O-029 - A DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMISED TRIAL OF EXTRACORPOREAL SHOCKWAVE THERAPY AS A NOVEL TREATMENT FOR INTERMITTENT CLAUDICATION.

TOPIC:
Peripheral Occlusive Arterial Disease
AUTHORS:
Cai P. (Academic Vascular Surgery Unit, Hull York Medical School ~ Hull ~ United Kingdom) , Pymer S. (Academic Vascular Surgery Unit, Hull York Medical School ~ Hull ~ United Kingdom) , Ibeggazene S. (College of Health, Wellbeing and Life Sciences, Sheffield Hallam University ~ Sheffield ~ United Kingdom) , Hitchman L. (Academic Vascular Surgery Unit, Hull York Medical School ~ Hull ~ United Kingdom) , Carradice D. (Academic Vascular Surgery Unit, Hull York Medical School ~ Hull ~ United Kingdom) , Chetter I. (Academic Vascular Surgery Unit, Hull York Medical School ~ Hull ~ United Kingdom) , Smith G. (Academic Vascular Surgery Unit, Hull York Medical School ~ Hull ~ United Kingdom)
Introduction:
Peripheral occlusive arterial disease affects 202 million people worldwide, with intermittent claudication as its most prevalent manifestation. The recommended management for non life-limiting intermittent claudication is conservative and includes best medical therapy in the form of antiplatelet and statin therapy, smoking cessation and supervised exercise. However, provision of supervised exercise programs and uptake among intermittent claudication patients is very poor. Extracorporeal ShockWave Therapy (ESWT) technology has been adapted from renal lithotripsy to a variety of musculoskeletal uses and in vitro and in vivo data has shown improved perfusion of the myocardium and hind leg in the setting of arterial ischaemia. Pilot data has demonstrated that ESWT is effective for improving walking distances in patients with intermittent claudication (1). This study aims to consider its effectiveness for improving quality of life in patients with intermittent claudication.
Methods:
In a double-blind, sham-controlled, randomized trial, patients with intermittent claudication were randomized in a 1:1 ratio to ESWT or sham treatment. Patients were blinded to their group allocation. The treatment group received ESWT to the calf muscle of the symptomatic leg for 3 times a week for 3 weeks. The control group underwent the exact same frequency and length of treatment without the delivery of ESWT but instead a hidden speaker simulated the delivery of ESWT. The primary endpoint was change in the Physical Functioning domain of the SF-36 quality of life questionnaire at 12-week follow-up when compared to baseline. Secondary endpoints included changes in claudication and maximum walking distances measured by a standardized treadmill protocol, and changes in ABPIs pre and post exercise, amongst others. All outcomes were assessed by a blinded assessor.
Results:
138 patients were recruited and randomized, reaching full study power. 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 at 12 weeks. 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 significant difference in ABPIs was seen between the two groups. No adverse events were recorded throughout the study period and follow up related to the use of ESWT.
Conclusion:
This study demonstrates that ESWT is clinically effective for improving quality of life and walking distances in patients with intermittent claudication, and it is also safe and well tolerated by the patients. It should be considered as an adjunct to conservative management, especially in patients not willing or unable to participate in supervised exercise programs.
References:
(1) Harwood AE, Green J, Cayton T, Raza A, Wallace T, Carradice D, Chetter IC, Smith GE. A feasibility double-blind randomized placebo-controlled trial of extracorporeal shockwave therapy as a novel treatment for intermittent claudication. J Vasc Surg. 2018 Feb;67(2):514-521.e2. doi: 10.1016/j.jvs.2017.07.105. Epub 2017 Sep 22. PMID: 28943002.