****The Effect of Monochromatic Infrared Energy on Transcutaneous Oxygen Measurements and Protective Sensation: Results of a C
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Diabetic peripheral neuropathy often causes a loss of protective sensation (LOPS) that can lead to an increased risk for falls, foot wounds, or amputation.1-7 Loss of protective sensation is defined as insensitivity at two or more sites on the foot as measured by the 5.07 log, or 10-g, Semmes Weinstein monofilament (SWM).3,4,8
A relatively new modality using monochromatic infrared energy (MIRE) — a form of light therapy — has shown promise in improving sensation in people with diabetic neuropathy. It is delivered at an infrared wavelength of 890 nm, which is above the visible light spectrum, via the Anodyne Therapy System® (ATS; Anodyne Therapy LLC, Tampa, Fla) using therapy pads that contain 60 superluminous gallium aluminum arsenide diodes that pulse 292 times per second.9,10
Monochromatic infrared energy has been in use since 1994 when it was cleared for marketing by the Food and Drug Administration (FDA) for increasing local circulation and for reducing pain.1,9 The proposed mechanism of action for MIRE is to increase the microcirculation of the tissues under the diodes3,9,11 as a result of hemoglobin absorbing the infrared wavelength and releasing small amounts of nitric oxide (NO) in the blood vessels.12 This is believed by some9 to increase endothelial cell formation of NO, a powerful vasodilator and angiogenesis mediator.9,11,12 Angiogenesis and vasodilation increase circulating oxygen levels in the treated tissues. Scanning laser Doppler has been used in case studies demonstrating improved tissue perfusion, or microcirculation, in the tissues receiving MIRE treatment.3,9,11
Transcutaneous oxygen (TcPO2) testing is a non-invasive way to measure local tissue oxygen perfusion.13 Clinically, TcPO2 measurements are used to measure trends with hyperbaric oxygen (HBO) therapy, evaluate peripheral circulation in diabetes, assess wound hypoxia, and determine amputation level.13,14 Transcutaneous oxygen testing is performed by attaching an electrode to a quietly resting patient. The electrode warms the skin and measures the subsequent oxygen diffusion across the skin. Transcutaneous oxygen testing should be performed in a consistent manner from patient to patient using standardized test sites and appropriately calibrated machines13,14 and has been commonly used, with published suggestions and protocols for reproducible data, to qualify patients for HBO treatments.13-16 Despite its use in hyperbaric oxygen research, TcPO2 testing has not been used clinically or in research to determine the effects of MIRE on local tissue oxygen perfusion.
Recent studies have indicated that MIRE helps restore LOPS in patients with peripheral neuropathy.1-3,6 Whether the improvement in LOPS in these studies was related to a concomitant change in oxygen perfusion remains unknown because randomized controlled trials investigating the effects of MIRE on tissue perfusion or the relationship between LOPS and tissue perfusion in people with diabetic peripheral neuropathy have not been conducted.
A quasi-experimental, randomized, double-blinded clinical study was conducted to: 1) examine the effects of published neuropathy protocol for MIRE treatments on tissue perfusion, measured as a change in TcPO2 levels compared to self-controlled sham treatment; 2) determine the effects of the published MIRE neuropathy protocol on sensation on the feet of diabetic subjects with LOPS1,17,18; 3) examine MIRE’s effects on pain; and 4) examine the relationship between TcPO2 levels and LOPS.
1. Kochman AB, Carnegie DH, Burke TJ. Symptomatic reversal of peripheral neuropathy in patients with diabetes. J Am Podiatr Med Assoc. 2002;92(3):125–130.
2. Leonard DR, Farooqi HM, Myers S. Restoration of sensation, reduced pain, and improved balance in subjects with diabetic peripheral neuropathy. Diabetes Care. 2004;27:168–172.
3. Prendergast JJ, Miranda G, Sanchez M. Improvement of sensory impairment in patients with peripheral neuropathy. Endocr Prac. 2004;10:24–30.
4. Cavanagh PR, Ulbrecht JS, Caputo GM. The biomechanics of the foot in diabetes mellitus. In: Bowker JH, Pfeifer MA, eds. Levin and O’Neal’s The Diabetic Foot. St. Louis, Mo: Mosby, Inc.;2001:181.
5. Centers for Disease Control and Prevention. National Diabetes Fact Sheet: General Information and National Estimates on Diabetes in the United States, 2002. Available at: at www.diabetes.org. Accessed March 12, 2004.
6. Kochman AB. Monochromatic infrared photo energy and physical therapy for peripheral neuropathy: influence on sensation, balance, and falls. J Geriatr Phys Ther. 2004;27:16–19.
7. Centers for Disease Control and Prevention. National Diabetes Fact Sheet: General Information and National Estimates on Diabetes in the United States, 2005. Available at: www.diabetes.org. Accessed March 14, 2006.
