The aim of the study is to evaluate the efficacy of Disci/Rhus toxicodendron. comp.® in patients with chronic low back pain compared to waiting list group, or placebo.
Chronic low back pain is a significant health problem in industrialized countries. Use of complementary medicine is increasing in patients with low back pain. Until now there is no evidence for the efficacy of Disci/Rhus toxicodendron. comp.® in patients with chronic low back pain.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
150
s.c. application 10 ml (1 ampul) in 5 to 10 parts on different back pain sites verum group 12 treatments: 8 in the first 4 weeks and 4 in the next 4 weeks
s.c. application 10 ml (1 ampul) in 5 to 10 parts on different back pain sites 12 treatments: 8 in the first 4 weeks and 4 in the next 4 weeks
o Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center
Berlin, Germany
Visual analogue scale (0-100 mm) low back pain
Time frame: once after 8 weeks
Back function (back function scale FFbHR)
Time frame: once at week 8 and 26
visual analogue scale (0-100 mm) low back pain
Time frame: once after week 26
days with medication
Time frame: week 4 to 8
quality of life (SF-36)
Time frame: once at week 8 and 26
pain disability scale (PDI)
Time frame: once at week 8 and 26
emotional pain scale (SES)
Time frame: once at week 8 and 26
influence of patient expectancy
Time frame: once at week 8 and 26
influence of physician expectancy
Time frame: once at week 8 and 26
Responder rate 36% VAS pain intensity
Time frame: once at week 8 and 26
numbers of days with absence from work
Time frame: between week 4 and 8
days with physician visits because of low back pain
Time frame: between week 4 and 8
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