NCT03036761已完成不适用
Interest of Auriculotherapy in Prophylaxis of Migraine and Headache in Patients With Migraines
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Hopital Foch
- 入组人数
- 90
- 试验地点
- 4
- 主要终点
- Number of days with migraine and non-migraine headache post inclusion.
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Months 至 80 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
- •Non inclusion Criteria:
- •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.
排除标准
- •Allergy or infection of the auricle
- •Pregnancy
研究组 & 干预措施
AUR+: Auriculotherapy
Experimental
Patients benefit from 3 sessions of auriculotherapy at one month intervals.
干预措施: Auriculotherapy (Procedure)
AUR-: No auriculotherapy
No Intervention
Patients do not benefit from auriculotherapy.
结局指标
主要结局
Number of days with migraine and non-migraine headache post inclusion.
时间窗: 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.
次要结局
- Intensity of pain episodes (migraines and non-migraine headaches) post inclusion: numerical scale(3 months)
- Evaluation of the quality of life of the patient: MIDAS score(3 months)
- Tolerance of auriculotherapy treatment(3 months)
- Number of days with migraine post inclusion.(3 months)
- Number of days with non migraine headache post inclusion.(3 months)
- Evolution of antalgic use (triptan and non-triptan) in migraine patients.(3 months)
研究者
研究点 (4)
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