Headache, MigraineMigauricNCT03036761
Interest of Auriculotherapy in Prophylaxis of Migraine and Headache in Patients With Migraines
A study testing Auriculotherapy in people with Headache, Migraine, run by Hopital Foch at 4 sites in France.
Trial summary
The aim of the study is to show that auriculotherapy decreases the number of days with painful episodes of migraine and headache after 3 months of treatment Read more about this study
- Who is it for?
- Ages 18 months to 80 years, women only
- Conditions the study is for
- Headache, Migraine
- What is being tested?
- Auriculotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 4 sitesFrance
- Study dates
- 18 Jan 2017to 22 Mar 2021
- 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 months to 80 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Woman;
- Aged from 18 to 80;
- Benefiting from social security scheme or legal successor;
- Having given their non-opposition to the study; ·
- Diagnosis of chronical migraine for more than 6 months;
- Without background treatment or with stable background therapy for more than 1 month;
Show all 18Show fewer
- Presenting a calendar of migraines and headaches mentioning the number of days with pain, intensity of pain and treatments for at least 3 months.
- Non inclusion Criteria:
- Man;
- Patient with less than 6 painful episodes in 3 months;
- History or actual mental health disorder;
- Dependence on opioids or tranquillizers;
- Secondary headaches;
- Incapacitated to keep a diary of the migraines / headaches / treatments;
- Contraindications for the use of auriculotherapy (scheduled Magnetic resonance imaging examination, declared pregnancy, breastfeeding, artificial heart valves, Haemophilia, effective anticoagulation treatment);
- Having received auriculotherapy treatment in the indication of the study in the last 12 months before inclusion;
- Scheduled to start a new drug or non-drug therapy which could interfere with the study (antidepressant, opioids, anticonvulsant psychological therapy, physiotherapy, deep brain stimulation, etc..);
- Modification of background treatment during the month before inclusion.
Who cannot join
- Allergy or infection of the auricle
- Pregnancy
Trial locations and contacts
4 sites in 1 country.
France4 sites
Cabinet Médical
Maisons-Alfort, 94700
Centre Médical de L'Olivier
Montigny-le-Bretonneux, 78180
GHP Saint Joseph
Paris, 75014
Hopital Foch
Suresnes, 92150
About this study
The aim of the study is to show that auriculotherapy decreases the number of days with painful episodes of migraine and headache after 3 months of treatment
Read the detailed description
Prospective, multicenter, controlled and randomized study.
At the inclusion:
- initial assessment of migraine and headache attacks of the last 3 months with the migraine/headache/treatment diary;
- quality of life assessment (MIDAS questionnaire).
Patients are randomized in 2 groups (distribution 2/3 AUR+, 1/3 AUR-):
- AUR+: experimental group "Auriculotherapy". Patients benefit from 3 sessions of auriculotherapy at one month intervals.
- AUR-: control group. Patients do not benefit from auriculotherapy.
After 3 months, a visit of Algology is carried out :
- final assessment of migraine and headache attacks of the last 3 months with the migraine/headache/treatment diary;
- quality of life assessment (MIDAS questionnaire).
- Conditions
- Headache, Migraine
- Being tested
- Auriculotherapy
- Keywords
- Auriculotherapy
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AuriculotherapyProcedure or surgery
3 sessions of auriculotherapy at one month intervals.
| Study group | Role | What they receive |
|---|---|---|
| AUR+: Auriculotherapy | Experimental | Patients benefit from 3 sessions of auriculotherapy at one month intervals. Receives: Procedure: Auriculotherapy |
| AUR-: No auriculotherapy | No intervention | Patients do not benefit from auriculotherapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days with migraine and non-migraine headache post inclusion.
Evaluated with the patient's migraine/headache/treatment diary of the last 3 months after inclusion.
One day with painful episodes of migraines and non-migraines headaches is a day when:
- the pain episode lasts more than 4 hours,
- or the pain episode is suppressed by a specific treatment known to the patient.
Measured: 3 months
Secondary outcomes (6)
Number of days with migraine post inclusion.
Evaluated with the patient's migraine/headache/treatment diay of the last 3 months after inclusion.
One day with painful episodes of migraines is a day when:
- the pain episode lasts more than 4 hours,
- or the pain episode is suppressed by a specific treatment known to the patient.
Measured: 3 months
Number of days with non migraine headache post inclusion.
Evaluated with the patient's migraine/headache/treatment diary of the last 3 months after inclusion.
One day with painful episodes of non-migraines headaches is a day when:
- the pain episode lasts more than 4 hours,
- or the pain episode is suppressed by a specific treatment known to the patient.
Measured: 3 months
Intensity of pain episodes (migraines and non-migraine headaches) post inclusion: numerical scale
The intensity of the pain episodes is evaluated by the patient on a numerical scale of 1 to 3 (1 = low, 2 = moderate, 3 = intense) which is in the patient's migraine/headache/treatment diary of the 3 months after inclusion.
The outcome is evaluated by the calculation of the sum of the pain intensities of migraines and non-migraine headaches .
Measured: 3 months
Evolution of antalgic use (triptan and non-triptan) in migraine patients.
Evaluated with the patient's migraine/headache/treatment diary of the last 3 months after inclusion.
