****The Effect of Monochromatic Infrared Energy on Transcutaneous Oxygen Measurements and Protective Sensation: Results of a C
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Compared to baseline, sensation improved for group 1 after both six (P <0.02) and 12 (P <0.001) active MIRE treatments. No significant change in the number of sites able to sense the 5.07 SWM after six sham treatments in either group 1 or group 2 was observed.2 Monochromatic infrared energy significantly decreased the number of sites insensitive to the 5.07 SWM in group 1 but improvements in sensation, pain reduction, or neuropathic symptoms among participants with more profound sensory loss (group 2) were not statistically significant. The authors reported no significant improvements in ankle reflexes or vibratory sensitivity to a 128-Hz tuning fork during the study.
According to information listed on the Anodyne Therapy, LLC website (www.anodynetherapy.com), TcPO2 levels improved on a single patient (accessed December 12, 2003) and several scanning laser Doppler (Moor Instruments, Devon, UK) images show increased circulation. Burke9,11 reported that in 30 minutes, MIRE can increase local microcirculation by as much as 3,200%. He further reports, based on an online NO overview for which references are not provided, that in neuropathic feet, MIRE treatment increased microcirculation 10 times more than warmth alone. Finally, Burke11 reported on wound centers in Wisconsin that have noted increases in TcPO2 with MIRE, which he contributes to increased oxygen availability from the vasodilation induced by NO.
Wimberley et al9 report use of TcPO2 measurements as a major trend parameter and valuable indicator of tissue PO2 in adults. A repeated measures study20 compared laser Doppler flowmetry, skin perfusion pressure, and TcPO2 (44° C) on 21 consecutive patients with severe lower extremity arterial disease and found the same magnitude of variation with short-term measurements for all three methods. When the authors excluded TcPO2 measurements below 10 mm Hg, the mean coefficients of variations were 0.08 short-term and 0.31 day-to-day.
This study expands on the methods used by Leonard et al.2 All study participants served as their own control and the same inclusion criteria (diabetic neuropathy), MIRE pad placement, sensation testing protocol, and sites using the 5.07 (10-g) SWM were used. This study was approved by both the Norwalk Hospital and Nova Southeastern University IRBs.
Design. This was a quasi-experimental, randomized, double-blinded, pretest-posttest controlled study. All participants served as their own control by having each leg randomly assigned to either the sham or active treatment group. The first participant was randomized, by the toss of a coin, to which leg received the active/sham treatment with MIRE units labeled A or B. Subsequent participants were sequentially assigned A or B units for each leg to ensure equal groups. This assignment was consistent for all the treatments, with each leg receiving the same-labeled MIRE units as the first treatment.
The manufacturer, who disabled the sham units internally so no energy was emitted even though the machine power indicator light was on, provided all treatment units. Furthermore, because MIRE therapy pads do not emit visible light on either the active or the sham units, it was impossible for the investigators to distinguish the active from sham units. Thus, the authors, additional investigators, and participants were blinded to the active or sham status of the MIRE units. The principle author performed all pre- and posttest measurements. Investigators were notified of the sham/active status of the MIRE units by the manufacturer on return receipt of the units at the end of the study before data analysis.
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