Acupuncture in Chronic Migraine: A Randomized Controlled Trial
Recruitment status was Recruiting
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Purpose
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 | Intervention |
|---|---|
|
Patients With Chronic Migraine |
Procedure: acupuncture Drug: topiramate |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Acupuncture in Chronic Migraine: A Randomized Controlled Trial |
- Mean monthly number of headache days with moderate or severe intensity [ Time Frame: 3 months ] [ Designated as safety issue: No ]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.
- ≥ 30% or ≥ 50% reduction in mean monthly headache days with moderate or severe intensity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Mean monthly total headache days [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Reduction from baseline in the use of acute headache medications [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Short-Form 36-Item Health Survey(SF-36) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Beck Depression Inventory(BDI) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Migraine disability assessment questionnaire (MIDAS) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Plasma CGRP level [ Time Frame: 3 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 68 |
| Study Start Date: | August 2008 |
| Estimated Study Completion Date: | August 2010 |
| Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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. |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations| Contact: Chun pai Yang, MD | 886928654977 | neuralyung@gmail.com |
| Taiwan | |
| Kuang Tien General Hospital | Recruiting |
| Taichung, Taiwan, 433 | |
| Contact: Nai-Hwei Wang, MD 886426885599 fengcheese@gmail.com | |
| Principal Investigator: Chun-Pai Yang, MD | |
More Information
No publications provided by Kuang Tien General Hospital
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Kuang-Tien General Hospital |
| ClinicalTrials.gov Identifier: | NCT01096420 History of Changes |
| Other Study ID Numbers: | 9713 |
| Study First Received: | March 29, 2010 |
| Last Updated: | March 30, 2010 |
| Health Authority: | Taiwan: Department of Health |
Keywords provided by Kuang Tien General Hospital:
|
chronic migraine acupuncture Topiramate Randomized trial |
Additional relevant MeSH terms:
|
Migraine Disorders Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Topiramate Anticonvulsants |
Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Neuroprotective Agents Protective Agents Physiological Effects of Drugs Anti-Obesity Agents |
ClinicalTrials.gov processed this record on June 18, 2013