The German multicenter, randomized, partially blinded, prospective trial of acupuncture for chronic low-back pain: a preliminary report on the rationale and design of the trial.
BACKGROUND
The efficacy of acupuncture treatment for chronic low-back pain has not been reliably proven because of a lack of good quality studies, leading to the necessity of developing the German Acupuncture Trial for Chronic Low-Back Pain (GERAC-cLBP) study.


OBJECTIVE
The aim is to assess the effectiveness of traditional Chinese acupuncture for chronic low-back pain compared to sham acupuncture and with a conventional standard therapy.


METHODS
This trial is a nationwide, multicenter, randomized, prospective, partially blinded study. The primary endpoint is the success rate after 6 months. Success is defined as an improvement of 33% or more of three pain-related items on the Van-Korff Pain Score or an improvement of 12% or more in the disability measured by the Hanover Functional Ability Questionnaire. Assessment of the effectiveness of the blinding of patients to the form of acupuncture they received will be conducted. All clinical endpoints are assessed centrally by blinded independent observers. The sample size, with a total of 1062 patients to be enrolled, is based on power calculations. Independent central randomization, data collection, data processing, and statistical analysis are provided. Success rates will be tested for differences using two-sided Fisher exact tests. In the primary analysis, all tests will be carried out on the basis of the intention-to-treat principle. Secondary analyses will be conducted according to protocol approaches.


METHODS
The pilot phase of the trial started in February 2002, the estimated duration of the study is 2.5 years. Enrollment is anticipated to be completed in the winter of 2003.


CONCLUSIONS
The GERAC-cLBP study is currently the world's largest controlled trial of the effectiveness of acupuncture treatment for low-back pain. It will contribute to the evaluation of efficacy by means of evidence based medicine.
Haake
Michael
M
Orthopedic Department, University of Regensburg, Bad Abbach, Germany. m.haake@rheuma-ortho-zentrum.de
Müller
Hans-Helge
HH
Schade-Brittinger
Carmen
C
Prinz
Helge
H
Basler
Heinz-Dieter
HD
Streitberger
Konrad
K
Schäfer
Helmut
H
Molsberger
Albrecht
A
D015670:Acupuncture Therapy / Q000379:methods; D002908:Chronic Disease; D002985:Clinical Protocols / Q000592:standards; D004311:Double-Blind Method; D005260:Female; D005858:Germany; D006801:Humans; D017116:Low Back Pain / Q000628:therapy*; D008297:Male; D011446:Prospective Studies; D012107:Research Design / Q000592:standards; D013997:Time Factors