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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Todd Telemeco, Shenandoah University
ClinicalTrials.gov Identifier:
NCT01513148
First received: January 9, 2012
Last updated: July 10, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Peripheral Neuropathy
Device: Superluminous light diode

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: The Effect of Light Therapy on Superficial Radial Nerve Conduction Using a Clustered Array of Infrared Super Luminous and Red Light Emitting Diodes

Resource links provided by NLM:


Further study details as provided by Shenandoah University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Negative Peak Latency (Milliseconds) [ Time Frame: pre-treatment, 0 min, 2 min, 4 min, 6 min, 8 min and 10 min after treatment ] [ Designated as safety issue: No ]
    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.

  • Temperature (Degrees C) [ Time Frame: pre-treatment, 0 min, 2 min, 4 min, 6 min, 8 min and 10 min after treatment ] [ Designated as safety issue: No ]
    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


Enrollment: 32
Study Start Date: June 2006
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Dynatronics Solaris Model 705

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01513148

Locations
United States, Virginia
Shenandoah University Divsion of Physical Therapy
Winchester, Virginia, United States, 22601
Sponsors and Collaborators
Shenandoah University
Investigators
Principal Investigator: Todd A Telemeco, PhD Shenandoah University
  More Information

Publications:
Responsible Party: Todd Telemeco, Associate Professor, Shenandoah University
ClinicalTrials.gov Identifier: NCT01513148     History of Changes
Other Study ID Numbers: 06-750
Study First Received: January 9, 2012
Results First Received: June 11, 2012
Last Updated: July 10, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on April 16, 2014