NCT01152632

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2010

Longer than P75 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

January 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 29, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

December 2, 2014

Status Verified

August 1, 2012

Enrollment Period

3.4 years

First QC Date

June 27, 2010

Last Update Submit

November 25, 2014

Conditions

Keywords

acupuncturemigrainespecific acupointsbrain network

Outcome Measures

Primary Outcomes (1)

  • improvement of headache frequency

    4 weeks

Study Arms (5)

specific points of Bladder meridian and Shanjiao meridian

EXPERIMENTAL

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

non-specific points of Bladder meridian and Shanjiao meridian

EXPERIMENTAL

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

specific points of Stomach meridian

ACTIVE COMPARATOR

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

non-acupoints

PLACEBO COMPARATOR

Three non-acupoints were chosen,two of which were located on the arm and one one the leg.

Other: manual acupuncture

waiting list

NO INTERVENTION

Interventions

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

Also known as: acupuncture
non-acupointsnon-specific points of Bladder meridian and Shanjiao meridianspecific points of Bladder meridian and Shanjiao meridianspecific points of Stomach meridian

Eligibility Criteria

Age17 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chengdu University of Traditional Chinese Medicine

Chengdu, Sichuan, 610075, China

Location

Related Publications (1)

  • Li Z, Zhou J, Lan L, Cheng S, Sun R, Gong Q, Wintermark M, Zeng F, Liang F. Concurrent brain structural and functional alterations in patients with migraine without aura: an fMRI study. J Headache Pain. 2020 Dec 7;21(1):141. doi: 10.1186/s10194-020-01203-5.

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

  • Fanrong Liang, Master

    Chengdu University of Traditional Chinese Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2010

First Posted

June 29, 2010

Study Start

January 1, 2010

Primary Completion

June 1, 2013

Study Completion

December 1, 2013

Last Updated

December 2, 2014

Record last verified: 2012-08

Locations