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Acupuncture in Chronic Migraine: A Randomized Controlled Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01096420
Recruitment Status : Completed
First Posted : March 31, 2010
Last Update Posted : August 14, 2013
Information provided by (Responsible Party):
Chun-pai Yang, Kuang Tien General Hospital

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).

Condition or disease Intervention/treatment Phase
Patients With Chronic Migraine Procedure: acupuncture Drug: topiramate Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acupuncture in Chronic Migraine: A Randomized Controlled Trial
Study Start Date : August 2008
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Acupuncture Migraine
Drug Information available for: Topiramate

Arm Intervention/treatment
Experimental: acupuncture 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.

Active Comparator: topiramate 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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. ≥ 30% or ≥ 50% reduction in mean monthly headache days with moderate or severe intensity [ Time Frame: 3 months ]
  2. Mean monthly total headache days [ Time Frame: 3 months ]
  3. Reduction from baseline in the use of acute headache medications [ Time Frame: 3 months ]
  4. Short-Form 36-Item Health Survey(SF-36) [ Time Frame: 3 months ]
  5. Beck Depression Inventory(BDI) [ Time Frame: 3 months ]
  6. Migraine disability assessment questionnaire (MIDAS) [ Time Frame: 3 months ]
  7. Plasma CGRP level [ Time Frame: 3 months ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01096420

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Kuang Tien General Hospital
Taichung, Taiwan, 433
Sponsors and Collaborators
Kuang Tien General Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Chun-pai Yang, MD, Kuang Tien General Hospital Identifier: NCT01096420    
Other Study ID Numbers: 9713
First Posted: March 31, 2010    Key Record Dates
Last Update Posted: August 14, 2013
Last Verified: August 2013
Keywords provided by Chun-pai Yang, Kuang Tien General Hospital:
chronic migraine
Randomized trial
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs