Study of Key Electro-acupuncture Technique on Migraine

February 3, 2020 updated by: Shanghai University of Traditional Chinese Medicine
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.

Study Overview

Status

Completed

Conditions

Intervention / 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 Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200032
        • Longhua Hospital,Shanghai University of Traditional Chinese Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Migraine Disability Assessment Questionnaire (MIDAS)
Time Frame: 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
20 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The medical outcomes study 36-item short-form health survey(SF-36)
Time Frame: 20 days
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
Time Frame: 20 days
marker
20 days
peripheral Calcitonin gene related peptide(CGRP) protein expression
Time Frame: 20 days
marker
20 days
peripheral Nuclear factor-kappa B(NF-кB) protein expression
Time Frame: 20 days
marker
20 days
Visual Analogue Scale (VAS) to assess pain
Time Frame: 20 days
Visual Analogue Scale (VAS) were applied to measure pain in patients
20 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai University of Traditional Chinese Medicine

Investigators

  • Study Director: Jian Pei, Ph.D, Longhua Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

July 30, 2015

First Submitted That Met QC Criteria

October 18, 2015

First Posted (Estimate)

October 20, 2015

Study Record Updates

Last Update Posted (Actual)

February 5, 2020

Last Update Submitted That Met QC Criteria

February 3, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 643857003534

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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