Effects of Percutaneous Neuromodulation on Plasticity in the Somatosensory System in Healthy Subjects

Effects of Percutaneous Neuromodulation on Plasticity in the Somatosensory System

Echography guided percutaneous neuromodulation is a physical therapy technique, whose main objective is the treatment of pain with direct stimulation of the peripheral nerves using a rome needle of acupuncture as an active electrode for applying currents of electrostimulation.

The neurophysiological basis and the effects on the sensory and motor systems of this technique are not characterised. The present study proposes to perform the intervention on the area adjacent to the median nerve and to apply different stimulation protocols on healthy subjects to answer those questions.

Study Overview

Status

Completed

Conditions

Detailed Description

Intervention is going to be performed in the medial side of the arm, where the median nerve is accessible to the intervention. The theoretical basis of the technique is to produce specific controlled changes in the somatosensory system using synaptic plasticity, to ultimate affect the perception of pain through reduction of nociception afference. Subsequently, the protocols are based on synaptic physiology and the circuitry of the somatosensory system.

The protocols are the following:

  1. - low-frequency and high-intensity of stimulation: 2hz during 16 min at an slightly annoying intensity, to induce synaptic depression on the c-fibers circuit, presumably carrying nociception.
  2. - high-frequency and low-intensity of stimulation: 100 hz in 5 second trains, separated by 1 min of no current with a perceptible but mild intensity, to induce potentiation of a-beta fibers, presumably englobing mechanoreceptors which inhibit nociception through gate control in the spinal cord.
  3. - placebo group has got the same intervention, but without current.

The study design is an experimental clinical trial, with randomized order of intervention with repeated measurements. This means each subject is having the three protocols at randomized order, with a gap of at least two weeks between them. The study is triple-blinded.

Somatomotor system variables, as sensory and pain pressure thresholds, grip strength, surface electromyographic activity and blood flow are evaluated on the hand of the subject. The arm to treat was also randomized for each subject The measurements are pre-intervention, post-intervention and 24 hours after the intervention for each protocol. Blood flow are measured only pre-intervention and post-intervention.

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alicante
      • Elche, Alicante, Spain, 03203
        • Clínica Francisco Ortega Rehabilitación Avanzada, S.L.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion criteria:

  • healthy.
  • more than 18 years old
  • amateur athlete.

Exclusion criteria:

  • to suffer or to have suffered any pathology on the arm on the last 30 days.
  • to suffer some disease discouraging current application or needle¡ing, as coagulation deficit, etc.
  • to suffer some disease as diabetes mellitus, cancer, neurology disease, depression, fibromyalgia, etc.
  • to consume drugs as coagulants, anti-depressant, pregabalin, etc during investigation or the first week before investigation.
  • to consume nsaids the last 48 hours before investigation or during investigation.
  • to consume opioids the first week before investigation or during investigation.
  • belonephobia.
  • professional athlete
  • to be pregnant
  • to suffer immunodepression

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low-frequency and high-intensity

The intervention of ultrasound guided percutaneous neuromodulation is applied over the median nerve.

The parameters are continuous stimulation of low frequency (2 hz) and high intensity (slightly painful) during 16 minutes.

It is a technique that consists in the electrical stimulation of peripheral nerve trunks, inserting an acupuncture needle in its path and using it as an electrode to apply electrical current
Experimental: High-frequency and low-intensity

The intervention of ultrasound guided percutaneous neuromodulation is applied over the median nerve.

The parameters are high frequency (100 hz) and low intensity trains. There are 5 trains, 5 second active current and 55 second without current per train.

The current is off on the first 11 minutes and the next 5 minutes it will be on. The total time is 16 minutes.

