The Use of i/t Curve in Assessment of Phototherapy Effects

• Sponsor: University of Rzeszow (Other)
• Overall Status: Completed
• CT.gov ID: NCT02618642
• Collaborator: (none)
• Enrollment: 60
• Arms: 4
• Actual Duration (Months): 40.9

Study Details

Study Description

Brief Summary

Conventional electrodiagnostic examination is useful in daily physiotherapeutic practice. Nevertheless, the subjective assessment of muscle contraction and perceived current vibrations carries the risk of error and thus is a limitation of the method. Therefore, the use of the I/T curve coefficient was proposed in this study. This coefficient is the arithmetic mean of the electrical charge needed to trigger a sensory or motor reaction at different widths of the electrical pulse. PILER (Polychromatic Incoherent Low-Energy Radiation) light affects the sensory and motor excitability of the tissue. The resulting changes may depend on the colour of the filter used in the irradiations.

The study aimed to:

1. To evaluate changes in neuromuscular excitability occurring after PILER irradiation using filters of different colours.

2. To evaluate the usefulness of the I/T curve coefficient in neuromuscular excitation test.

60 healthy volunteers were assigned to one of four groups irradiated with: 1 - Piler light + red filter, 2 - Piler light + blue filter, 3 - Piler light without a filter, 4 - placebo.

Main Outcome Measures were plotting I/T curve coefficient for rectangular (■I/T coeff) and triangular (▲I/T coeff) pulses and the pressure pain threshold (PPT).

Condition or Disease	Intervention/Treatment	Phase
Nerve Disorders	Radiation: Irradiations of the biceps brachii muscle with PILER light. The participants were randomized into 4 groups: group v - no filter/ group x - red filter/ group y - blue filter/ group z - placebo.	N/A

Detailed Description

Electrodiagnostic examination is a valuable addition to clinical trials and is useful in disorders of neuromuscular excitability.

The I/T curve is a non-invasive electrodiagnostic method for the quantitative assessment of neuromuscular excitation. Plotting it makes it possible to determine the rheobase (minimum stimulus amplitude to reach the stimulation threshold with a long pulse duration /1000 ms/) and chronaxie (minimum duration of a stimulus with an amplitude twice that of the rheobase needed to reach the stimulation threshold.

Traditional electrodiagnostic examination is popular among clinicians due to its availability, ease of administration and usefulness in physiotherapeutic practice. The subjective assessment of muscle contraction and perceived current vibrations carries the risk of error and thus is a limitation of the method. Therefore, use of the I/T curve coefficient was proposed in this study. This coefficient is the arithmetic mean of the electrical charge needed to trigger a sensory or motor reaction at different widths of the electrical pulse.

Polarized polychromatic incoherent low-energy radiation (PILER light) can affect the sensory and motor excitability of living tissue. The biological activity of light results from the energy of its ordered electromagnetic waves acting on living cells. No thermal effect is present, as the density of the energy transmitted to the tissues is low.PILER therapy often uses filters of different colours, each showing a slightly different effect on excitable tissue.

The research questions of this randomised experiment were:

