****The Effect of Monochromatic Infrared Energy on Transcutaneous Oxygen Measurements and Protective Sensation: Results of a C
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Limitations of this study include the small sample size and small effect size. A Type II error (failure to identify an existing difference) may have occurred because the assumptions on which this study was designed were not realized — a large effect size and a sample size of 20. The effect size was small, demonstrated by the low change scores, and only 18 patients met the study inclusion criteria.
This study could not demonstrate a significant impact of MIRE on circulation using TcPO2 measurements, partly because of a lack of power related to the sample size and the unequal baseline distribution for this variable as a result of randomization. However, this finding was surprising, given claims of circulation increases up to 3,200% based on laser Doppler images.9,11 No participants improved to the literature-supported27 threshold of 25 mm Hg difference for intra-week variation.
Additionally, 31 feet had TcPO2 measurements (average of two dorsal sites) from pre- to posttest within ±11 mm Hg, with only eight feet varying more than 11 mm Hg between pre- and posttest measurements. Three of the eight feet had TcPO2 change scores of 11.5 mm Hg; thus, only five feet varied more than 11.5 mm Hg. These findings are consistent with TcPO2 reliability studies19,26 reporting repeated measurements in shorter time frames and indicate the observed change was a normal variation of TcPO2 testing (±11 mm Hg) instead of a treatment effect. These scores may further support the use of TcPO2 testing as a measure of perfusion over time.
This study demonstrated no statistically significant treatment effect for MIRE compared to sham on a small group of persons with diabetes who served as their own controls. This study calls into question results of previous studies that demonstrate significantly improved sensation with MIRE treatments. In this study, significant improvements in sensation were observed in both the sham and active treatment group but no differences were found between the two treatment groups on any of the outcome measures studied. This is not to say that MIRE is completely ineffective; as described in the literature review, previous research has demonstrated restored protective sensation.1,2,6,23,28,29 Because no other modality or intervention has been reported in the literature to restore protective sensation in the same manner, this remains an interesting and valuable avenue for future research. For now, clinicians using MIRE should be aware that the evidence supporting restored sensation may not be as strong as previously reported.
To answer some of the remaining questions surrounding the effectiveness of MIRE, this study should be repeated using a larger sample size and with patients who do not serve as their own control. Including more objective measurements of nerve response, such as current perception threshold, also would be valuable.
Observed improvements in both the active and sham groups warrants further research because it may have a physiological basis or represent a Hawthorne or placebo effect. Studies that continue to use patients as their own control could help determine if a more general physiological effect to the contralateral limb occurs. Additionally, it would be interesting to assess if any other modality — eg, transcutaneous electrical nerve stimulation (TENS) — has the ability to alter sensation in persons with diabetes and LOPS.
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