An interventional study of acupuncture and topiramate in Patients With Chronic Migraine, sponsored by Kuang Tien General Hospital. Completed at 1 site in Taiwan. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2013-08-14.
Sponsored by Kuang Tien General Hospital · Not applicable, Interventional, and Treatment
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).
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.
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's enrollment of 68 is below the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Kuang Tien General Hospital is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Procedure: acupuncture
Drug: topiramate
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.
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.
Mean monthly number of headache days with moderate or severe intensity
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.
Time frame: 3 months
≥ 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
This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.
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Kuang Tien General Hospital