Near Infrared Light for the Treatment of Painful Peripheral Neuropathy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Peripheral Neuropathy

Intervention / Treatment
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* Device: MIRE
* Device: Sham Device


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MIRE<br>Subjects randomized to this arm will receive treatment with monochromatic near infrared photo energy (MIRE). | Device: MIRE<br>* Monochromatic near infrared photo energy (MIRE). A 30-minute application of MIRE results in a radiant exposure of 43.2 joules per square centimeter (J/cm^2). The design of the flexible pads allows the infrared energy to be delivered perpendicular to and in contact with the involved site. MIRE applied to the skin facilitates the release of a small molecule of the free radical nitric oxide from hemoglobin and other proteins in surrounding tissue. Increased levels of nitric oxide improve the circulation of blood enhancing wound healing and reducing pain.<br>* Other names: Anodyne Therapy System;|
| Sham Comparator: Sham<br>Subjects randomized to this arm will receive treatment with the sham device, which is non-active but otherwise identical to the study device. | Device: Sham Device<br>* The sham device is non-active but otherwise identical to the study device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects That Have a Greater Than or Equal to Forty Percent Decrease on the Visual Analog Pain Scale at the End of Four Weeks of Treatment | Pain was measured by a 10 cm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes. On this scale 0 means no pain and 10 cm means extreme pain. The investigator measures the mark made by the subject in cm and records this for the value of pain. | baseline, 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects That Have a Forty Percent Reduction of Pain Measured by the Neuropathic Pain Scale at the End of Four Weeks of Treatment | The neuropathic pain scale consists of 10 questions with individual answers rated from 1 to 10, with 0 = no pain to 10 = the most intense pain imaginable. The overall score could range from 0 to 100, with 0 = no pain to 100 = the most intense pain imaginable. | baseline, 4 weeks | 
| Percentage of Subjects That Have an Improvement of Two Points or More on the SF-8 at the End of Four Weeks of Treatment | The SF-8 Health Survey has 8 questions, each question measuring each of the eight domains of health. Scores are calibrated so that 50 is the average score or norm. A lower score indicates poorer health, and a higher score indicates excellent health. | baseline, 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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painful, peripheral, neuropathy, light, therapy