****The Effect of Monochromatic Infrared Energy on Transcutaneous Oxygen Measurements and Protective Sensation: Results of a C
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No statistically significant differences in pain, sensation, or TcPO2 measurements were found between feet treated with active MIRE and feet treated with sham MIRE in participating persons with diabetes who served as their own controls. Definitive conclusions cannot be drawn about MIRE’s effect on TcPO2 measurements because randomization led to an unequal baseline distribution. Sites randomized to the active treatment group had significantly lower TcPO2 values than those receiving sham treatment. While statistically significant, the observed mean difference (3.6 mm Hg) is not clinically significant. Additionally, post-hoc analysis showed that when outcomes for both feet of the participant with the lowest scoring foot are removed from the analysis, the pretest scores are no longer significantly different. It could be argued that the lower pretest scores in the active treatment group provided a competitive advantage by increasing the potential for improved circulation given the wide range of normal TcPO2 values (45 to 96 mm Hg).24,25 Similarly, although the circulation of the feet in the active group may not have been capable of a response sufficient to be significant, such an occurrence is unlikely because the lowest scoring foot at pretest had a change score of +20 mm Hg for the average of the two dorsal TcPO2 test sites — the highest change experienced by any foot in the study. Additionally, five feet in the active group compared to two feet in the sham group had a >15% increase in TcPO2 scores — above literature reports for percentage variation associated with TcPO2 testing.22,26,27
Despite these responses, neither the change experienced in each group nor the difference in posttest TcPO2 scores for the active and sham groups were statistically significant and the overall change was within the literature-reported variability for TcPO2 testing.26,27 While no significant differences for pain were observed, statistically significant improvements in sensation, similar to the results reported by other authors,1,2,6 were found. However, the change was significant for both the active- and sham MIRE-treated feet. These results are consistent with the findings of the only other double-blinded study18 comparing the effects of 12 active MIRE treatments to 12 sham MIRE treatments on sensation. Several factors can explain these results. First, these results may be attributed to the Hawthorne effect, as others have suggested.18 Second, local heating effects of the MIRE may result in a consensual reflex type response affecting the contralateral limb. There may be other yet unidentified relationships related to the physiology of neuropathy and MIRE that result in a more general response capable of producing such effects. The fact that both active and sham groups had significantly improved sensation in this and another study18 warrants further research. Although an interesting objective, no correlation could be drawn between LOPS and TcPO2 Likewise, no other studies have reported any such relationship.
Overall, this study controlled many variables lacking in previous studies. First, it was prospective, randomized, and double-blinded, using each participant as his or her own control. Second, every participant received the same treatment parameters with no confounding additional interventions. Third, one researcher performed all pre- and posttests in a consistent manner and in a clinically controlled environment using established guidelines. Fourth, changes in medications were documented and examined for potential effects. Finally, data analysis was performed to compare the effects of the active and sham intervention as well as to ascertain the within-group difference between pre- and posttest results.
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