Trial Outcomes & Findings for The Use of i/t Curve in Assessment of Phototherapy Effects (NCT NCT02618642)
NCT ID: NCT02618642
Last Updated: 2020-01-13
Results Overview
Increase in PPT meant decrease in sensitivity to pressure in the muscle. Decrease in PPT meant increase in sensitivity to pressure in the muscle.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
baseline measurement and 3 weeks after a series of 10 phototherapy treatments
Results posted on
2020-01-13
Participant Flow
60 participants meeting inclusion criteria (healthy volunteers) were randomized into 4 groups Setting: Centre for Innovative Research in Medical and Natural Sciences, the University of Rzeszów Faculty of Medicine, Poland.
Participant milestones
| Measure |
PILER Light Irradiation Treatments With Red Filter
Group x: Participants received a series of 10 PILER light (polychromatic incoherent low-energy radiation) irradiation with a red filter (visible red radiation and infrared; 650-800 nm and 800-3900 nm, respectively), each session lasted 10 minutes,
|
PILER Light Irradiation Treatments With Blue Filter
Group y: Participants received a series of 10 PILER light (polychromatic incoherent low-energy radiation) irradiation with a blue filter (blue radiation; 440-480 nm), each session lasted 10 minutes,
|
PILER Light Irradiation Treatments Without a Filter
Group v: Participants received a series of 10 PILER light (polychromatic incoherent low-energy radiation) irradiation without filter (white radiation in the entire spectrum and near-infrared radiation; 480-3400 nm), each session lasted 10 minutes,
|
Placebo
Group z: placebo irradiation (without a filter, 3 min, distance: 100 cm); each session lasted 3 minutes
|
|---|---|---|---|---|
|
Before 10 PILER Irradiation Treatments
STARTED
|
15
|
15
|
15
|
15
|
|
Before 10 PILER Irradiation Treatments
COMPLETED
|
15
|
15
|
15
|
15
|
|
Before 10 PILER Irradiation Treatments
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
After 10 PILER Irradiation Treatments
STARTED
|
15
|
15
|
15
|
15
|
|
After 10 PILER Irradiation Treatments
COMPLETED
|
15
|
15
|
15
|
15
|
|
After 10 PILER Irradiation Treatments
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group x: PILER Irradiation Treatments With Red Filter
n=15 Participants
Piler light + red filter Group x: irradiation with a red filter (visible red radiation and infrared; 650-800 nm and 800-3900 nm, respectively) time of phototherapy treatment: 10 minutes for one session 10 irradiations to the biceps brachii muscle
|
Group y: PILER Irradiation Treatments With Blue Filter
n=15 Participants
Piler light + blue filter Group y: irradiation with a blue filter (blue radiation; 440-480 nm) time of phototherapy treatment: 10 minutes for one session 10 irradiations to the biceps brachii muscle
|
Group v: PILER Irradiation Treatments Without a Filter
n=15 Participants
Piler light without a filter Group v: irradiation without a filter (white radiation in the entire spectrum and near-infrared radiation; 480-3400 nm) one session lasted 10 minutes 10 irradiations to the biceps brachii muscle
|
Group z: Placebo
n=15 Participants