8. Centers for Medicare and Medicaid Services. CMS Decision Memo. Diabetic peripheral neuropathy with loss of protective sensation (LOPS) (CAG-00059N). Available at: www.cms.hhs.gov/mcd/search.asp?clickon=search. Accessed April 16, 2004.
9. Burke TJ. 5 Questions — and answers — about MIRE treatment. Adv Skin Wound Care. 2003;16:369–371.
10. Goldberg N. Monochromatic infrared photo energy and DPN. Diabetic Microvascular Complications Today. 2005;March/April:30–32.
11. Burke TJ. Nitric oxide: its role in diabetes, peripheral neuropathy, and wound healing. Vol. 2005: Diabetes In Control, 2004. Available at: www.diabetesincontrol.com/anodyne/burkeseries.shtml. Accessed January 14, 2005.
12. Horwitz LR, Burke TJ, Carnegie D. Augmentation of wound healing using monochromatic infrared energy. Adv Skin Wound Care. 1999;12:35–40.
13. Rich K. Transcutaneous oxygen measurements: implications for nursing. J Vasc Nurs. 2001;19:55–61.
14. Sheffield PJ, Buckley CJ. Transcutaneous oximetry: a sophisticated tool for assessing tissue oxygenation and potential for wound healing. In: Sheffield PJ, Fife CE, Smith APS, eds. Wound Care Practice. Flagstaff, Ariz: Best Publishing Co.;2004:117–136.
15. Clarke D. Transcutaneous monitoring of pO2 in hyperbaric medicine. Patient Focus Circle™, Vol. DK-2700. Denmark: Radiometer Medical A/S;1997:1–20.
16. Nicasio M, Larson-Lohr V, Kimbrell P. Transcutaneous oxygen measurements. In: Larson-Lohr V, Norvell HC, eds. Hyperbaric Nursing. Flagstaff, Ariz: Best Publishing Co.;2002:304–314.
17. Anodyne® Therapy System Professional Unit 480 JCAHO policy and procedure manual. Vol. 2004: Anodyne® Therapy, 2004.
18. Clifft J, Kasser RJ, Newton TS, Bush AJ. The effect of monochromatic infrared energy on sensation in patients with diabetic peripheral neuropathy. Diabetes Care. 2005;28:2896–2900.
19. Wimberley P, Burnett R, Covington A, et al. Guidelines for transcutaneous po2 and pco2 measurement. Clinica Chimica Acta. 1990;190:S41–S50.
20. Lukkari-Rautiainen E, Lepantalo M, Pietila J. Reproducibility of skin blood flow, perfusion pressure and oxygen tension measurements in advanced lower limb ischaemia. Eur J Vasc Surg. 1989;3:345–350.
21. National Institute of Diabetes and Digestive and Kidney Disease. Feet Can Last a Lifetime: a health care provider’s guide to preventing diabetes foot problems. National Diabetes Education Program;2004.
22. Jörneskog G. Measurements of transcutaneous oxygen tension in patients with diabetic foot complications. Denmark: Radiometer Medical;AS 132; 2001;May 1:1–3.
23. Volkert W, Hassan A, Smock VL, et al. Effectiveness of monochromatic infrared photo energy and physical therapy for peripheral neuropathy: changes in sensation, pain, and balance — a preliminary, multi-center study. Phys Occupational Ther Geriatr. 2005;24:1–17.
24. Dowd G, Linge K, Bentley G. Measurement of transcutaneous oxygen pressure in normal and ischaemic skin. J Bone Joint Surg. 1983;65(suppl B):79–83.
25. Dowd G, Linge K, Bentley G. The effect of age and sex of normal volunteers upon the transcutaneous oxygen tension in the lower limb. Clin Phys Physiol Meas. 1983;4:65–68.
26. Olerud JE, Pecoraro RE, Burgess EM, et al. Reliability of transcutaneous oxygen tension (TcPo2) measurements in elderly normal subjects. Scand J Clin Lab Invest. 1987;47:535–541.
27. de Graaff JC, Ubbink DT, Legemate DA, de Haan RJ, Jacobs J. Interobserver and intraobserver reproducibility of peripheral blood and oxygen pressure measurements in the assessment of lower extremity arterial disease. J Vasc Surg. 2001;33:1033–1040.
28. DeLellis SL, Carnegie DH, Burke TJ. Improved sensitivity in patients with peripheral neuropathy: effects of monochromatic infrared photo energy. J Am Podiatr Med Assoc. 2005;95:143–147.
29. Harkless L, DeLellis SL, Carnegie DH, Burke TJ. Improved foot sensitivity and pain reduction in patients with peripheral neuropathy after treatment with monochromatic infrared photo energy — MIRE. J Diabetes Complic. 2006;20:81–87.