NCT00599586

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."

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
480

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2008

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 24, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

June 29, 2010

Status Verified

June 1, 2010

Enrollment Period

1.8 years

First QC Date

January 3, 2008

Last Update Submit

June 27, 2010

Conditions

Migraine

Keywords

migraineacupunctureefficacysafetymeridianacupoint

Outcome Measures

Primary Outcomes (2)

  • number of days with migraine

    4 weeks

  • frequency of migraine attacks

    4 weeks

Secondary Outcomes (2)

  • Migraine-Specific Quality-of-Life Questionnaire

    a month

  • Transcranial Doppler Sonography

    a month

Study Arms (4)

group 1

EXPERIMENTAL

specific acupoints of Shaoyang meridians

Other: acupuncture

Group 2

EXPERIMENTAL

Non-specific acupoints of Shaoyang meridians

Other: acupuncture

group 3

EXPERIMENTAL

Acupoints of other meridians

Other: acupuncture

group 4

SHAM COMPARATOR

Non-acupoints

Other: acupuncture

Interventions

acupunctureOTHER

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

Also known as: electro-acupuncture
Group 2group 1group 3group 4

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.)
  • Consistent with the diagnostic criteria of Premonitory Migraine and Non- Premonitory Migraine.
  • Attacks of migraine are equal to or more than 2 times in the last three months.
  • With more than one year history of migraine
  • Informed consent is signed by a subject or his lineal relation.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chengdu University of TCM

Chengdu, Sichuan, 610075, China

Location

Related Publications (6)

  • 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.

    PMID: 15870415RESULT

  • 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.

    PMID: 25549933DERIVED

  • 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.

    PMID: 22697367DERIVED

  • 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.

    PMID: 22231691DERIVED

  • 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.

    PMID: 21435214DERIVED

  • 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.

    PMID: 18928574DERIVED

MeSH Terms

Conditions

Migraine Disorders

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Fan-rong Liang, master

    Chengdu University of TCM

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 3, 2008

First Posted

January 24, 2008

Study Start

November 1, 2007

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

June 29, 2010

Record last verified: 2010-06

Locations

CN(1)