief Title
Interest of Relaxation From Patients With Pain Due to Migraine
Acronym
MIGREL
Official Title
Interest of Relaxation From Patients With Pain Due to Migraine
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
Relaxation (Schultz), Migraine, antipain center

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Relaxation
Arm Type
Experimental
Arm Description
Relaxation (Schultz)+ medical treatment (beta-bloquant or Oxetorone)+ patient's education
Arm Title
without relaxation
Arm Type
No Intervention
Arm Description
Patients have no relaxation (only medical treatment+ education)
Intervention Type
Behavioral
Intervention Name(s)
relaxation (Schultz)
Intervention Description
Patients have relaxation consultations during 2 months
Primary Outcome Measure Information:
Title
Comparison of reduction of migraine frequency between the 2 groups (with or without relaxation)
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Comparison between the 2 groups of intensity of migraine, medication use and quality of life
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LAURENT Bernard, MD PhD
Organizational Affiliation
Centre Hospitalier Universitaire de Saint Etienne
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
PICKERING Gisèle, MD
Organizational Affiliation
Centre d'Investigation Clinique de Clermont-Ferrand
Official's Role
Study Chair
Facility Information:
Facility Name
Consultation de la douleur du CHU d'Amiens
City
Amiens
ZIP/Postal Code
80000
Country
France
Facility Name
UTCD - CHU Pellegrin
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
CETD - CHU de Caen
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
CETD du CHU Gabriel Montpied
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
CETD CHU de Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Consultation de la douleur - CH Emile Roux
City
Le Puy-en Velay
ZIP/Postal Code
43000
Country
France
Facility Name
CETD CH de Nemours
City
Nemours
ZIP/Postal Code
77140
Country
France
Facility Name
CETD du CHU de Saint-ETienne
City
Saint Etienne
ZIP/Postal Code
42055
Country
France
Facility Name
CETD Hôpital Rangueil
City
Toulouse
ZIP/Postal Code
31403
Country
France

12. IPD Sharing Statement

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Interest of Relaxation From Patients With Pain Due to Migraine

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