Migraine Nervous System Diseases Migraine
Conditions
Interventions
Chronic pain sufferers (migraine) are randomly allocated to one of the three treatment groups:
1. Verum-acupuncture
2. Sham-acupuncture
3. Established standard therapy
Sponsors
Ruhr-University Bochum (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary endpoints are: 1. Change in days of migraine 12 weeks after start of treatment 2. Migraine intensity 3. Intake of acute-medication 4. 12-item Short Form health survey (SF-12) 5. Von-Korff-Pain-Scale 6. Global Patient Assessment 7. Economic and quality parameters | — |
Countries
Germany
Outcome results
None listed