O080 A double-blind, placebo-controlled, randomised trial of extracorporeal shockwave therapy as a novel treatment for intermittent claudication.

Abstract

Abstract Introduction Intermittent claudication (IC) is a prevalent manifestation of peripheral arterial disease and affects about 3% of the UK population. Current guidance for the management of nonlife limiting IC is supervised exercise and best medical therapy. Supervised exercise however is not readily available across the nation and has poor recruitment and retention rates. Pilot data has demonstrated that Extracorporeal ShockWave Therapy (ESWT) is effective for improving walking distance in patients with IC. This study aims to consider its effectiveness for improving quality of life (QoL). Methods In a double-blind, sham-controlled, randomised trial, patients with IC were randomised in a 1:1 ratio to ESWT or sham treatment. The primary endpoint was change in physical functioning at 12-week follow-up, as measured by the SF-36. Secondary endpoints included changes in walking distances and ABPI. Results 138 patients were randomised. The ESWT group had a significantly higher physical functioning score at 12 weeks (Mdn 41 vs 34, z=-2.1, p=0.033). They also had significantly longer claudication (Mdn 125 vs 88, z=-2.9, p=0.004) and maximum (Mdn 179 vs 129, z=-2.4, p=0.013) walking distances. The change from baseline to 12-weeks was also significantly greater in the ESWT group for claudication (Mdn 51 vs 24, z=-2.8, p<0.01) and maximum (Mdn 63 vs 17, z=-4 p<0.01) walking distance. No difference observed in ABPI. Conclusion This study demonstrates that ESWT is safe, well tolerated and clinically effective for improving QoL and walking distances in patients with IC. Take-home message Extracorporeal shockwave therapy improves quality of life and walking distances, and could potentially be used as a non-invasive adjunct to supervised exercise or in institutions were supervised exercise is not available.