Effectiveness of Radial Extracorporeal Shockwave Therapy in Patients with Acute Low Back Pain-Randomized Controlled Trial.

Tobias Lange,Albert Schulze Boevingloh,Sebastian Bockholt,Lukas P Lampe,Niklas Deventer,Georg Gosheger,Tobias L Schulte

doi:10.3390/jcm10235569

Abstract

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.

Highlights

There were no significant differences between the two groups in the visual analogue scale for aLBP (VAS-LBP), Roland and Morris Disability Questionnaire (RDQ), Oswestry disability index (ODI), EQ-5D-3L, or BDI-II scores (Table 1)
The results suggest that Radial extracorporeal shockwave therapy (rESWT) combined with physiotherapy and analgesia was not superior to analgesia and physiotherapy alone, in relation to pain intensity and physical function
Han et al found that pain intensity decreased significantly when ESWT was administered to patients with chronic low back pain

Summary

Introduction

Acute low back pain (aLBP), with a lifetime prevalence of up to 85% among 18–74-year-olds, is one of the most common types of pain associated with the musculoskeletal system [1–3]. The costs of treatment for musculoskeletal disease have been increasing dramatically in Western countries in recent years. In 2008, they accounted for 11.2% of total health-care costs in Germany [4]. The German National Care Guidelines on “nonspecific low back pain” list nondrug therapies and assesses the evidence of their efficacy in the treatment of acute nonspecific low back pain [5].

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Conclusion