Acupuncture in Chronic Migraine: A Randomized Controlled Trial

Patients With Chronic Migraine Clinical Trial

Official title:

Acupuncture in Chronic Migraine: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01096420
• Other study ID #: 9713
• Status: Completed
• Phase: N/A
• First received: March 29, 2010
• Last updated: August 12, 2013
• Start date: August 2008
• Est. completion date: August 2010

Study information

• Verified date: August 2013
• Source: Kuang Tien General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 ß-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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Migraine Disorders
• Patients With Chronic Migraine

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Kuang Tien General Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
Kuang Tien General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months	No
Secondary	= 30% or = 50% reduction in mean monthly headache days with moderate or severe intensity		3 months	No
Secondary	Mean monthly total headache days		3 months	No
Secondary	Reduction from baseline in the use of acute headache medications		3 months	No
Secondary	Short-Form 36-Item Health Survey(SF-36)		3 months	No
Secondary	Beck Depression Inventory(BDI)		3 months	No
Secondary	Migraine disability assessment questionnaire (MIDAS)		3 months	No
Secondary	Plasma CGRP level		3 months	No