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

Peripheral Neuropathy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01513148
• Other study ID #: 06-750
• Status: Completed
• Phase: N/A
• First received: January 9, 2012
• Last updated: July 10, 2013
• Start date: June 2006
• Est. completion date: September 2008

Study information

• Verified date: July 2013
• Source: Shenandoah University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Peripheral Nervous System Diseases
• Peripheral Neuropathy

Intervention

Device:
• Superluminous light diode
900W, 880nm, 1.6 J/cm2 for 30sec

Locations

Country	Name	City	State
United States	Shenandoah University Divsion of Physical Therapy	Winchester	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Shenandoah University

Country where clinical trial is conducted

United States, 

References & Publications (3)

Downie AW, Scott TR. An improved technique for radial nerve conduction studies. J Neurol Neurosurg Psychiatry. 1967 Aug;30(4):332-6. — View Citation

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

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nerve Conduction Velocity (Meters Per Second)	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	No
Secondary	Negative Peak Latency (Milliseconds)	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	No
Secondary	Temperature (Degrees C)	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	No