Condition category
Nervous System Diseases
Date applied
28/06/2005
Date assigned
02/08/2005
Last edited
09/07/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.gerac.de

Contact information

Type

Scientific

Primary contact

Prof Hans-Christoph Diener

ORCID ID

Contact details

University Essen
Department of Neurology
Hufelandstr 55
Essen
45122
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2001-006

Study information

Scientific title

Acronym

gerac-MIG

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.

Ethics approval

Not provided at time of registration.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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

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

Overall trial start date

25/04/2002

Overall trial end date

15/06/2005

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1295

Participant 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

Recruitment start date

25/04/2002

Recruitment end date

15/06/2005

Locations

Countries of recruitment

Germany

Trial participating centre

University Essen
Essen
45122
Germany

Sponsor information

Organisation

Ruhr-University Bochum (Germany)

Sponsor details

c/o Prof. Dr. H.J. Trampisch
Universitaetsstr. 150
Bochum
44780
Germany

Sponsor type

University/education

Website

http://www.amib.ruhr-uni-bochum.de

Funders

Funder type

Industry

Funder name

German public health insurance providers: AOK, BKK, IKK, Bundesknappschaft, Bundesverband der Landwirtschaftlichen Krankenkassen and Seekasse (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

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

Publication citations

  1. Endres HG, Zenz M, Schaub C, Molsberger A, Haake M, Streitberger K, Skipka G, Maier C, , [German Acupuncture Trials (gerac) address problems of methodology associated with acupuncture studies]., Schmerz, 2005, 19, 3, 201-4, 206, 208-10 passim, doi: 10.1007/s00482-004-0345-z.

  2. Diener HC, Kronfeld K, Boewing G, Lungenhausen M, Maier C, Molsberger A, Tegenthoff M, Trampisch HJ, Zenz M, Meinert R, , Efficacy of acupuncture for the prophylaxis of migraine: a multicentre randomised controlled clinical trial., Lancet Neurol, 2006, 5, 4, 310-316, doi: 10.1016/S1474-4422(06)70382-9.

  3. Molsberger A, Diener HC, Krämer J, Michaelis J, Schäfer H, Trampisch HJ, Victor N, Zenz M, [German acupuncture studies]., Z Arztl Fortbild Qualitatssich, 2004, 98, 6, 468-471.

Additional files

Editorial Notes