Effects of Light Emitting Diode Irradiation on the Conduction Parameters of the Superficial Radial Nerve

July 10, 2013 updated by: Todd Telemeco, Shenandoah University

The Effect of Light Therapy on Superficial Radial Nerve Conduction Using a Clustered Array of Infrared Super Luminous and Red Light Emitting Diodes

The introduction of light emitting diode (LED) devices as a novel treatment for pain relief in place of low-level laser warrants fundamental research on the effect of LED devices on one of the potential explanatory mechanisms: peripheral neurophysiology in vivo. A randomized controlled study will be conducted by measuring nerve conduction on the superficial radial nerve of healthy subjects (n=64). One baseline measurement and five post-irradiation recordings (2-min interval each) will be performed of the nerve conduction velocity (NCV) and peak latency (PL) and peak amplitude (PA). The experimental group (=32) will receive an irradiation of 2 J/cm2 with an infrared LED device (Dynatronics Solaris Model 705), while the placebo group will be treated by sham irradiation. The purpose of this study is to investigate the effects of LED light on the conduction velocity and amplitude of the superficial radial nerve.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Winchester, Virginia, United States, 22601
        • Shenandoah University Divsion of Physical Therapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • no history of neurological disease, polyneuropathy, peripheral neuropathy or cervical radiculopathy

Exclusion Criteria:

  • positive findings during the clinical screening examination suggestive of an underlying neurological disease, polyneuropathy, peripheral neuropathy or cervical radiculopathy.
  • a history of a neurological disease, polyneuropathy, peripheral neuropathy or cervical radiculopathy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Superluminous Light Diode Irradiation
Application of super luminous diodes light irradiation over the superficial radial nerve
Device: Superluminous light diode
900W, 880nm, 1.6 J/cm2 for 30sec
Other Names:
  • Dynatronics Solaris Model 705
PLACEBO_COMPARATOR: Sham Superluminous Light Diode Irradiation
Sham Superluminous Light Diode Irradiation over the Superficial Radial Nerve for the same time period as the intervention group
Device: Superluminous light diode
900W, 880nm, 1.6 J/cm2 for 30sec
Other Names:
  • Dynatronics Solaris Model 705

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nerve Conduction Velocity (Meters Per Second)
Time Frame: pre-treatment, 0 min, 2 min, 4 min, 6 min, 8 min and 10 min after treatment
Change in nerve conduction velocity (m/s) from pre-treatment to 0 minute (immediately after treatment), and at 2 min intervals after treatment until 10 minutes post treatment occurs. Calculated difference scores at each time point = nerve conduction velocity (NCV) - baseline NCV. A positive variance represented an increase from baseline and is interpreted as being an increase or faster velocity.
pre-treatment, 0 min, 2 min, 4 min, 6 min, 8 min and 10 min after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Negative Peak Latency (Milliseconds)
Time Frame: pre-treatment, 0 min, 2 min, 4 min, 6 min, 8 min and 10 min after treatment
Change in negative peak latency (ms) from pre-treatment to 0 minute (immediately after treatment), and at 2 min intervals after treatment until 10 minutes post treatment occurs. Calculated difference scores at each time period = negative peak latency NPL - baseline NPL. A positive variance can be interpreted as being increase from baseline or a prolonged or slowed NPL.
pre-treatment, 0 min, 2 min, 4 min, 6 min, 8 min and 10 min after treatment
Temperature (Degrees C)
Time Frame: pre-treatment, 0 min, 2 min, 4 min, 6 min, 8 min and 10 min after treatment
Change in superficial skin temperature (degrees C) from pre-treatment to 0 minute (immediately after treatment), and at 2 min intervals after treatment until 10 minutes post treatment occurs. Calculated difference scores at each time point = Temperature - Temperature at baseline. A positive variance int his calculation can be interpreted as being an increase from baseline or an increase in skin temperature
pre-treatment, 0 min, 2 min, 4 min, 6 min, 8 min and 10 min after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shenandoah University

Investigators

  • Principal Investigator: Todd A Telemeco, PhD, Shenandoah University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (ACTUAL)

September 1, 2008

Study Completion (ACTUAL)

September 1, 2008

Study Registration Dates

First Submitted

January 9, 2012

First Submitted That Met QC Criteria

January 16, 2012

First Posted (ESTIMATE)

January 20, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

July 29, 2013

Last Update Submitted That Met QC Criteria

July 10, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-750

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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