title: Extracorporeal shockwave therapy for the treatment of lower limb intermittent claudication: study protocol for a randomised controlled trial (the SHOCKWAVE 1 trial).
abstract: Peripheral 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.
  
  
  
  Patients 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.
  
  
  
  This 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.
  
  
  
  ClinicalTrials.gov, NCT02652078 . Registered on 17 October 2014.
authors.affiliation: Academic Vascular Surgery Unit, Hull and East Yorkshire Hospitals NHS Trust, Hull Royal Infirmary, Anlaby Road, Hull, HU3 2JZ, UK.
authors.forename: Thomas
authors.initials: T
authors.lastname: Cayton
authors.affiliation: Academic Vascular Surgery Unit, Hull and East Yorkshire Hospitals NHS Trust, Hull Royal Infirmary, Anlaby Road, Hull, HU3 2JZ, UK.
authors.forename: Amy E
authors.initials: AE
authors.lastname: Harwood
authors.affiliation: Academic Vascular Surgery Unit, Hull and East Yorkshire Hospitals NHS Trust, Hull Royal Infirmary, Anlaby Road, Hull, HU3 2JZ, UK.
authors.forename: George E
authors.initials: GE
authors.lastname: Smith
authors.affiliation: Academic Vascular Surgery Unit, Hull and East Yorkshire Hospitals NHS Trust, Hull Royal Infirmary, Anlaby Road, Hull, HU3 2JZ, UK. joshua.totty@hyms.ac.uk.
authors.forename: Joshua P
authors.initials: JP
authors.lastname: Totty
authors.affiliation: Academic Vascular Surgery Unit, Hull and East Yorkshire Hospitals NHS Trust, Hull Royal Infirmary, Anlaby Road, Hull, HU3 2JZ, UK.
authors.forename: Daniel
authors.initials: D
authors.lastname: Carradice
authors.affiliation: Academic Vascular Surgery Unit, Hull and East Yorkshire Hospitals NHS Trust, Hull Royal Infirmary, Anlaby Road, Hull, HU3 2JZ, UK.
authors.forename: Ian C
authors.initials: IC
authors.lastname: Chetter
mesh_terms: D055109:Ankle Brachial Index; D002985:Clinical Protocols; D004311:Double-Blind Method; D004739:England; D005080:Exercise Test; D017079:Exercise Tolerance; D000074059:Extracorporeal Shockwave Therapy / Q000009:adverse effects; D006801:Humans; D007383:Intermittent Claudication / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D035002:Lower Extremity / Q000098:blood supply*; D018919:Neovascularization, Physiologic; D058729:Peripheral Arterial Disease / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D020127:Recovery of Function; D012107:Research Design; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome