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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01152632
Other study ID # 30930112/C190301
Secondary ID
Status Completed
Phase N/A
First received June 27, 2010
Last updated November 25, 2014
Start date January 2010
Est. completion date December 2013

Study information

Verified date August 2012
Source Chengdu University of Traditional Chinese Medicine
Contact n/a
Is FDA regulated No
Health authority China: National Natural Science Foundation
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date December 2013
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender Both
Age group 17 Years to 45 Years
Eligibility 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

Study Design

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


Related Conditions & MeSH terms


Intervention

Other:
manual acupuncture
thirty minutes duration every time, five times per week for one course, a total four courses

Locations

Country Name City State
China Chengdu University of Traditional Chinese Medicine Chengdu Sichuan

Sponsors (1)

Lead Sponsor Collaborator
Chengdu University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary improvement of headache frequency 4 weeks No
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