NCT00904527

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2006

Typical duration for not_applicable

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 19, 2009

Completed
Last Updated

July 28, 2015

Status Verified

July 1, 2015

Enrollment Period

2.8 years

First QC Date

May 18, 2009

Last Update Submit

July 27, 2015

Conditions

Migraine

Keywords

Relaxation (Schultz)Migraineantipain center

Outcome Measures

Primary Outcomes (1)

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

    4 months

Secondary Outcomes (1)

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

    4 months

Study Arms (2)

Relaxation

EXPERIMENTAL

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

Behavioral: relaxation (Schultz)

without relaxation

NO INTERVENTION

Patients have no relaxation (only medical treatment+ education)

Interventions

relaxation (Schultz)BEHAVIORAL

Patients have relaxation consultations during 2 months

Relaxation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age \> 18 years
  • to 14 days of migraines per month

You may not qualify if:

  • Headache by medication abuse
  • Patients who already know relaxation technics
  • Depression
  • Contra indication of using beta-bloquant or Oxetorone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Consultation de la douleur du CHU d'Amiens

Amiens, 80000, France

Location

UTCD - CHU Pellegrin

Bordeaux, 33000, France

Location

CETD - CHU de Caen

Caen, 14033, France

Location

CETD du CHU Gabriel Montpied

Clermont-Ferrand, 63000, France

Location

CETD CHU de Grenoble

Grenoble, 38043, France

Location

Consultation de la douleur - CH Emile Roux

Le Puy-en-Velay, 43000, France

Location

CETD CH de Nemours

Nemours, 77140, France

Location

CETD du CHU de Saint-ETienne

Saint-Etienne, 42055, France

Location

CETD Hôpital Rangueil

Toulouse, 31403, France

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • LAURENT Bernard, MD PhD

    Centre Hospitalier Universitaire de Saint Etienne

    STUDY DIRECTOR

  • PICKERING Gisèle, MD

    Centre d'Investigation Clinique de Clermont-Ferrand

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2009

First Posted

May 19, 2009

Study Start

June 1, 2006

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

July 28, 2015

Record last verified: 2015-07

Locations

FR(9)