Peripheral Neuropathy
Conditions
Brief 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.
Interventions
DEVICESuperluminous light diode
900W, 880nm, 1.6 J/cm2 for 30sec
Sponsors
Shenandoah University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nerve Conduction Velocity (Meters Per Second) | 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
| Measure | Time frame | Description |
|---|---|---|
| Negative Peak Latency (Milliseconds) | 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. |
| Temperature (Degrees C) | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Light Therapy Application of super luminous diodes light irradiation over the superficial radial nerve | 16 |
| Sham Irradiation Sham Irradiation over the Superficial Radial Nerve for the same time period as the intervention group | 16 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 2 | 2 |
Baseline characteristics
| Characteristic | Sham Irradiation | Light Therapy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 16 Participants | 32 Participants |
| Age Continuous | 25.5 years STANDARD_DEVIATION 3.9 | 24.5 years STANDARD_DEVIATION 2.1 | 24.7 years STANDARD_DEVIATION 3.2 |
| Region of Enrollment United States | 16 participants | 16 participants | 32 participants |
| Sex: Female, Male Female | 13 Participants | 12 Participants | 25 Participants |
| Sex: Female, Male Male | 3 Participants | 4 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 16 | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 |
Outcome results
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.
Time frame: pre-treatment, 0 min, 2 min, 4 min, 6 min, 8 min and 10 min after treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Light NCV Pretreatment | Nerve Conduction Velocity (Meters Per Second) | 0.000 m/s | Standard Deviation 0 |
| Light NCV Time 0 | Nerve Conduction Velocity (Meters Per Second) | -0.358 m/s | Standard Deviation 1.2 |
| Light NCV Time 2 | Nerve Conduction Velocity (Meters Per Second) | 0.447 m/s | Standard Deviation 1.616 |
| Light NCV Time 4 | Nerve Conduction Velocity (Meters Per Second) | 0.147 m/s | Standard Deviation 1.785 |
| Light NCV Time 6 | Nerve Conduction Velocity (Meters Per Second) | -0.041 m/s | Standard Deviation 1.741 |
| Light NCV Time 8 | Nerve Conduction Velocity (Meters Per Second) | 0.280 m/s | Standard Deviation 1.801 |
| Light NCV Time 10 | Nerve Conduction Velocity (Meters Per Second) | 0.100 m/s | Standard Deviation 2.117 |
| Sham NCV Pretreatment | Nerve Conduction Velocity (Meters Per Second) | 0.000 m/s | Standard Deviation 0 |
| Sham NCV Time 0 | Nerve Conduction Velocity (Meters Per Second) | 0.151 m/s | Standard Deviation 1.251 |
| Sham NCV Time 2 | Nerve Conduction Velocity (Meters Per Second) | -0.004 m/s | Standard Deviation 1.386 |
| Sham NCV Time 4 | Nerve Conduction Velocity (Meters Per Second) | 0.447 m/s | Standard Deviation 1.616 |
| Sham NCV Time 6 | Nerve Conduction Velocity (Meters Per Second) | 1.116 m/s | Standard Deviation 1.53 |
| Sham NCV Time 8 | Nerve Conduction Velocity (Meters Per Second) | 0.521 m/s | Standard Deviation 1.652 |
| Sham NCV Time 10 | Nerve Conduction Velocity (Meters Per Second) | 0.675 m/s | Standard Deviation 2.012 |
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.
Time frame: pre-treatment, 0 min, 2 min, 4 min, 6 min, 8 min and 10 min after treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Light NCV Pretreatment | Negative Peak Latency (Milliseconds) | 0.000 ms | Standard Deviation 0 |
| Light NCV Time 0 | Negative Peak Latency (Milliseconds) | 0.414 ms | Standard Deviation 0.429 |
| Light NCV Time 2 | Negative Peak Latency (Milliseconds) | 0.007 ms | Standard Deviation 0.07 |
| Light NCV Time 4 | Negative Peak Latency (Milliseconds) | -0.007 ms | Standard Deviation 0.08 |
| Light NCV Time 6 | Negative Peak Latency (Milliseconds) | 0 ms | Standard Deviation 0.755 |
| Light NCV Time 8 | Negative Peak Latency (Milliseconds) | -0.014 ms | Standard Deviation 0.083 |
| Light NCV Time 10 | Negative Peak Latency (Milliseconds) | -0.007 ms | Standard Deviation 0.096 |
| Sham NCV Pretreatment | Negative Peak Latency (Milliseconds) | -0.007 ms | Standard Deviation 0.059 |
| Sham NCV Time 0 | Negative Peak Latency (Milliseconds) | 0.000 ms | Standard Deviation 0.065 |
| Sham NCV Time 2 | Negative Peak Latency (Milliseconds) | -0.021 ms | Standard Deviation 0.077 |
| Sham NCV Time 4 | Negative Peak Latency (Milliseconds) | -0.050 ms | Standard Deviation 0.073 |
| Sham NCV Time 6 | Negative Peak Latency (Milliseconds) | -0.021 ms | Standard Deviation 0.077 |
| Sham NCV Time 8 | Negative Peak Latency (Milliseconds) | -0.028 ms | Standard Deviation 0.096 |
| Sham NCV Time 10 | Negative Peak Latency (Milliseconds) | 0 ms | Standard Deviation 0 |
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
Time frame: pre-treatment, 0 min, 2 min, 4 min, 6 min, 8 min and 10 min after treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Light NCV Pretreatment | Temperature (Degrees C) | 0.000 Degrees Celsius | Standard Deviation 0 |
| Light NCV Time 0 | Temperature (Degrees C) | 0.414 Degrees Celsius | Standard Deviation 0.429 |
| Light NCV Time 2 | Temperature (Degrees C) | 0.993 Degrees Celsius | Standard Deviation 0.626 |
| Light NCV Time 4 | Temperature (Degrees C) | 0.686 Degrees Celsius | Standard Deviation 1.21 |
| Light NCV Time 6 | Temperature (Degrees C) | 0.757 Degrees Celsius | Standard Deviation 1.336 |
| Light NCV Time 8 | Temperature (Degrees C) | 0.786 Degrees Celsius | Standard Deviation 1.341 |
| Light NCV Time 10 | Temperature (Degrees C) | 0.778 Degrees Celsius | Standard Deviation 1.432 |
| Sham NCV Pretreatment | Temperature (Degrees C) | 0.000 Degrees Celsius | Standard Deviation 0 |
| Sham NCV Time 0 | Temperature (Degrees C) | 0.814 Degrees Celsius | Standard Deviation 0.662 |
| Sham NCV Time 2 | Temperature (Degrees C) | 1.021 Degrees Celsius | Standard Deviation 0.591 |
| Sham NCV Time 4 | Temperature (Degrees C) | 0.993 Degrees Celsius | Standard Deviation 0.626 |
| Sham NCV Time 6 | Temperature (Degrees C) | 1.007 Degrees Celsius | Standard Deviation 0.796 |
| Sham NCV Time 8 | Temperature (Degrees C) | 0.928 Degrees Celsius | Standard Deviation 0.82 |
| Sham NCV Time 10 | Temperature (Degrees C) | 0.878 Degrees Celsius | Standard Deviation 0.847 |