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

Study Overview
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Brief Summary
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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.

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

Conditions
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Peripheral Neuropathy

Intervention / Treatment
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* Device: Superluminous light diode


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Superluminous Light Diode Irradiation<br>Application of super luminous diodes light irradiation over the superficial radial nerve | Device: Superluminous light diode<br>* 900W, 880nm, 1.6 J/cm2 for 30sec<br>* Other names: Dynatronics Solaris Model 705;|
| Placebo Comparator: Sham Superluminous Light Diode Irradiation<br>Sham Superluminous Light Diode Irradiation over the Superficial Radial Nerve for the same time period as the intervention group | Device: Superluminous light diode<br>* 900W, 880nm, 1.6 J/cm2 for 30sec<br>* Other names: Dynatronics Solaris Model 705;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |