Restoration of sensation, reduced pain, and improved balance in subjects with diabetic peripheral neuropathy: a double-blind, randomized, placebo-controlled study with monochromatic near-infrared treatment.
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.


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 < 0.02 and 0.001). Sham treatments did not improve sensitivity to the SWM, but subsequent active treatments did (P < 0.002). The MNSI measures of neuropathic symptoms decreased significantly (from 4.7 to 3.1; P < 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 < 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.
Leonard
David R
DR
Joslin Center for Diabetes, Morton Plant Mease Healthcare, Clearwater, Florida 33756, USA.
Farooqi
M Hamed
MH
Myers
Sara
S
D000368:Aged; D000369:Aged, 80 and over; D000700:Analgesics / Q000627:therapeutic use; D003929:Diabetic Neuropathies / Q000628:therapy*; D004311:Double-Blind Method; D005260:Female; D005528:Foot; D006801:Humans; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000517:prevention & control*; D010147:Pain Measurement; D010919:Placebos; D004856:Postural Balance / Q000502:physiology*
D000700:Analgesics; D010919:Placebos