1. Does PILER light affect sensory and motor excitation?

2. Does the electromagnetic wavelength of PILER light influence its effect?

3. Is the I/T curve coefficient a useful measure of sensory and motor excitation?

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Masking Description: A total of the 120 participants who agreed to fulfil the inclusion criteria throughout the study were randomly chosen by drawing marked squares from an opaque envelope. They were helped by an assistant researcher. The sixty individuals were selected in this way Next, those who were enrolled were further randomized into four groups, each including 15 individuals:
• Primary Purpose: Basic Science
• Official Title: The Use of i/t Curve in Assessment of Effects of Biceps Brachii Phototherapy With PILER Light
• Actual Study Start Date: Feb 1, 2016
• Actual Primary Completion Date: Jul 1, 2019
• Actual Study Completion Date: Jul 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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	Radiation: Irradiations of the biceps brachii muscle with PILER light. The participants were randomized into 4 groups: group v - no filter/ group x - red filter/ group y - blue filter/ group z - placebo.; Biceps brachii examination was carried out before (examination 1) and after (examination 2) a series of 10 PILER light treatments. It included a traditional electrodiagnostic examination and the assessment of the pressure pain threshold (PPT). The electrodiagnostic examination of the muscle was performed using the unipolar stimulation method from the direct motor point. The passive electrode (6 cm x 6 cm) was attached to the side of the distal part of the forearm, and the distal edge of the electrode was adjacent to the proximal edge of the ulnar styloid process. The examination was performed with a Multitronic MT3 electrotherapy apparatus set. PPT at the direct motor point was determined using an algometer (Algometer commander TM ITECH Medical Industries). A head with a rubber jacket with a surface area of 0.5 cm2 was used to cause pressure pain. Pressure was exerted until the participant reported pain, at which time the force (lbs) marked by the algometer was recorded.
Active Comparator: 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	Radiation: Irradiations of the biceps brachii muscle with PILER light. The participants were randomized into 4 groups: group v - no filter/ group x - red filter/ group y - blue filter/ group z - placebo.; Biceps brachii examination was carried out before (examination 1) and after (examination 2) a series of 10 PILER light treatments. It included a traditional electrodiagnostic examination and the assessment of the pressure pain threshold (PPT). The electrodiagnostic examination of the muscle was performed using the unipolar stimulation method from the direct motor point. The passive electrode (6 cm x 6 cm) was attached to the side of the distal part of the forearm, and the distal edge of the electrode was adjacent to the proximal edge of the ulnar styloid process. The examination was performed with a Multitronic MT3 electrotherapy apparatus set. PPT at the direct motor point was determined using an algometer (Algometer commander TM ITECH Medical Industries). A head with a rubber jacket with a surface area of 0.5 cm2 was used to cause pressure pain. Pressure was exerted until the participant reported pain, at which time the force (lbs) marked by the algometer was recorded.
Active Comparator: 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	Radiation: Irradiations of the biceps brachii muscle with PILER light. The participants were randomized into 4 groups: group v - no filter/ group x - red filter/ group y - blue filter/ group z - placebo.; Biceps brachii examination was carried out before (examination 1) and after (examination 2) a series of 10 PILER light treatments. It included a traditional electrodiagnostic examination and the assessment of the pressure pain threshold (PPT). The electrodiagnostic examination of the muscle was performed using the unipolar stimulation method from the direct motor point. The passive electrode (6 cm x 6 cm) was attached to the side of the distal part of the forearm, and the distal edge of the electrode was adjacent to the proximal edge of the ulnar styloid process. The examination was performed with a Multitronic MT3 electrotherapy apparatus set. PPT at the direct motor point was determined using an algometer (Algometer commander TM ITECH Medical Industries). A head with a rubber jacket with a surface area of 0.5 cm2 was used to cause pressure pain. Pressure was exerted until the participant reported pain, at which time the force (lbs) marked by the algometer was recorded.
Placebo Comparator: 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	Radiation: Irradiations of the biceps brachii muscle with PILER light. The participants were randomized into 4 groups: group v - no filter/ group x - red filter/ group y - blue filter/ group z - placebo.; Biceps brachii examination was carried out before (examination 1) and after (examination 2) a series of 10 PILER light treatments. It included a traditional electrodiagnostic examination and the assessment of the pressure pain threshold (PPT). The electrodiagnostic examination of the muscle was performed using the unipolar stimulation method from the direct motor point. The passive electrode (6 cm x 6 cm) was attached to the side of the distal part of the forearm, and the distal edge of the electrode was adjacent to the proximal edge of the ulnar styloid process. The examination was performed with a Multitronic MT3 electrotherapy apparatus set. PPT at the direct motor point was determined using an algometer (Algometer commander TM ITECH Medical Industries). A head with a rubber jacket with a surface area of 0.5 cm2 was used to cause pressure pain. Pressure was exerted until the participant reported pain, at which time the force (lbs) marked by the algometer was recorded.

