Clinical trial NCT01096420: Acupuncture in Chronic Migraine: A Randomized Controlled Trial
Official title: Acupuncture in Chronic Migraine: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients With Chronic Migraine
Keywords: chronic migraine
acupuncture
Topiramate
Randomized trial
Lead sponsor: Kuang Tien General Hospital
Sponsor class: OTHER
First posted: 2010-03-31
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mean monthly number of headache days with moderate or severe intensity
timeFrame: 3 months
Secondary outcomes:
measure: ≥ 30% or ≥ 50% reduction in mean monthly headache days with moderate or severe intensity
timeFrame: 3 months
measure: Mean monthly total headache days
timeFrame: 3 months
measure: Reduction from baseline in the use of acute headache medications
timeFrame: 3 months
measure: Short-Form 36-Item Health Survey(SF-36)
timeFrame: 3 months
measure: Beck Depression Inventory(BDI)
timeFrame: 3 months
measure: Migraine disability assessment questionnaire (MIDAS)
timeFrame: 3 months
measure: Plasma CGRP level
timeFrame: 3 months
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Kuang Tien General Hospital
Study officials:
References:
citation: 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.