The purpose of this study is to determine whether the transcutaneous application of unmodulated 5 Kilohertz (KHz) alternating currents are effective in decreasing the thermal and mechanical experimental pain and cause changes in peripheral nerve conduction. Moreover evidence whether the effect and comfort of this current is greater than Conventional TENS (Transcutaneous Electrical Nerve Stimulation) commonly used for the treatment of clinical pain.
In the last years several animal experimental studies have evidenced that high frequency unmodulated currents about 5 KHz can cause a peripheral nerve block. However electric currents with these high frequencies that are usually used for the treatment of pain in humans are interrupted or modulated (i.e. interferential currents) This evidences in animals could have application in pain treatment, characterized by overactive nervous system. For this reason it was decided to compare the effects on experimental pain and peripheral nerve conduction of this new electric current versus sham stimulation and TENS (Transcutaneous Electrical Nerve Stimulation). The scientific literature on transcutaneous electrical stimulation in humans and changes in nerve conduction and / or somatosensory thresholds focuses mainly on TENS (Transcutaneous Electrical Nerve Stimulation). Therefore TENS is a good reference standard to compare the effect of this new currents.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
38
5 KHz transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
TENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
Sham transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
Mechanical Pain Threshold During Treatment
The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton
Time frame: during treatment at 15 min
Thermal Pain Threshold During Treatment
The heat pain threshold will be measured by a computer controlled thermo-foil heating device and will be expressed in ºC
Time frame: during treatment at 15 min.
Nerve Conduction Latency Immediately After Treatment
The compound action potential latencies will be measured and will be expressed in ms.
Time frame: immediately after treatment at 20 min.
Tactile Threshold During Treatment
The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton
Time frame: during treatment at 15 min.
Habituation to Electrical Stimulation
The habituation to electrical stimulation along experimental session will be measured by recording the difference on current intensity (mA) at the start of the treatment session (1 min) and end of the same (20 min)
Time frame: Start treatment session (1 min), end treatment session (20 min)
Perception Current Comfortability
Participants will choose the current treatment that has found more comfortable
Time frame: At the end of the third experimental session, 3 days
Change Current Density (mA/cm2)
Change in current density (mA/cm2), it will be recorded at 1 min. start of the treatment session and at 20 min of the same.
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Time frame: at 1 min. treatment session, at 20 min. treatment session
Change From Baseline in Nerve Conduction Amplitude ( µV)
The compound action potential amplitudes ( µV) will be measured.
Time frame: Baseline,immediately after treatment at 20 min..
Baseline Mechanical Pain Threshold
The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton
Time frame: Baseline at 0 min.
Mechanical Pain Threshold Post-treatment 20 Min.
The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton
Time frame: at 20 min. post-treatment
Mechanical Pain Threshold Post-treatment 40 Min.
The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton.
Time frame: at 40 min. post-treatment
Baseline Thermal Pain Threshold
The heat pain threshold will be measured by a computer controlled thermo-foil heating device and will be expressed in ºC
Time frame: Baseline at 0 min.
Thermal Pain Threshold Post-treatment 20 Min.
The heat pain threshold will be measured by a computer controlled thermo-foil heating device and will be expressed in ºC
Time frame: at 20 min. post-treatment
Thermal Pain Threshold Post-treatment 40 Min.
The heat pain threshold will be measured by a computer controlled thermo-foil heating device and will be expressed in ºC
Time frame: at 40 min. post-treatment
Baseline Nerve Conduction Latency
The compound action potential latencies will be measured and will be expressed in ms.
Time frame: Baseline at 0 min.
Nerve Conduction Latency Post-treatment 20 Min.
The compound action potential latencies will be measured and will be expressed in ms.
Time frame: at 20 min. post-treatment
Nerve Conduction Latency Post-treatment 40 Min.
The compound action potential latencies will be measured and will be expressed in ms.
Time frame: at 40 min. post-treatment
Baseline Tactile Threshold
The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton
Time frame: Baseline at 0 min.
Tactile Threshold Post-treatment 20 Min.
The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton
Time frame: at 20 min. post-treatment
Tactile Threshold Post-treatment 40 Min.
The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton
Time frame: at 40 min. post-treatment