Extracorporeal shockwave therapy for the treatment of lower limb intermittent claudication: study protocol for a randomised controlled trial (the SHOCKWAVE 1 trial)

Thomas Cayton,Amy E Harwood,George E Smith,Daniel Carradice,Joshua P Totty,Ian C Chetter

doi:10.1186/s13063-017-1844-4

Abstract

BackgroundPeripheral arterial disease (PAD) has a population prevalence of 4.6% with intermittent claudication (IC) presenting as one of the earliest and most common symptoms. PAD has detrimental effects on patients’ walking ability in terms of maximum walking distance (MWD) and pain-free walking distance (PFWD). Research has suggested extracorporeal shockwave therapy (ESWT) may induce angiogenesis in treated tissue; therefore, our objective is to assess the tolerability and efficacy of ESWT as a novel treatment of intermittent claudication.Methods/designPatients with unilateral claudication will be randomised to receive either ESWT (PiezoWave 2 shockwave system) or sham treatment to the calf muscle bulk three times per week for 3 weeks. All patients are blinded to treatment group, and all assessments will be performed by a masked assessor. Treatment tolerability using a visual analogue scale, ankle-brachial pressure index, MWD, PFWD and safety will all be formally assessed as outcome measures at baseline and at 4, 8 and 12 weeks follow-up.DiscussionThis trial will be the first of its kind in terms of methodology in relation to ESWT for intermittent claudication. A double-masked randomised controlled trial will provide useful information about the potential for the use of ESWT as a non-invasive treatment option and the need for further robust research.Trial registrationClinicalTrials.gov, NCT02652078. Registered on 17 October 2014.

Highlights

Peripheral arterial disease (PAD) is common in western society with a prevalence estimated at 20% of those aged over 60 [1]
The physiological negative effects caused by PAD are hypothesised to be due in part to recurrent episodes of ischaemia-reperfusion injury (IRI), which occurs as claudicants exercise and rest
This study found no adverse events secondary to shockwave therapy

Summary

Introduction

Peripheral arterial disease (PAD) is common in western society with a prevalence estimated at 20% of those aged over 60 [1]. The medicinal use of high energy extracorporeal shockwaves did not develop until the 1980s, when they were targeted to fragment urinary stones (lithotripsy); results led to this technique becoming the gold standard treatment option for urolithiasis [9] From this point the developing use of extracorporeal shockwave therapy (ESWT) followed an interesting course which started after an incidental finding of iliac bone thickening in patients undergoing lithotripsy, which proposed the potential osteoblastic effect of shockwave therapy [11]. Researchers confirmed these observations through a number of clinical trials using shockwave therapy on delayed non-union fractures [12,13,14]. Observational improvements to soft tissue wounds overlying these fractures treated with ESWT encouraged research into the benefits of shockwave therapy in hard-to-heal chronic soft tissue wounds [15]

Methods

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Discussion

Conclusion