N/A
N=60
The Use of i/t Curve in Assessment of Phototherapy Effects
Nerve Disorders
Bottom Line
View on ClinicalTrials.gov: NCT02618642 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: Change in the Pressure Pain Threshold (PPT) — 0.0; -0.5; -1.3; -0.6 lbs — p=0.3879
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 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)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of Rzeszow
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Pressure Pain Threshold (PPT) |
0.0; -0.5; -1.3; -0.6 | 0.3879 |
| PRIMARY Calculation of Sensory i/t Curve Coefficient for Rectangle (■I/T Coeff) |
0.0007; 0.0008; 0.0006; 0.0001 | 0.4669 |
| PRIMARY Calculation of Sensory I/T Curve Coefficient for Triangular (▲I/T Coeff) Pulses |
0.0014; 0.0018; 0.0015; 0.0018 | 0.9596 |
| PRIMARY Calculation of Motor i/t Curve Coefficient for Rectangle (■I/T Coeff) |
0.0009; 0.0015; 0.0006; 0.0007 | 0.0110 sig |
| PRIMARY Calculation of Motor I/T Curve Coefficient for Triangular (▲I/T Coeff) Pulses |
0.0028; 0.0050; 0.0024; 0.0030 | 0.0200 sig |
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).
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02618642). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.