placebo Group z: placebo irradiation (without a filter, 3 min, distance: 100 cm). time of phototherapy treatment: 3 minutes for one session distance of 1meter 10 irradiations to the biceps brachii muscle
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=60 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=15 Participants
|
15 Participants
n=15 Participants
|
15 Participants
n=15 Participants
|
15 Participants
n=15 Participants
|
60 Participants
n=60 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=60 Participants
|
|
Age, Continuous
|
22 years
n=15 Participants
|
22.5 years
n=15 Participants
|
22 years
n=15 Participants
|
22 years
n=15 Participants
|
22 years
n=60 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=15 Participants
|
9 Participants
n=15 Participants
|
11 Participants
n=15 Participants
|
11 Participants
n=15 Participants
|
41 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=15 Participants
|
6 Participants
n=15 Participants
|
4 Participants
n=15 Participants
|
4 Participants
n=15 Participants
|
19 Participants
n=60 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Poland
|
15 participants
n=15 Participants
|
15 participants
n=15 Participants
|
15 participants
n=15 Participants
|
15 participants
n=15 Participants
|
15 participants
n=60 Participants
|
|
sensory i/t curve coefficient for rectangle
|
0.0005 Coulomb
STANDARD_DEVIATION 0.0002 • n=15 Participants
|
0.0006 Coulomb
STANDARD_DEVIATION 0.0002 • n=15 Participants
|
0.0006 Coulomb
STANDARD_DEVIATION 0.0005 • n=15 Participants
|
0.0005 Coulomb
STANDARD_DEVIATION 0.0003 • n=15 Participants
|
0.0005 Coulomb
STANDARD_DEVIATION 0.0003 • n=60 Participants
|
|
sensory i/t curve coefficient for triangle
|
0.0012 Coulomb
STANDARD_DEVIATION 0.0007 • n=15 Participants
|
0.0010 Coulomb
STANDARD_DEVIATION 0.0004 • n=15 Participants
|
0.0015 Coulomb
STANDARD_DEVIATION 0.0014 • n=15 Participants
|
0.0012 Coulomb
STANDARD_DEVIATION 0.0008 • n=15 Participants
|
0.0012 Coulomb
STANDARD_DEVIATION 0.0009 • n=60 Participants
|
|
motor i/t curve coefficient for rectangle
|
0.0009 Coulomb
STANDARD_DEVIATION 0.0003 • n=15 Participants
|
0.00013 Coulomb
STANDARD_DEVIATION 0.0004 • n=15 Participants
|
0.0005 Coulomb
STANDARD_DEVIATION 0.0002 • n=15 Participants
|
0.0009 Coulomb
STANDARD_DEVIATION 0.0003 • n=15 Participants
|
0.0009 Coulomb
STANDARD_DEVIATION 0.0004 • n=60 Participants
|
|
motor i/t curve coefficient for triangle
|
0.0034 Coulomb
STANDARD_DEVIATION 0.0012 • n=15 Participants
|
0.0035 Coulomb
STANDARD_DEVIATION 0.0015 • n=15 Participants
|
0.0021 Coulomb
STANDARD_DEVIATION 0.0007 • n=15 Participants
|
0.0035 Coulomb
STANDARD_DEVIATION 0.0015 • n=15 Participants
|
0.0031 Coulomb
STANDARD_DEVIATION 0.0013 • n=60 Participants
|
|
Sensory Pain Pressure Threshold
|
7.2 lbs
STANDARD_DEVIATION 2.8 • n=15 Participants
|
8.3 lbs
STANDARD_DEVIATION 3.2 • n=15 Participants
|
9.8 lbs
STANDARD_DEVIATION 3.6 • n=15 Participants
|
9.9 lbs
STANDARD_DEVIATION 5.2 • n=15 Participants
|
8.8 lbs
STANDARD_DEVIATION 3.8 • n=60 Participants
|
PRIMARY outcome
Timeframe: baseline measurement and 3 weeks after a series of 10 phototherapy treatmentsIncrease in PPT meant decrease in sensitivity to pressure in the muscle. Decrease in PPT meant increase in sensitivity to pressure in the muscle.
