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

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

Abstract

© 2017 The Author(s). Background: 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. Methods/design: 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. Discussion: 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. Trial registration: ClinicalTrials.gov, NCT02652078. Registered on 17 October 2014.

Citation

Harwood, A. E., Smith, G. E., Totty, J. P., Carradice, D., Chetter, I. C., Harwood, A., Totty, J., Cayton, T., & Smith, G. (2017). Extracorporeal shockwave therapy for the treatment of lower limb intermittent claudication: Study protocol for a randomised controlled trial (the SHOCKWAVE 1 trial). Trials, 18(1), https://doi.org/10.1186/s13063-017-1844-4

• Journal Article Type: Article
• Acceptance Date: Feb 17, 2017
• Online Publication Date: Mar 6, 2017
• Publication Date: 2017-12
• Deposit Date: Jun 12, 2017
• Publicly Available Date: Jun 12, 2017
• Journal: Trials
• Print ISSN: 1745-6215
• Publisher: Springer Verlag
• Peer Reviewed: Peer Reviewed
• Volume: 18
• Issue: 1
• DOI: https://doi.org/10.1186/s13063-017-1844-4
• Keywords: Medicine (miscellaneous); Pharmacology (medical)
• Public URL: https://hull-repository.worktribe.com/output/452274
• Publisher URL: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-017-1844-4
• Additional Information: This is a copy of an open access article published in Trials, 2017, v.18.
• Contract Date: Jun 12, 2017