Nerve Disorders
Conditions
Keywords
electrodiagnostics, i/t curve, neuromuscular excitation, PILER (Polychromatic Incoherent Low-Energy Radiation), algometry
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).
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?
Interventions
RADIATIONIrradiations 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.
Sponsors
University of Rzeszow
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
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:
Eligibility
Sex/Gender
ALL
Age
21 Years to 23 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 15 |
| 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 | 15 |
| 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 | 15 |
| 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 | 15 |
| Total | 60 |
Baseline characteristics
| Characteristic | 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 |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 15 Participants | 15 Participants | 15 Participants | 60 Participants |
| Age, Continuous | 22 years | 22.5 years | 22 years | 22 years | 22 years |
| motor i/t curve coefficient for rectangle | 0.0009 Coulomb STANDARD_DEVIATION 0.0003 | 0.00013 Coulomb STANDARD_DEVIATION 0.0004 | 0.0005 Coulomb STANDARD_DEVIATION 0.0002 | 0.0009 Coulomb STANDARD_DEVIATION 0.0003 | 0.0009 Coulomb STANDARD_DEVIATION 0.0004 |
| motor i/t curve coefficient for triangle | 0.0034 Coulomb STANDARD_DEVIATION 0.0012 | 0.0035 Coulomb STANDARD_DEVIATION 0.0015 | 0.0021 Coulomb STANDARD_DEVIATION 0.0007 | 0.0035 Coulomb STANDARD_DEVIATION 0.0015 | 0.0031 Coulomb STANDARD_DEVIATION 0.0013 |
| Race and Ethnicity Not Collected | — | — | — | — | 0 Participants |
| Region of Enrollment Poland | 15 participants | 15 participants | 15 participants | 15 participants | 15 participants |
| sensory i/t curve coefficient for rectangle | 0.0005 Coulomb STANDARD_DEVIATION 0.0002 | 0.0006 Coulomb STANDARD_DEVIATION 0.0002 | 0.0006 Coulomb STANDARD_DEVIATION 0.0005 | 0.0005 Coulomb STANDARD_DEVIATION 0.0003 | 0.0005 Coulomb STANDARD_DEVIATION 0.0003 |
| sensory i/t curve coefficient for triangle | 0.0012 Coulomb STANDARD_DEVIATION 0.0007 | 0.0010 Coulomb STANDARD_DEVIATION 0.0004 | 0.0015 Coulomb STANDARD_DEVIATION 0.0014 | 0.0012 Coulomb STANDARD_DEVIATION 0.0008 | 0.0012 Coulomb STANDARD_DEVIATION 0.0009 |
| Sensory Pain Pressure Threshold | 7.2 lbs STANDARD_DEVIATION 2.8 | 8.3 lbs STANDARD_DEVIATION 3.2 | 9.8 lbs STANDARD_DEVIATION 3.6 | 9.9 lbs STANDARD_DEVIATION 5.2 | 8.8 lbs STANDARD_DEVIATION 3.8 |
| Sex: Female, Male Female | 10 Participants | 9 Participants | 11 Participants | 11 Participants | 41 Participants |
| Sex: Female, Male Male | 5 Participants | 6 Participants | 4 Participants | 4 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 15 |
Outcome results
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.
Time frame: baseline measurement and 3 weeks after a series of 10 phototherapy treatments
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Piler Light + Red Filter | Calculation of Motor i/t Curve Coefficient for Rectangle (■I/T Coeff) | 0.0009 Coulomb | Standard Deviation 0.0003 |
| Piler Light + Blue Filter | Calculation of Motor i/t Curve Coefficient for Rectangle (■I/T Coeff) | 0.0015 Coulomb | Standard Deviation 0.0003 |
| Piler Light Without a Filter | Calculation of Motor i/t Curve Coefficient for Rectangle (■I/T Coeff) | 0.0006 Coulomb | Standard Deviation 0.0003 |
| Placebo | Calculation of Motor i/t Curve Coefficient for Rectangle (■I/T Coeff) | 0.0007 Coulomb | Standard Deviation 0.0004 |
Comparison: the results in the irradiated group (n=45) and the control group (n=15) were compared.p-value: 0.011Wilcoxon (Mann-Whitney)
Comparison: comparison was conducted of the results obtained with a different filter (groups v, x, y,p-value: 0.1165Kruskal-Wallis
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.
