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Completed

NCT Number: NCT02580968

Study of Key Electro-acupuncture Technique on Migraine

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.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Longhua Hospital,Shanghai University of Traditional Chinese Medicine

Shanghai, 200032, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

electro-acupuncture

Device

electro-acupuncture on acupoints according to the traditional syndrome diagnosis.once per day, for 20 days.

Flunarizine Hydrochloride

Drug

flunarizine hydrochloride ，10mg/day，for 20 days。

Other names: flunarizine

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Shanghai University of Traditional Chinese Medicine

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 20, 2015
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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