Trials / Completed
CompletedNCT01096420
Acupuncture in Chronic Migraine: A Randomized Controlled Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 68 (actual)
- Sponsor
- Kuang Tien General Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2008-08-01
- Primary completion
- 2010-08-01
- Completion
- 2010-08-01
- First posted
- 2010-03-31
- Last updated
- 2013-08-14
Locations
1 site across 1 country: Taiwan
Source: ClinicalTrials.gov record NCT01096420. Inclusion in this directory is not an endorsement.