It is a technique that consists in the electrical stimulation of peripheral nerve trunks, inserting an acupuncture needle in its path and using it as an electrode to apply electrical current
Sham Comparator: Control group
The intervention of ultrasound guided percutaneous neuromodulation is applied over the median nerve without current during 16 minutes.
It is a technique that consists in the electrical stimulation of peripheral nerve trunks, inserting an acupuncture needle in its path and using it as an electrode to apply electrical current

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mechanical Threshold elicited with Von Frey Filaments
Time Frame: Pre-intervention / baseline
We use Von Frey Filaments of increasing caliber to make pression in the evaluated areas. When the test subject reports perception of mechanical sensation, that caliber is considered the pressure threshold to elicit mechanical. The test is performed with subject's eyes closed
Pre-intervention / baseline
Mechanical Threshold elicited with Von Frey Filaments
Time Frame: Immediately after the intervention
We use Von Frey Filaments of increasing caliber to make pression in the evaluated areas. When the test subject reports perception of mechanical sensation, that caliber is considered the pressure threshold to elicit mechanical. The test is performed with subject's eyes closed.
Immediately after the intervention
Mechanical Threshold elicited with Von Frey Filaments
Time Frame: 24 hours after the intervention
We use Von Frey Filaments of increasing caliber to make pression in the evaluated areas. When the test subject reports perception of mechanical sensation, that caliber is considered the pressure threshold to elicit mechanical. The test is performed with subject's eyes closed.
24 hours after the intervention
Pinprick pain threshold elicited with Von Frey Filaments
Time Frame: pre-intervention / baseline
We use Von Frey Filaments of increasing caliber to make pression in the evaluated areas. When the test subject reports perception of pinprick sensation, that caliber is considered the pressure threshold to elicit pinprick pain. The test is performed with subject's eyes closed
pre-intervention / baseline
Pinprick pain threshold elicited with Von Frey Filaments
Time Frame: Immediately after the intervention
We use Von Frey Filaments of increasing caliber to make pression in the evaluated areas. When the test subject reports perception of pinprick sensation, that caliber is considered the pressure threshold to elicit pinprick pain. The test is performed with subject's eyes closed
Immediately after the intervention
Pinprick pain threshold elicited with Von Frey Filaments
Time Frame: 24 hours after the intervention
We use Von Frey Filaments of increasing caliber to make pression in the evaluated areas. When the test subject reports perception of pinprick sensation, that caliber is considered the pressure threshold to elicit pinprick pain. The test is performed with subject's eyes closed
24 hours after the intervention
Pain evocated with Von Frey Filaments.
Time Frame: Pre-intervention / baseline
We use Von Frey Filaments of increasing caliber to make pression with 100g, 180g and 300g in the evaluated areas. Each filament to make pression three times. The subject reports the pain in a scale of 0-10 number (scale NSR: 0 is any pain and 10 is the maximal perception of pain. The test is performed with subject's eyes closed.
Pre-intervention / baseline
Pain evocated with Von Frey Filaments.
Time Frame: Immediately after the intervention
We use Von Frey Filaments of increasing caliber to make pression with 100g, 180g and 300g in the evaluated areas. Each filament to make pression three times. The subject reports the pain in a scale of 0-10 number (scale NSR: 0 is any pain and 10 is the maximal perception of pain. The test is performed with subject's eyes closed.
Immediately after the intervention
Pain evocated with Von Frey Filaments.
Time Frame: 24 hours after the intervention
We use Von Frey Filaments of increasing caliber to make pression with 100g, 180g and 300g in the evaluated areas. Each filament to make pression three times. The subject reports the pain in a scale of 0-10 number (scale NSR: 0 is any pain and 10 is the maximal perception of pain. The test is performed with subject's eyes closed.
24 hours after the intervention
Pressure pain threshold with algometer.
Time Frame: pre-intervention / baseline
On the marked areas we make pressure with pressure algometer. When the subject experiences any sense of pain, he/she has to say "stop" and immediately the algometer was removed. The number in Kg marked by the algometer is annotated. The mean of two measurements was taken for analysis. The second measurement was taken with a minimum of 30 seconds after the previous one.
