Extracorporeal shockwave therapy for intermittent claudication: Medium-term outcomes from a double-blind randomised placebo-controlled pilot trial

Jordan Luke Green, Amy Elizabeth Harwood, George Edward Smith, Tushar Das, Ali Raza, Thomas Cayton, Tom Wallace, Daniel Carradice, Ian Clifford Chetter

Research output: Contribution to journalArticle

3 Citations (Scopus)
2 Downloads (Pure)

Abstract

Objectives: Peripheral arterial disease most commonly presents as intermittent claudication (IC). Early evidence has suggested that extracorporeal shockwave therapy is efficacious in the short term for the management of intermittent claudication. The objective of this pilot trial was to evaluate the medium-term efficacy of this treatment. Methods: This double-blind randomised placebo-controlled pilot trial randomised patients with unilateral intermittent claudication in a 1:1 fashion to receive extracorporeal shockwave therapy or a sham treatment for three sessions per week over three weeks. Primary outcomes were maximum walking distance and intermittent claudication distance using a fixed-load treadmill test. Secondary outcomes included pre- and post-exertional ankle-brachial pressure indices, safety and quality of life assessed using generic (SF36, EQ-5D-3L) and disease-specific (vascular quality of life) measures. All outcome measures were assessed at 12 months post-treatment. Results: Thirty participants were included in the study (extracorporeal shockwave therapy, n = 15; sham, n = 15), with 26 followed up and analysed at 12 months (extracorporeal shockwave therapy, n = 13; sham, n = 13). Intragroup analysis demonstrated significant improvements in maximum walking distance, intermittent claudication distance and post-exertional ankle-brachial pressure indices (p < 0.05) in the active treatment group, with no improvements in pre-exertional ankle-brachial pressure indices. Significant improvements in quality of life were observed in 3 out of 19 domains assessed in the active group. A re-intervention rate of 26.7% was seen in both groups. Conclusions: These findings suggest that extracorporeal shockwave therapy is effective in improving walking distances at 12 months. Although this study provides important pilot data, a larger study is needed to corroborate these findings and to investigate the actions of this treatment. ISRCTN: NCT02652078.

Original languageEnglish
Pages (from-to)531-539
Number of pages9
JournalVascular
Volume26
Issue number5
Early online date3 May 2018
DOIs
Publication statusPublished - 1 Oct 2018
Externally publishedYes

Keywords

  • Extracorporeal shockwave therapy
  • intermittent claudication
  • peripheral arterial disease
  • randomised controlled trial

ASJC Scopus subject areas

  • Surgery
  • Radiology Nuclear Medicine and imaging
  • Cardiology and Cardiovascular Medicine

Fingerprint Dive into the research topics of 'Extracorporeal shockwave therapy for intermittent claudication: Medium-term outcomes from a double-blind randomised placebo-controlled pilot trial'. Together they form a unique fingerprint.

  • Cite this