Universitätsklinikum Münster, Klinik für Allgemeine Orthopädie und Tumororthopädie
Münster, North Rhine-Westphalia, 48149, Germany
NCT Number: NCT02253771
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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Münster, North Rhine-Westphalia, 48149, Germany
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
low back pain for less than 3 months
Exclusion criteria
Shockwave therapy with 2000 impulses/treatment at 12 Hz; 8 treatment over 4 weeks, twice a week
Other names: EMS Swiss Dolorclast® Classic (EMS Electro Medical Systems S.a.), CE Certificate: 0124
sham shockwave therapy by an identically looking device without any function
Time frame: Day 0; 7; 14; 21; 28, after 6 and 8 weeks.
Change in pain, using visual analogue scale (VAS 1-10)
Time frame: day 0; 7; 14; 21, after 6 and 8 weeks.
Oswestry disability Index
Time frame: day 0; 7; 14; 21, after 6 and 8 weeks.
Beck's depression scale
Time frame: day 0; 7; 14; 21, after 6 and 8 weeks.
EQ-5D
Time frame: day 0; 7; 14; 21, after 6 and 8 weeks.
Roland-Morris-Score
University Hospital Muenster
Other
Shockwave Therapy for Acute Low Back Pain: a Randomized Placebo-controlled Clinical Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.