****The Effect of Monochromatic Infrared Energy on Transcutaneous Oxygen Measurements and Protective Sensation: Results of a C
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Diabetic peripheral neuropathy often causes a loss of protective sensation (LOPS) that can lead to an increased risk for falls, foot wounds, or amputation.1-7 Loss of protective sensation is defined as insensitivity at two or more sites on the foot as measured by the 5.07 log, or 10-g, Semmes Weinstein monofilament (SWM).3,4,8
A relatively new modality using monochromatic infrared energy (MIRE) — a form of light therapy — has shown promise in improving sensation in people with diabetic neuropathy. It is delivered at an infrared wavelength of 890 nm, which is above the visible light spectrum, via the Anodyne Therapy System® (ATS; Anodyne Therapy LLC, Tampa, Fla) using therapy pads that contain 60 superluminous gallium aluminum arsenide diodes that pulse 292 times per second.9,10
Monochromatic infrared energy has been in use since 1994 when it was cleared for marketing by the Food and Drug Administration (FDA) for increasing local circulation and for reducing pain.1,9 The proposed mechanism of action for MIRE is to increase the microcirculation of the tissues under the diodes3,9,11 as a result of hemoglobin absorbing the infrared wavelength and releasing small amounts of nitric oxide (NO) in the blood vessels.12 This is believed by some9 to increase endothelial cell formation of NO, a powerful vasodilator and angiogenesis mediator.9,11,12 Angiogenesis and vasodilation increase circulating oxygen levels in the treated tissues. Scanning laser Doppler has been used in case studies demonstrating improved tissue perfusion, or microcirculation, in the tissues receiving MIRE treatment.3,9,11
Transcutaneous oxygen (TcPO2) testing is a non-invasive way to measure local tissue oxygen perfusion.13 Clinically, TcPO2 measurements are used to measure trends with hyperbaric oxygen (HBO) therapy, evaluate peripheral circulation in diabetes, assess wound hypoxia, and determine amputation level.13,14 Transcutaneous oxygen testing is performed by attaching an electrode to a quietly resting patient. The electrode warms the skin and measures the subsequent oxygen diffusion across the skin. Transcutaneous oxygen testing should be performed in a consistent manner from patient to patient using standardized test sites and appropriately calibrated machines13,14 and has been commonly used, with published suggestions and protocols for reproducible data, to qualify patients for HBO treatments.13-16 Despite its use in hyperbaric oxygen research, TcPO2 testing has not been used clinically or in research to determine the effects of MIRE on local tissue oxygen perfusion.
Recent studies have indicated that MIRE helps restore LOPS in patients with peripheral neuropathy.1-3,6 Whether the improvement in LOPS in these studies was related to a concomitant change in oxygen perfusion remains unknown because randomized controlled trials investigating the effects of MIRE on tissue perfusion or the relationship between LOPS and tissue perfusion in people with diabetic peripheral neuropathy have not been conducted.
A quasi-experimental, randomized, double-blinded clinical study was conducted to: 1) examine the effects of published neuropathy protocol for MIRE treatments on tissue perfusion, measured as a change in TcPO2 levels compared to self-controlled sham treatment; 2) determine the effects of the published MIRE neuropathy protocol on sensation on the feet of diabetic subjects with LOPS1,17,18; 3) examine MIRE’s effects on pain; and 4) examine the relationship between TcPO2 levels and LOPS.
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