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Acupuncture in Chronic Migraine: A Randomized Controlled Trial

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ClinicalTrials.gov Identifier: NCT01096420
Recruitment Status : Completed
First Posted : March 31, 2010
Last Update Posted : August 14, 2013
Sponsor:
Information provided by (Responsible Party):
Chun-pai Yang, Kuang Tien General Hospital

Tracking Information
First Submitted Date  ICMJE March 29, 2010
First Posted Date  ICMJE March 31, 2010
Last Update Posted Date August 14, 2013
Study Start Date  ICMJE August 2008
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 30, 2010)
Mean monthly number of headache days with moderate or severe intensity [ Time Frame: 3 months ]
a day with headache pain that lasts ≧ 4 h with peak severity of moderate or severe intensity, or any severity or duration if the subject takes and response to a triptan or ergot.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01096420 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2010)
  • ≥ 30% or ≥ 50% reduction in mean monthly headache days with moderate or severe intensity [ Time Frame: 3 months ]
  • Mean monthly total headache days [ Time Frame: 3 months ]
  • Reduction from baseline in the use of acute headache medications [ Time Frame: 3 months ]
  • Short-Form 36-Item Health Survey(SF-36) [ Time Frame: 3 months ]
  • Beck Depression Inventory(BDI) [ Time Frame: 3 months ]
  • Migraine disability assessment questionnaire (MIDAS) [ Time Frame: 3 months ]
  • Plasma CGRP level [ Time Frame: 3 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acupuncture in Chronic Migraine: A Randomized Controlled Trial
Official Title  ICMJE Acupuncture in Chronic Migraine: A Randomized Controlled Trial
Brief Summary The aim of this study was to investigate the efficacy and tolerance of acupuncture treatment compared with pharmacologic treatment in patients with chronic migraines.Besides, the investigators tested whether the clinical effects of acupuncture in chronic migraine prophylaxis are mediated by changes of the plasma CGRP (Calcitonin gene-related peptide).
Detailed Description

Subjects who completed the prospective baseline periods and meet met the prespecified entry criteria will be randomized into 2 groups: acupuncture treatment, and topiramate treatment group.

Subjects will be allowed to continue taking acute migraine medications for the treatment of breakthrough attacks during the trial, but any migraine preventive medications will be prohibited.

Written informed consent was obtained from all participants before entering the study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Patients With Chronic Migraine
Intervention  ICMJE
  • Procedure: acupuncture

    Each patient had a fixed and classic acupuncture points Ex-HN-3,BL-2,GB-20,EX-HN-5 bilaterally in their 24 sessions.

    Acupuncture consisted of 24 sessions of 30 min duration, administrated over 12 weeks (two sessions per week).

    Sterile disposable and steel needle (3210) were used .

    The needles were manipulated by rotation methods to produce a characteristic sensation know as De Qi.

  • Drug: topiramate

    The patients were submitted to the topiramate treatment also for 12 consecutive weeks.

    The study phase consists of a 4-week titration and a 8-week maintenance period.

    All dosages of topiramate will be initiated at 25 mg/d hs and increased by 25 mg/d weekly to a maximum of 100 mg/day (or to the maximal tolerated dose).

    Study drug was administered daily in equally divided twice daily doses.

Study Arms  ICMJE
  • Experimental: acupuncture
    Intervention: Procedure: acupuncture
  • Active Comparator: topiramate
    Intervention: Drug: topiramate
Publications * Yang CP, Chang MH, Liu PE, Li TC, Hsieh CL, Hwang KL, Chang HH. Acupuncture versus topiramate in chronic migraine prophylaxis: a randomized clinical trial. Cephalalgia. 2011 Nov;31(15):1510-21. doi: 10.1177/0333102411420585. Epub 2011 Oct 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 30, 2010)
68
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2010
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 18 to 75 years old
  • Patients were required to have a diagnosis of chronic migraine with or without medication overuse that satisfied the ICHD-2 criteria during the last 3 months prior to trial entry, with an established migraine history for at least 1 year.

Exclusion Criteria:

  • Patients did not fulfill the criteria of ≧ 15 days or response to triptans or ergots on at least 8 days in prospective baseline periods .
  • The presence of headaches other than chronic migraine (such as another primary chronic headache or any secondary headache).
  • Migraine prophylaxis agents during last 3 months including β-blockers, anti-depressants, calcium channel blockers, anti-epileptic agents or cycle-modulating hormonal drugs.
  • Migraine onset after age 50 or the age at onset of CM > 60 years.
  • History of hepatic disorder, nephrolithiasis or other severe illness.
  • Cognitive impairment interfering with the subject's ability to follow instructions and describe symptoms.
  • Prior fearful experience of acupuncture.
  • Bleeding diathesis or anticoagulation.
  • Pregnant or nursing.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01096420
Other Study ID Numbers  ICMJE 9713
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chun-pai Yang, Kuang Tien General Hospital
Study Sponsor  ICMJE Kuang Tien General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Kuang Tien General Hospital
Verification Date August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP