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Study of Key Electro-acupuncture Technique on Migraine

Primary Purpose

Migraine

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
electro-acupuncture
flunarizine hydrochloride
Sponsored by
Shanghai University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine focused on measuring Electroacupuncture therapy, Migraine, Acupuncture Therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Longhua Hospital,Shanghai University of Traditional Chinese Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

electro-acupuncture

routin medicine

Arm Description

100hz, 2min. electro-acupoint: LI4(Large Intestine4) with LV3(Liver3).5times a week. lasting for 4 weeks.

one tablet of flunarizine hydrochloride tablet per day. lasting for 20days

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
peripheral Nitrogen Monoxide(NO) protein expression
marker
peripheral Calcitonin gene related peptide(CGRP) protein expression
marker
peripheral Nuclear factor-kappa B(NF-кB) protein expression
marker
Visual Analogue Scale (VAS) to assess pain
Visual Analogue Scale (VAS) were applied to measure pain in patients

Full Information

First Posted
July 30, 2015
Last Updated
February 3, 2020
Sponsor
Shanghai University of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02580968
Brief Title
Study of Key Electro-acupuncture Technique on Migraine
Official Title
Study of Key Electro-acupuncture Technique on Migraine
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai University of Traditional Chinese Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
Electroacupuncture therapy, Migraine, Acupuncture Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
electro-acupuncture
Arm Type
Experimental
Arm Description
100hz, 2min. electro-acupoint: LI4(Large Intestine4) with LV3(Liver3).5times a week. lasting for 4 weeks.
Arm Title
routin medicine
Arm Type
Active Comparator
Arm Description
one tablet of flunarizine hydrochloride tablet per day. lasting for 20days
Intervention Type
Device
Intervention Name(s)
electro-acupuncture
Intervention Description
electro-acupuncture on acupoints according to the traditional syndrome diagnosis.once per day, for 20 days.
Intervention Type
Drug
Intervention Name(s)
flunarizine hydrochloride
Other Intervention Name(s)
flunarizine
Intervention Description
flunarizine hydrochloride ，10mg/day，for 20 days。
Primary Outcome Measure Information:
Title
Migraine Disability Assessment Questionnaire (MIDAS)
Description
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
Time Frame
20 days
Secondary Outcome Measure Information:
Title
The medical outcomes study 36-item short-form health survey(SF-36)
Description
A 36-item short-form (SF-36) was constructed to survey health status in the Medical Outcomes Study
Time Frame
20 days
Title
peripheral Nitrogen Monoxide(NO) protein expression
Description
marker
Time Frame
20 days
Title
peripheral Calcitonin gene related peptide(CGRP) protein expression
Description
marker
Time Frame
20 days
Title
peripheral Nuclear factor-kappa B(NF-кB) protein expression
Description
marker
Time Frame
20 days
Title
Visual Analogue Scale (VAS) to assess pain
Description
Visual Analogue Scale (VAS) were applied to measure pain in patients
Time Frame
20 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jian Pei, Ph.D
Organizational Affiliation
Longhua Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Longhua Hospital,Shanghai University of Traditional Chinese Medicine
City
Shanghai
ZIP/Postal Code
200032
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Study of Key Electro-acupuncture Technique on Migraine

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