NCT03036761

Brief 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

4 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

January 18, 2017

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 30, 2017

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2021

Completed
Last Updated

April 21, 2021

Status Verified

April 1, 2021

Enrollment Period

3.9 years

First QC Date

January 27, 2017

Last Update Submit

April 20, 2021

Conditions

Headache, Migraine

Keywords

Auriculotherapy

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months

Secondary Outcomes (6)

  • Number of days with migraine post inclusion.

    3 months

  • Number of days with non migraine headache post inclusion.

    3 months

  • Intensity of pain episodes (migraines and non-migraine headaches) post inclusion: numerical scale

    3 months

  • Evolution of antalgic use (triptan and non-triptan) in migraine patients.

    3 months

  • Evaluation of the quality of life of the patient: MIDAS score

    3 months

  • +1 more secondary outcomes

Study Arms (2)

AUR+: Auriculotherapy

EXPERIMENTAL

Patients benefit from 3 sessions of auriculotherapy at one month intervals.

Procedure: Auriculotherapy

AUR-: No auriculotherapy

NO INTERVENTION

Patients do not benefit from auriculotherapy.

Interventions

AuriculotherapyPROCEDURE

3 sessions of auriculotherapy at one month intervals.

AUR+: Auriculotherapy

Eligibility Criteria

Age18 Months - 80 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWoman
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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;
  • Presenting a calendar of migraines and headaches mentioning the number of days with pain, intensity of pain and treatments for at least 3 months.
  • 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);
  • 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..);

You may not qualify if:

  • Allergy or infection of the auricle
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Cabinet Médical

Maisons-Alfort, 94700, France

Location

Centre Médical de L'Olivier

Montigny-le-Bretonneux, 78180, France

Location

GHP Saint Joseph

Paris, 75014, France

Location

Hopital Foch

Suresnes, 92150, France

Location

Related Publications (1)

  • 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.

    PMID: 37284181DERIVED

MeSH Terms

Conditions

Migraine Disorders

Interventions

Auriculotherapy

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Mireille Michel-Cherqui, MD

    Hopital Foch

    PRINCIPAL INVESTIGATOR

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

January 27, 2017

First Posted

January 30, 2017

Study Start

January 18, 2017

Primary Completion

December 14, 2020

Study Completion

March 22, 2021

Last Updated

April 21, 2021

Record last verified: 2021-04

Locations

FR(4)