Study of Key Electro-acupuncture Technique on Migraine
1 other identifier
interventional
2
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 30, 2015
CompletedFirst Posted
Study publicly available on registry
October 20, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedFebruary 5, 2020
February 1, 2020
2.8 years
July 30, 2015
February 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
The medical outcomes study 36-item short-form health survey(SF-36)
20 days
peripheral Nitrogen Monoxide(NO) protein expression
20 days
peripheral Calcitonin gene related peptide(CGRP) protein expression
20 days
peripheral Nuclear factor-kappa B(NF-кB) protein expression
20 days
Visual Analogue Scale (VAS) to assess pain
20 days
Study Arms (2)
electro-acupuncture
EXPERIMENTAL100hz, 2min. electro-acupoint: LI4(Large Intestine4) with LV3(Liver3).5times a week. lasting for 4 weeks.
routin medicine
ACTIVE COMPARATORone tablet of flunarizine hydrochloride tablet per day. lasting for 20days
Interventions
electro-acupuncture on acupoints according to the traditional syndrome diagnosis.once per day, for 20 days.
flunarizine hydrochloride ，10mg/day，for 20 days。
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- other systemic, neurological and psychiatric disorders; headache caused by other diseases; not treatment compliance during the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Longhua Hospital,Shanghai University of Traditional Chinese Medicine
Shanghai, 200032, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jian Pei, Ph.D
Longhua Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2015
First Posted
October 20, 2015
Study Start
March 1, 2015
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
February 5, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share