****The Effect of Monochromatic Infrared Energy on Transcutaneous Oxygen Measurements and Protective Sensation: Results of a C
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The study group consisted of 18 participants (12 men and 6 women) with a mean age of 65 ± 13 years (range 39 to 86 years). Three were current smokers and the mean self-reported length of time since the onset/diagnosis of diabetes was 14.6 ± 11years (see Table 1). As per the study design, each treatment group (active and sham) consisted of nine right and nine left feet. The mean number of 30-minute treatments received during the 3 to 4 week study was 11.7
Paired t-tests showed no statistically significant difference in the pain or sensation pretest scores between the active or sham treatment groups. However, a statistically significant difference (P = 0.04) was noted in the TcPO2 pretest values between the sham and active group (see Table 2). The average mean values varied 3.6 mm Hg (clinically insignificant) from 48.9 mm Hg (sham group) to 45.3 mm Hg (active group). No statistically significant difference was found in the amount of change in TcPO2 scores between the active and sham treatment groups (P = 0.07). The mean change (± SD) in TcPO2 scores was 1.5 ± 9.6 mm Hg for the active feet and -1.3 ± 7.7 mm Hg for the sham feet. No statistically significant differences were noted between the active and sham groups for changes in sensation (P = 0.4) or pain (P = 0.4) (see Table 3).
No significant correlation was found between changes in TcPO2 and sensation (r = 0.1, P >0.05) or between actual TcPO2 and sensation scores (r = 0.3, P >0.05). Additionally, no significant differences were noted when pre- and posttest data for TcPO2 or pain were compared. However, a statistically significant change in sensation was noted for both the active (P = 0.002) and sham (P = 0.01) treatment groups between pre- and posttest.
During the seventh treatment session, one participant reported discomfort on one foot, now known to have been receiving active treatment. The research assistant immediately inspected the foot and noted a linear scabbed wound located at the distal lateral edge of the diode pad placed on the dorsum of the foot. The wound was not consistent with a burn. It was not possible to determine if the wound was an incidental scratch or caused by the edge of the diode pad. The wound was covered with a transparent film dressing and closed within 7 days. The participant did not wish to withdraw from the study and completed the protocol with no other adverse events.
None of the four participants who consumed caffeine or nicotine before a testing session had a significant change in TcPO2 scores that would skew results.
During the course of the study, four participants had medication changes. One decreased the dose of furosemide and started linezolid; one started taking insulin, gabapentin, and lisinopril during the course of the study; one started taking a beta-blocker; and one started azithromycin and had a cortisone shot in the left knee earlier in the posttest evaluation day.
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