Randomized Controlled Trial of Treating Migraine With Acupuncture

Migraine Clinical Trial

Official title:

Randomized Controlled Trial of Treating Migraine With Acupuncture

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00599586
• Other study ID #: 2006CB5045011
• Secondary ID: 2006CB5045011
• Status: Completed
• Phase: N/A
• First received: January 3, 2008
• Last updated: June 27, 2010
• Start date: November 2007
• Est. completion date: September 2009

Study information

• Verified date: June 2010
• Source: Chengdu University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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."

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."

Recruitment information / eligibility

• Status: Completed
• Enrollment: 480
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Other:
• acupuncture
Subjects are treated five days a week continuously, and for four weeks.They are treated 30min every time.

Locations

Country	Name	City	State
China	Chengdu University of TCM	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Chengdu University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

References & Publications (1)

Linde K, Streng A, Jürgens 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of days with migraine		4 weeks	No
Primary	frequency of migraine attacks		4 weeks	No
Secondary	Migraine-Specific Quality-of-Life Questionnaire		a month	Yes
Secondary	Transcranial Doppler Sonography		a month	No