Efficacy and safety of acupuncture for chronic pain caused by gonarthrosis: A study protocol of an ongoing multi-centre randomised controlled clinical trial [ISRCTN27450856]

BMC Complementary and Alternative Medicine

Norbert Victor⁴  Hanns-Peter Scharf²  Jürgen Krämer³  Christine Knauer⁴  Ulrich Mansmann⁴  Steffen Witte⁴  Konrad Streitberger¹ 

[1] Clinic of Anaesthesiology, University of Heidelberg, Im Neuenheimer Feld 110, D-69120 Heidelberg, Germany;Clinic of Orthopaedics, University of Heidelberg, Mannheim, Theodor-Kutzer-Ufer, D-68167 Mannheim, Germany;Clinic of Orthopaedics, University of Bochum, Josefs-Krankenhaus, Gudrunstraβe 5, D-44791 Bochum, Germany;Institute for Medical Biometry and Informatics, University of Heidelberg, Im Neuenheimer Feld 305, D-69120 Heidelberg, Germany

关键词: protocol;    randomized clinical trial;    gonarthrosis;    acupuncture;   

Others  :  1234321
DOI  :  10.1186/1472-6882-4-6

 received in 2004-02-20, accepted in 2004-03-24,  发布年份 2004

【 摘 要 】

Background

Controlled clinical trials produced contradictory results with respect to a specific analgesic effect of acupuncture. There is a lack of large multi-centre acupuncture trials. The German Acupuncture Trial represents the largest multi-centre study of acupuncture in the treatment of chronic pain caused by gonarthrosis up to now.

Methods

900 patients will be randomised to three treatment arms. One group receives verum acupuncture, the second sham acupuncture, and the third conservative standard therapy. The trial protocol is described with eligibility criteria, detailed information on the treatment definition, blinding, endpoints, safety evaluation, statistical methods, sample size determination, monitoring, legal aspects, and the current status of the trial.

Discussion

A critical discussion is given regarding the considerations about standardisation of the acupuncture treatment, the choice of the control group, and the blinding of patients and observers.

【 授权许可】

   
2004 Streitberger et al; licensee BioMed Central Ltd. This is an Open Access article: verbatim copying and redistribution of this article are permitted in all media for any purpose, provided this notice is preserved along with the article's original URL.

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