Acupuncture in Chronic Migraine: A Randomized Controlled Trial
NCT ID: NCT01096420
Last Updated: 2013-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
68 participants
INTERVENTIONAL
2008-08-31
2010-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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acupuncture
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.
topiramate
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Kuang Tien General Hospital
OTHER
Responsible Party
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Chun-pai Yang
MD
Locations
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Kuang Tien General Hospital
Taichung, Taiwan, Taiwan
Countries
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References
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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.
Other Identifiers
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9713
Identifier Type: -
Identifier Source: org_study_id