Outcome Measures

Primary Outcome Measures

1. Change in the Pressure Pain Threshold (PPT) [baseline measurement and 3 weeks after a series of 10 phototherapy treatments]

   Increase in PPT meant decrease in sensitivity to pressure in the muscle. Decrease in PPT meant increase in sensitivity to pressure in the muscle.

2. Calculation of Sensory i/t Curve Coefficient for Rectangle (■I/T Coeff) [baseline measurement and 3 weeks after a series of 10 phototherapy treatments]

   Based 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.

3. Calculation of Sensory I/T Curve Coefficient for Triangular (▲I/T Coeff) Pulses [baseline measurement and 3 weeks after a series of 10 phototherapy treatments]

   Based 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.

4. Calculation of Motor i/t Curve Coefficient for Rectangle (■I/T Coeff) [baseline measurement and 3 weeks after a series of 10 phototherapy treatments]

   Based 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.

5. Calculation of Motor I/T Curve Coefficient for Triangular (▲I/T Coeff) Pulses [baseline measurement and 3 weeks after a series of 10 phototherapy treatments]

   Based 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 23 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria included: informed consent, good tolerance of current pulses, completion of all phototherapy sessions, declaration of alcohol/drugs/smoking abstinence

The exclusion criteria were: acute inflammatory processes and fever, the presence of pigmented moles in the irradiated area, exposure to any other physical factors, a history of upper limb trauma, and upper limb overload.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Rzeszow

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 21, 2015

More Information

Publications

None provided.

• Responsible Party: Jolanta Zwolińska, PhD, University of Rzeszow
• ClinicalTrials.gov Identifier: NCT02618642
• Other Study ID Numbers: jz.i/t
• First Posted: Dec 1, 2015
• Last Update Posted: Jan 13, 2020
• Last Verified: Dec 1, 2019

• Keywords provided by Jolanta Zwolińska, PhD, University of Rzeszow: electrodiagnostics; i/t curve; neuromuscular excitation; PILER (Polychromatic Incoherent Low-Energy Radiation); algometry

Study Results

Participant Flow

Recruitment Details	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.

Arm/Group Title	PILER Light Irradiation Treatments With Red Filter	PILER Light Irradiation Treatments With Blue Filter	PILER Light Irradiation Treatments Without a Filter	Placebo
Arm/Group Description	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,	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,	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,	Group z: placebo irradiation (without a filter, 3 min, distance: 100 cm); each session lasted 3 minutes
Period Title: Before 10 PILER Irradiation Treatments
STARTED	15	15	15	15
COMPLETED	15	15	15	15
NOT COMPLETED	0	0	0	0
Period Title: Before 10 PILER Irradiation Treatments
STARTED	15	15	15	15
COMPLETED	15	15	15	15
NOT COMPLETED	0	0	0	0

Baseline Characteristics

Arm/Group Title	Group x: PILER Irradiation Treatments With Red Filter	Group y: PILER Irradiation Treatments With Blue Filter	Group v: PILER Irradiation Treatments Without a Filter	Group z: Placebo	Total
Arm/Group Description	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	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	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	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 of all reporting groups
Overall Participants	15	15	15	15	60
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	15 100%	15 100%	15 100%	15 100%	60 100%
>=65 years	0 0%	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	22	22.5	22	22	22
Sex: Female, Male (Count of Participants)
Female	10 66.7%	9 60%	11 73.3%	11 73.3%	41 68.3%
Male	5 33.3%	6 40%	4 26.7%	4 26.7%	19 31.7%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
Poland	15 100%	15 100%	15 100%	15 100%	15 25%
sensory i/t curve coefficient for rectangle (Coulomb) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Coulomb]	0.0005 (0.0002)	0.0006 (0.0002)	0.0006 (0.0005)	0.0005 (0.0003)	0.0005 (0.0003)
sensory i/t curve coefficient for triangle (Coulomb) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Coulomb]	0.0012 (0.0007)	0.0010 (0.0004)	0.0015 (0.0014)	0.0012 (0.0008)	0.0012 (0.0009)
motor i/t curve coefficient for rectangle (Coulomb) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Coulomb]	0.0009 (0.0003)	0.00013 (0.0004)	0.0005 (0.0002)	0.0009 (0.0003)	0.0009 (0.0004)
motor i/t curve coefficient for triangle (Coulomb) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Coulomb]	0.0034 (0.0012)	0.0035 (0.0015)	0.0021 (0.0007)	0.0035 (0.0015)	0.0031 (0.0013)
Sensory Pain Pressure Threshold (lbs) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [lbs]	7.2 (2.8)	8.3 (3.2)	9.8 (3.6)	9.9 (5.2)	8.8 (3.8)

