The Immediate Clinical Effects Following a Single Radial Shock Wave Therapy in Pressure Ulcers: A Preliminary Randomized Controlled Trial of The SHOWN Project.

Abstract

Objective: Recent preliminary reports indicate that extracorporeal shock wave therapy (ESWT) might be useful for chronic wounds, especially venous leg ulcers and diabetic foot ulcers. However, there is limited evidence for the utility and safety of ESWT in pressure ulcers (PUs). Therefore, this randomized controlled trial (RCT) aimed to assess immediate planimetric and clinical effects following a single radial ESWT session in PUs. Approach: A group of 40 patients with PUs was randomly assigned into 2 groups: active ESWT (n = 20), which underwent a single treatment with radial ESWT (300 + 100 impulses/1 cm2, 2.5 bars, 0.15 mJ/mm2, and 5 Hz) and placebo ESWT (n = 20), which was exposed to sham-radial ESWT. All patients continued standard wound care procedures. The planimetric assessment and clinical outcomes using Wound Bed Score (WBS) and Bates-Jansen Wound Assessment Tool (BWAT) were assessed before (M0) and after ESWT sessions (M1). Results: There was a significant planimetric enhancement observed after active ESWT reported as a reduction in all metric parameters: wound area from 11.51 to 8.09 cm2 (p < 0.001), wound length from 4.97 to 4.41 cm (p < 0.001), and wound width from 3.15 to 2.49 cm (p < 0.0001). Also, there was a significant beneficial clinical improvement observed with a WBS as an increased score from 3.85 to 9.65 points (p < 0.001) and with the BWAT as a decreased score from 45.45 to 30.70 points (p < 0.001). In turn, a regression in the placebo ESWT group was observed in all studied outcomes. Innovation: This study is the first RCT to provide the positive and immediate clinical effects of radial ESWT in promoting the healing of PUs. Conclusion: This preliminary RCT showed that even a single session of ESWT is a promising and clinically effective modality in managing PUs. However, there is still limited data regarding the usefulness of ESWT in PUs, and further studies are in demand.