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

Centre Hospitalier Universitaire de Saint Etienne

Status: Completed

Conditions: Migraine

Treatments: Behavioral: relaxation (Schultz)

Study type: Interventional

Funder types: Other

Identifiers

NCT00904527

0601001b

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Relaxation

Experimental group

Description:

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

Treatment:

Behavioral: relaxation (Schultz)

without relaxation

No Intervention group

Description:

Patients have no relaxation (only medical treatment+ education)