Restoration of Sensation, Reduced Pain, and Improved Balance in Subjects With Diabetic Peripheral Neuropathy

Abstract

OBJECTIVE -Diabetic peripheral neuropathy (DPN) has been thought to be progressive and irreversible. Recently, symptomatic reversal of DPN was reported after treatments with a near-infrared medical device, the Anodyne Therapy System (ATS). However, the study was not controlled nor was the investigator blinded. We initiated this study to determine whether treatments with the ATS would decrease pain and/or improve sensation diminished due to DPN under a sham-controlled, double-blind protocol. RESEARCH DESIGN AND METHODS-Tests involved the use of the 5.07 and 6.65 Semmes Weinstein monofilament (SWM) and a modified Michigan Neuropathy Screening Instrument (MNSI). Twenty-seven patients, nine of whom were insensitive to the 6.65 SWM and 18 who were sensitive to this filament but insensitive to the 5.07 SWM, were studied. Each lower extremity was treated for 2 weeks with sham or active ATS, and then both received active treatments for an additional 2 weeks.RESULTS -The group of 18 patients who could sense the 6.65 SWM but were insensitive to the 5.07 SWM at baseline obtained a significant decrease in the number of sites insensate after both 6 and 12 active treatments (P Ͻ 0.02 and 0.001). Sham treatments did not improve sensitivity to the SWM, but subsequent active treatments did (P Ͻ 0.002). The MNSI measures of neuropathic symptoms decreased significantly (from 4.7 to 3.1; P Ͻ 0.001). Pain reported on the 10-point visual analog scale decreased progressively from 4.2 at entry to 3.2 after 6 treatments and to 2.3 after 12 treatments (both P Ͻ 0.03). At entry, 90% of subjects reported substantial balance impairment; after treatment, this decreased to 17%. However, among the group of nine patients with greater sensory impairment measured by insensitivity to the 6.65 SWM at baseline, improvements in sensation, neuropathic symptoms, and pain reduction were not significant. CONCLUSIONS -ATS treatments improve sensation in the feet of subjects with DPN, improve balance, and reduce pain.

Terapias não farmacológicas no alívio da dor neuropática diabética: uma revisão bibliográfica

“…The predominant study type included the double blind, randomized, and placebo-controlled approaches, and therapeutic modalities included acupuncture (17,20) , reiki, electrical stimulation (22) , frequency rhythmic electrical modulation system (FREMS) (12,23) , pulsed electromagnetic fields (PEMF) (24) , the low intensity laser, monochromatic infrared (15,(25)(26) , and percutaneous electrical stimulation (PENS) (27) .…”

“…The mechanism through which photo stimulation produces biological effects are not well known, however, evidence points to stimulation of mitochondrial cytochrome resulting in increased cellular activity and healing (26) . The effects of monochromatic infrared, were also investigated in a double-blind, placebo controlled study (25) . Subjects received either an active infrared monochrome or a fictitious one for 2 weeks, and had limb sensitivity assessed through 5.07 and 6.65 Semmes Weinstein monofilament (SWM), and the Michigan Neuropathy Screening Instrument (MNSI).…”

Painful diabetic neuropathy

“…Side effects and lack of response to conventional treatment have forced many patients to try alternative therapies such as acupuncture [5], near-infrared phototherapy [22], low-intensity laser therapy [23], magnetic field therapies [24] and transcutaneous electrical nerve stimulation (TENS) [5] and, as a last resort, implantation of an electrical spinal cord stimulator [25]. In this issue of Diabetologia, Bosi et al investigate the efficacy of frequency-modulated electromagnetic neural stimulation (FREMS) therapy and report a significant improvement in pain scores and in some measures of nerve function [26].…”

Effective treatment of symptomatic diabetic polyneuropathy by high-frequency external muscle stimulation

“…A recently published meta-analysis provided evidence that i. v. treatment with α-lipoic acid improves positive neuropathic symptoms and neuropathic deficits in DSP [4]. Transcutaneous electrical nerve stimulation (TENS) [5,6], percutaneous electrical nerve stimulation [7], spinal cord stimulation [8], other physical therapies [11,12] and acupuncture [13] have also successfully been used as non-pharmacological therapies, while electrical stimulation therapy through stocking electrodes was not effective [14].…”