Outcome measures
| Measure |
Piler Light + Red Filter
n=15 Participants
Radiation: Piler light phototherapy Piler light (polychromatic incoherent low-energy radiation) + red filter time of phototherapy treatment: 10 minutes for one session
Piler light phototherapy: Piler light + red filter: phototherapy, 10 treatment sessions,10 minutes for one session Piler light + blue filter: phototherapy, 10 treatment sessions,10 minutes for one session Piler light without a filter: phototherapy, 10 treatment sessions, 10 minutes for one session
Piler light + red filter: 10 people Piler light + blue filter: 10 people Piler light without a filter: 10 people
|
Piler Light + Blue Filter
n=15 Participants
Radiation: Piler light phototherapy Piler light (polychromatic incoherent low-energy radiation)+ blue filter time of phototherapy treatment: 10 minutes for one session
Piler light phototherapy: Piler light + red filter: phototherapy, 10 treatment sessions,10 minutes for one session Piler light + blue filter: phototherapy, 10 treatment sessions,10 minutes for one session Piler light without a filter: phototherapy, 10 treatment sessions, 10 minutes for one session
Piler light + red filter: 10 people Piler light + blue filter: 10 people Piler light without a filter: 10 people
|
Piler Light Without a Filter
n=15 Participants
Radiation: Piler light phototherapy Piler light (polychromatic incoherent low-energy radiation)without a filter time of phototherapy treatment: 10 minutes for one session
Piler light phototherapy: Piler light + red filter: phototherapy, 10 treatment sessions,10 minutes for one session Piler light + blue filter: phototherapy, 10 treatment sessions,10 minutes for one session Piler light without a filter: phototherapy, 10 treatment sessions, 10 minutes for one session
Piler light + red filter: 10 people Piler light + blue filter: 10 people Piler light without a filter: 10 people
|
Placebo
n=15 Participants
3 min irradiation with Piler light from 1 meter
|
|---|---|---|---|---|
|
Change in the Pressure Pain Threshold (PPT)
|
0.0 lbs
Standard Deviation 2.0
|
-0.5 lbs
Standard Deviation 1.6
|
-1.3 lbs
Standard Deviation 3.7
|
-0.6 lbs
Standard Deviation 2.6
|
PRIMARY outcome
Timeframe: baseline measurement and 3 weeks after a series of 10 phototherapy treatmentsBased on the results of the electrodiagnostic test, sensory I/T curve was plotted for rectangular (■) pulses.The I/T curve coefficient was calculated as the mean value of the electric charge that caused the sensory response (notification by the subject of the sensation of current vibrations) according to the following equations:■I/T coeff = (q1+q2 +…+q13 )/13 , where pulse current × pulse duration = q in coulombs. Comparisons were made based on the changes in the ■I/T coeff, observed as a result of PILER irradiations.
Outcome measures
| Measure |
Piler Light + Red Filter
n=15 Participants
Radiation: Piler light phototherapy Piler light (polychromatic incoherent low-energy radiation) + red filter time of phototherapy treatment: 10 minutes for one session
Piler light phototherapy: Piler light + red filter: phototherapy, 10 treatment sessions,10 minutes for one session Piler light + blue filter: phototherapy, 10 treatment sessions,10 minutes for one session Piler light without a filter: phototherapy, 10 treatment sessions, 10 minutes for one session
Piler light + red filter: 10 people Piler light + blue filter: 10 people Piler light without a filter: 10 people
|
Piler Light + Blue Filter
n=15 Participants
Radiation: Piler light phototherapy Piler light (polychromatic incoherent low-energy radiation)+ blue filter time of phototherapy treatment: 10 minutes for one session
Piler light phototherapy: Piler light + red filter: phototherapy, 10 treatment sessions,10 minutes for one session Piler light + blue filter: phototherapy, 10 treatment sessions,10 minutes for one session Piler light without a filter: phototherapy, 10 treatment sessions, 10 minutes for one session
Piler light + red filter: 10 people Piler light + blue filter: 10 people Piler light without a filter: 10 people
|
Piler Light Without a Filter
n=15 Participants
Radiation: Piler light phototherapy Piler light (polychromatic incoherent low-energy radiation)without a filter time of phototherapy treatment: 10 minutes for one session
Piler light phototherapy: Piler light + red filter: phototherapy, 10 treatment sessions,10 minutes for one session Piler light + blue filter: phototherapy, 10 treatment sessions,10 minutes for one session Piler light without a filter: phototherapy, 10 treatment sessions, 10 minutes for one session
Piler light + red filter: 10 people Piler light + blue filter: 10 people Piler light without a filter: 10 people
|
Placebo
n=15 Participants
3 min irradiation with Piler light from 1 meter
|
|---|---|---|---|---|
|
Calculation of Sensory i/t Curve Coefficient for Rectangle (■I/T Coeff)
|
0.0007 Coulomb
Standard Deviation 0.0004
|
0.0008 Coulomb
Standard Deviation 0.0002
|
0.0006 Coulomb
Standard Deviation 0.0003
|
0.0001 Coulomb
Standard Deviation 0.0004
|
PRIMARY outcome
Timeframe: baseline measurement and 3 weeks after a series of 10 phototherapy treatmentsBased on the results of the electrodiagnostic test, sensory I/T curve was plotted for triangular (▲I/T coeff) pulses.The I/T curve coefficient was calculated as the mean value of the electric charge that caused the sensory response (notification by the subject of the sensation of current vibrations) according to the following equations:▲I/T coeff = (q1+q2+… +q10) /10 , where pulse current × pulse duration = q in coulombs. Comparisons were made based on the changes in the ▲I/T coeff, observed as a result of PILER irradiations.
