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Study of Key Electro-acupuncture Technique on Migraine

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ClinicalTrials.gov Identifier: NCT02580968
Recruitment Status : Completed
First Posted : October 20, 2015
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Migraine Device: electro-acupuncture Drug: flunarizine hydrochloride Not Applicable

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  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Key Electro-acupuncture Technique on Migraine
Study Start Date : March 2015
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture Migraine
U.S. FDA Resources

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 Name: flunarizine



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. peripheral Nitrogen Monoxide(NO) protein expression [ Time Frame: 20 days ]
    marker

  3. peripheral Calcitonin gene related peptide(CGRP) protein expression [ Time Frame: 20 days ]
    marker

  4. peripheral Nuclear factor-kappa B(NF-кB) protein expression [ Time Frame: 20 days ]
    marker

  5. Visual Analogue Scale (VAS) to assess pain [ Time Frame: 20 days ]
    Visual Analogue Scale (VAS) were applied to measure pain in patients



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02580968


Locations
China
Longhua Hospital,Shanghai University of Traditional Chinese Medicine
Shanghai, China, 200032
Sponsors and Collaborators
Shanghai University of Traditional Chinese Medicine
Investigators
Study Director: pei jian, master Longhua Hospital

Responsible Party: Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT02580968     History of Changes
Other Study ID Numbers: 643857003534
First Posted: October 20, 2015    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Shanghai University of Traditional Chinese Medicine:
Electroacupuncture therapy
Migraine
Acupuncture Therapy

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Flunarizine
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Vasodilator Agents