Unmodulated 5 Kilohertz Currents Versus TENS: Effect on Pain Thresholds, Tactile Threshold, and Nerve Conduction

Unmodulated 5 Kilohertz Alternating Currents Versus TENS: Effect on Mechanical and Thermal Pain Thresholds, Tactile Threshold, and Peripheral Nerve Conduction in Humans.

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Device: 5 KHz; Device: TENS; Device: Sham stimulation

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.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Participants will be volunteer healthy students of Physiotherapy, University of Castilla - La Mancha, older than 18 years.

Exclusion Criteria:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 5 KHz; Transcutaneous application of 5 KHz current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a "strong but comfortable" sensation, just below motor threshold.	Device: 5 KHz; 5 KHz transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
Experimental: TENS; Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a "strong but comfortable" sensation, just below motor threshold. Currents parameters are frequency 110 Hz and pulse width 200 microseconds	Device: TENS; TENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
Sham Comparator: Sham Stimulation; Electrodes are placed over the course of the superficial radial nerve in the right forearm for a 20 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel.	Device: Sham stimulation; Sham transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mechanical Pain Threshold During Treatment	The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton	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	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.	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	during treatment at 15 min.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Start treatment session (1 min), end treatment session (20 min)
Perception Current Comfortability	Participants will choose the current treatment that has found more comfortable	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.	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.	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	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	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.	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	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	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	at 40 min. post-treatment
Baseline Nerve Conduction Latency	The compound action potential latencies will be measured and will be expressed in ms.	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.	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.	at 40 min. post-treatment
Baseline Tactile Threshold	The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton	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	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	at 40 min. post-treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin Temperature	Skin temperature (ºC) will be recorded in all assessment times.	Baseline, during treatment at 15 min., immediately after treatment at 20 min., at 20 min. post-treatment, at 40 min. post-treatment

Collaborators and Investigators

• Sponsor: University of Castilla-La Mancha
• Collaborators: Hospital Nacional de Parapléjicos de Toledo
• Investigators: Principal Investigator: Juan Avendaño-Coy, MsC, University of Castilla-La Mancha, Toledo, Spain

Publications and helpful links

General Publications

• Avendano-Coy J, Gomez-Soriano J, Goicoechea-Garcia C, Basco-Lopez JA, Taylor J. Effect of Unmodulated 5-kHz Alternating Currents Versus Transcutaneous Electrical Nerve Stimulation on Mechanical and Thermal Pain, Tactile Threshold, and Peripheral Nerve Conduction: A Double-Blind, Placebo-Controlled Crossover Trial. Arch Phys Med Rehabil. 2017 May;98(5):888-895. doi: 10.1016/j.apmr.2016.11.020. Epub 2016 Dec 23.

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: November 18, 2014
• First Submitted That Met QC Criteria: December 15, 2014
• First Posted (Estimate): December 19, 2014

Study Record Updates

• Last Update Posted (Actual): July 31, 2017
• Last Update Submitted That Met QC Criteria: July 3, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Electric Stimulation Therapy; Transcutaneous Electric Nerve Stimulation; Pain Threshold; Unmodulated Alternating Currents; Neural Conduction
• Other Study ID Numbers: javendano