Efficacy and safety of acupuncture in Chronic MIGraine

Not Applicable

Completed

• Conditions: Migraine; Nervous System Diseases

• Registration Number: ISRCTN52683557
• Lead Sponsor: Ruhr-University Bochum (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08-02
• Last Update Posted: 30 October 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1295

Inclusion Criteria

1. Member of participating health insurance company
2. Age between 18 and 65
3. Signed informed consent
4. Ability to read and speak sufficient German
5. First migraine attack before the age of 50
6. First migraine diagnosis at least six months before
7. Two to six migraine attacks in four weeks
8. Duration of migraine attacks 4 to 72 hours without acute-medication or at least 2 hours with acute-medication
9. Two migraine characteristics have to be met, at least one accompaniment

Exclusion Criteria

1. Severe migraine-attacks with inability to go to work on more than four days a month
2. Other neurological disease
3. Seconday headache
4. Neuralgia of the face or head
5. More than six days of non-migrainous headache a month
6. Experience with acupuncture against migraine
7. Any acupuncture in the last 12 months
8. Previous unsuccessful therapy with beta-blocker
9. Drug abuse
10. Pregnancy
11. Nursing mother
12. Insufficient contraception
13. Intake of antipsychotic or antidepressant drugs
14. Participation in another clinical trial
15. Intake of analgesics on more than three days a month because of other chronic pain
16. Use of prophylactic migraine medication in the last six months
17. Ongoing cortisone therapy
18. Epilepsy
19. Manifest psychiatric disease

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary endpoint is to assess the efficacy of standardised acupuncture (verum-acupuncture) in the treatment of chronic migraine in comparison to standardised sham-acupuncture and to standard therapy regarding the reduction of migraine days 26 weeks after start of treatment.

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints are: <br>1. Change in days of migraine 12 weeks after start of treatment<br>2. Migraine intensity<br>3. Intake of acute-medication<br>4. 12-item Short Form health survey (SF-12)<br>5. Von-Korff-Pain-Scale<br>6. Global Patient Assessment<br>7. Economic and quality parameters