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ISRCTN
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ISRCTN36780548
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ClinicalTrials.gov identifier
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Public title
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Efficacy and safety of acupuncture for chronic pain caused by tension-type headache: a multi-centre randomised controlled clinical trial
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Scientific title
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Acronym
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Gerac-sks
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Serial number at source
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1748
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Germany
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Disease/condition/study domain
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Tension-type headache
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Participants - inclusion criteria
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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).
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Participants - exclusion criteria
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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.
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Anticipated start date
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29/04/2002
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Anticipated end date
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15/06/2005
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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945
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Interventions
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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).
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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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)
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Sources of funding
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German public health insurance providers: AOK, BKK, IKK, Bundesknappschaft, Bundesverband der Landwirtschaftlichen Krankenkassen, and Seekasse (Germany)
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Trial website
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http://www.gerac.de
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Publications
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Contact name
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Prof
Martin
Tegenthoff
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Address
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Bürkle de la Camp Platz 1
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City/town
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Bochum
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Zip/Postcode
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44789
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Country
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Germany
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Tel
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+49 (0)234 3026809
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Email
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martin.tegenthoff@ruhr-uni-bochum.de
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Sponsor
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Ruhr-University Bochum (Germany)
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Address
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c/o Prof. Dr. H.J. Trampisch
Universitaetsstr. 150
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City/town
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Bochum
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Zip/Postcode
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44780
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Country
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Germany
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Tel
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+49 (0)234 3227790
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Fax
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+49 (0)234 3214325
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Email
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hans.j.trampisch@ruhr-uni-bochum.de
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Sponsor website:
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http://www.amib.ruhr-uni-bochum.de/
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Date applied
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08/06/2005
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Last edited
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11/09/2009
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Date ISRCTN assigned
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29/06/2005
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