Effect of High Frequency Electrical Currents in Healthy Subjects.

High Frequency Current Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02837458
• Other study ID #: ddsm18
• Status: Completed
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: December 20, 2017

Study information

• Verified date: April 2017
• Source: University of Castilla-La Mancha
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 20, 2017
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• High Frequency Current

Intervention

Device:
• High-Frequency
high-Frequency electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
• Sham Stimulation
Sham transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)

Locations

Country	Name	City	State
Spain	Diego Serrano-Muñoz	Toledo

Sponsors (2)

Lead Sponsor	Collaborator
University of Castilla-La Mancha	Hospital Nacional de Parapléjicos de Toledo

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Baseline Tactile Threshold	The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton	baseline at 0 min
Primary	Baseline Muscle Strength	The muscle strength will be measured with a dynamometer and will be expressed in Newton	Baseline at 0 min
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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