Interest of Relaxation From Patients With Pain Due to Migraine

NCT ID: NCT00904527

Last Updated: 2015-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2009-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Relaxation

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

Group Type EXPERIMENTAL

relaxation (Schultz)

Intervention Type BEHAVIORAL

Patients have relaxation consultations during 2 months

without relaxation

Patients have no relaxation (only medical treatment+ education)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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relaxation (Schultz)

Patients have relaxation consultations during 2 months

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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LAURENT Bernard, MD PhD

Role: STUDY_DIRECTOR

Centre Hospitalier Universitaire de Saint Etienne

PICKERING Gisèle, MD

Role: STUDY_CHAIR

Centre d'Investigation Clinique de Clermont-Ferrand

Locations

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Consultation de la douleur du CHU d'Amiens

Amiens, , France

Site Status

UTCD - CHU Pellegrin

Bordeaux, , France

Site Status

CETD - CHU de Caen

Caen, , France

Site Status

CETD du CHU Gabriel Montpied

Clermont-Ferrand, , France

Site Status

CETD CHU de Grenoble

Grenoble, , France

Site Status

Consultation de la douleur - CH Emile Roux

Le Puy-en-Velay, , France

Site Status

CETD CH de Nemours

Nemours, , France

Site Status

CETD du CHU de Saint-ETienne

Saint-Etienne, , France

Site Status

CETD Hôpital Rangueil

Toulouse, , France

Site Status

Countries

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France

Other Identifiers

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0601001b

Identifier Type: -

Identifier Source: org_study_id

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