Study of Key Electro-acupuncture Technique on Migraine

Not Applicable

Completed

• Conditions: Migraine
• Interventions: Drug: flunarizine hydrochloride; Device: electro-acupuncture

• Registration Number: NCT02580968
• Lead Sponsor: Shanghai University of Traditional Chinese Medicine

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-07-30
• Study First Submitted QC: 2015-10-18
• Study First Posted: 2015-10-20
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-03
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
routin medicine	flunarizine hydrochloride	one tablet of flunarizine hydrochloride tablet per day. lasting for 20days
electro-acupuncture	electro-acupuncture	100hz, 2min. electro-acupoint: LI4(Large Intestine4) with LV3(Liver3).5times a week. lasting for 4 weeks.

Primary Outcome Measures

Name	Time	Method
Migraine Disability Assessment Questionnaire (MIDAS)	20 days	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Longhua Hospital,Shanghai University of Traditional Chinese Medicine; 🇨🇳 Shanghai, China