****The Effect of Monochromatic Infrared Energy on Transcutaneous Oxygen Measurements and Protective Sensation: Results of a C
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After the electrodes were connected, a photograph was taken to ensure same electrode placement at the posttest. Each subject used one pillow that could be folded in half for comfort and was covered with a lap blanket during testing. Participants were asked to remain still and quiet and were checked intermittently. Readings were recorded at 20 minutes.
Next, participants were scheduled to receive 12, 30-minute MIRE and sham treatments to their bare feet and legs two to four times per week for 3 to 5 weeks, the number of treatments determined according to manufacturer suggested protocol and subject availability. Due to inclement weather and seasonal conflicts, the protocol was modified to allow for 11 or 12 treatment sessions. This modification is consistent with other published studies providing a range of treatments.6,23 The manufacturer (Anodyne Therapy, LLC) donated four MIRE Model 120 home units for use in this study. Two units delivered active MIRE at the standard manufacturer pre-set energy level of 70% full power of the professional system (1.5 J/cm2/min) and two units were sham, delivering no energy or warmth.
Per manufacturer guidelines for infection control, the skin of each participant was protected by a clear plastic barrier at the pad placement locations.17 Two diode pads were placed on the dorsal and plantar surfaces of each foot and two diode pads on the medial and lateral sides of each lower leg.17 This pad placement has been used by other investigators2,3 and directly treats the tissues being tested. Elastic Velcro® straps, supplied by the manufacturer, were used to hold the pads in place.17 The units were turned on and a timer was set for 30 minutes. Participants were checked every 10 minutes during the first treatment to minimize the potential for superficial burns and to ascertain the treatment was comfortable.17 Subsequent treatments occurred with each leg receiving the same-labeled unit as the first visit.
Within 3 days of the last treatment, the posttest questionnaire was completed for medication changes and the pain level for each leg was reassessed. Participants again rated their pain on a scale from 0 to 10 without prompting to their initial pain reports. After rating their pain levels, they were informed of their pretest pain levels as a point of interest. Participants could add statements but the pain rating provided without prompting was not changed. Then sensation and TcPO2 tests were performed in the same manner as the pretest; investigators referred to the pretest photographs to best duplicate electrode placement.
Data analysis. All variables collected were entered into Microsoft Excel 2000. Descriptive statistics were calculated for the following variables: age, gender, years with diabetes, and smoking status. Medication use was reported at each pre- and posttest session and changes were noted. Paired t-tests were calculated for the pretest scores of the active and sham feet to determine likeness for each of the three endpoints. Paired t-tests were used to compare baseline to posttest for the average of two TcPO2 measurements, pain and sensation, for each foot and to compare the change scores between the active and sham groups. Pearson’s correlation coefficient was calculated to examine the relationship between TcPO2 results and LOPS and the relationship between the number of days from pre- and posttests compared to the TcPO2 measurements. Data analysis was performed, and confirmed by an independent biostatistician, using SPSS 12.0 (SPSS, Chicago, Ill).
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