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Completed

NCT Number: NCT01513148

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

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.

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Key information

Conditions

Peripheral Neuropathy Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shenandoah University Divsion of Physical Therapy

Winchester, Virginia, 22601, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Superluminous light diode

Device

900W, 880nm, 1.6 J/cm2 for 30sec

Other names: Dynatronics Solaris Model 705

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Shenandoah University

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jan 20, 2012
Registry last updated
Jul 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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