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Completed

NCT Number: NCT04475133

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

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.

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Key information

Conditions

Healthy Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clínica Francisco Ortega Rehabilitación Avanzada, S.L.

Elche, Alicante, 03203, Spain

About this study

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:

  • - 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.
  • - 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.
  • - 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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

  5. 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

  6. 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

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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

  14. 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

  15. 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

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. 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.

  25. 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.

  26. 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.

  27. 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.

  28. 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.

  29. 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.

  30. 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.

Sponsors and collaborators

Lead sponsor

Clinica Francisco Ortega Rehabilitacion Avanzada SL

Other

Registry information

Official study title

Effects of Percutaneous Neuromodulation on Plasticity in the Somatosensory System

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 17, 2020
Registry last updated
Feb 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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