Efficacy and safety of acupuncture in Chronic MIGraine
| ISRCTN | ISRCTN52683557 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52683557 |
| Secondary identifying numbers | 2001-006 |
- 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
Scientific
University Essen
Department of Neurology
Hufelandstr 55
Essen
45122
Germany
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 | 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 study start date | 25/04/2002 |
| Completion date | 15/06/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
45122
Germany
Sponsor information
Ruhr-University Bochum (Germany)
University/education
University/education
c/o Prof. Dr. H.J. Trampisch
Universitaetsstr. 150
Bochum
44780
Germany
| Website | http://www.amib.ruhr-uni-bochum.de |
|---|---|
"ROR" |
https://ror.org/04tsk2644 |
Funders
Funder type
Industry
German public health insurance providers: AOK, BKK, IKK, Bundesknappschaft, Bundesverband der Landwirtschaftlichen Krankenkassen and Seekasse (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/06/2005 | Yes | No | |
| Results article | results | 01/04/2006 | Yes | No |
Editorial Notes
03/10/2017: internal review.