pre-intervention / baseline
Change in pressure pain threshold with algometer.
Time Frame: Immediately after the intervention
On the marked areas we make pressure with pressure algometer. When the subject experiences any sense of pain, he/she has to say "stop" and immediately the algometer was removed. The number in Kg marked by the algometer is annotated. The mean of two measurements was taken for analysis. The second measurement was taken with a minimum of 30 seconds after the previous one.
Immediately after the intervention
Change in pressure pain threshold with algometer.
Time Frame: 24 hours after the intervention
On the marked areas we make pressure with pressure algometer. When the subject experiences any sense of pain, he/she has to say "stop" and immediately the algometer was removed. The number in Kg marked by the algometer is annotated. The mean of two measurements was taken for analysis. The second measurement was taken with a minimum of 30 seconds after the previous one.
24 hours after the intervention
Maximum grip force with dynamometer
Time Frame: pre-intervention / baseline
The subject is standing with the dynamometer in his hand. He/she must press the dynamometer during 5 second, 3 times with 30 seconds to rest between them.
pre-intervention / baseline
Change in maximum grip force with dynamometer
Time Frame: Immediately after the intervention
The subject is standing with the dynamometer in his hand. He/she must press the dynamometer during 5 second, 3 times with 30 seconds to rest between them.
Immediately after the intervention
Change in maximum grip force with dynamometer.
Time Frame: 24 hours after the intervention
The subject is standing with the dynamometer in his hand. He/she must press the dynamometer during 5 second, 3 times with 30 seconds to rest between them.
24 hours after the intervention
Maximum grip force with surface electromyography.
Time Frame: pre-intervention / baseline
The subject is standing with the dynamometer in his hand. He/she must press the dynamometer during 5 second, 3 times with 30 seconds to rest between them.
pre-intervention / baseline
Change in maximum grip force with surface electromyography.
Time Frame: Immediately after the intervention
The subject is standing with the dynamometer in his hand. He/she must press the dynamometer during 5 second, 3 times with 30 seconds to rest between them.
Immediately after the intervention
Change in maximum grip force with surface electromyography.
Time Frame: 24 hours after the intervention
The subject is standing with the dynamometer in his hand. He/she must press the dynamometer during 5 second, 3 times with 30 seconds to rest between them.
24 hours after the intervention
Arterial peak systolic velocity with Color Doppler Ultrasonography
Time Frame: pre-intervention / baseline
On the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial peak systolic during 5 cardiac cycles.
pre-intervention / baseline
Change in arterial peak systolic velocity with Color Doppler Ultrasonography in placebo group
Time Frame: Immediately after the needle insertion
In placebo group, on the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial peak systolic during 5 cardiac cycles inmediately after introduce the needly in the arm.
Immediately after the needle insertion
Change in arterial peak systolic velocity with Color Doppler Ultrasonography
Time Frame: Immediately after the intervention
On the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial peak systolic during 5 cardiac cycles.
Immediately after the intervention
Arterial volume flow with Color Doppler Ultrasonography
Time Frame: pre-intervention / baseline
On the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial volume flow during 5 cardiac cycles.
pre-intervention / baseline
Change in arterial volume flow with Color Doppler Ultrasonography
Time Frame: Immediately after the needle insertion
In placebo group, on the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial volume flow during 5 cardiac cycles.
Immediately after the needle insertion
Change in arterial volume flow with Color Doppler Ultrasonography
Time Frame: Immediately after the intervention
On the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial volume flow during 5 cardiac cycles.
Immediately after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electric current threshold of perception with low frequency
Time Frame: pre-intervention / baseline
Using the intervention needle as an active electrode. The parameters are 2 hz and 150 msec of pulse duration and the intensity was increased progressively. When the subject experienced any sense of pain, sensitivity and muscle contraction in the needle and arm, he/she must tell it and the threshold is annotated.
pre-intervention / baseline
Change in Electric current threshold of perception with low frequency
