Near Infrared Light for the Treatment of Painful Peripheral Neuropathy
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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|
- 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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
|Study Start Date:||July 2005|
|Study Completion Date:||April 2010|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00125268
|United States, Arizona|
|Mayo Clinic Arizona|
|Scottsdale, Arizona, United States, 85254|
|Principal Investigator:||Matthew A Butters, MD||Mayo Clinic|