Near Infrared Light for the Treatment of Painful Peripheral Neuropathy

A Phase III, Double Blind, Randomized, Placebo-controlled Study to Assess the Efficacy of Adjunct Monochromatic Near-infrared Photoenergy (MIRE) in Patients With Painful Axonal Peripheral Neuropathy

The purpose of this study is to determine if near infrared light therapy is effective in decreasing pain in patients with painful peripheral neuropathy. The hypothesis of the study was that the percentage of subjects with at least 40% improvement in visual analog scale score for pain after 4 weeks of treatment is higher for Monochromatic Near-infrared Photoenergy (MIRE) treatment than for sham treatment.

Pain is a very common symptom, between 65-80%, in patients with peripheral neuropathy. This study is designed to evaluate the effectiveness of monochromatic near infrared photoenergy therapy (MIRE) in the treatment of pain in axonal peripheral neuropathy. This will be compared with a placebo (sham) device.

The MIRE is a FDA approved, drug-free, non-invasive, medical therapeutic device that uses near-infrared light emitting diodes to deliver monochromatic near infrared photoenergy (MIRE) through contact with the skin. The effect of MIRE is believed to increase local blood circulation by dilating vessels and to reduce pain by decreasing local swelling and inflammation. MIRE is also thought to increase local levels of nitric oxide (NO) which may decrease pain levels.

Study subjects will receive treatment with the device or the placebo device 3 times per week for 4 weeks. Response will be measured during and after the treatment period.

Inclusion Criteria:

• Adults ages 18-85; able to give informed consent
• Documented painful, distal peripheral neuropathy of idiopathic cause, or related to impaired glucose tolerance or diabetes mellitus.
• Neuropathy documented by one of the following studies: nerve conduction studies and needle electromyography (EMG); quantitative sensory testing of the foot with Computer Aided Sensory Evaluator (CASE IV); quantitative sudomotor axon reflex test (Quantitative Sweat MeasurementSystem [Q-Sweat]); neurology specialty examination; and neuropathy impairment score (NIS) of less than 25.
• Stable pharmacotherapy for neuropathic pain for at least two weeks.
• Optimal pharmacotherapy has been achieved.
• Subjects cannot be on Cyclooxygenase-2 (COX 2) inhibitors
• Pain Visual Analog Scale (VAS) of greater than or equal to 4/10
• Subject has provided written informed consent
• Not currently using transcutaneous electrical nerve stimulation (TENS)
• Not currently receiving acupuncture

Exclusion Criteria:

• Pregnant or likely to become pregnant
• Current diagnosis of cancer
• Neuropathy impairment score (NIS) of greater than 25.
• Diagnosis of severe neuropathy of known etiology for which specific treatment is available (i.e., acute and chronic inflammatory polyradiculoneuropathies, vasculitis, B 12 deficiency).
• Unstable diabetes mellitus defined as a hemoglobin A1c (HbA1c) greater than 9%, and/or 10% of fasting blood sugars greater than 300 mg/dl for the week prior to enrollment.