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Completed

NCT Number: NCT01687660

Acupuncture for Migraine Prophylaxis

Hypothesis: Acupuncture obtains an abiding effect on migraine prophylaxis Design: A open-label randomized controlled trial. 249 participants will be included. Three arms: acupuncture in acupoint-meridian, non-acupoint-meridian group, and waiting list.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chengdu University of TCM

Chengdu, Sichuan, 610075, China

About this study

Aim: to attest the abiding efficacy and safety of acupuncture for migraine prophylaxis Design: A open-label randomized controlled trial will be performed in Chengdu, Hunan and Chongqing province. Two hundred and forty-three participants will be randomly assign to acupoint-meridian group, non-acupoint-meridian group, and wait-and-see group. Each participants will receive 20 sessions of acupuncture in 4 weeks, with a duration of 30 minutes in a session. After all the treatments was accomplished, there will be 5 times follow-ups in the impending every 4 weeks. The primary outcome is frequency of migraine attacks 16 weeks after inclusion. Secondary outcomes include frequency of migraine attacks at the 4th and 24th week, headache severity, MSQ(Migraine Specific Quality of Life Questionnaire MSQ Version2.1), etc.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age of a subject is between 18 and 65 years old(initially occured beneath the age of 50), male or female;
  • in accordance with diagnosis of migraine without aura in International Classification of Headache Disorders, ICHD-2, by IHS;
  • 2 to 8 times attack per month in recent 3 months, with each period beyond 15 days;
  • with migraine history for over 1 year;
  • be able and willing to finish the headache diary in baseline ;
  • informed consent form must be signed by patient or lineal relative;

Exclusion criteria

  • Patients who are unconscious, psychotic.
  • Patients with aggravating tumor and other serious consumptive disease, and who are subject to infection and bleeding.
  • With serious primary illness or disease of cardiovascular, liver, renal, gastrointestinal, hematological systems and so on.
  • Pregnant women or women in lactation.

Treatment and study plan

Acupuncture

Other

apply acupuncture to prevent the migraine attack

Primary outcomes

  1. frequency of migraine attacks

    Time frame: 16th week after inclusion

    to assess the frequency of migraine attacks at the 16th week after inclusion

Secondary outcomes

  1. frequency of migraine attacks

    Time frame: 4th and 24th week after inclusion

    to assess the frequency of migraine attacks at the 4th and 24th week respectively

  2. headache severity

    Time frame: 0 day, 4th, 8th, 12th, 16th, 20th, 24th week after inclusion

    to evaluate the change of severity of headache

Other outcomes

  1. MSQ(Migraine Specific Quality of Life Questionnaire MSQ Version2.1)

    Time frame: the day of inclusion and 4th week after inclusion

    to observe the change of MSQ

  2. acupuncture expectation scale

    Time frame: 1 day

    an outcome to indicate the expectation of patient towards acupuncture treatment for migraine

Sponsors and collaborators

Lead sponsor

Li ying

Other

Collaborators

  • Chongqing Medical University
  • Hunan University of Traditional Chinese Medicine

Registry information

Official study title

A Continuous Study on Abiding Effect of Acupuncture for Migraine Treatment

Acronym: AMP

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Sep 19, 2012
Registry last updated
Feb 17, 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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