Interest of Relaxation From Patients With Pain Due to Migraine
NCT ID: NCT00904527
Last Updated: 2015-07-28
Study Results
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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COMPLETED
NA
60 participants
INTERVENTIONAL
2006-06-30
2009-04-30
Brief Summary
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Detailed Description
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* 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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Relaxation
Relaxation (Schultz)+ medical treatment (beta-bloquant or Oxetorone)+ patient's education
relaxation (Schultz)
Patients have relaxation consultations during 2 months
without relaxation
Patients have no relaxation (only medical treatment+ education)
No interventions assigned to this group
Interventions
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relaxation (Schultz)
Patients have relaxation consultations during 2 months
Eligibility Criteria
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Inclusion Criteria
* 5 to 14 days of migraines per month
Exclusion Criteria
* Patients who already know relaxation technics
* Depression
* Contra indication of using beta-bloquant or Oxetorone
18 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Saint Etienne
OTHER
Responsible Party
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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
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, , France
Countries
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Other Identifiers
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0601001b
Identifier Type: -
Identifier Source: org_study_id
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