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Effectiveness of Radial Extracorporeal Shockwave Therapy in Patients with Acute Low Back Pain—Randomized Controlled Trial
The aim of this study was to investigate the effect of radial extracorporeal shockwave therapy (rESWT) primarily on acute lumbar back pain (aLBP), and secondarily on physical function and quality of life. This randomized, placebo-controlled, single-blinded trial with 12-week follow-up (FU) randomize...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8658438/ https://www.ncbi.nlm.nih.gov/pubmed/34884271 http://dx.doi.org/10.3390/jcm10235569 |
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author | Lange, Tobias Deventer, Niklas Gosheger, Georg Lampe, Lukas P Bockholt, Sebastian Schulze Boevingloh, Albert Schulte, Tobias L |
author_facet | Lange, Tobias Deventer, Niklas Gosheger, Georg Lampe, Lukas P Bockholt, Sebastian Schulze Boevingloh, Albert Schulte, Tobias L |
author_sort | Lange, Tobias |
collection | PubMed |
description | The aim of this study was to investigate the effect of radial extracorporeal shockwave therapy (rESWT) primarily on acute lumbar back pain (aLBP), and secondarily on physical function and quality of life. This randomized, placebo-controlled, single-blinded trial with 12-week follow-up (FU) randomized 63 patients with aLBP 1:1 into two groups receiving either rESWT (intervention) or sham rESWT (placebo) with a manipulated shockwave head not delivering any shockwaves. Both, rESWT and sham procedure were carried out eight times for four weeks. Both groups received additional analgesics and physiotherapy twice a week. Primary patient-reported outcome measure (PROM) was the visual analogue scale for aLBP (VAS-LBP). Secondary PROMs included the Oswestry disability index (ODI), Roland and Morris Disability Questionnaire (RDQ), EuroQol EQ-5D-3L, and the Beck Depression Index (BDI-II). Primary endpoint was a between-arm comparison of mean changes in VAS-LBP from baseline to final FU. At randomization, there were no differences between the two groups in relation to age and PROMs. Both groups showed significant improvement in all PROMs at final FU. VAS-LBP declined by 60.7% (p < 0.001) in the intervention and by 86.4% (p < 0.001) in the sham group. The intervention group showed significantly less pain relief after 4 and 12 weeks. The EQ-5D submodality pain showed significantly inferior results for the intervention (1.5 (0.58)) compared to the sham group (1.1 (0.33)) (p < 0.014) after eight weeks. No significant intergroup differences were observed for RDQ, ODI or BDI-II. Additional rESWT alongside conventional guideline therapy in aLBP does not have any significant effects on pain intensity, physical function, or quality of life. To the best of our knowledge, this is the first study with a high level of evidence reporting the efficacy of rESWT in aLBP treatment and will be a future basis for decision-making. |
format | Online Article Text |
id | pubmed-8658438 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-86584382021-12-10 Effectiveness of Radial Extracorporeal Shockwave Therapy in Patients with Acute Low Back Pain—Randomized Controlled Trial Lange, Tobias Deventer, Niklas Gosheger, Georg Lampe, Lukas P Bockholt, Sebastian Schulze Boevingloh, Albert Schulte, Tobias L J Clin Med Article The aim of this study was to investigate the effect of radial extracorporeal shockwave therapy (rESWT) primarily on acute lumbar back pain (aLBP), and secondarily on physical function and quality of life. This randomized, placebo-controlled, single-blinded trial with 12-week follow-up (FU) randomized 63 patients with aLBP 1:1 into two groups receiving either rESWT (intervention) or sham rESWT (placebo) with a manipulated shockwave head not delivering any shockwaves. Both, rESWT and sham procedure were carried out eight times for four weeks. Both groups received additional analgesics and physiotherapy twice a week. Primary patient-reported outcome measure (PROM) was the visual analogue scale for aLBP (VAS-LBP). Secondary PROMs included the Oswestry disability index (ODI), Roland and Morris Disability Questionnaire (RDQ), EuroQol EQ-5D-3L, and the Beck Depression Index (BDI-II). Primary endpoint was a between-arm comparison of mean changes in VAS-LBP from baseline to final FU. At randomization, there were no differences between the two groups in relation to age and PROMs. Both groups showed significant improvement in all PROMs at final FU. VAS-LBP declined by 60.7% (p < 0.001) in the intervention and by 86.4% (p < 0.001) in the sham group. The intervention group showed significantly less pain relief after 4 and 12 weeks. The EQ-5D submodality pain showed significantly inferior results for the intervention (1.5 (0.58)) compared to the sham group (1.1 (0.33)) (p < 0.014) after eight weeks. No significant intergroup differences were observed for RDQ, ODI or BDI-II. Additional rESWT alongside conventional guideline therapy in aLBP does not have any significant effects on pain intensity, physical function, or quality of life. To the best of our knowledge, this is the first study with a high level of evidence reporting the efficacy of rESWT in aLBP treatment and will be a future basis for decision-making. MDPI 2021-11-26 /pmc/articles/PMC8658438/ /pubmed/34884271 http://dx.doi.org/10.3390/jcm10235569 Text en © 2021 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Article Lange, Tobias Deventer, Niklas Gosheger, Georg Lampe, Lukas P Bockholt, Sebastian Schulze Boevingloh, Albert Schulte, Tobias L Effectiveness of Radial Extracorporeal Shockwave Therapy in Patients with Acute Low Back Pain—Randomized Controlled Trial |
title | Effectiveness of Radial Extracorporeal Shockwave Therapy in Patients with Acute Low Back Pain—Randomized Controlled Trial |
title_full | Effectiveness of Radial Extracorporeal Shockwave Therapy in Patients with Acute Low Back Pain—Randomized Controlled Trial |
title_fullStr | Effectiveness of Radial Extracorporeal Shockwave Therapy in Patients with Acute Low Back Pain—Randomized Controlled Trial |
title_full_unstemmed | Effectiveness of Radial Extracorporeal Shockwave Therapy in Patients with Acute Low Back Pain—Randomized Controlled Trial |
title_short | Effectiveness of Radial Extracorporeal Shockwave Therapy in Patients with Acute Low Back Pain—Randomized Controlled Trial |
title_sort | effectiveness of radial extracorporeal shockwave therapy in patients with acute low back pain—randomized controlled trial |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8658438/ https://www.ncbi.nlm.nih.gov/pubmed/34884271 http://dx.doi.org/10.3390/jcm10235569 |
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