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Completed

NCT Number: NCT02837458

Effect of High Frequency Electrical Currents 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Diego Serrano-Muñoz

Toledo, 45004, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High-Frequency

Device

high-Frequency electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)

Sham stimulation

Device

Sham transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)

Primary outcomes

  1. Baseline Mechanical Pain Threshold

    Time frame: baseline at 0 min

    The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton

  2. Baseline Tactile Threshold

    Time frame: baseline at 0 min

    The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton

  3. Baseline Muscle Strength

    Time frame: Baseline at 0 min

    The muscle strength will be measured with a dynamometer and will be expressed in Newton

  4. Mechanical Pain Threshold after treatment at 30 min

    Time frame: Immediately after treatment at 30 min

    The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton

  5. Tactile Threshold after treatment at 30 min

    Time frame: Immediately after treatment at 30 min

    The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton

  6. Muscle Strength after treatment at 30 min

    Time frame: Immediately after treatment at 30 min

    The muscle strength will be measured with a dynamometer and will be expressed in Newton

Secondary outcomes

  1. Change from baseline in Mechanical Pain Threshold

    Time frame: 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

  2. Change from baseline in TactileThreshold

    Time frame: 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

  3. Change from baseline in Muscle strength

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Castilla-La Mancha

Other

Collaborators

  • Hospital Nacional de Parapléjicos de Toledo

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jul 19, 2016
Registry last updated
Feb 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.