Outcome Measures

1. Primary Outcome

Title	Change in the Pressure Pain Threshold (PPT)
Description	Increase in PPT meant decrease in sensitivity to pressure in the muscle. Decrease in PPT meant increase in sensitivity to pressure in the muscle.
Time Frame	baseline measurement and 3 weeks after a series of 10 phototherapy treatments

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Piler Light + Red Filter	Piler Light + Blue Filter	Piler Light Without a Filter	Placebo
Arm/Group Description	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	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	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	3 min irradiation with Piler light from 1 meter
Measure Participants	15	15	15	15
Mean (Standard Deviation) [lbs]	0.0 (2.0)	-0.5 (1.6)	-1.3 (3.7)	-0.6 (2.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Piler Light + Red Filter, Piler Light + Blue Filter, Piler Light Without a Filter, Placebo
	Comments	the results in the irradiated group (n=45) and the control group (n=15) were compared
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.3879
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Piler Light + Red Filter, Piler Light + Blue Filter, Piler Light Without a Filter
	Comments	comparison was conducted of the results obtained with a different filter were compared
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.5361
	Comments
	Method	Kruskal-Wallis
	Comments

2. Primary Outcome

Title	Calculation of Sensory i/t Curve Coefficient for Rectangle (■I/T Coeff)
Description	Based 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.
Time Frame	baseline measurement and 3 weeks after a series of 10 phototherapy treatments

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PILER Light Irradiation Treatments With Red Filter	PILER Light Irradiation Treatments With Blue Filter	PILER Light Irradiation Treatments Without a Filter	Placebo
Arm/Group Description	Piler light + red filter Radiation: Piler light phototherapy Piler light (polychromatic incoherent low-energy radiation) + red filter time of phototherapy treatment: 10 minutes for one session	Piler light + blue filter Radiation: Piler light phototherapy Piler light (polychromatic incoherent low-energy radiation)+ blue filter time of phototherapy treatment: 10 minutes for one session	Piler light without a filter Radiation: Piler light phototherapy Piler light (polychromatic incoherent low-energy radiation)without a filter time of phototherapy treatment: 10 minutes for one session	3 min irradiation with Piler light from 1 meter
Measure Participants	15	15	15	15
Mean (Standard Deviation) [Coulomb]	0.0007 (0.0004)	0.0008 (0.0002)	0.0006 (0.0003)	0.0001 (0.0004)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Piler Light + Red Filter, Piler Light + Blue Filter, Piler Light Without a Filter, Placebo
	Comments	the results in the irradiated group (n=45) vs the control group (placebo) (n=15) were compared.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.4669
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Piler Light + Red Filter, Piler Light + Blue Filter, Piler Light Without a Filter
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.4161
	Comments
	Method	Kruskal-Wallis
	Comments

3. Primary Outcome

Title	Calculation of Sensory I/T Curve Coefficient for Triangular (▲I/T Coeff) Pulses
Description	Based 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.
Time Frame	baseline measurement and 3 weeks after a series of 10 phototherapy treatments

