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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:
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).
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Piler light + red filter | Active Comparator | 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 |
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| Piler light + blue filter | Active Comparator | 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 |
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| Piler light without a filter | Active Comparator | 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 | Placebo Comparator | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. | Radiation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Pressure Pain Threshold (PPT) | Increase in PPT meant decrease in sensitivity to pressure in the muscle. Decrease in PPT meant increase in sensitivity to pressure in the muscle. | baseline measurement and 3 weeks after a series of 10 phototherapy treatments |
| Calculation of Sensory i/t Curve Coefficient for Rectangle (■I/T Coeff) | 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. | baseline measurement and 3 weeks after a series of 10 phototherapy treatments |
| Calculation of Sensory I/T Curve Coefficient for Triangular (▲I/T Coeff) Pulses | 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. | baseline measurement and 3 weeks after a series of 10 phototherapy treatments |
| Calculation of Motor i/t Curve Coefficient for Rectangle (■I/T Coeff) | 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. |
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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.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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, |
| FG001 | 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, |
| FG002 | 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, |
| FG003 | Placebo | Group z: placebo irradiation (without a filter, 3 min, distance: 100 cm); each session lasted 3 minutes |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Before 10 PILER Irradiation Treatments |
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| After 10 PILER Irradiation Treatments |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group x: PILER Irradiation Treatments With Red Filter | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Change in the Pressure Pain Threshold (PPT) | Increase in PPT meant decrease in sensitivity to pressure in the muscle. Decrease in PPT meant increase in sensitivity to pressure in the muscle. | Posted | Mean | Standard Deviation | lbs | baseline measurement and 3 weeks after a series of 10 phototherapy treatments |
|
3 weeks
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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 | 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 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jolanta Zwolińska PhD | Rzeszow University | 48 505095199 | jolantazwolinska@op.pl |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 21, 2015 | Dec 6, 2019 | Prot_SAP_000.pdf |
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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:
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| baseline measurement and 3 weeks after a series of 10 phototherapy treatments |
| Calculation of Motor I/T Curve Coefficient for Triangular (▲I/T Coeff) Pulses | 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. | baseline measurement and 3 weeks after a series of 10 phototherapy treatments |
| COMPLETED |
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| NOT COMPLETED |
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| Group y: PILER Irradiation Treatments With Blue Filter |
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 |
| BG002 | Group v: PILER Irradiation Treatments Without a Filter | 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 |
| BG003 | Group z: Placebo | 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 |
| BG004 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| sensory i/t curve coefficient for rectangle | Based on the results of the electrodiagnostic test, an 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 | Mean | Standard Deviation | Coulomb |
|
| sensory i/t curve coefficient for triangle | Measure Description: Measure Description: Based on the results of the electrodiagnostic test, an 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 | Mean | Standard Deviation | Coulomb |
|
| motor i/t curve coefficient for rectangle | Measure Description: Based on the results of the electrodiagnostic test, an 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 | Mean | Standard Deviation | Coulomb |
|
| motor i/t curve coefficient for triangle | Measure Description: Measure Description: Based on the results of the electrodiagnostic test, an 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 | Mean | Standard Deviation | Coulomb |
|
| Sensory Pain Pressure Threshold | Mean | Standard Deviation | lbs |
|
| OG001 | 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 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 |
| OG002 | 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 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 |
| OG003 | Placebo | 3 min irradiation with Piler light from 1 meter |
|
|
|
| Primary | Calculation of Sensory i/t Curve Coefficient for Rectangle (■I/T Coeff) | 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. | Posted | Mean | Standard Deviation | Coulomb | baseline measurement and 3 weeks after a series of 10 phototherapy treatments |
|
|
|
|
| Primary | Calculation of Sensory I/T Curve Coefficient for Triangular (▲I/T Coeff) Pulses | 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. | Posted | Mean | Standard Deviation | Coulomb | baseline measurement and 3 weeks after a series of 10 phototherapy treatments |
|
|
|
|
| Primary | Calculation of Motor i/t Curve Coefficient for Rectangle (■I/T Coeff) | 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. | Posted | Mean | Standard Deviation | Coulomb | baseline measurement and 3 weeks after a series of 10 phototherapy treatments |
|
|
|
|
| Primary | Calculation of Motor I/T Curve Coefficient for Triangular (▲I/T Coeff) Pulses | 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. | Posted | Mean | Standard Deviation | Coulomb | baseline measurement and 3 weeks after a series of 10 phototherapy treatments |
|
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | 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 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 | 0 | 15 | 0 | 15 | 0 | 15 |
| EG002 | 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 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 | 0 | 15 | 0 | 15 | 0 | 15 |
| EG003 | Placebo | 3 min irradiation with Piler light from 1 meter | 0 | 15 | 0 | 15 | 0 | 15 |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
|
| 0.4161 |
| Superiority |
| 0.0907 |
| Superiority |
| Kruskal-Wallis |
| 0.1165 |
| Superiority |
| 0.0014 |
| Superiority |
comparison was conducted of the results obtained with a different filter (groups v, x, y, |