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Randomized Controlled Trial of Treating Migraine With Acupuncture

Primary Purpose

Migraine

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
acupuncture
Sponsored by
Chengdu University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine focused on measuring migraine, acupuncture, efficacy, safety, meridian, acupoint

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Chengdu University of TCM

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Sham Comparator

Arm Label

group 1

Group 2

group 3

group 4

Arm Description

specific acupoints of Shaoyang meridians

Non-specific acupoints of Shaoyang meridians

Acupoints of other meridians

Non-acupoints

Outcomes

Primary Outcome Measures

number of days with migraine
frequency of migraine attacks

Secondary Outcome Measures

Migraine-Specific Quality-of-Life Questionnaire
Transcranial Doppler Sonography

Full Information

First Posted
January 3, 2008
Last Updated
June 27, 2010
Sponsor
Chengdu University of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00599586
Brief Title
Randomized Controlled Trial of Treating Migraine With Acupuncture
Official Title
Randomized Controlled Trial of Treating Migraine With Acupuncture
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Chengdu University of Traditional Chinese Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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."

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
migraine, acupuncture, efficacy, safety, meridian, acupoint

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
480 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group 1
Arm Type
Experimental
Arm Description
specific acupoints of Shaoyang meridians
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Non-specific acupoints of Shaoyang meridians
Arm Title
group 3
Arm Type
Experimental
Arm Description
Acupoints of other meridians
Arm Title
group 4
Arm Type
Sham Comparator
Arm Description
Non-acupoints
Intervention Type
Other
Intervention Name(s)
acupuncture
Other Intervention Name(s)
electro-acupuncture
Intervention Description
Subjects are treated five days a week continuously, and for four weeks.They are treated 30min every time.
Primary Outcome Measure Information:
Title
number of days with migraine
Time Frame
4 weeks
Title
frequency of migraine attacks
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Migraine-Specific Quality-of-Life Questionnaire
Time Frame
a month
Title
Transcranial Doppler Sonography
Time Frame
a month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fan-rong Liang, master
Organizational Affiliation
Chengdu University of TCM
Official's Role
Study Chair
Facility Information:
Facility Name
Chengdu University of TCM
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610075
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
15870415
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.
Results Reference
result
PubMed Identifier
25549933
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.
Results Reference
derived
PubMed Identifier
22697367
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.
Results Reference
derived
PubMed Identifier
22231691
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.
Results Reference
derived
PubMed Identifier
21435214
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.
Results Reference
derived
PubMed Identifier
18928574
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.
Results Reference
derived

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Randomized Controlled Trial of Treating Migraine With Acupuncture

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