Blinding
and Randomisation
The patients can only be blinded with respect to the
acupuncture treatment given. Blinding
with respect to the
standard therapy is not possible. The investigator cannot be blinded. The
WOMAC, the global patient assessment, and the SF12 are
measured during a telephone interview
performed by a
call centre. The person performing the interview is blinded with respect
to the therapy of
the patient. Patients blindness to the mode of
acupuncture is assessed after
the last follow up
by asking the patient to guess their group assignment. Additionally, patients
are asked directly
after the intervention phase for the quantity of care they have received during
the treatments.
The 1:1:1 block-randomisation, stratified by the trial
centre, is performed from an independent
centre via
fax.
(aus:
|
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
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
BMC Complementary and Alternative Medicine 2004, 4:6 doi:10.1186/1472-6882-4-6
The electronic version of this article is the complete one and can be found
online at: http://www.biomedcentral.com/1472-6882/4/6
|
Received |
|
20 February 2004 |
|
Accepted |
|
24 March 2004 |
|
Published |
|
24 March 2004 |
© 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.
"http://www.biomedcentral.com/1472-6882/4/6"
)