Efficacy and safety of acupuncture for chronic pain caused by tension-type headache: a multi-centre randomised controlled clinical trial
| ISRCTN | ISRCTN36780548 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN36780548 |
| Secondary identifying numbers | 1748 |
- Submission date
- 08/06/2005
- Registration date
- 29/06/2005
- Last edited
- 11/09/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Martin Tegenthoff
Scientific
Scientific
Bürkle de la Camp Platz 1
Bochum
44789
Germany
| Phone | +49 (0)234 3026809 |
|---|---|
| martin.tegenthoff@ruhr-uni-bochum.de |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Multi-centre |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | Gerac-sks |
| Study objectives | The aim of the study is to evaluate the efficacy of Chinese acupuncture = TCM acupuncture (verum) in comparison to sham-acupuncture and standard therapy (drug therapy with amitriptyline) in tension-type headache. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Tension-type headache |
| Intervention | Chronic pain sufferers (tension-type headache) are randomly allocated to one of the three treatment groups (verum acupuncture, sham acupuncture, or established standard therapy = amitriptyline). |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Amitriptyline |
| Primary outcome measure | The binary endpoint is success, yes or no, 6 months after randomization. Success is defined as a reduction of the number of headache days per month of more than 50% in comparison with the number per month at baseline. |
| Secondary outcome measures | Pain intensity, von Korff Score, health-related quality of life (12-Item Short-Form Health Survey SF-12), Global Patient Assessment, number of adverse and severe adverse events, quality parameters e.g. the assessment of patients blindness to the mode of acupuncture (by asking the patient to guess their group assignment after the last follow up) |
| Overall study start date | 29/04/2002 |
| Completion date | 15/06/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 945 |
| Key inclusion criteria | Signed informed consent, aged 18-65, diagnosis of tension-type headache according to the criteria of the International Headache Society, tension-type headaches for >6 months, at least 10 headache days per month during the last 4 weeks before randomization (completed baseline headache diary), each day is rated as a headache day if headaches persisted for at least 4 hours or if the administration of analgesics is necessary to attenuate the pain, von Korff Chronic Pain Score at least Grade I, ability to speak and read German (to understand the questionnaires and telephone interviews). |
| Key exclusion criteria | Additional migraines for more than 1 day per month, secondary headaches, additional chronic pain as a result of other additional diseases, prophylaxis of headaches with drugs during the last 12 months, modification of a permanent analgesic therapy, or a new cortison-therapy within the last 8 weeks before randomization, abuse of drugs or pain medication, any acupuncture treatment against tension-type headaches at any time, or previous treatment with needle-acupuncture in any other indication in the last year. |
| Date of first enrolment | 29/04/2002 |
| Date of final enrolment | 15/06/2005 |
Locations
Countries of recruitment
- Germany
Study participating centre
Bürkle de la Camp Platz 1
Bochum
44789
Germany
44789
Germany
Sponsor information
Ruhr-University Bochum (Germany)
University/education
University/education
c/o Prof. Dr. H.J. Trampisch
Universitaetsstr. 150
Bochum
44780
Germany
| Phone | +49 (0)234 3227790 |
|---|---|
| hans.j.trampisch@ruhr-uni-bochum.de | |
| 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 |
