1. Extracorporeal shockwave therapy for intermittent claudication: Medium-term outcomes from a double-blind randomised placebo-controlled pilot trial
- Author
-
Ali Raza, Jordan Luke Green, Ian Chetter, Amy E. Harwood, Tom Wallace, Daniel Carradice, Tushar Das, George Edward Smith, and Thomas Cayton
- Subjects
Extracorporeal Shockwave Therapy ,Male ,Time Factors ,Arterial disease ,medicine.medical_treatment ,Pilot Projects ,030204 cardiovascular system & hematology ,Placebo ,law.invention ,Medium term ,Double blind ,03 medical and health sciences ,Peripheral Arterial Disease ,0302 clinical medicine ,Randomized controlled trial ,Double-Blind Method ,law ,Surveys and Questionnaires ,medicine ,Humans ,Radiology, Nuclear Medicine and imaging ,Ankle Brachial Index ,030212 general & internal medicine ,Aged ,Exercise Tolerance ,business.industry ,Pilot trial ,General Medicine ,Recovery of Function ,Intermittent Claudication ,Middle Aged ,Intermittent claudication ,Treatment Outcome ,England ,Extracorporeal shockwave therapy ,Anesthesia ,Exercise Test ,Quality of Life ,Surgery ,Female ,medicine.symptom ,Cardiology and Cardiovascular Medicine ,business - 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 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.
- Published
- 2018