Outcome measures
| Measure |
Piler Light + Red Filter
n=15 Participants
Radiation: Piler light phototherapy Piler light (polychromatic incoherent low-energy radiation) + red filter time of phototherapy treatment: 10 minutes for one session
Piler light phototherapy: Piler light + red filter: phototherapy, 10 treatment sessions,10 minutes for one session Piler light + blue filter: phototherapy, 10 treatment sessions,10 minutes for one session Piler light without a filter: phototherapy, 10 treatment sessions, 10 minutes for one session
Piler light + red filter: 10 people Piler light + blue filter: 10 people Piler light without a filter: 10 people
|
Piler Light + Blue Filter
n=15 Participants
Radiation: Piler light phototherapy Piler light (polychromatic incoherent low-energy radiation)+ blue filter time of phototherapy treatment: 10 minutes for one session
Piler light phototherapy: Piler light + red filter: phototherapy, 10 treatment sessions,10 minutes for one session Piler light + blue filter: phototherapy, 10 treatment sessions,10 minutes for one session Piler light without a filter: phototherapy, 10 treatment sessions, 10 minutes for one session
Piler light + red filter: 10 people Piler light + blue filter: 10 people Piler light without a filter: 10 people
|
Piler Light Without a Filter
n=15 Participants
Radiation: Piler light phototherapy Piler light (polychromatic incoherent low-energy radiation)without a filter time of phototherapy treatment: 10 minutes for one session
Piler light phototherapy: Piler light + red filter: phototherapy, 10 treatment sessions,10 minutes for one session Piler light + blue filter: phototherapy, 10 treatment sessions,10 minutes for one session Piler light without a filter: phototherapy, 10 treatment sessions, 10 minutes for one session
Piler light + red filter: 10 people Piler light + blue filter: 10 people Piler light without a filter: 10 people
|
Placebo
n=15 Participants
3 min irradiation with Piler light from 1 meter
|
|---|---|---|---|---|
|
Calculation of Sensory I/T Curve Coefficient for Triangular (▲I/T Coeff) Pulses
|
0.0014 Coulomb
Standard Deviation 0.0014
|
0.0018 Coulomb
Standard Deviation 0.0007
|
0.0015 Coulomb
Standard Deviation 0.0007
|
0.0018 Coulomb
Standard Deviation 0.0019
|
PRIMARY outcome
Timeframe: baseline measurement and 3 weeks after a series of 10 phototherapy treatmentsBased on the results of the electrodiagnostic test, motor I/T curve was plotted for rectangular (■) pulses.The I/T curve coefficient was calculated as the mean value of the electric charge that caused the motor response (threshold muscle contraction) according to the following equations:■I/T coeff = (q1+q2 +…+q13 )/13 , where pulse current × pulse duration = q in coulombs. Comparisons were made based on the changes in the ■I/T coeff, observed as a result of PILER irradiations.
