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Completed

NCT Number: NCT00904527

Interest of Relaxation From Patients With Pain Due to Migraine

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

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Consultation de la douleur du CHU d'Amiens, Amiens, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

relaxation (Schultz)

Behavioral

Patients have relaxation consultations during 2 months

Primary outcomes

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

    Time frame: 4 months

Secondary outcomes

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

    Time frame: 4 months

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Acronym: MIGREL

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
May 19, 2009
Registry last updated
Jul 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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