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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| shockwave therapy | Experimental | shockwave therapy |
|
| Placebo treatment | Placebo Comparator | sham shockwave therapy by an identically looking device without any function |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| shockwave therapy | Device | Shockwave therapy with 2000 impulses/treatment at 12 Hz; 8 treatment over 4 weeks, twice a week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain, using visual analogue scale (VAS) | Change in pain, using visual analogue scale (VAS 1-10) | Day 0; 7; 14; 21; 28, after 6 and 8 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in other clinical questionnaires (Oswestry disability Index) | Oswestry disability Index | day 0; 7; 14; 21, after 6 and 8 weeks. |
| Change in other clinical questionnaires (Beck's depression scale) |
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Inclusion Criteria:
low back pain for less than 3 months
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Niklas Deventer, Dr. med. | Universitätsklinikum Münster, Klinik für Allgemeine Orthopädie und Tumororthopädie | Principal Investigator |
| Tobias Schulte, Prof. Dr. med. | Department of Orthopaedics and Trauma Surgery, University Hospital, Ruhr University Bochum | Study Director |
| Tobias Lange, Dr. med., MBA | Department of Orthopaedics and Trauma Surgery, University Hospital, Ruhr University Bochum | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Münster, Klinik für Allgemeine Orthopädie und Tumororthopädie | Münster | North Rhine-Westphalia | 48149 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18588702 | Background | Barker KL, Elliott CJ, Sackley CM, Fairbank JC. Treatment of chronic back pain by sensory discrimination training. A Phase I RCT of a novel device (FairMed) vs. TENS. BMC Musculoskelet Disord. 2008 Jun 28;9:97. doi: 10.1186/1471-2474-9-97. | |
| 21482199 | Background | Seco J, Kovacs FM, Urrutia G. The efficacy, safety, effectiveness, and cost-effectiveness of ultrasound and shock wave therapies for low back pain: a systematic review. Spine J. 2011 Oct;11(10):966-77. doi: 10.1016/j.spinee.2011.02.002. Epub 2011 Apr 9. |
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| ID | Term |
|---|---|
| D000074059 | Extracorporeal Shockwave Therapy |
| ID | Term |
|---|---|
| D014464 | Ultrasonic Therapy |
| D003972 | Diathermy |
| D006979 | Hyperthermia, Induced |
| D013812 | Therapeutics |
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| placebo shockwave therapy | Device | sham shockwave therapy by an identically looking device without any function |
|
Beck's depression scale
| day 0; 7; 14; 21, after 6 and 8 weeks. |
| Change in other clinical questionnaires (EQ-5D) | EQ-5D | day 0; 7; 14; 21, after 6 and 8 weeks. |
| Change in other clinical questionnaires (Roland-Morris-Score) | Roland-Morris-Score | day 0; 7; 14; 21, after 6 and 8 weeks. |
| D026741 |
| Physical Therapy Modalities |
| D012046 | Rehabilitation |