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Clinical Trials/NCT02837458
NCT02837458
Completed
Not Applicable

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

University of Castilla-La Mancha1 site in 1 country14 target enrollmentMay 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
High Frequency Current
Sponsor
University of Castilla-La Mancha
Enrollment
14
Locations
1
Primary Endpoint
Baseline Mechanical Pain Threshold
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2017
End Date
December 20, 2017
Last Updated
6 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
University of Castilla-La Mancha
Responsible Party
Sponsor

Eligibility 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.
  • 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.

Outcomes

Primary Outcomes

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

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

Baseline Muscle Strength

Time Frame: 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

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

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

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

  • Change from baseline in Mechanical Pain Threshold(baseline at 0 min, immediately after treatment at 30 min)
  • Change from baseline in TactileThreshold(baseline at 0 min, immediately after treatment at 30 min)
  • Change from baseline in Muscle strength(baseline at 0 min, immediately after treatment at 30 min)

Study Sites (1)

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