The purpose of this study is to determine whether shockwave therapy is more effective in the treatment of unspecific acute low back pain than sham therapy. 60 patients with acute low back pain will be recruited to a single-blinded, randomized, placebo-controlled trial. They are randomized to receive either shockwave therapy or sham treatment by a identically looking device for 4 weeks, twice a week. Additionally patients receive physiotherapy twice a week and are allowed to take an anti-inflammatory drug, if necessary for even 4 weeks. The primary outcome variable will be measured at day 0, every week during treatment (day 7; 14; 21 and 28) and up to 4 weeks after the last treatment. The clinical outcome will be primarily measured by pain intensity using a visual analogue scale. Secondary outcome measures are Oswestry Disability Index, Beck's Pain Depression Scale, Roland Morris Disability Questionnaire and the EQ-5D. Data will be analysed for the difference in change of scores between groups using one-way t-test.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
63
Shockwave therapy with 2000 impulses/treatment at 12 Hz; 8 treatment over 4 weeks, twice a week
sham shockwave therapy by an identically looking device without any function
Universitätsklinikum Münster, Klinik für Allgemeine Orthopädie und Tumororthopädie
Münster, North Rhine-Westphalia, Germany
Change in pain, using visual analogue scale (VAS)
Change in pain, using visual analogue scale (VAS 1-10)
Time frame: Day 0; 7; 14; 21; 28, after 6 and 8 weeks.
Change in other clinical questionnaires (Oswestry disability Index)
Oswestry disability Index
Time frame: day 0; 7; 14; 21, after 6 and 8 weeks.
Change in other clinical questionnaires (Beck's depression scale)
Beck's depression scale
Time frame: day 0; 7; 14; 21, after 6 and 8 weeks.
Change in other clinical questionnaires (EQ-5D)
EQ-5D
Time frame: day 0; 7; 14; 21, after 6 and 8 weeks.
Change in other clinical questionnaires (Roland-Morris-Score)
Roland-Morris-Score
Time frame: day 0; 7; 14; 21, after 6 and 8 weeks.
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