Outcome measures
| Measure |
Piler Light + Red Filter
n=15 Participants
Radiation: Piler light phototherapy Piler light (polychromatic incoherent low-energy radiation) + red filter time of phototherapy treatment: 10 minutes for one session
Piler light phototherapy: Piler light + red filter: phototherapy, 10 treatment sessions,10 minutes for one session Piler light + blue filter: phototherapy, 10 treatment sessions,10 minutes for one session Piler light without a filter: phototherapy, 10 treatment sessions, 10 minutes for one session
Piler light + red filter: 10 people Piler light + blue filter: 10 people Piler light without a filter: 10 people
|
Piler Light + Blue Filter
n=15 Participants
Radiation: Piler light phototherapy Piler light (polychromatic incoherent low-energy radiation)+ blue filter time of phototherapy treatment: 10 minutes for one session
Piler light phototherapy: Piler light + red filter: phototherapy, 10 treatment sessions,10 minutes for one session Piler light + blue filter: phototherapy, 10 treatment sessions,10 minutes for one session Piler light without a filter: phototherapy, 10 treatment sessions, 10 minutes for one session
Piler light + red filter: 10 people Piler light + blue filter: 10 people Piler light without a filter: 10 people
|
Piler Light Without a Filter
n=15 Participants
Radiation: Piler light phototherapy Piler light (polychromatic incoherent low-energy radiation)without a filter time of phototherapy treatment: 10 minutes for one session
Piler light phototherapy: Piler light + red filter: phototherapy, 10 treatment sessions,10 minutes for one session Piler light + blue filter: phototherapy, 10 treatment sessions,10 minutes for one session Piler light without a filter: phototherapy, 10 treatment sessions, 10 minutes for one session
Piler light + red filter: 10 people Piler light + blue filter: 10 people Piler light without a filter: 10 people
|
Placebo
n=15 Participants
3 min irradiation with Piler light from 1 meter
|
|---|---|---|---|---|
|
Calculation of Motor i/t Curve Coefficient for Rectangle (■I/T Coeff)
|
0.0009 Coulomb
Standard Deviation 0.0003
|
0.0015 Coulomb
Standard Deviation 0.0003
|
0.0006 Coulomb
Standard Deviation 0.0003
|
0.0007 Coulomb
Standard Deviation 0.0004
|
PRIMARY outcome
Timeframe: baseline measurement and 3 weeks after a series of 10 phototherapy treatmentsBased on the results of the electrodiagnostic test, Motor I/T curve was plotted for triangular (▲I/T coeff) pulses.The I/T curve coefficient was calculated as the mean value of the electric charge that caused the motor response (threshold muscle contraction) according to the following equations:▲I/T coeff = (q1+q2+… +q10) /10 , where pulse current × pulse duration = q in coulombs. Comparisons were made based on the changes in the ▲I/T coeff, observed as a result of PILER irradiations.
Outcome measures
| Measure |
Piler Light + Red Filter
n=15 Participants
Radiation: Piler light phototherapy Piler light (polychromatic incoherent low-energy radiation) + red filter time of phototherapy treatment: 10 minutes for one session
Piler light phototherapy: Piler light + red filter: phototherapy, 10 treatment sessions,10 minutes for one session Piler light + blue filter: phototherapy, 10 treatment sessions,10 minutes for one session Piler light without a filter: phototherapy, 10 treatment sessions, 10 minutes for one session
Piler light + red filter: 10 people Piler light + blue filter: 10 people Piler light without a filter: 10 people
|
Piler Light + Blue Filter
n=15 Participants
Radiation: Piler light phototherapy Piler light (polychromatic incoherent low-energy radiation)+ blue filter time of phototherapy treatment: 10 minutes for one session
Piler light phototherapy: Piler light + red filter: phototherapy, 10 treatment sessions,10 minutes for one session Piler light + blue filter: phototherapy, 10 treatment sessions,10 minutes for one session Piler light without a filter: phototherapy, 10 treatment sessions, 10 minutes for one session
Piler light + red filter: 10 people Piler light + blue filter: 10 people Piler light without a filter: 10 people
|
Piler Light Without a Filter
n=15 Participants
Radiation: Piler light phototherapy Piler light (polychromatic incoherent low-energy radiation)without a filter time of phototherapy treatment: 10 minutes for one session
Piler light phototherapy: Piler light + red filter: phototherapy, 10 treatment sessions,10 minutes for one session Piler light + blue filter: phototherapy, 10 treatment sessions,10 minutes for one session Piler light without a filter: phototherapy, 10 treatment sessions, 10 minutes for one session
Piler light + red filter: 10 people Piler light + blue filter: 10 people Piler light without a filter: 10 people
|
Placebo
n=15 Participants
3 min irradiation with Piler light from 1 meter
|
|---|---|---|---|---|
|
Calculation of Motor I/T Curve Coefficient for Triangular (▲I/T Coeff) Pulses
|
0.0028 Coulomb
Standard Deviation 0.0009
|
0.0050 Coulomb
Standard Deviation 0.0014
|
0.0024 Coulomb
Standard Deviation 0.0009
|
0.0030 Coulomb
Standard Deviation 0.0019
|
Adverse Events
Piler Light + Red Filter
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Piler Light + Blue Filter
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Piler Light Without a Filter
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
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