Study of Key Electro-acupuncture Technique on Migraine

Study Overview
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Brief Summary
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A random controlled trail to evaluate the efficacy of migraine standard electroacupuncture formula, and to analysis the regulation of the intensity-effects and to observe the peripheral NO, CGRP and NF-кB expression level of migraine patients after electroacupuncture treatment.

Detailed Description
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acupuncture group(group A): treated by acupuncture for 20 days, 1 time per day control group(group B): treated by FlunarizineHydrochloride for 20 days, 1 table per day.

Official Title
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Study of Key Electro-acupuncture Technique on Migraine

Conditions
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Migraine

Intervention / Treatment
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* Device: electro-acupuncture
* Drug: flunarizine hydrochloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: met the diagnostic criteria for migraine; suffering from migraine attacks; migraine attacks for more than 5 days per month, and lasts for 3 months; voluntarily join this study with informed consents. Exclusion Criteria: other systemic, neurological and psychiatric disorders; headache caused by other diseases; not treatment compliance during the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: electro-acupuncture<br>100hz, 2min. electro-acupoint: LI4(Large Intestine4) with LV3(Liver3).5times a week. lasting for 4 weeks. | Device: electro-acupuncture<br>* electro-acupuncture on acupoints according to the traditional syndrome diagnosis.once per day, for 20 days.<br>|
| Active Comparator: routin medicine<br>one tablet of flunarizine hydrochloride tablet per day. lasting for 20days | Drug: flunarizine hydrochloride<br>* flunarizine hydrochloride ，10mg/day，for 20 days。<br>* Other names: flunarizine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Migraine Disability Assessment Questionnaire (MIDAS) | a scientifically reliable and valid measure of migraine disability that can improve communication between patients and physicians, assess migraine severity and act as an outcome measure to monitor treatment efficacy | 20 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The medical outcomes study 36-item short-form health survey(SF-36) | A 36-item short-form (SF-36) was constructed to survey health status in the Medical Outcomes Study | 20 days | 
| peripheral Nitrogen Monoxide(NO) protein expression | marker | 20 days | 
| peripheral Calcitonin gene related peptide(CGRP) protein expression | marker | 20 days | 
| peripheral Nuclear factor-kappa B(NF-кB) protein expression | marker | 20 days | 
| Visual Analogue Scale (VAS) to assess pain | Visual Analogue Scale (VAS) were applied to measure pain in patients | 20 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electroacupuncture therapy, Migraine, Acupuncture Therapy