h1 bulletImproved Foot Sensitivity and Pain Reduction in Patients with Peripheral Neuropathy After Treatment with MIRE



Lawrence B. Harkless, DPM**
Salvatore L. DeLellis, DPM*
Dale H. Carnegie, DPM†
Thomas J. Burke, PhD‡


** University of Texas Health Science Center San Antonio, San Antonio, TX

*Gulf Coast Foot, Ankle and Wound Center, Tarpon Springs, FL.
†Podiatric Service, Denver Health Medical Center, Denver,CO.
‡Research and Clinical Affairs, Anodyne Therapy LLC, Tampa, FL.




The medical records of 2239 patients (mean age=73 years) with established peripheral neuropathy (PN) were examined to determine whether treatment with MIRE was, in fact, associated with increased foot sensitivity to the Semmes Weinstein monofilament (SWM) 5.07 and a reduction in neuropathic pain. The PN in 1395 of these patients (62%) was due to diabetes. Prior to treatment with MIRE, of the 10 tested sites (5 on each foot), 7.1F2.9 were insensitive to the SWM 5.07, and 2078 patients (93%) exhibited loss of protective sensationdefined by Medicare as a loss of sensation at two or more sites on either foot. After treatment, the number of insensate sites on both feetdecreased to 2.4± 2.6, an improvement of 66%. Of the 2078 (93%) patients initially presenting with loss of protective sensation, 1106 (53%)no longer had loss of protective sensation after treatment ( P< .0001); 1563 patients (70%) also exhibited neuropathic pain in addition to sensory impairment. Prior to treatment with MIRE, pain measured on the 11-point visual analogue scale (VAS) was 7.2±2.2 points, despitethe use of a variety of pain-relieving therapeutic agents. After treatment with MIRE, pain was reduced by 4.8±2.4 points, a 67% reduction.Therefore, MIRE appears to be associated with significant clinical improvement in foot sensation and, simultaneously, a reduction inneuropathic pain in a large cohort of primarily Medicare aged, community-dwelling patients, initially diagnosed with PN. The quality of life associated with these two outcomes cannot be underappreciated.