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

NCT04475133 | Completed

• 1 other identifier: NMP19/20-FREMPI
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Echography guided percutaneous neuromodulation; Plasticity; somatomotor system; Peripheral nerve stimulation; Pain

Outcome Measures

Primary Outcomes (24)

• Mechanical Threshold elicited with Von Frey Filaments

  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

  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

  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

  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

  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

  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.

  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.

  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.

  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.

  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.

  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.

  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

  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

  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.

  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.

  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.

  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.

  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

  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

  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

  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

  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

  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

  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 Outcomes (30)

• Electric current threshold of perception with low frequency

  pre-intervention / baseline

• Change in Electric current threshold of perception with low frequency

  Immediately after the intervention

• Change in Electric current threshold of perception with low frequency

  24 hours after the intervention

• Electric current threshold of perception with high frequency

  pre-intervention / baseline

• Change electric current threshold of perception with high frequency

  Immediately after the intervention

Study Arms (3)

Low-frequency and high-intensity

EXPERIMENTAL

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.

Other: Ultrasound guided percutaneous neuromodulation

High-frequency and low-intensity

EXPERIMENTAL

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.

Other: Ultrasound guided percutaneous neuromodulation

Control group

SHAM COMPARATOR

The intervention of ultrasound guided percutaneous neuromodulation is applied over the median nerve without current during 16 minutes.

Other: Ultrasound guided percutaneous neuromodulation

Interventions

Ultrasound guided percutaneous neuromodulation OTHER

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

Control group; High-frequency and low-intensity; Low-frequency and high-intensity

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinica Francisco Ortega Rehabilitacion Avanzada SL: lead

Study Sites (1)

Clínica Francisco Ortega Rehabilitación Avanzada, S.L.

Elche, Alicante, 03203, Spain

Location

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  RESULT

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Patricia Beltrá López

  Clínica Francisco Javier Ortega Puebla

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Order of treatments was randomized by a third person not involved in any of the other phases. Also, after the care provider has inserted the needle in the three groups, another third person without involvement in any other phase of the study choose the assigned treatment between three pre-programmed closed set of parameters in the stimulation machine, thus leaving treatment unknown for the care provider, the participant, the investigator and the outcome assessor, which received only encoded names for the groups.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized intervention of repeated measures, quadruple-blinded

Study Record Dates

• First Submitted: July 8, 2020
• First Posted: July 17, 2020
• Study Start: August 13, 2020
• Primary Completion: October 29, 2020
• Study Completion: October 29, 2020
• Last Updated: February 2, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)