Clinical trial NCT04346719: Percutaneous High Frequency Alternating Current Stimulation in Healthy Volunteers
Official title: Percutaneous High Frequency Alternating Current Stimulation: Effects on Somatosensory and Motor Threshold in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Electrical Stimulation
Neuromodulation
Keywords: high-frequency alternating current
nerve block
somatosensory threshold
motor threshold
percutaneous electrical stimulation
Lead sponsor: University of Castilla-La Mancha
Sponsor class: OTHER
First posted: 2020-04-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.
* 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

Primary outcomes:
measure: Antidromic median sensory nerve action potential
timeFrame: Baseline at 0 minutes
measure: Tactile Threshold
timeFrame: Baseline at 0 minutes
measure: Oscillation Frequency of tissue assessed by MyotonPro
timeFrame: Baseline at 0 minutes
measure: Stiffness of tissue assessed by MyotonPro
timeFrame: Baseline at 0 minutes
measure: Decrement (elasticity) of tissue assessed by MyotonPro
timeFrame: Baseline at 0 minutes
measure: Pressure Pain Threshold
timeFrame: Baseline at 0 minutes
measure: Muscle strength
timeFrame: Baseline at 0 minutes
measure: Tactile Threshold
timeFrame: During treatment at 15 minutes
measure: Oscillation Frequency of tissue assessed by MyotonPro
timeFrame: During treatment at 15 minutes
measure: Stiffness of tissue assessed by MyotonPro
timeFrame: During treatment at 15 minutes
measure: Decrement (elasticity) of tissue assessed by MyotonPro
timeFrame: During treatment at 15 minutes
measure: Pressure Pain Threshold
timeFrame: During treatment at 15 minutes
measure: Antidromic median sensory nerve action potential
timeFrame: Immediately after treatment at 20 minutes
measure: Tactile Threshold
timeFrame: Immediately after treatment at 20 minutes
measure: Oscillation Frequency of tissue assessed by MyotonPro
timeFrame: Immediately after treatment at 20 minutes
measure: Stiffness of tissue assessed by MyotonPro
timeFrame: Immediately after treatment at 20 minutes
measure: Decrement (elasticity) of tissue assessed by MyotonPro
timeFrame: Immediately after treatment at 20 minutes
measure: Pressure Pain Threshold
timeFrame: Immediately after treatment at 20 minutes
measure: Muscle strength
timeFrame: Immediately after treatment at 20 minutes
measure: Antidromic median sensory nerve action potential
timeFrame: Immediately after treatment at 30 minutes
measure: Tactile Threshold
timeFrame: Immediately after treatment at 30 minutes
measure: Oscillation Frequency of tissue assessed by MyotonPro
timeFrame: Immediately after treatment at 30 minutes
measure: Stiffness of tissue assessed by MyotonPro
timeFrame: Immediately after treatment at 30 minutes
measure: Decrement (elasticity) of tissue assessed by MyotonPro
timeFrame: Immediately after treatment at 30 minutes
measure: Pressure Pain Threshold
timeFrame: Immediately after treatment at 30 minutes
measure: Muscle strength
timeFrame: Immediately after treatment at 30 minutes
Secondary outcomes:
measure: Baseline nerve temperature
timeFrame: Baseline at 0 minutes, at 15 minutes, immediately after treatment at 20 minutes, and immediately after treatment at 30 minutes
measure: Baseline flux temperature
timeFrame: Baseline at 0 minutes, at 15 minutes, immediately after treatment at 20 minutes, and immediately after treatment at 30 minutes
measure: Numerical Discomfort Rate Score
timeFrame: After the intervention at 35 minutes
measure: Numerical Pain Rate Score
timeFrame: After the intervention at 35 minutes
measure: Number of participants with intervention-related adverse effects
timeFrame: After the intervention at 35 minutes
measure: Blinding success
timeFrame: After the intervention at 35 minutes
Other outcomes:
Locations:
city: Toledo
country: Spain
facility: Castilla-La Mancha University
Study officials:
affiliation: Castilla-La Mancha University
name: Juan Avendaño-Coy, PhD
role: STUDY_DIRECTOR
References: