D. Silva-Mendoza1,2,5, M. A. Lavor2, T. Saing1,2, A. T. Guliyev1,2, D. Joule1,2,3, F. J. Yanquez1,4 1Synvesta Vascular Care, Vascular Surgery, Tucson, ARIZONA, USA 2Saguaro Surgical PC, Wound Care Department, Tucson, ARIZONA, USA 3University Of Arizona, College Of Medicine, Tucson, AZ, USA 4University Of Arizona, Division Of Vascular Surgery – Faculty, Tucson, AZ, USA 5Saint Louis University School Of Medicine, School Of Medicine, St. Louis, MO, USA
Introduction: Intermittent claudication is the hallmark of lower extremity peripheral artery disease (PAD). This severe, exertional pain from ischemia in the lower extremities is suffered by nearly 30% of individuals with PAD. Many patients exhaust all conventional therapeutics, finding no effective or durable pain relief for their symptoms
Methods: This study, alternatively, reports the use of High Frequency Bioelectronic Therapy (HFBT) to reduce lower extremity pain from claudication.18 patients participated in this double-blind, sham-controlled, parallel arm study. Exercise (calf raises) was done before and after a 10-minute HFBT (Genuine-Device) or sham treatment with the TrueRelief device, done twice per week for three weeks. Exercise-induced pain was measured before and after treatment as time to onset of pain, time to significant pain (required stopping exercise), and time to recovery from pain. Ankle-brachial indices (ABIs) were also measured before and after each set of calf raises. Subjective patient-reported improvement was also assessed
Results: Patients treated with the genuine device showed significantly faster recovery time (p = .019) and significantly better patient-reported outcomes (p < .001) when compared with patients treated with the sham device. There was no significant difference between genuine and sham devices in terms of time to onset of pain or ABI. However, post hoc tests indicated that there was a significant improvement in the mean time to pain onset in the genuine device group (p < .001) that was not present in the sham group
Conclusion: HFBT delivered via the TrueRelief device may offer an alternative therapy for pain relief in patients with claudication, and a significant improvement in health-related quality of life (HRQOL). HFBT has previously proved significant improvement in microvascular blood flow. Our findings show a plausible clinical representation of increased macrovascular flow. These results warrant further inquiries into the benefits of HFBT therapy on patients with PAD, specifically in whether or not treatment could ameliorate symptoms of acute ischemia prior to emergency vascular surgeries, improve vascular outflow before and after interventional procedures, or reduce vasospasm intra and postoperatively
