OBJECTIVE -The purpose of this study was to determine the effect of monochromatic infrared energy (MIRE) on plantar sensation in subjects with diabetic peripheral neuropathy.RESEARCH DESIGN AND METHODS -In this randomized, double-blind, placebocontrolled study, 39 subjects with diabetic peripheral neuropathy completed the 8-week study. Subjects received 30 min of active or placebo MIRE three times a week for 4 weeks. Plantar sensation was tested with monofilaments at the beginning of the study (M1), following 4 weeks of treatment (M2), and after an additional 4 weeks of nontreatment (M3). The number of sites that could sense the 5.07 monofilament was totaled at M1, M2, and M3. Data were analyzed using a special repeated-measures statistic followed by a post hoc Tukey-Kramer test.RESULTS -The average number of sites that patients could sense the 5.07 monofilament increased for both the active and placebo groups. There were significant gains from M1 to M2 (P Ͻ 0.002), no significant gains from M2 to M3 (P ϭ 0.234), and significant gains from M1 to M3 (P Ͻ 0.002) for both the active and placebo groups. There were no significant differences between active and placebo groups at any measurement.CONCLUSIONS -Thirty minutes of active MIRE applied 3 days per week for 4 weeks was no more effective than placebo MIRE in increasing sensation in subjects with diabetic peripheral neuropathy. Clinicians should be aware that MIRE may not be an effective modality for improving sensory impairments in patients with diabetic neuropathy. Diabetes Care 28:2896 -2900, 2005D iabetes is an increasingly prevalent disease that can have serious complications resulting in escalating health care costs. Recent reports indicate that over 18 million Americans have diabetes (1-3) and almost 30% of adults with diabetes have peripheral neuropathy (4), which increases their risk for developing foot ulcers and contributes to the incidence of lower-extremity amputations (3,5-10). The total cost attributed to managing patients with diabetes in the U.S. was an estimated $132 billion in 2002 (3).Screening for peripheral neuropathy in patients with diabetes is recommended to identify individuals at risk for foot ulcerations and lower-extremity amputations (11-16). After confirming peripheral neuropathy and the loss of protective sensation, treatment usually focuses on education in foot care and regular foot assessment (9,16). More recently, however, a variety of health care professionals have used devices that produce monochromatic infrared energy (MIRE) in an attempt to improve lower-extremity sensation in patients with peripheral neuropathy. MIRE devices were approved by the Food and Drug Administration in 1994 to increase circulation and reduce pain (17,18). There are reports in the literature of the use of MIRE for treating patients with wounds (19) and soft-tissue trauma (20), but several recent studies (21-26) describe the use of MIRE in treating patients with lower-extremity sensory neuropathy. In two separate uncontrolled studies (21,22), MIRE was...
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