A search of the literature based on the MEDLINE database failed to identify any randomized controlled trials focusing on skin contact monochromatic infrared energy. Several case series focusing on different clinical applications were identified. These are reviewed below.
Thomasson reported on the outcomes of series of 563 patients treated with skin contact MIRE who were diagnosed with trapezius tendonitis, splenius capitus tendonitis, temporomandibular capsulitis, or myofascial pain. Patients were treated with one to twelve sessions of skin contact MIRE. The authors report an 88%–90% improvement rate within each diagnostic group. However, there was no control group nor a discussion of how treatment response was assessed.
Kochman and colleagues reported on the use of skin contact MIRE in the treatment of 49 patients with diabetic neuropathy. The principal outcome was change in sensation, as measured with a Semmes-Weinstein monofilament. Four diode arrays were used, the first placed on the distal posterior aspect of the tibia, the second placed over the anterior distal tibia, and the third and fourth placed on the dorsal and ventral surfaces of the foot, respectively. On the basis of Semmes-Weinstein monofilament values, 98% exhibited improved sensation after six treatments, and all had improved sensation after twelve treatments. However, the absence of a control group limits interpretation of these findings.
Horwitz and colleagues investigated the use of skin contact MIRE as a technique to promote healing of five patients with venous or diabetic ulcers (four patients) and one patient with an ulcer related to scleroderma. Patients were instructed to use a skin contact MIRE device at home. While the ulcers improved in all patients, the small number of patients and the lack of a control group prevent scientific interpretation.
Several retrospective or prospective case studies were identified that reported that MIRE treatment was associated with an improvement in peripheral neuropathy, as measured by changes in sensitivity recorded by the Semmes-Weinstein monofilament. The lack of a control group limits interpretation of these studies. Leonard and colleagues reported on the results of a placebo controlled randomized trial of 27 patients with diabetic peripheral neuropathy. Patients essentially served as their own control as each limb was treated with either an Anodyne Professional Therapy System™ or a placebo device for two weeks, then both limbs were treated with the Anodyne Professional Therapy System™. Outcomes were assessed with a Semmes-Weinstein monofilament. While the authors reported improved sensitivity, less pain and better balance in limbs treated with the active device, larger studies with longer follow-up are required to confirm treatment efficacy
A search of the literature was completed through MEDLINE database for the period of October 2003 through September 2006. No additional published studies were identified that would prompt reconsideration of the policy statement, which remains unchanged.
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