Interest of Relaxation From Patients With Pain Due to Migraine

Migraine Clinical Trial

— MIGREL  

Official title:

Interest of Relaxation From Patients With Pain Due to Migraine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00904527
• Other study ID #: 0601001b
• Status: Completed
• Phase: N/A
• First received: May 18, 2009
• Last updated: July 27, 2015
• Start date: June 2006
• Est. completion date: April 2009

Study information

• Verified date: July 2015
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: French Data Protection Authority
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Behavioral:
• relaxation (Schultz)
Patients have relaxation consultations during 2 months

Locations

Country	Name	City	State
France	Consultation de la douleur du CHU d'Amiens	Amiens
France	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 CH de Nemours	Nemours
France	CETD du CHU de Saint-ETienne	Saint Etienne
France	CETD Hôpital Rangueil	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of reduction of migraine frequency between the 2 groups (with or without relaxation)		4 months	No
Secondary	Comparison between the 2 groups of intensity of migraine, medication use and quality of life		4 months	No