NCT01687660

Brief Summary

Hypothesis: Acupuncture obtains an abiding effect on migraine prophylaxis Design: A open-label randomized controlled trial. 249 participants will be included. Three arms: acupuncture in acupoint-meridian， non-acupoint-meridian group, and waiting list.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
249

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2012

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

First Submitted

Initial submission to the registry

August 31, 2012

Completed
1 day until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 19, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

February 17, 2020

Status Verified

February 1, 2020

Enrollment Period

2 years

First QC Date

August 31, 2012

Last Update Submit

February 13, 2020

Conditions

Migraine Without AuraUnilateral Headache

Keywords

acupuncturemigraine prophylaxis

Outcome Measures

Primary Outcomes (1)

  • frequency of migraine attacks

    to assess the frequency of migraine attacks at the 16th week after inclusion

    16th week after inclusion

Secondary Outcomes (2)

  • frequency of migraine attacks

    4th and 24th week after inclusion

  • headache severity

    0 day, 4th, 8th, 12th, 16th, 20th, 24th week after inclusion

Other Outcomes (2)

  • MSQ(Migraine Specific Quality of Life Questionnaire MSQ Version2.1)

    the day of inclusion and 4th week after inclusion

  • acupuncture expectation scale

    1 day

Study Arms (3)

acupoint-meridian group

EXPERIMENTAL

Apply traditional acupuncture to prevent the migraine attack according to TCM theory

Other: acupuncture

sham-acupoint group

OTHER

sham-acupoint will be penetrated for migraine prophylaxis.

Other: acupuncture

waiting list

NO INTERVENTION

No acupuncture nor other methods will be conducted in this group.

Interventions

acupunctureOTHER

apply acupuncture to prevent the migraine attack

acupoint-meridian groupsham-acupoint group

Eligibility Criteria

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

You may qualify if:

  • Age of a subject is between 18 and 65 years old(initially occured beneath the age of 50), male or female;
  • in accordance with diagnosis of migraine without aura in International Classification of Headache Disorders, ICHD-2, by IHS;
  • to 8 times attack per month in recent 3 months, with each period beyond 15 days;
  • with migraine history for over 1 year;
  • be able and willing to finish the headache diary in baseline ;
  • informed consent form must be signed by patient or lineal relative;

You may not qualify if:

  • Patients who are unconscious, psychotic.
  • Patients with aggravating tumor and other serious consumptive disease, and who are subject to infection and bleeding.
  • With serious primary illness or disease of cardiovascular, liver, renal, gastrointestinal, hematological systems and so on.
  • 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 (2)

  • Zhao L, Chen J, Li Y, Sun X, Chang X, Zheng H, Gong B, Huang Y, Yang M, Wu X, Li X, Liang F. The Long-term Effect of Acupuncture for Migraine Prophylaxis: A Randomized Clinical Trial. JAMA Intern Med. 2017 Apr 1;177(4):508-515. doi: 10.1001/jamainternmed.2016.9378.

    PMID: 28241154DERIVED

  • Chen J, Zhao L, Zheng H, Li Y, Yang M, Chang X, Gong B, Huang Y, Liu Y, Liang F. Evaluating the prophylaxis and long-term effectiveness of acupuncture for migraine without aura: study protocol for a randomized controlled trial. Trials. 2013 Oct 30;14:361. doi: 10.1186/1745-6215-14-361.

    PMID: 24171782DERIVED

MeSH Terms

Conditions

Migraine without AuraHeadache

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Migraine DisordersHeadache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Fanrong Liang, Professor

    Chengdu University of Traditional Chinese Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chengdu University of Traditional Chinese Medicine

Study Record Dates

First Submitted

August 31, 2012

First Posted

September 19, 2012

Study Start

September 1, 2012

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

February 17, 2020

Record last verified: 2020-02

Locations

CN(1)