Acupuncture in Chronic Migraine: A Randomized Controlled Trial

Not Applicable

Completed

• Conditions: Patients With Chronic Migraine
• Interventions: Procedure: acupuncture; Drug: topiramate

• Registration Number: NCT01096420
• Lead Sponsor: 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).

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.

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2010-03-29
• Study First Submitted QC: 2010-03-30
• Study First Posted: 2010-03-31
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-12
• Last Update Posted: 2013-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
acupuncture	acupuncture	-
topiramate	topiramate	-

Primary Outcome Measures

Name	Time	Method
Mean monthly number of headache days with moderate or severe intensity	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

Name	Time	Method
≥ 30% or ≥ 50% reduction in mean monthly headache days with moderate or severe intensity	3 months
Mean monthly total headache days	3 months
Reduction from baseline in the use of acute headache medications	3 months
Short-Form 36-Item Health Survey(SF-36)	3 months
Beck Depression Inventory(BDI)	3 months
Plasma CGRP level	3 months
Migraine disability assessment questionnaire (MIDAS)	3 months

Trial Locations

Locations (1)

Kuang Tien General Hospital; 🇨🇳 Taichung, Taiwan