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group x: PILER Irradiation Treatments With Red Filter	Group y: PILER Irradiation Treatments With Blue Filter	Group v: PILER Irradiation Treatments Without a Filter	Group z: Placebo
Arm/Group Description	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	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	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	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
Measure Participants	15	15	15	15
Mean (Standard Deviation) [Coulomb]	0.0014 (0.0014)	0.0018 (0.0007)	0.0015 (0.0007)	0.0018 (0.0019)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Piler Light + Red Filter, Piler Light + Blue Filter, Piler Light Without a Filter, Placebo
	Comments	the results in the irradiated group (n=45) and the control group (n=15) were compared.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.9596
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Piler Light + Red Filter, Piler Light + Blue Filter, Piler Light Without a Filter
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0907
	Comments
	Method	Kruskal-Wallis
	Comments

4. Primary Outcome

Title	Calculation of Motor i/t Curve Coefficient for Rectangle (■I/T Coeff)
Description	Based 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.
Time Frame	baseline measurement and 3 weeks after a series of 10 phototherapy treatments

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group x: PILER Irradiation Treatments With Red Filter	Group y: PILER Irradiation Treatments With Blue Filter	Group v: PILER Irradiation Treatments Without a Filter	Group z: Placebo
Arm/Group Description	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	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	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	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
Measure Participants	15	15	15	15
Mean (Standard Deviation) [Coulomb]	0.0009 (0.0003)	0.0015 (0.0003)	0.0006 (0.0003)	0.0007 (0.0004)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Piler Light + Red Filter, Piler Light + Blue Filter, Piler Light Without a Filter, Placebo
	Comments	the results in the irradiated group (n=45) and the control group (n=15) were compared.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0110
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Piler Light + Red Filter, Piler Light + Blue Filter, Piler Light Without a Filter
	Comments	comparison was conducted of the results obtained with a different filter (groups v, x, y,
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.1165
	Comments
	Method	Kruskal-Wallis
	Comments

5. Primary Outcome

Title	Calculation of Motor I/T Curve Coefficient for Triangular (▲I/T Coeff) Pulses
Description	Based 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.
Time Frame	baseline measurement and 3 weeks after a series of 10 phototherapy treatments

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group x: PILER Irradiation Treatments With Red Filter	Group y: PILER Irradiation Treatments With Blue Filter	Group v: PILER Irradiation Treatments Without a Filter	Group z: Placebo
Arm/Group Description	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	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	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	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
Measure Participants	15	15	15	15
Mean (Standard Deviation) [Coulomb]	0.0028 (0.0009)	0.0050 (0.0014)	0.0024 (0.0009)	0.0030 (0.0019)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Piler Light + Red Filter, Piler Light + Blue Filter, Piler Light Without a Filter, Placebo
	Comments	he results in the irradiated group (n=45) and the control group (n=15) were compared
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0200
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Piler Light + Red Filter, Piler Light + Blue Filter, Piler Light Without a Filter
	Comments
	Type of Statistical Test	Superiority
	Comments	comparison was conducted of the results obtained with a different filter (groups v, x, y,
Statistical Test of Hypothesis	p-Value	0.0014
	Comments
	Method	Kruskal-Wallis
	Comments

Adverse Events

Time Frame	3 weeks
Arm/Group Title	Piler Light + Red Filter		Piler Light + Blue Filter		Piler Light Without a Filter		Placebo
Arm/Group Description	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		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		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		3 min irradiation with Piler light from 1 meter
All Cause Mortality
	Piler Light + Red Filter		Piler Light + Blue Filter		Piler Light Without a Filter		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)		0/15 (0%)		0/15 (0%)
Serious Adverse Events
	Piler Light + Red Filter		Piler Light + Blue Filter		Piler Light Without a Filter		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)		0/15 (0%)		0/15 (0%)
Other (Not Including Serious) Adverse Events
	Piler Light + Red Filter		Piler Light + Blue Filter		Piler Light Without a Filter		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)		0/15 (0%)		0/15 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.