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

Efficacy and safety of acupuncture for chronic pain caused by gonarthrosis: A study protocol of an ongoing multi-centre randomised controlled clinical trial [ISRCTN27450856]
Received February 20, 2004; Accepted March 24, 2004.
Published online 2004 March 24
Konrad Streitberger,1 Steffen Witte,2 Ulrich Mansmann,2 Christine Knauer,2 J?rgen Krâmer,3 Hanns-Peter Scharf,4 and Norbert Victor2
BMC Complementary and Alternative Medicine
PubMed Central

Copyright Š 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.

1Clinic of Anaesthesiology, University of Heidelberg, Im Neuenheimer Feld 110, D-69120 Heidelberg, Germany

2Institute for Medical Biometry and Informatics, University of Heidelberg, Im Neuenheimer Feld 305, D-69120 Heidelberg, Germany

3Clinic of Orthopaedics, University of Bochum, Josefs-Krankenhaus, Gudrunstraβe 5, D-44791 Bochum, Germany

4Clinic of Orthopaedics, University of Heidelberg, Mannheim, Theodor-Kutzer-Ufer, D-68167 Mannheim, Germany

Corresponding author.

Konrad Streitberger: Konrad_Streitberger@med.uni-heidelberg.de; Steffen Witte: witte@imbi.uni-heidelberg.de; Ulrich Mansmann: mansmann@imbi.uni-heidelberg.de; Christine Knauer: knauer@imbi.uni-heidelberg.de; J?rgen Krâmer: juergen.kraemer@ruhr-uni-bochum.de; Hanns-Peter Scharf: hanns-peter.scharf@ortho.ma.uni-heidelberg.de; Norbert Victor: victor@imbi.uni-heidelberg.de

Abstract
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.

Keywords: acupuncture, gonarthrosis, randomized clinical trial, protocol

Please visit the website to view the article in its entirety.