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Efficacy and safety of acupuncture in Chronic MIGraine - a multicentre, randomised, controlled clinical trial
ISRCTN ISRCTN52683557
DOI 10.1186/ISRCTN52683557
ClinicalTrials.gov identifier
EudraCT number
Public title Efficacy and safety of acupuncture in Chronic MIGraine - a multicentre, randomised, controlled clinical trial
Scientific title
Acronym gerac-MIG
Serial number at source 2001-006
Study hypothesis 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.
Lay summary
Ethics approval Not provided at time of registration.
Study design Randomised controlled trial
Countries of recruitment Germany
Disease/condition/study domain Migraine
Participants - 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
Participants - 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
Anticipated start date 25/04/2002
Anticipated end date 15/06/2005
Status of trial Completed
Patient information material
Target number of participants 1295
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
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.
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
Sources of funding German public health insurance providers: AOK, BKK, IKK, Bundesknappschaft, Bundesverband der Landwirtschaftlichen Krankenkassen and Seekasse (Germany)
Trial website http://www.gerac.de
Publications Protocol in:
1. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15959826

Results in:
1. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16545747
2. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15527187
Contact name Prof  Hans-Christoph  Diener
  Address University Essen
Department of Neurology
Hufelandstr 55
  City/town Essen
  Zip/Postcode 45122
  Country Germany
Sponsor Ruhr-University Bochum (Germany)
  Address c/o Prof. Dr. H.J. Trampisch
Universitaetsstr. 150
  City/town Bochum
  Zip/Postcode 44780
  Country Germany
  Sponsor website: http://www.amib.ruhr-uni-bochum.de
Date applied 28/06/2005
Last edited 09/07/2007
Date ISRCTN assigned 02/08/2005
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