Time Frame: Immediately after the intervention
Using the intervention needle as an active electrode. The parameters are 2 hz and 150 msec of pulse duration and the intensity was increased progressively. When the subject experienced any sense of pain, sensitivity and muscle contraction in the needle and arm, he/she must tell it and the threshold is annotated.
Immediately after the intervention
Change in Electric current threshold of perception with low frequency
Time Frame: 24 hours after the intervention
Using the intervention needle as an active electrode. The parameters are 2 hz and 150 msec of pulse duration and the intensity was increased progressively. When the subject experienced any sense of pain, sensitivity and muscle contraction in the needle and arm, he/she must tell it and the threshold is annotated.
24 hours after the intervention
Electric current threshold of perception with high frequency
Time Frame: pre-intervention / baseline
Using the intervention needle as an active electrode. The parameters are 100 hz and 150 msec of pulse duration and the intensity was increased progressively. When the subject experienced any sense of pain, sensitivity and muscle contraction in the needle and arm, he/she must tell it and the threshold is annotated.
pre-intervention / baseline
Change electric current threshold of perception with high frequency
Time Frame: Immediately after the intervention
Using the intervention needle as an active electrode. The parameters are 100 hz and 150 msec of pulse duration and the intensity was increased progressively. When the subject experienced any sense of pain, sensitivity and muscle contraction in the needle and arm, he/she must tell it and the threshold is annotated.
Immediately after the intervention
Change electric current threshold of perception with high frequency
Time Frame: 24 hours after the intervention
Using the intervention needle as an active electrode. The parameters are 100 hz and 150 msec of pulse duration and the intensity was increased progressively. When the subject experienced any sense of pain, sensitivity and muscle contraction in the needle and arm, he/she must tell it and the threshold is annotated.
24 hours after the intervention
Force grip resistance with dynamometer
Time Frame: Pre-intervention / Baseline
The subject is standing with the dynamometer in his hand. He/she must press the dynamometer during one minute trying to maintain maximal force.
Pre-intervention / Baseline
Change in Force grip resistance with dynamometer.
Time Frame: Immediately after the intervention
The subject is standing with the dynamometer in his hand. He/she must press the dynamometer during one minute trying to maintain maximal force.
Immediately after the intervention
Change in Force grip resistance with dynamometer.
Time Frame: 24 hours after the intervention
The subject is standing with the dynamometer in his hand. He/she must press the dynamometer during one minute trying to maintain maximal force.
24 hours after the intervention
Force grip resistance with surface electromyography.
Time Frame: Pre-intervention / Baseline
The subject is standing with the dynamometer in his hand. He/she must press the dynamometer during one minute trying to maintain maximal force.
Pre-intervention / Baseline
Change in Force grip resistance with surface electromyography.
Time Frame: Immediately after the intervention
The subject is standing with the dynamometer in his hand. He/she must press the dynamometer during one minute trying to maintain maximal force.
Immediately after the intervention
Change in Force grip resistance with surface electromyography.
Time Frame: 24 hours after the intervention
The subject is standing with the dynamometer in his hand. He/she must press the dynamometer during one minute trying to maintain maximal force.
24 hours after the intervention
Neural tension test (ROM)
Time Frame: pre-intervention / baseline
The subject is lying on the stretcher. We make a neurodynamic test and when she/he experience tension in his/her arm, she/he must tell us "stop". We measure the range of motion of the elbow extension as the outcome
pre-intervention / baseline
Change in neural tension test (ROM)
Time Frame: Immediately after the intervention
The subject is lying on the stretcher. We make a neurodynamic test and when she/he experience tension in his/her arm, she/he must tell us "stop". We measure the range of motion of the elbow extension as the outcome
Immediately after the intervention
Change in neural tension test (ROM)
Time Frame: 24 hours after the intervention
The subject is lying on the stretcher. We make a neurodynamic test and when she/he experience tension in his/her arm, she/he must tell us "stop". We measure the range of motion of the elbow extension as the outcome
