Near Infrared Light for the Treatment of Painful Peripheral Neuropathy
Condition: Peripheral Neuropathy
MeSH terms: Peripheral Nervous System Diseases
Intervention: MIRE; Sham Device
Intervention description: 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.; The sham device is non-active but otherwise identical to the study device.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: painful; peripheral; neuropathy; light; therapy

Summary:

      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.
    

Eligibility criteria:

        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.