MigraineMIGRELNCT00904527
Interest of Relaxation From Patients With Pain Due to Migraine
A study testing relaxation (Schultz) in people with Migraine, run by Centre Hospitalier Universitaire de Saint Etienne at 9 sites in France.
Trial summary
The purpose of this study is to determine whether relaxation (autogenic training of Schultz) is effective in treatment for migraine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine
- What is being tested?
- relaxation (Schultz)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 9 sitesFrance
- Study dates
- Jun 2006to Apr 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 18 years
- 5 to 14 days of migraines per month
Who cannot join
- Headache by medication abuse
- Patients who already know relaxation technics
- Depression
- Contra indication of using beta-bloquant or Oxetorone
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Consultation de la douleur du CHU d'Amiens
Amiens, 80000
UTCD - CHU Pellegrin
Bordeaux, 33000
CETD - CHU de Caen
Caen, 14033
CETD du CHU Gabriel Montpied
Clermont-Ferrand, 63000
CETD CHU de Grenoble
Grenoble, 38043
Consultation de la douleur - CH Emile Roux
Le Puy-en-Velay, 43000
CETD CH de Nemours
Nemours, 77140
CETD du CHU de Saint-ETienne
Saint-Etienne, 42055
CETD Hôpital Rangueil
Toulouse, 31403
About this study
The purpose of this study is to determine whether relaxation (autogenic training of Schultz) is effective in treatment for migraine.
Read the detailed 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.
- Conditions
- Migraine
- Being tested
- relaxation (Schultz)
- Keywords
- Relaxation (Schultz), Migraine, antipain center
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
relaxation (Schultz)Behavioural
Patients have relaxation consultations during 2 months
| Study group | Role | What they receive |
|---|---|---|
| Relaxation | Experimental | Relaxation (Schultz)+ medical treatment (beta-bloquant or Oxetorone)+ patient's education Receives: Behavioral: relaxation (Schultz) |
| without relaxation | No intervention | Patients have no relaxation (only medical treatment+ education) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of reduction of migraine frequency between the 2 groups (with or without relaxation)
Measured: 4 months
Secondary outcomes (1)
Comparison between the 2 groups of intensity of migraine, medication use and quality of life
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2009 (estimated)
- Study startJun 2006
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LAURENT Bernard, MD PhD, Study director, Centre Hospitalier Universitaire de Saint EtiennePICKERING Gisèle, MD, Study chair, Centre d'Investigation Clinique de Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00904527
- Sponsor's protocol ID
- 0601001b
- Acronym
- MIGREL
- Status last verified
- Jul 2015
- First submitted
- 18 May 2009
- Last updated
- 28 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Relaxation From Patients With Pain Due to Migraine
- ClinicalTrials.gov ID
- NCT00904527
- Acronym / sponsor ID
- MIGREL / 0601001b
- Conditions
- Migraine
- Keywords
- Relaxation (Schultz), Migraine, antipain center
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 19 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether relaxation (autogenic training of Schultz) is effective in treatment for migraine.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Relaxation | Experimental | Behavioral: relaxation (Schultz)Relaxation (Schultz)+ medical treatment (beta-bloquant or Oxetorone)+ patient's education |
| without relaxation | No intervention | –Patients have no relaxation (only medical treatment+ education) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age > 18 years
- 5 to 14 days of migraines per month
Key exclusion criteria (4 listed)
- Headache by medication abuse
- Patients who already know relaxation technics
- Depression
- Contra indication of using beta-bloquant or Oxetorone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| relaxation (Schultz)Patients have relaxation consultations during 2 months | Behavioural | Relaxation |
Primary outcome
Comparison of reduction of migraine frequency between the 2 groups (with or without relaxation)
Time frame: 4 months
1 secondary outcome
Comparison between the 2 groups of intensity of migraine, medication use and quality of life
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
LAURENT Bernard, MD PhD study director
Centre Hospitalier Universitaire de Saint Etienne
PICKERING Gisèle, MD study chair
Centre d'Investigation Clinique de Clermont-Ferrand
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing relaxation (Schultz) in people with Migraine, run by Centre Hospitalier Universitaire de Saint Etienne at 9 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of reduction of migraine frequency between the 2 groups (with or without relaxation) (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2015.