24 hours after the intervention
Change in arterial end-diastolic velocity with Color Doppler Ultrasonography
Time Frame: Immediately after the needle insertion
In the placebo group, on the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial end-diastolic velocity during 5 cardiac cycles.
Immediately after the needle insertion
Arterial time average mean velocity during cardiac cycle with Color Doppler Ultrasonography
Time Frame: pre-intervention / baseline
On the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial time average mean velocity during 5 cardiac cycles.
pre-intervention / baseline
Change in arterial time average mean velocity during cardiac cycle with Color Doppler Ultrasonography
Time Frame: Immediately after the needle insertion
In the placebo group, on the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial time average mean velocity during 5 cardiac cycles.
Immediately after the needle insertion
Arterial end-diastolic velocity with Color Doppler Ultrasonography
Time Frame: pre-intervention / baseline
On the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial end-diastolic velocity during 5 cardiac cycles.
pre-intervention / baseline
Change in arterial end-diastolic velocity with Color Doppler Ultrasonography
Time Frame: Immediately after the intervention
On the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial end-diastolic velocity during 5 cardiac cycles.
Immediately after the intervention
Change in arterial time average mean velocity during cardiac cycle with Color Doppler
Time Frame: Immediately after the intervention
On the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial time average mean velocity during 5 cardiac cycles.
Immediately after the intervention
Arterial time average maximun velocity during cardiac cycle with Color Doppler
Time Frame: pre-intervention / baseline
On the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial time average maximun velocity during 5 cardiac cycles.
pre-intervention / baseline
Change in arterial time average maximun velocity during cardiac cycle with Color Doppler
Time Frame: Immediately after the needle insertion
In placebo group, on the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial time average maximun velocity during 5 cardiac cycles.
Immediately after the needle insertion
Change in arterial time average maximun velocity during cardiac cycle with Color Doppler
Time Frame: Immediately after the intervention
On the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial time average maximun velocity during 5 cardiac cycles.
Immediately after the intervention
Arterial pulsatility index during cardiac cycle with Color Doppler
Time Frame: pre-intervention / baseline
On the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial pulsatility index during 5 cardiac cycles.
pre-intervention / baseline
Change in arterial pulsatility index during cardiac cycle with Color Doppler
Time Frame: Immediately after the needle insertion
In placebo group, on the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial pulsatility index during 5 cardiac cycles.
Immediately after the needle insertion
Change in arterial pulsatility index during cardiac cycle with Color Doppler
Time Frame: Immediately after the intervention
On the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial pulsatility index during 5 cardiac cycles.
Immediately after the intervention
Arterial arterial resistivity index during cardiac cycle with Color Doppler
Time Frame: pre-intervention / baseline
In placebo group, on the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial resistivity index during 5 cardiac cycles.
pre-intervention / baseline
Change in arterial resistivity index during cardiac cycle with Color Doppler
Time Frame: Immediately after the needle insertion
On the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial resistivity index during 5 cardiac cycles.
Immediately after the needle insertion
Change in arterial resistivity index during cardiac cycle with Color Doppler
Time Frame: Immediately after the intervention
On the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial resistivity index during 5 cardiac cycles.
Immediately after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Patricia Beltrá López, Clínica Francisco Javier Ortega Puebla

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 13, 2020

Primary Completion (Actual)

October 29, 2020

Study Completion (Actual)

October 29, 2020

Study Registration Dates

First Submitted

July 8, 2020

First Submitted That Met QC Criteria

July 16, 2020

First Posted (Actual)

July 17, 2020

Study Record Updates

Last Update Posted (Actual)

February 2, 2022

Last Update Submitted That Met QC Criteria

January 19, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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