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Effect of High Frequency Electrical Currents in Healthy Subjects.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02837458
Recruitment Status : Completed
First Posted : July 19, 2016
Last Update Posted : February 19, 2020
Sponsor:
Collaborator:
Hospital Nacional de Parapléjicos de Toledo
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
High Frequency Current Device: High-Frequency Device: Sham Stimulation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Application of High Frequency Electrical Currents: Effects on Mechanical Threshold, Tactile Threshold and Evoked Potentials in Healthy Subjects.
Actual Study Start Date : May 1, 2017
Actual Primary Completion Date : September 30, 2017
Actual Study Completion Date : December 20, 2017

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)




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02837458


Locations
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Spain
Diego Serrano-Muñoz
Toledo, Spain, 45004
Sponsors and Collaborators
University of Castilla-La Mancha
Hospital Nacional de Parapléjicos de Toledo
Investigators
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Principal Investigator: Diego Serrano-Muñoz, MsC Hospital Nacional de Parapléjicos, Toledo
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Castilla-La Mancha
ClinicalTrials.gov Identifier: NCT02837458    
Other Study ID Numbers: ddsm18
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: February 19, 2020
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Castilla-La Mancha:
Electric current
Nerve block
somatosensory evaluation