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Acupuncture in Chronic Migraine: A Randomized Controlled Trial

Primary Purpose

Patients With Chronic Migraine

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
acupuncture
topiramate
Sponsored by
Kuang Tien General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patients With Chronic Migraine focused on measuring chronic migraine, acupuncture, Topiramate, Randomized trial

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Kuang Tien General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

acupuncture

topiramate

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
March 29, 2010
Last Updated
August 12, 2013
Sponsor
Kuang Tien General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01096420
Brief Title
Acupuncture in Chronic Migraine: A Randomized Controlled Trial
Official Title
Acupuncture in Chronic Migraine: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kuang Tien General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Chronic Migraine
Keywords
chronic migraine, acupuncture, Topiramate, Randomized trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
acupuncture
Arm Type
Experimental
Arm Title
topiramate
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
acupuncture
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
topiramate
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean monthly number of headache days with moderate or severe intensity
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
≥ 30% or ≥ 50% reduction in mean monthly headache days with moderate or severe intensity
Time Frame
3 months
Title
Mean monthly total headache days
Time Frame
3 months
Title
Reduction from baseline in the use of acute headache medications
Time Frame
3 months
Title
Short-Form 36-Item Health Survey(SF-36)
Time Frame
3 months
Title
Beck Depression Inventory(BDI)
Time Frame
3 months
Title
Migraine disability assessment questionnaire (MIDAS)
Time Frame
3 months
Title
Plasma CGRP level
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Kuang Tien General Hospital
City
Taichung
ZIP/Postal Code
433
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
22019576
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.
Results Reference
derived

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Acupuncture in Chronic Migraine: A Randomized Controlled Trial

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