Efficacy and safety of acupuncture in Chronic MIGraine

ISRCTN	ISRCTN52683557
DOI	https://doi.org/10.1186/ISRCTN52683557
Protocol serial number	2001-006
Sponsor	Ruhr-University Bochum (Germany)
Funder	German public health insurance providers: AOK, BKK, IKK, Bundesknappschaft, Bundesverband der Landwirtschaftlichen Krankenkassen and Seekasse (Germany)

Submission date: 28/06/2005
Registration date: 02/08/2005
Last edited: 03/10/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Hans-Christoph Diener
Scientific

University Essen
Department of Neurology
Hufelandstr 55
Essen
45122
Germany

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Efficacy and safety of acupuncture in Chronic MIGraine - a multicentre, randomised, controlled clinical trial
Study acronym	gerac-MIG
Study objectives	The goal of the trial 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 endpoints are the subjective estimation of the therapies through the patient and safety of the therapies.
Ethics approval(s)	Not provided at time of registration.
Health condition(s) or problem(s) studied	Migraine
Intervention	Chronic pain sufferers (migraine) are randomly allocated to one of the three treatment groups: 1. Verum-acupuncture 2. Sham-acupuncture 3. Established standard therapy
Intervention type	Other
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	15/06/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	1295
Key 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
Key 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
Date of first enrolment	25/04/2002
Date of final enrolment	15/06/2005

Locations

Countries of recruitment

Germany

Study participating centre

University Essen

Essen
45122
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2006		Yes	No
Protocol article	protocol	01/06/2005		Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

03/10/2017: internal review.