Ultrasound therapy for treatment of lower extremity intermittent claudication

Background: While often thought of as a diagnostic tool, ultrasound (US) can also potentially be used as a therapeutic modality. US applies mechanical stress on endothelial cells and induces nitric oxide synthase, which regulates the secretion of nitric oxide, a potent vasodilator. In animal ischemic models, US has been shown to improve hindlimb, myocardial, and cerebral perfusion. We performed a pilot trial of US therapy in the lower extremities of human subjects with intermittent claudication. Methods: 10 subjects (5 male, 5 female, mean age 69.7 +/- 10.3) with intermittent claudication were recruited. Both legs were placed in a specially designed boot with a water interface between US transducers and the legs. Subjects underwent pulsed US therapy at 250 kHz frequency for 30 min for three treatments a week for six weeks. Pre and post treatment ankle:brachial index (ABI), 6-min walk (6 MW), Walking Impairment Questionnaire (WIQ), and Short Form 36 (SF36) were performed. Pre and post-treatment results were compared with paired t-test. Results: Six minute walking distance at baseline was 352 +/- 70 m, after one treatment session 353 +/- 70 m (p = 0.99), and at completion 372 +/- 71 m (p = 0.015). There was a trend toward improved ABI after 6 weeks of treatment (0.53 +/- 0.17 vs 0.64 +/- 0.12, p = 0.083). After six weeks, significant improvements were noted in overall WIQ score (2.00 +/- 1.48 vs 2.63 +/- 1.38, p = 0.0001), WIQ (distance) 2.07 +/- 1.54 vs 2.73 +/- 1.42 (p = 0.036), and WIQ (stair) 2.00 +/- 1.67 vs 2.62 +/- 1.24, p = 0.034, with a trend in WIQ (speed), 1.89 +/- 1.26 vs 2.46 +/- 1.43, p = 0.069. In the SF-36, significant improvements were noted in the domains of physical functioning (44.0 +/- 41.6 vs 50.5 +/- 41.1, p = 0.009) and role limitations - physical (35.0 +/- 48.3 vs 60.0 +/- 49.6, p = 0.006) after six weeks. Conclusions: Therapeutic US is a potential noninvasive treatment for intermittent claudication. Pilot study patients noted significant improvements in 6 MW and WIQ results after 6 weeks of treatment. A nonsignificant improvement in ABI was noted. Further research will be needed to clarify optimal treatment frequency and duration. (C) 2021 Elsevier Inc. All rights reserved.