Near Infrared Light for the Treatment of Painful Peripheral Neuropathy

Last updated: August 2, 2012
Sponsor: Mayo Clinic
Overall Status: Terminated

Phase

3

Condition

Peripheral Neuropathy

Neurologic Disorders

Treatment

N/A

Clinical Study ID

NCT00125268
927-05 00
  • Ages 18-85
  • All Genders

Study 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

Inclusion Criteria:

  • Adults ages 18-85; able to give informed consent

  • Documented painful, distal peripheral neuropathy of idiopathic cause, or related toimpaired glucose tolerance or diabetes mellitus.

  • Neuropathy documented by one of the following studies: nerve conduction studies andneedle electromyography (EMG); quantitative sensory testing of the foot with ComputerAided Sensory Evaluator (CASE IV); quantitative sudomotor axon reflex test (Quantitative Sweat MeasurementSystem [Q-Sweat]); neurology specialty examination; andneuropathy 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

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 isavailable (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.

Study Design

Total Participants: 30
Study Start date:
July 01, 2005
Estimated Completion Date:
April 30, 2010

Study Description

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.

Connect with a study center

  • Mayo Clinic Arizona

    Scottsdale, Arizona 85254
    United States

    Site Not Available

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