The sum of antalgic use (triptan and non-triptan):
- total number of triptan taken;
- number of days with triptan;
- total number of non-triptan analgesics taken;
- number of days with non-triptan analgesics.
Measured: 3 months
Evaluation of the quality of life of the patient: MIDAS score
Calculation of the MIDAS score during the inclusion visit and 3 months after the inclusion visit.
Measured: 3 months
Tolerance of auriculotherapy treatment
The presence or absence of adverse events attributed to the treatment of auriculotherapy by the patient.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2017 (estimated)
- Study start18 Jan 2017
- Primary completion14 Dec 2020
- Study completion22 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Headache, MigraineStudies of the same condition, open and under way.
- 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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mireille Michel-Cherqui, MD, Principal investigator, Hopital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03036761
- Sponsor's protocol ID
- 2016/58
- Other IDs
- 2016-A01534-47
- Acronym
- Migauric
- Status last verified
- Apr 2021
- First submitted
- 27 Jan 2017
- Last updated
- 21 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Michel-Cherqui M, Ma S, d'Ussel M, Ebbo D, Spassova A, Chaix-Couturier C, Szekely B, Fischler M, Lemaire N, Le Guen M. Auriculotherapy in prevention of migraine attacks: an open randomized trial. Front Neurol. 2023 May 22;14:1193752. doi: 10.3389/fneur.2023.1193752. eCollection 2023.
PubMed 37284181
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Auriculotherapy in Prophylaxis of Migraine and Headache in Patients With Migraines
- ClinicalTrials.gov ID
- NCT03036761
- Acronym / sponsor ID
- Migauric / 2016/58
- Conditions
- Headache, Migraine
- Keywords
- Auriculotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 18 Jan 2017 (actual)
- Primary completion
- 14 Dec 2020 (actual)
- Study completion
- 22 Mar 2021 (actual)
- First posted
- 30 Jan 2017 (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 aim of the study is to show that auriculotherapy decreases the number of days with painful episodes of migraine and headache after 3 months of treatment
Detailed description
Prospective, multicenter, controlled and randomized study.
At the inclusion:
- initial assessment of migraine and headache attacks of the last 3 months with the migraine/headache/treatment diary;
- quality of life assessment (MIDAS questionnaire).
Patients are randomized in 2 groups (distribution 2/3 AUR+, 1/3 AUR-):
- AUR+: experimental group "Auriculotherapy". Patients benefit from 3 sessions of auriculotherapy at one month intervals.
- AUR-: control group. Patients do not benefit from auriculotherapy.
After 3 months, a visit of Algology is carried out :
- final assessment of migraine and headache attacks of the last 3 months with the migraine/headache/treatment diary;
- quality of life assessment (MIDAS questionnaire).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AUR+: Auriculotherapy | Experimental | Procedure: AuriculotherapyPatients benefit from 3 sessions of auriculotherapy at one month intervals. |
| AUR-: No auriculotherapy | No intervention | –Patients do not benefit from auriculotherapy. |
Who may qualify
- Ages
- 18 months to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (18 listed)
- Woman;
- Aged from 18 to 80;
- Benefiting from social security scheme or legal successor;
- Having given their non-opposition to the study; ·
- Diagnosis of chronical migraine for more than 6 months;
Key exclusion criteria (2 listed)
- Allergy or infection of the auricle
- Pregnancy
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 |
|---|---|---|
| Auriculotherapy3 sessions of auriculotherapy at one month intervals. | Procedure or surgery | AUR+: Auriculotherapy |
Primary outcome
Number of days with migraine and non-migraine headache post inclusion.
Time frame: 3 months
Evaluated with the patient's migraine/headache/treatment diary of the last 3 months after inclusion. One day with painful episodes of migraines and non-migraines headaches is a day when: * the pain episode lasts more than 4 hours, * or the pain episode is suppressed by a specific treatment known to the patient.
6 secondary outcomes
Number of days with migraine post inclusion.
Time frame: 3 months
Number of days with non migraine headache post inclusion.
Time frame: 3 months
Intensity of pain episodes (migraines and non-migraine headaches) post inclusion: numerical scale
Time frame: 3 months
Evolution of antalgic use (triptan and non-triptan) in migraine patients.
Time frame: 3 months
Evaluation of the quality of life of the patient: MIDAS score
Time frame: 3 months
Tolerance of auriculotherapy treatment
Time frame: 3 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 21 Apr 2021.
- Derived from this study: PubMed 37284181Michel-Cherqui M, Ma S, d'Ussel M, Ebbo D, Spassova A, Chaix-Couturier C, Szekely B, Fischler M, Lemaire N, Le Guen M. Auriculotherapy in prevention of migraine attacks: an open randomized trial. Front Neurol. 2023 May 22;14:1193752. doi: 10.3389/fneur.2023.1193752. eCollection 2023.
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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.
Mireille Michel-Cherqui, MD principal investigator
Hopital Foch
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auriculotherapy in people with Headache, Migraine, run by Hopital Foch at 4 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 18 inclusion and 2 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 21 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Number of days with migraine and non-migraine headache post inclusion. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03036761, which also lists 1 linked publication.
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 21 Apr 2021.