Skip to main content
Clinical Trials/NCT04346719
NCT04346719
Completed
Not Applicable

Percutaneous High Frequency Alternating Current Stimulation: Effects on Somatosensory and Motor Threshold in Healthy Volunteers

University of Castilla-La Mancha1 site in 1 country60 target enrollmentJune 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Electrical Stimulation
Sponsor
University of Castilla-La Mancha
Enrollment
60
Locations
1
Primary Endpoint
Pressure Pain Threshold
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

High-frequency alternating currents of greater than 1 kHz applied on peripheral nerves has been used in animal studies to produce a motor nerve block. It has been evidenced that frequencies higher than 5 kHz are necessary to produce a complete peripheral nerve block in primates, whose nerve thickness is more similar to humans.

Detailed Description

Our previous studies with transcutaneous HFAC, suggest high-frequency stimulation (10 and 20 kHz) have an inhibitory effect over muscle strength and somatosensory threshold. However, in these studies the intensity needed to reach block threshold is very high. The purpose of the present work is to reduce the amount of current intensity needed using a percutaneous approach by apply two acupuncture needles near the nerve as electrodes.

Registry
clinicaltrials.gov
Start Date
June 1, 2020
End Date
November 17, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Castilla-La Mancha
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Healthy volunteers
  • Ability to perform all clinical tests and understand the study process, as well as obtaining informed consent.
  • Tolerance to the application of electrotherapy.
  • That they have not diagnosed any pathology.
  • They do not present a contraindication to puncture and / or the application of electric currents.

Exclusion Criteria

  • Neuromuscular disease.
  • Epilepsy.
  • Trauma, surgery or pain affecting the upper limb
  • 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

Pressure Pain Threshold

Time Frame: Immediately after treatment at 30 minutes

The PPT will be measured with an algometer and will be expressed in Newtons

Muscle strength

Time Frame: Immediately after treatment at 30 minutes

Muscle strength will be measured with a dynamometer and will be expressed in Kgs.

Antidromic median sensory nerve action potential

Time Frame: Immediately after treatment at 30 minutes

The recording electrodes were placed on the second finger and the stimulus will be applied on the median nerve (above the elbow joint). The stimulus will consist of a train of 10 pulses (100 μs width), applied at supramaximal stimulation, presented at 1 Hz (DS7A, Digitimer Ltd). Negative peak latency (NPL), positive peak latency (PPL), and peak-to-peak amplitude (PPA) will be registered with a specific software (Signal software, CED).

Decrement (elasticity) of tissue assessed by MyotonPro

Time Frame: Immediately after treatment at 30 minutes

This outcome measure is obtained by a device named MyotonPro. The logarithmic decrement of the damping oscillations characterizes muscle elasticity which is the ability of the muscle to restore its initial shape after contraction. The muscle will be assessed is opponens pollicis muscle

Tactile Threshold

Time Frame: Immediately after treatment at 30 minutes

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

Stiffness of tissue assessed by MyotonPro

Time Frame: Immediately after treatment at 30 minutes

This outcome measure is obtained by a device named MyotonPro. Stiffness reflects the resistance of the muscle to the force deforming the muscle. The muscle will be assessed is opponens pollicis muscle

Oscillation Frequency of tissue assessed by MyotonPro

Time Frame: Immediately after treatment at 30 minutes

This outcome measure is obtained by a device named MyotonPro. The frequency of the damped oscillations characterizes the muscle tone. The muscle will be assessed is opponens pollicis muscle

Secondary Outcomes

  • Numerical Pain Rate Score(After the intervention at 35 minutes)
  • Number of participants with intervention-related adverse effects(After the intervention at 35 minutes)
  • Blinding success(After the intervention at 35 minutes)
  • Baseline flux temperature(Baseline at 0 minutes, at 15 minutes, immediately after treatment at 20 minutes, and immediately after treatment at 30 minutes)
  • Baseline nerve temperature(Baseline at 0 minutes, at 15 minutes, immediately after treatment at 20 minutes, and immediately after treatment at 30 minutes)
  • Numerical Discomfort Rate Score(After the intervention at 35 minutes)

Study Sites (1)

Loading locations...

Similar Trials