Institut
fur Sozialmedizin, Epidemiologie und Gesundheitsokonomie, Klinikum Charit ,
Humboldt-Universitat zu Berlin, Berlin, Germany. benno.brinkhaus@charite.de
BACKGROUND: We report on the study design and protocols of two randomized
controlled trials (Acupuncture Randomized Trials = ART) that investigate the
efficacy of acupuncture in the treatment of chronic low back pain and osteoarthritis
of the knee, respectively. OBJECTIVE: To investigate whether acupuncture is
more efficacious than (a) no treatment or (b) minimal acupuncture in the
treatment of low back pain and osteoarthritis. DESIGN: Two randomized,
controlled, multicenter trials with three treatment arms and a total
follow-up time of 52 weeks. SETTING: 30 practitioners and outpatient units in
Germany specialized in acupuncture treatment. PATIENTS: 300 patients will be
included in each study. In the low back pain trial, patients will be included
according to clinical diagnosis. In the osteoarthritis pain trial, patients
will be included according to the American College of Rheumatology criteria.
INTERVENTIONS: Patients are randomly assigned to receive either (1)
semi-standardized acupuncture (150 patients), (2) minimal acupuncture at
non-acupuncture points (75 patients), or (3) no treatment for two months
followed by semi-standardized acupuncture (75 patients, waiting list
control). Acupuncture treatment consists of 12 sessions per patient over a
period of 8 weeks. MAIN OUTCOME MEASURE: The main outcome measure is the
difference between baseline and the end of the 8-week treatment period in the
following parameters: pain intensity as measured by a visual analogue scale
(VAS; 0-100 mm) in the low back pain trial and by the Western Ontario and
McMaster Universities Osteoarthritis Score (WOMAC) in the osteoarthritis
trial. OUTLOOK: The results of these two studies (available in 2004) will
provide health care providers and policy makers with the information needed
to make scientifically sound assessments of acupuncture therapy. Copyright 2003 S. Karger GmbH, Freiburg
