Effects of Light Emitting Diode Irradiation on the Conduction Parameters of the Superficial Radial Nerve - Full Text View

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

Resource links provided by NLM:

MedlinePlus related topics: Peripheral Nerve Disorders

U.S. FDA Resources

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, 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

Secondary Outcome Measures:

negative peak latency (milliseconds) [ Time Frame: pre-treatment, 0 min, 2 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
amplitude (microvolts) [ Time Frame: pre-treatment, 0 min, 2 min, 6 min, 8 min and 10 min after treatment ] [ Designated as safety issue: No ]
Change in amplitude (micro volt) from pre-treatment to 0 minute (immediately after treatment), and at 2 min intervals after treatment until 10 minutes post treatment occurs

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: Light Therapy 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 Irradiation Sham 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:

Greathouse DG, Currier DP, Gilmore RL. Effects of clinical infrared laser on superficial radial nerve conduction. Phys Ther. 1985 Aug;65(8):1184-7.

Downie AW, Scott TR. An improved technique for radial nerve conduction studies. J Neurol Neurosurg Psychiatry. 1967 Aug;30(4):332-6. No abstract available.

Snyder-Mackler L, Bork CE. Effect of helium-neon laser irradiation on peripheral sensory nerve latency. Phys Ther. 1988 Feb;68(2):223-5.

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
Last Updated:	January 16, 2012
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 May 19, 2013