Clinical trial NCT00599586: Randomized Controlled Trial of Treating Migraine With Acupuncture
Official title: Randomized Controlled Trial of Treating Migraine With Acupuncture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Keywords: migraine
acupuncture
efficacy
safety
meridian
acupoint
Lead sponsor: Chengdu University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2008-01-24
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to testify whether acupuncture is effective for migraine, and provide evidence for the hypothesis that"Acupuncture effect is based on meridians, and gathering of meridian Qi is the key point."

Detailed description: The purpose of the study is to testify whether acupuncture is effective for migraine, through treating migraine patients for a month, using different acupoints according to literatures of treating migraine with acupuncture, and try to provide clinical evidence for the hypothesis that"Acupuncture effect is based on meridians, and gathering of meridian Qi is the key point."

Eligibility criteria: Inclusion Criteria:

1. Age of a subject is older than 18 and is younger than 65.(The subject is younger than 50 when he was ill for the first time.)
2. Consistent with the diagnostic criteria of Premonitory Migraine and Non- Premonitory Migraine.
3. Attacks of migraine are equal to or more than 2 times in the last three months.
4. With more than one year history of migraine
5. Informed consent is signed by a subject or his lineal relation.

Exclusion Criteria:

1. With serious protopathy or disease of cardiovascular, liver, renal,gastrointestinal, hematological systems and so on.
2. Psychotic，patients with allergic constitution or easily getting infected or bleeding.
3. Patients have used drugs for preventing migraine in the last four weeks.
4. Pregnant women or women in lactation.

Primary outcomes:
measure: number of days with migraine
timeFrame: 4 weeks
measure: frequency of migraine attacks
timeFrame: 4 weeks
Secondary outcomes:
measure: Migraine-Specific Quality-of-Life Questionnaire
timeFrame: a month
measure: Transcranial Doppler Sonography
timeFrame: a month
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Chengdu University of TCM
state: Sichuan
Study officials:
affiliation: Chengdu University of TCM
name: Fan-rong Liang, master
role: STUDY_CHAIR
References:
citation: Linde K, Streng A, Jurgens S, Hoppe A, Brinkhaus B, Witt C, Wagenpfeil S, Pfaffenrath V, Hammes MG, Weidenhammer W, Willich SN, Melchart D. Acupuncture for patients with migraine: a randomized controlled trial. JAMA. 2005 May 4;293(17):2118-25. doi: 10.1001/jama.293.17.2118.
citation: Zheng H, Huang W, Li J, Zheng Q, Li Y, Chang X, Sun G, Liang F. Association of pre- and post-treatment expectations with improvements after acupuncture in patients with migraine. Acupunct Med. 2015 Apr;33(2):121-8. doi: 10.1136/acupmed-2014-010679. Epub 2014 Dec 30.
citation: Deng ZQ, Zheng H, Zhao L, Zhou SY, Li Y, Liang FR. Health economic evaluation of acupuncture along meridians for treating migraine in China: results from a randomized controlled trial. BMC Complement Altern Med. 2012 Jun 14;12:75. doi: 10.1186/1472-6882-12-75.
citation: Li Y, Zheng H, Witt CM, Roll S, Yu SG, Yan J, Sun GJ, Zhao L, Huang WJ, Chang XR, Zhang HX, Wang DJ, Lan L, Zou R, Liang FR. Acupuncture for migraine prophylaxis: a randomized controlled trial. CMAJ. 2012 Mar 6;184(4):401-10. doi: 10.1503/cmaj.110551. Epub 2012 Jan 9.
citation: Zhao L, Zhang FW, Li Y, Wu X, Zheng H, Cheng LH, Liang FR. Adverse events associated with acupuncture: three multicentre randomized controlled trials of 1968 cases in China. Trials. 2011 Mar 24;12:87. doi: 10.1186/1745-6215-12-87.
citation: Li Y, Liang F, Yu S, Liu X, Tang Y, Yang X, Tian X, Yan J, Sun G, Chang X, Zheng H, Zhang H, Ma T. Randomized controlled trial to treat migraine with acupuncture: design and protocol. Trials. 2008 Oct 20;9:57. doi: 10.1186/1745-6215-9-57.