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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04346719
Other study ID # Neuromodest-pHFAC
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2020
Est. completion date November 17, 2020

Study information

Verified date November 2020
Source University of Castilla-La Mancha
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date November 17, 2020
Est. primary completion date November 17, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
10 kHz stimulation (Myomed 932, Enraf-Nonius)
A charge-balanced, symmetric, biphasic sinusoidal current without modulation will be delivered at a frequency of 10 kHz. The stimulation intensity will be defined as that sufficient to produce a "strong but comfortable" sensation, just below motor threshold, over the median nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft,Netherlands)
20 kHz stimulation (Myomed 932, Enraf-Nonius)
A charge-balanced, symmetric, biphasic sinusoidal current without modulation will be delivered at a frequency of 20 kHz. The stimulation intensity will be defined as that sufficient to produce a "strong but comfortable" sensation, just below motor threshold, over the median nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft,Netherlands)
Sham stimulation (Myomed 932, Enraf-Nonius)
Sham stimulation will be delivered at a frequency of 10 kHz only during the first 30 seconds.

Locations

Country Name City State
Spain Castilla-La Mancha University Toledo

Sponsors (1)

Lead Sponsor Collaborator
University of Castilla-La Mancha

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Antidromic median sensory nerve action potential 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). Baseline at 0 minutes
Primary Tactile Threshold The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton Baseline at 0 minutes
Primary Oscillation Frequency of tissue assessed by MyotonPro 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 Baseline at 0 minutes
Primary Stiffness of tissue assessed by MyotonPro 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 Baseline at 0 minutes
Primary Decrement (elasticity) of tissue assessed by MyotonPro 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 Baseline at 0 minutes
Primary Pressure Pain Threshold The PPT will be measured with an algometer and will be expressed in Newtons Baseline at 0 minutes
Primary Muscle strength Muscle strength will be measured with a dynamometer and will be expressed in Kgs. Baseline at 0 minutes
Primary Tactile Threshold The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton During treatment at 15 minutes
Primary Oscillation Frequency of tissue assessed by MyotonPro 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 During treatment at 15 minutes
Primary Stiffness of tissue assessed by MyotonPro 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 During treatment at 15 minutes
Primary Decrement (elasticity) of tissue assessed by MyotonPro 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 During treatment at 15 minutes
Primary Pressure Pain Threshold The PPT will be measured with an algometer and will be expressed in Newtons During treatment at 15 minutes
Primary Antidromic median sensory nerve action potential 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). Immediately after treatment at 20 minutes
Primary Tactile Threshold The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton Immediately after treatment at 20 minutes
Primary Oscillation Frequency of tissue assessed by MyotonPro 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 Immediately after treatment at 20 minutes
Primary Stiffness of tissue assessed by MyotonPro 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 Immediately after treatment at 20 minutes
Primary Decrement (elasticity) of tissue assessed by MyotonPro 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 Immediately after treatment at 20 minutes
Primary Pressure Pain Threshold The PPT will be measured with an algometer and will be expressed in Newtons Immediately after treatment at 20 minutes
Primary Muscle strength Muscle strength will be measured with a dynamometer and will be expressed in Kgs. Immediately after treatment at 20 minutes
Primary Antidromic median sensory nerve action potential 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). Immediately after treatment at 30 minutes
Primary Tactile Threshold The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton Immediately after treatment at 30 minutes
Primary Oscillation Frequency of tissue assessed by MyotonPro 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 Immediately after treatment at 30 minutes
Primary Stiffness of tissue assessed by MyotonPro 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 Immediately after treatment at 30 minutes
Primary Decrement (elasticity) of tissue assessed by MyotonPro 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 Immediately after treatment at 30 minutes
Primary Pressure Pain Threshold The PPT will be measured with an algometer and will be expressed in Newtons Immediately after treatment at 30 minutes
Primary Muscle strength Muscle strength will be measured with a dynamometer and will be expressed in Kgs. Immediately after treatment at 30 minutes
Secondary Baseline nerve temperature Nerve temperature will be measured using a termodoppler (Celsius degrees) Baseline at 0 minutes, at 15 minutes, immediately after treatment at 20 minutes, and immediately after treatment at 30 minutes
Secondary Baseline flux temperature Flux will be measured using a termodoppler Baseline at 0 minutes, at 15 minutes, immediately after treatment at 20 minutes, and immediately after treatment at 30 minutes
Secondary Numerical Discomfort Rate Score the possible discomfort caused by the interventions will be assess by a numerical rate score. The NRS consists of a scale from 0 (no discomfort) to 10 (worst possible discomfort) After the intervention at 35 minutes
Secondary Numerical Pain Rate Score The NRS consists of a scale from 0 (no pain) to 10 (worst possible pain) After the intervention at 35 minutes
Secondary Number of participants with intervention-related adverse effects the possible adverse effects caused by the interventions will be assess by a questionnaire After the intervention at 35 minutes
Secondary Blinding success Blinding of subjects and researchers will be assessed using the James Index After the intervention at 35 minutes
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