Unmodulated 5 Kilohertz Currents Versus TENS: Effect on Pain Thresholds, Tactile Threshold, and Nerve Conduction
- Conditions
- Pain
- Registration Number
- NCT02320838
- Lead Sponsor
- University of Castilla-La Mancha
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
- Participants will be volunteer healthy students of Physiotherapy, University of Castilla - La Mancha, older than 18 years.
- Neuromuscular disease.
- Epilepsy.
- Trauma, surgery or pain affecting the upper limb, shoulder girdle or cervical area.
- Osteosynthesis material in the upper limb.
- Diabetes.
- Cancer.
- Cardiovascular disease.
- Pacemaker or other implanted electrical device.
- Take any drug (NSAIDs, corticosteroids, antidepressants, analgesics, antiepileptics, ...) during the study and in the previous 7 days.
- Presence of tattoos or other external agent introduced into the treatment or assessment area.
- Pregnancy.
- Sensitivity disturbance in upper limb.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Thermal Pain Threshold During Treatment during treatment at 15 min. The heat pain threshold will be measured by a computer controlled thermo-foil heating device and will be expressed in ºC
Mechanical Pain Threshold During Treatment during treatment at 15 min The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton
Nerve Conduction Latency Immediately After Treatment immediately after treatment at 20 min. The compound action potential latencies will be measured and will be expressed in ms.
Tactile Threshold During Treatment during treatment at 15 min. The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton
- Secondary Outcome Measures
Name Time Method Change Current Density (mA/cm2) at 1 min. treatment session, at 20 min. treatment session 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.
Nerve Conduction Latency Post-treatment 20 Min. at 20 min. post-treatment The compound action potential latencies will be measured and will be expressed in ms.
Nerve Conduction Latency Post-treatment 40 Min. at 40 min. post-treatment The compound action potential latencies will be measured and will be expressed in ms.
Habituation to Electrical Stimulation Start treatment session (1 min), end treatment session (20 min) 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)
Change From Baseline in Nerve Conduction Amplitude ( µV) Baseline,immediately after treatment at 20 min.. The compound action potential amplitudes ( µV) will be measured.
Mechanical Pain Threshold Post-treatment 20 Min. at 20 min. post-treatment The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton
Baseline Thermal Pain Threshold Baseline at 0 min. The heat pain threshold will be measured by a computer controlled thermo-foil heating device and will be expressed in ºC
Thermal Pain Threshold Post-treatment 20 Min. at 20 min. post-treatment The heat pain threshold will be measured by a computer controlled thermo-foil heating device and will be expressed in ºC
Baseline Tactile Threshold Baseline at 0 min. The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton
Perception Current Comfortability At the end of the third experimental session, 3 days Participants will choose the current treatment that has found more comfortable
Mechanical Pain Threshold Post-treatment 40 Min. at 40 min. post-treatment The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton.
Tactile Threshold Post-treatment 20 Min. at 20 min. post-treatment The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton
Tactile Threshold Post-treatment 40 Min. at 40 min. post-treatment The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton
Baseline Mechanical Pain Threshold Baseline at 0 min. The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton
Thermal Pain Threshold Post-treatment 40 Min. at 40 min. post-treatment The heat pain threshold will be measured by a computer controlled thermo-foil heating device and will be expressed in ºC
Baseline Nerve Conduction Latency Baseline at 0 min. The compound action potential latencies will be measured and will be expressed in ms.