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

Abstract OBJECTIVE 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.METHODS 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 4 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 Oswestry Disability Index (ODI), Roland & 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. RESULTS 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 < .001) in the intervention and by 86.4% (P < .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 8 weeks. No significant intergroup differences were observed for RDQ, ODI or BDI-II.CONCLUSIONS Additional rESWT alongside conventional guideline therapy in aLBP does not have any significant effects on pain intensity, physical function, or quality of life.IMPACT STATEMENT 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.