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Near Infrared Light for the Treatment of Painful Peripheral Neuropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00125268
Recruitment Status : Terminated (Unable to enroll enough patients)
First Posted : July 29, 2005
Results First Posted : September 5, 2012
Last Update Posted : September 5, 2012
Anodyne Therapy, LLC
Information provided by:
Mayo Clinic

Brief 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.

Condition or disease Intervention/treatment Phase
Peripheral Neuropathy Device: MIRE Device: Sham Device Phase 3

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2005
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: MIRE
Subjects randomized to this arm will receive treatment with monochromatic near infrared photo energy (MIRE).
Device: MIRE
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.
Other Name: Anodyne Therapy System

Sham Comparator: Sham
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
The sham device is non-active but otherwise identical to the study device.

Primary Outcome Measures :
  1. 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 [ Time Frame: baseline, 4 weeks ]
    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.

Secondary Outcome Measures :
  1. 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 [ Time Frame: baseline, 4 weeks ]
    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.

  2. Percentage of Subjects That Have an Improvement of Two Points or More on the SF-8 at the End of Four Weeks of Treatment [ Time Frame: baseline, 4 weeks ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00125268

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United States, Arizona
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85254
Sponsors and Collaborators
Mayo Clinic
Anodyne Therapy, LLC
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Principal Investigator: Matthew A Butters, MD Mayo Clinic
Additional Information:

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Responsible Party: Matthew Butters, M.D. Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00125268    
Other Study ID Numbers: 927-05 00
First Posted: July 29, 2005    Key Record Dates
Results First Posted: September 5, 2012
Last Update Posted: September 5, 2012
Last Verified: August 2012
Keywords provided by Mayo Clinic:
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases