Study protocol

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

Konrad Streitberger¹ , Steffen Witte² , Ulrich Mansmann² , Christine Knauer² , Jürgen Krämer³ , Hanns-Peter Scharf⁴ and Norbert Victor²

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

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

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

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

author email corresponding author email

BMC Complementary and Alternative Medicine 2004, 4:6doi:10.1186/1472-6882-4-6

Published:	24 March 2004

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.