Trial Outcomes & Findings for Effects of Light Emitting Diode Irradiation on the Conduction Parameters of the Superficial Radial Nerve (NCT NCT01513148)
NCT ID: NCT01513148
Last Updated: 2013-07-29
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
32 participants
Primary outcome timeframe
pre-treatment, 0 min, 2 min, 4 min, 6 min, 8 min and 10 min after treatment
Results posted on
2013-07-29
Participant Flow
Participant milestones
| Measure |
Light Therapy
Application of super luminous diodes light irradiation over the superficial radial nerve
|
Sham Irradiation
Sham Irradiation over the Superficial Radial Nerve for the same time period as the intervention group
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
|
Overall Study
COMPLETED
|
14
|
14
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Light Therapy
Application of super luminous diodes light irradiation over the superficial radial nerve
|
Sham Irradiation
Sham Irradiation over the Superficial Radial Nerve for the same time period as the intervention group
|
|---|---|---|
|
Overall Study
Protocol Violation
|
2
|
2
|
Baseline Characteristics
Effects of Light Emitting Diode Irradiation on the Conduction Parameters of the Superficial Radial Nerve
Baseline characteristics by cohort
| Measure |
Light Therapy
n=16 Participants
Application of super luminous diodes light irradiation over the superficial radial nerve
|
Sham Irradiation
n=16 Participants
Sham Irradiation over the Superficial Radial Nerve for the same time period as the intervention group
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
24.5 years
STANDARD_DEVIATION 2.1 • n=5 Participants
|
25.5 years
STANDARD_DEVIATION 3.9 • n=7 Participants
|
24.7 years
STANDARD_DEVIATION 3.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
16 participants
n=7 Participants
|
32 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: pre-treatment, 0 min, 2 min, 4 min, 6 min, 8 min and 10 min after treatmentChange 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.
Outcome measures
| Measure |
Light NCV Pretreatment
n=14 Participants
NCV at baseline, before the application of super luminous diodes light irradiation over the superficial radial nerve
|
Light NCV Time 0
n=14 Participants
NCV at time 0, immediately following the application of super luminous diodes light irradiation over the superficial radial nerve
|
Light NCV Time 2
n=14 Participants
NCV 2 minutes following the application of super luminous diodes light irradiation over the superficial radial nerve
|
Light NCV Time 4
n=14 Participants
NCV 4 minutes following the application of super luminous diodes light irradiation over the superficial radial nerve
|
Light NCV Time 6
n=14 Participants
NCV 6 minutes following the application of super luminous diodes light irradiation over the superficial radial nerve
|
Light NCV Time 8
n=14 Participants
NCV 8 minutes following the application of super luminous diodes light irradiation over the superficial radial nerve
|
Light NCV Time 10
n=14 Participants
NCV 10 minutes following the application of super luminous diodes light irradiation over the superficial radial nerve
|
Sham NCV Pretreatment
n=14 Participants
NCV at baseline, before the application of sham superluminous diodes light irradiation over the superficial radial nerve
|
Sham NCV Time 0
n=14 Participants
NCV immediately (Time 0) following the application of superluminous diodes light irradiation over the superficial radial nerve
|
Sham NCV Time 2
n=14 Participants
NCV 2 minutes following the application of sham superluminous diodes light irradiation over the superficial radial nerve
|
Sham NCV Time 4
n=14 Participants
NCV 4 minutes following the application of sham superluminous diodes light irradiation over the superficial radial nerve
|
Sham NCV Time 6
n=14 Participants
NCV 6 minutes following the application of sham superluminous diodes light irradiation over the superficial radial nerve
|
Sham NCV Time 8
n=14 Participants
NCV 8 minutes following the application of sham superluminous diodes light irradiation over the superficial radial nerve
|
Sham NCV Time 10
n=14 Participants
NCV 10 minutes following the application of sham superluminous diodes light irradiation over the superficial radial nerve
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Nerve Conduction Velocity (Meters Per Second)
|
0.000 m/s
Standard Deviation 0.000
|
-0.358 m/s
Standard Deviation 1.200
|
0.447 m/s
Standard Deviation 1.616
|
0.147 m/s
Standard Deviation 1.785
|
-0.041 m/s
Standard Deviation 1.741
|
0.280 m/s
Standard Deviation 1.801
|
0.100 m/s
Standard Deviation 2.117
|
0.000 m/s
Standard Deviation 0.000
|
0.151 m/s
Standard Deviation 1.251
|
-0.004 m/s
Standard Deviation 1.386
|
0.447 m/s
Standard Deviation 1.616
|
1.116 m/s
Standard Deviation 1.530
|
0.521 m/s
Standard Deviation 1.652
|
0.675 m/s
Standard Deviation 2.012
|
SECONDARY outcome
Timeframe: pre-treatment, 0 min, 2 min, 4 min, 6 min, 8 min and 10 min after treatmentChange 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.
