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Acupuncture for Migraine: a Functional Magnetic Resonance Imaging (fMRI) Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Chengdu University of Traditional Chinese Medicine.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Chengdu University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT01152632
First received: June 27, 2010
Last updated: August 28, 2012
Last verified: August 2012
  Purpose

Selecting acupoints along meridians is the predominant principle in acupuncture treatment, and it is also considered to ensure acupuncture efficacy. This experiment is to investigate whether specific brain networks gradually come in formation in accordance with this kind of acupoint selection methods.


Condition Intervention
Migraine
Other: manual acupuncture

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acupuncture Treatment for Migraine: a Functional Magnetic Resonance Imaging Study

Resource links provided by NLM:


Further study details as provided by Chengdu University of Traditional Chinese Medicine:

Primary Outcome Measures:
  • improvement of headache frequency [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: specific points of Bladder meridian and Shanjiao meridian
In traditional Chinese acupuncture theory, Bladder meridian and Shanjiao meridian have been considered as the main pathological meridian location of migraine. Meanwhile, specific points on both meridians have been used widely in its treatment for a long time.
Other: manual acupuncture
thirty minutes duration every time, five times per week for one course, a total four courses
Other Name: acupuncture
Experimental: non-specific points of Bladder meridian and Shanjiao meridian
Non-specific points of Shaoyang meridians are also used in cure of migraine. It is conventionally thought to be less effective using non-specific points than specific ones.
Other: manual acupuncture
thirty minutes duration every time, five times per week for one course, a total four courses
Other Name: acupuncture
Active Comparator: specific points of Stomach meridian
Specific points of Stomache meridian for migraine were searched in Chinese ancient data. And this group is set to compare with specific points of Shaoyang meridians for their possible different brain networks.
Other: manual acupuncture
thirty minutes duration every time, five times per week for one course, a total four courses
Other Name: acupuncture
Placebo Comparator: non-acupoints
Three non-acupoints were chosen,two of which were located on the arm and one one the leg.
Other: manual acupuncture
thirty minutes duration every time, five times per week for one course, a total four courses
Other Name: acupuncture
No Intervention: waiting list

Detailed Description:

Every participants in the four intervention groups will go through functional magnetic imaging (fMRI) scan four times: the 1st scan will be performed at their baselines; the 2nd scan will be done after 2 courses (10 times) acupuncture treatment; the 3rd scan will be performed when the 4 courses end; the 4th scan will be operated after three-month enrollment.

Volunteers in waiting list group will undergo the above scans at the same time points in exception of acupuncture treatment.

  Eligibility

Ages Eligible for Study:   17 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • clinical diagnosis of non-aura Migraine formulated by the international headache society in 2004

Exclusion Criteria:

  • people with other types of headache
  • people with organic cerebral disorders
  • people with primary disorders
  • people in moderate or severe anxiety or depression
  • people in pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01152632

Contacts
Contact: Fanrong Liang, Master +86-13982253186 13982253186@139.com

Locations
China, Sichuan
Chengdu University of Traditional Chinese Medicine Recruiting
Chengdu, Sichuan, China, 610075
Contact: Fanrong Liang       13982253186@139.com   
Sponsors and Collaborators
Chengdu University of Traditional Chinese Medicine
Investigators
Study Chair: Fanrong Liang, Master Chengdu University of Traditional Chinese Medicine
  More Information

No publications provided

Responsible Party: Chengdu University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT01152632     History of Changes
Other Study ID Numbers: 30930112/C190301
Study First Received: June 27, 2010
Last Updated: August 28, 2012
Health Authority: China: National Natural Science Foundation

Keywords provided by Chengdu University of Traditional Chinese Medicine:
acupuncture
migraine
specific acupoints
brain network

Additional relevant MeSH terms:
Migraine Disorders
Brain Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases

ClinicalTrials.gov processed this record on November 20, 2014