Effect of High Frequency Electrical Currents in Healthy Subjects.

Not Applicable

Completed

• Conditions: High Frequency Current
• Interventions: Device: High-Frequency; Device: Sham Stimulation

• Registration Number: NCT02837458
• Lead Sponsor: University of Castilla-La Mancha

Brief Summary

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.

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 Timeline

• Study First Submitted: 2016-07-15
• Study First Submitted QC: 2016-07-15
• Study First Posted: 2016-07-19
• Status Verified: 2017-04
• Study Start: 2017-05-01
• Primary Completion: 2017-09-30
• Study Completion: 2017-12-20
• Last Update Submitted: 2020-02-17
• Last Update Posted: 2020-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High-Frequency	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.
Sham Stimulation	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.

Primary Outcome Measures

Name	Time	Method
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
Tactile Threshold after treatment at 30 min	Immediately after treatment at 30 min	The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton
Muscle Strength after treatment at 30 min	Immediately after treatment at 30 min	The muscle strength will be measured with a dynamometer and will be expressed in Newton
Baseline Tactile Threshold	baseline at 0 min	The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton
Baseline Muscle Strength	Baseline at 0 min	The muscle strength will be measured with a dynamometer and will be expressed in Newton
Mechanical Pain Threshold after treatment at 30 min	Immediately after treatment at 30 min	The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Diego Serrano-Muñoz; 🇪🇸 Toledo, Spain