Near Infrared Light for the Treatment of Painful Peripheral Neuropathy
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|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
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|Condition or disease||Intervention/treatment||Phase|
|Peripheral Neuropathy||Device: MIRE Device: Sham Device||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Active Comparator: MIRE
Subjects randomized to this arm will receive treatment with monochromatic near infrared photo energy (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.
- 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.
- 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.
- 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.
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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|
- 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
- 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.
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
|United States, Arizona|
|Mayo Clinic Arizona|
|Scottsdale, Arizona, United States, 85254|
|Principal Investigator:||Matthew A Butters, MD||Mayo Clinic|
|Responsible Party:||Matthew Butters, M.D. Principal Investigator, Mayo Clinic|
|Other Study ID Numbers:||
|First Posted:||July 29, 2005 Key Record Dates|
|Results First Posted:||September 5, 2012|
|Last Update Posted:||September 5, 2012|
|Last Verified:||August 2012|
Peripheral Nervous System Diseases
Nervous System Diseases