Outcome measures
| Measure |
Light NCV Pretreatment
n=14 Participants
NCV at baseline, before the application of super luminous diodes light irradiation over the superficial radial nerve
|
Light NCV Time 0
n=14 Participants
NCV at time 0, immediately following the application of super luminous diodes light irradiation over the superficial radial nerve
|
Light NCV Time 2
n=14 Participants
NCV 2 minutes following the application of super luminous diodes light irradiation over the superficial radial nerve
|
Light NCV Time 4
n=14 Participants
NCV 4 minutes following the application of super luminous diodes light irradiation over the superficial radial nerve
|
Light NCV Time 6
n=14 Participants
NCV 6 minutes following the application of super luminous diodes light irradiation over the superficial radial nerve
|
Light NCV Time 8
n=14 Participants
NCV 8 minutes following the application of super luminous diodes light irradiation over the superficial radial nerve
|
Light NCV Time 10
n=14 Participants
NCV 10 minutes following the application of super luminous diodes light irradiation over the superficial radial nerve
|
Sham NCV Pretreatment
n=14 Participants
NCV at baseline, before the application of sham superluminous diodes light irradiation over the superficial radial nerve
|
Sham NCV Time 0
n=14 Participants
NCV immediately (Time 0) following the application of superluminous diodes light irradiation over the superficial radial nerve
|
Sham NCV Time 2
n=14 Participants
NCV 2 minutes following the application of sham superluminous diodes light irradiation over the superficial radial nerve
|
Sham NCV Time 4
n=14 Participants
NCV 4 minutes following the application of sham superluminous diodes light irradiation over the superficial radial nerve
|
Sham NCV Time 6
n=14 Participants
NCV 6 minutes following the application of sham superluminous diodes light irradiation over the superficial radial nerve
|
Sham NCV Time 8
n=14 Participants
NCV 8 minutes following the application of sham superluminous diodes light irradiation over the superficial radial nerve
|
Sham NCV Time 10
n=14 Participants
NCV 10 minutes following the application of sham superluminous diodes light irradiation over the superficial radial nerve
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Negative Peak Latency (Milliseconds)
|
0.000 ms
Standard Deviation 0.000
|
0.414 ms
Standard Deviation 0.429
|
0.007 ms
Standard Deviation 0.070
|
-0.007 ms
Standard Deviation 0.080
|
0 ms
Standard Deviation 0.755
|
-0.014 ms
Standard Deviation 0.083
|
-0.007 ms
Standard Deviation 0.096
|
-0.007 ms
Standard Deviation 0.059
|
0.000 ms
Standard Deviation 0.065
|
-0.021 ms
Standard Deviation 0.077
|
-0.050 ms
Standard Deviation 0.073
|
-0.021 ms
Standard Deviation 0.077
|
-0.028 ms
Standard Deviation 0.096
|
0 ms
Standard Deviation 0
|
SECONDARY outcome
Timeframe: pre-treatment, 0 min, 2 min, 4 min, 6 min, 8 min and 10 min after treatmentChange 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
Outcome measures
| Measure |
Light NCV Pretreatment
n=14 Participants
NCV at baseline, before the application of super luminous diodes light irradiation over the superficial radial nerve
|
Light NCV Time 0
n=14 Participants
NCV at time 0, immediately following the application of super luminous diodes light irradiation over the superficial radial nerve
|
Light NCV Time 2
n=14 Participants
NCV 2 minutes following the application of super luminous diodes light irradiation over the superficial radial nerve
|
Light NCV Time 4
n=14 Participants
NCV 4 minutes following the application of super luminous diodes light irradiation over the superficial radial nerve
|
Light NCV Time 6
n=14 Participants
NCV 6 minutes following the application of super luminous diodes light irradiation over the superficial radial nerve
|
Light NCV Time 8
n=14 Participants
NCV 8 minutes following the application of super luminous diodes light irradiation over the superficial radial nerve
|
Light NCV Time 10
n=14 Participants
NCV 10 minutes following the application of super luminous diodes light irradiation over the superficial radial nerve
|
Sham NCV Pretreatment
n=14 Participants
NCV at baseline, before the application of sham superluminous diodes light irradiation over the superficial radial nerve
|
Sham NCV Time 0
n=14 Participants
NCV immediately (Time 0) following the application of superluminous diodes light irradiation over the superficial radial nerve
|
Sham NCV Time 2
n=14 Participants
NCV 2 minutes following the application of sham superluminous diodes light irradiation over the superficial radial nerve
|
Sham NCV Time 4
n=14 Participants
NCV 4 minutes following the application of sham superluminous diodes light irradiation over the superficial radial nerve
|
Sham NCV Time 6
n=14 Participants
NCV 6 minutes following the application of sham superluminous diodes light irradiation over the superficial radial nerve
|
Sham NCV Time 8
n=14 Participants
NCV 8 minutes following the application of sham superluminous diodes light irradiation over the superficial radial nerve
|
Sham NCV Time 10
n=14 Participants
NCV 10 minutes following the application of sham superluminous diodes light irradiation over the superficial radial nerve
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Temperature (Degrees C)
|
0.000 Degrees Celsius
Standard Deviation 0.000
|
0.414 Degrees Celsius
Standard Deviation 0.429
|
0.993 Degrees Celsius
Standard Deviation 0.626
|
0.686 Degrees Celsius
Standard Deviation 1.210
|
0.757 Degrees Celsius
Standard Deviation 1.336
|
0.786 Degrees Celsius
Standard Deviation 1.341
|
0.778 Degrees Celsius
Standard Deviation 1.432
|
0.000 Degrees Celsius
Standard Deviation 0.000
|
0.814 Degrees Celsius
Standard Deviation 0.662
|
1.021 Degrees Celsius
Standard Deviation 0.591
|
0.993 Degrees Celsius
Standard Deviation 0.626
|
1.007 Degrees Celsius
Standard Deviation 0.796
|
0.928 Degrees Celsius
Standard Deviation 0.820
|
0.878 Degrees Celsius
Standard Deviation 0.847
|
Adverse Events
Light Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham Irradiation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place