ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01513148
Recruitment Status : Completed
First Posted : January 20, 2012
Results First Posted : July 4, 2013
Last Update Posted : July 29, 2013
Sponsor:
Information provided by (Responsible Party):
Todd Telemeco, Shenandoah University

Brief Summary:
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 or disease Intervention/treatment Phase
Peripheral Neuropathy Device: Superluminous light diode Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : June 2006
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

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 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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

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): 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

Publications:
Responsible Party: Todd Telemeco, Associate Professor, Shenandoah University
ClinicalTrials.gov Identifier: NCT01513148     History of Changes
Other Study ID Numbers: 06-750
First Posted: January 20, 2012    Key Record Dates
Results First Posted: July 4, 2013
Last Update Posted: July 29, 2013
Last Verified: July 2013

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