Time frame: baseline measurement and 3 weeks after a series of 10 phototherapy treatments
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Piler Light + Red Filter | Calculation of Motor I/T Curve Coefficient for Triangular (▲I/T Coeff) Pulses | 0.0028 Coulomb | Standard Deviation 0.0009 |
| Piler Light + Blue Filter | Calculation of Motor I/T Curve Coefficient for Triangular (▲I/T Coeff) Pulses | 0.0050 Coulomb | Standard Deviation 0.0014 |
| Piler Light Without a Filter | Calculation of Motor I/T Curve Coefficient for Triangular (▲I/T Coeff) Pulses | 0.0024 Coulomb | Standard Deviation 0.0009 |
| Placebo | Calculation of Motor I/T Curve Coefficient for Triangular (▲I/T Coeff) Pulses | 0.0030 Coulomb | Standard Deviation 0.0019 |
Comparison: he results in the irradiated group (n=45) and the control group (n=15) were comparedp-value: 0.02Wilcoxon (Mann-Whitney)
p-value: 0.0014Kruskal-Wallis
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.
Time frame: baseline measurement and 3 weeks after a series of 10 phototherapy treatments
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Piler Light + Red Filter | Calculation of Sensory i/t Curve Coefficient for Rectangle (■I/T Coeff) | 0.0007 Coulomb | Standard Deviation 0.0004 |
| Piler Light + Blue Filter | Calculation of Sensory i/t Curve Coefficient for Rectangle (■I/T Coeff) | 0.0008 Coulomb | Standard Deviation 0.0002 |
| Piler Light Without a Filter | Calculation of Sensory i/t Curve Coefficient for Rectangle (■I/T Coeff) | 0.0006 Coulomb | Standard Deviation 0.0003 |
| Placebo | Calculation of Sensory i/t Curve Coefficient for Rectangle (■I/T Coeff) | 0.0001 Coulomb | Standard Deviation 0.0004 |
Comparison: the results in the irradiated group (n=45) vs the control group (placebo) (n=15) were compared.p-value: 0.4669Wilcoxon (Mann-Whitney)
p-value: 0.4161Kruskal-Wallis
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.
Time frame: baseline measurement and 3 weeks after a series of 10 phototherapy treatments
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Piler Light + Red Filter | Calculation of Sensory I/T Curve Coefficient for Triangular (▲I/T Coeff) Pulses | 0.0014 Coulomb | Standard Deviation 0.0014 |
| Piler Light + Blue Filter | Calculation of Sensory I/T Curve Coefficient for Triangular (▲I/T Coeff) Pulses | 0.0018 Coulomb | Standard Deviation 0.0007 |
| Piler Light Without a Filter | Calculation of Sensory I/T Curve Coefficient for Triangular (▲I/T Coeff) Pulses | 0.0015 Coulomb | Standard Deviation 0.0007 |
| Placebo | Calculation of Sensory I/T Curve Coefficient for Triangular (▲I/T Coeff) Pulses | 0.0018 Coulomb | Standard Deviation 0.0019 |
Comparison: the results in the irradiated group (n=45) and the control group (n=15) were compared.p-value: 0.9596Wilcoxon (Mann-Whitney)
p-value: 0.0907Kruskal-Wallis
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.
Time frame: baseline measurement and 3 weeks after a series of 10 phototherapy treatments
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Piler Light + Red Filter | Change in the Pressure Pain Threshold (PPT) | 0.0 lbs | Standard Deviation 2 |
| Piler Light + Blue Filter | Change in the Pressure Pain Threshold (PPT) | -0.5 lbs | Standard Deviation 1.6 |
| Piler Light Without a Filter | Change in the Pressure Pain Threshold (PPT) | -1.3 lbs | Standard Deviation 3.7 |
| Placebo | Change in the Pressure Pain Threshold (PPT) | -0.6 lbs | Standard Deviation 2.6 |
Comparison: the results in the irradiated group (n=45) and the control group (n=15) were comparedp-value: 0.3879Wilcoxon (Mann-Whitney)
Comparison: comparison was conducted of the results obtained with a different filter were comparedp-value: 0.5361Kruskal-Wallis