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Clinical Trials/NCT04884932
NCT04884932
Completed
Not Applicable

Percutaneous High Frequency Alternating Current Stimulation: Effects on Somatosensory and Motor Threshold in Healthy Volunteers With 30 kHz

University of Castilla-La Mancha1 site in 1 country48 target enrollmentMay 13, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Electrical Stimulation
Sponsor
University of Castilla-La Mancha
Enrollment
48
Locations
1
Primary Endpoint
Latency of Antidromic median sensory nerve action potential
Status
Completed
Last Updated
4 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

The previous studies with transcutaneous and percutaneous HFAC, suggest high-frequency stimulation (10 and 20 kHz) have an inhibitory effect over muscle strength and somatosensory threshold. However, the 30 kHz frequency has never been applied, and the hypothesis is that it can produce a greater blockage at the sensitive level and be a more comfortable application for the patient. The purpose of the present work is to determine if a greater blockage of the sensory component of the nerve occurs with this frequency and 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
May 13, 2021
End Date
August 16, 2021
Last Updated
4 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

Latency of Antidromic median sensory nerve action potential

Time Frame: Baseline at 0 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). Latency will be registered with a specific software (Signal software, CED) and will be expressed in millisecond.

Amplitude of Antidromic median sensory nerve action potential

Time Frame: Baseline at 0 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). Peak-to-peak amplitude (PPA) will be registered with a specific software (Signal software, CED) and will be expressed in millivolts.

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

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.

Latency 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). Latency will be registered with a specific software (Signal software, CED) and will be expressed in millisecond.

Amplitude 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). Peak-to-peak amplitude (PPA) will be registered with a specific software (Signal software, CED) and will be expressed in millivolts.

Secondary Outcomes

  • 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)
  • 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)

Study Sites (1)

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