MedTrace Logo

Near Infrared Light for the Treatment of Painful Peripheral Neuropathy

NCT00125268 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2012-09-05

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

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.

DEVICE

Sham Device

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

Sponsors & Collaborators

  • Anodyne Therapy, LLC

    collaborator INDUSTRY

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Matthew A Butters, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-07-31
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00125268 on ClinicalTrials.gov