Effect of High Frequency Electrical Currents in Healthy Subjects.

Application of High Frequency Electrical Currents: Effects on Mechanical Threshold, Tactile Threshold and Evoked Potentials in Healthy Subjects.

The purpose of this study is to determine whether the transcutaneous application of unmodulated high frequency alternating currents could produce a quickly conduction block of peripheral nerve.

Study Overview

• Status: Completed
• Conditions: High Frequency Current
• Intervention / Treatment: Device: High-Frequency; 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).

It has show that the diameter of the nerve it is related with the frequency to produce the conduction block. For this reason we decided to applied 30KHz to observe the effects on pain in patients with whiplash and to compare versus sham stimulation.

Only one study has applied 5KHz on experimental pain and they have demonstrated changes in somatosensory thresholds.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Toledo, Spain, 45004
    • Diego Serrano-Muñoz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy volunteers

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High-Frequency; Transcutaneous application of high frequency electrical current over the arm for a 30 minutes session. The intensity of the current will increase until participants report a "strong but comfortable" sensation, just below motor threshold.	Device: High-Frequency; high-Frequency 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 arm for a 30 minutes in the same manner as experimental group 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
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
Baseline Tactile Threshold	The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton	baseline at 0 min
Baseline Muscle Strength	The muscle strength will be measured with a dynamometer and will be expressed in Newton	Baseline at 0 min
Mechanical Pain Threshold after treatment at 30 min	The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton	Immediately after treatment at 30 min
Tactile Threshold after treatment at 30 min	The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton	Immediately after treatment at 30 min
Muscle Strength after treatment at 30 min	The muscle strength will be measured with a dynamometer and will be expressed in Newton	Immediately after treatment at 30 min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Mechanical Pain Threshold	The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton	baseline at 0 min, immediately after treatment at 30 min
Change from baseline in TactileThreshold	The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton	baseline at 0 min, immediately after treatment at 30 min
Change from baseline in Muscle strength	The muscle strength will be measured with a dynamometer and will be expressed in Newton	baseline at 0 min, immediately after treatment at 30 min

Collaborators and Investigators

• Sponsor: University of Castilla-La Mancha
• Collaborators: Hospital Nacional de Parapléjicos de Toledo
• Investigators: Principal Investigator: Diego Serrano-Muñoz, MsC, Hospital Nacional de Parapléjicos, Toledo

Publications and helpful links

General Publications

• Serrano-Munoz D, Avendano-Coy J, Simon-Martinez C, Taylor J, Gomez-Soriano J. 20-kHz alternating current stimulation: effects on motor and somatosensory thresholds. J Neuroeng Rehabil. 2020 Feb 19;17(1):22. doi: 10.1186/s12984-020-00661-x.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): September 30, 2017
• Study Completion (Actual): December 20, 2017

Study Registration Dates

• First Submitted: July 15, 2016
• First Submitted That Met QC Criteria: July 15, 2016
• First Posted (Estimate): July 19, 2016

Study Record Updates

• Last Update Posted (Actual): February 19, 2020
• Last Update Submitted That Met QC Criteria: February 17, 2020
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Nerve block; Electric current; somatosensory evaluation
• Other Study ID Numbers: ddsm18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No