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...
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MDPI AG
2021-11-01
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| Series: | Journal of Clinical Medicine |
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| Online Access: | https://www.mdpi.com/2077-0383/10/23/5569 |
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| author | Tobias Lange Niklas Deventer Georg Gosheger Lukas P Lampe Sebastian Bockholt Albert Schulze Boevingloh Tobias L Schulte |
| author_facet | Tobias Lange Niklas Deventer Georg Gosheger Lukas P Lampe Sebastian Bockholt Albert Schulze Boevingloh Tobias L Schulte |
| author_sort | Tobias Lange |
| collection | DOAJ |
| 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% (<i>p</i> < 0.001) in the intervention and by 86.4% (<i>p</i> < 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)) (<i>p</i> < 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. |
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| institution | Directory Open Access Journal |
| issn | 2077-0383 |
| language | English |
| last_indexed | 2024-03-10T04:51:17Z |
| publishDate | 2021-11-01 |
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| spelling | doaj.art-56a9a838c34f4a83a41249e1bffe2f4e2023-11-23T02:36:05ZengMDPI AGJournal of Clinical Medicine2077-03832021-11-011023556910.3390/jcm10235569Effectiveness of Radial Extracorporeal Shockwave Therapy in Patients with Acute Low Back Pain—Randomized Controlled TrialTobias Lange0Niklas Deventer1Georg Gosheger2Lukas P Lampe3Sebastian Bockholt4Albert Schulze Boevingloh5Tobias L Schulte6Department of Orthopaedics and Trauma Surgery, St. Josef-Hospital, Ruhr-University Bochum, 44791 Bochum, GermanyDepartment of Orthopaedics and Tumour Orthopaedics, Muenster University Hospital, 48149 Muenster, GermanyDepartment of Orthopaedics and Tumour Orthopaedics, Muenster University Hospital, 48149 Muenster, GermanyDepartment of Orthopaedics and Tumour Orthopaedics, Muenster University Hospital, 48149 Muenster, GermanyDepartment of Orthopaedics and Tumour Orthopaedics, Muenster University Hospital, 48149 Muenster, GermanyDepartment of Orthopaedics and Tumour Orthopaedics, Muenster University Hospital, 48149 Muenster, GermanyDepartment of Orthopaedics and Trauma Surgery, St. Josef-Hospital, Ruhr-University Bochum, 44791 Bochum, GermanyThe 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% (<i>p</i> < 0.001) in the intervention and by 86.4% (<i>p</i> < 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)) (<i>p</i> < 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.https://www.mdpi.com/2077-0383/10/23/5569low back painacuteradial shockwave therapyrandomized controlled trial (RCT)clinical outcomespine |
| spellingShingle | Tobias Lange Niklas Deventer Georg Gosheger Lukas P Lampe Sebastian Bockholt Albert Schulze Boevingloh Tobias L Schulte Effectiveness of Radial Extracorporeal Shockwave Therapy in Patients with Acute Low Back Pain—Randomized Controlled Trial Journal of Clinical Medicine low back pain acute radial shockwave therapy randomized controlled trial (RCT) clinical outcome spine |
| 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 | low back pain acute radial shockwave therapy randomized controlled trial (RCT) clinical outcome spine |
| url | https://www.mdpi.com/2077-0383/10/23/5569 |
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