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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Superluminous Light Diode Irradiation | Experimental | Application of super luminous diodes light irradiation over the superficial radial nerve |
|
| Sham Superluminous Light Diode Irradiation | Placebo Comparator | Sham Superluminous Light Diode Irradiation over the Superficial Radial Nerve for the same time period as the intervention group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Superluminous light diode | Device | 900W, 880nm, 1.6 J/cm2 for 30sec |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Todd A Telemeco, PhD | Shenandoah University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shenandoah University Divsion of Physical Therapy | Winchester | Virginia | 22601 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 4023064 | Background | Greathouse DG, Currier DP, Gilmore RL. Effects of clinical infrared laser on superficial radial nerve conduction. Phys Ther. 1985 Aug;65(8):1184-7. doi: 10.1093/ptj/65.8.1184. | |
| 4293407 | Background | Downie AW, Scott TR. An improved technique for radial nerve conduction studies. J Neurol Neurosurg Psychiatry. 1967 Aug;30(4):332-6. doi: 10.1136/jnnp.30.4.332. No abstract available. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Light Therapy | Application of super luminous diodes light irradiation over the superficial radial nerve |
| FG001 | Sham Irradiation | Sham Irradiation over the Superficial Radial Nerve for the same time period as the intervention group |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Light Therapy | Application of super luminous diodes light irradiation over the superficial radial nerve |
| BG001 | Sham Irradiation | Sham Irradiation over the Superficial Radial Nerve for the same time period as the intervention group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | m/s | pre-treatment, 0 min, 2 min, 4 min, 6 min, 8 min and 10 min after treatment |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Light Therapy | Application of super luminous diodes light irradiation over the superficial radial nerve |
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4 subjects were terminated early in the project, two from the light therapy group and two from the sham therapy group. All cases, we were unable to achieve an appropriate baseline temperature of 30 degrees celsius to allow continued participation
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Todd Telemeco | Shenandoah University | 540-545-7398 | ttelemec@su.edu |
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| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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|
| 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 |
| 3340661 | Background | Snyder-Mackler L, Bork CE. Effect of helium-neon laser irradiation on peripheral sensory nerve latency. Phys Ther. 1988 Feb;68(2):223-5. doi: 10.1093/ptj/68.2.223. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
NCV at time 0, immediately following the application of super luminous diodes light irradiation over the superficial radial nerve
| OG002 | Light NCV Time 2 | NCV 2 minutes following the application of super luminous diodes light irradiation over the superficial radial nerve |
| OG003 | Light NCV Time 4 | NCV 4 minutes following the application of super luminous diodes light irradiation over the superficial radial nerve |
| OG004 | Light NCV Time 6 | NCV 6 minutes following the application of super luminous diodes light irradiation over the superficial radial nerve |
| OG005 | Light NCV Time 8 | NCV 8 minutes following the application of super luminous diodes light irradiation over the superficial radial nerve |
| OG006 | Light NCV Time 10 | NCV 10 minutes following the application of super luminous diodes light irradiation over the superficial radial nerve |
| OG007 | Sham NCV Pretreatment | NCV at baseline, before the application of sham superluminous diodes light irradiation over the superficial radial nerve |
| OG008 | Sham NCV Time 0 | NCV immediately (Time 0) following the application of superluminous diodes light irradiation over the superficial radial nerve |
| OG009 | Sham NCV Time 2 | NCV 2 minutes following the application of sham superluminous diodes light irradiation over the superficial radial nerve |
| OG010 | Sham NCV Time 4 | NCV 4 minutes following the application of sham superluminous diodes light irradiation over the superficial radial nerve |
| OG011 | Sham NCV Time 6 | NCV 6 minutes following the application of sham superluminous diodes light irradiation over the superficial radial nerve |
| OG012 | Sham NCV Time 8 | NCV 8 minutes following the application of sham superluminous diodes light irradiation over the superficial radial nerve |
| OG013 | Sham NCV Time 10 | NCV 10 minutes following the application of sham superluminous diodes light irradiation over the superficial radial nerve |
|
|
| 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. | Posted | Mean | Standard Deviation | ms | pre-treatment, 0 min, 2 min, 4 min, 6 min, 8 min and 10 min after treatment |
|
|
|
| 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 | Posted | Mean | Standard Deviation | Degrees Celsius | pre-treatment, 0 min, 2 min, 4 min, 6 min, 8 min and 10 min after treatment |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Sham Irradiation | Sham Irradiation over the Superficial Radial Nerve for the same time period as the intervention group | 0 | 16 | 0 | 16 |
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