Clinical trial NCT04475133: Effects of Percutaneous Neuromodulation on Plasticity in the Somatosensory System in Healthy Subjects
Official title: Effects of Percutaneous Neuromodulation on Plasticity in the Somatosensory System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Echography guided percutaneous neuromodulation
Plasticity
somatomotor system
Peripheral nerve stimulation
Pain
Lead sponsor: Clinica Francisco Ortega Rehabilitacion Avanzada SL
Sponsor class: OTHER
First posted: 2020-07-17
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized intervention of repeated measures, quadruple-blinded
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mechanical Threshold elicited with Von Frey Filaments
timeFrame: Pre-intervention / baseline
measure: Mechanical Threshold elicited with Von Frey Filaments
timeFrame: Immediately after the intervention
measure: Mechanical Threshold elicited with Von Frey Filaments
timeFrame: 24 hours after the intervention
measure: Pinprick pain threshold elicited with Von Frey Filaments
timeFrame: pre-intervention / baseline
measure: Pinprick pain threshold elicited with Von Frey Filaments
timeFrame: Immediately after the intervention
measure: Pinprick pain threshold elicited with Von Frey Filaments
timeFrame: 24 hours after the intervention
measure: Pain evocated with Von Frey Filaments.
timeFrame: Pre-intervention / baseline
measure: Pain evocated with Von Frey Filaments.
timeFrame: Immediately after the intervention
measure: Pain evocated with Von Frey Filaments.
timeFrame: 24 hours after the intervention
measure: Pressure pain threshold with algometer.
timeFrame: pre-intervention / baseline
measure: Change in pressure pain threshold with algometer.
timeFrame: Immediately after the intervention
measure: Change in pressure pain threshold with algometer.
timeFrame: 24 hours after the intervention
measure: Maximum grip force with dynamometer
timeFrame: pre-intervention / baseline
measure: Change in maximum grip force with dynamometer
timeFrame: Immediately after the intervention
measure: Change in maximum grip force with dynamometer.
timeFrame: 24 hours after the intervention
measure: Maximum grip force with surface electromyography.
timeFrame: pre-intervention / baseline
measure: Change in maximum grip force with surface electromyography.
timeFrame: Immediately after the intervention
measure: Change in maximum grip force with surface electromyography.
timeFrame: 24 hours after the intervention
measure: Arterial peak systolic velocity with Color Doppler Ultrasonography
timeFrame: pre-intervention / baseline
measure: Change in arterial peak systolic velocity with Color Doppler Ultrasonography in placebo group
timeFrame: Immediately after the needle insertion
measure: Change in arterial peak systolic velocity with Color Doppler Ultrasonography
timeFrame: Immediately after the intervention
measure: Arterial volume flow with Color Doppler Ultrasonography
timeFrame: pre-intervention / baseline
measure: Change in arterial volume flow with Color Doppler Ultrasonography
timeFrame: Immediately after the needle insertion
measure: Change in arterial volume flow with Color Doppler Ultrasonography
timeFrame: Immediately after the intervention
Secondary outcomes:
measure: Electric current threshold of perception with low frequency
timeFrame: pre-intervention / baseline
measure: Change in Electric current threshold of perception with low frequency
timeFrame: Immediately after the intervention
measure: Change in Electric current threshold of perception with low frequency
timeFrame: 24 hours after the intervention
measure: Electric current threshold of perception with high frequency
timeFrame: pre-intervention / baseline
measure: Change electric current threshold of perception with high frequency
timeFrame: Immediately after the intervention
measure: Change electric current threshold of perception with high frequency
timeFrame: 24 hours after the intervention
measure: Force grip resistance with dynamometer
timeFrame: Pre-intervention / Baseline
measure: Change in Force grip resistance with dynamometer.
timeFrame: Immediately after the intervention
measure: Change in Force grip resistance with dynamometer.
timeFrame: 24 hours after the intervention
measure: Force grip resistance with surface electromyography.
timeFrame: Pre-intervention / Baseline
measure: Change in Force grip resistance with surface electromyography.
timeFrame: Immediately after the intervention
measure: Change in Force grip resistance with surface electromyography.
timeFrame: 24 hours after the intervention
measure: Neural tension test (ROM)
timeFrame: pre-intervention / baseline
measure: Change in neural tension test (ROM)
timeFrame: Immediately after the intervention
measure: Change in neural tension test (ROM)
timeFrame: 24 hours after the intervention
measure: Change in arterial end-diastolic velocity with Color Doppler Ultrasonography
timeFrame: Immediately after the needle insertion
measure: Arterial time average mean velocity during cardiac cycle with Color Doppler Ultrasonography
timeFrame: pre-intervention / baseline
measure: Change in arterial time average mean velocity during cardiac cycle with Color Doppler Ultrasonography
timeFrame: Immediately after the needle insertion
measure: Arterial end-diastolic velocity with Color Doppler Ultrasonography
timeFrame: pre-intervention / baseline
measure: Change in arterial end-diastolic velocity with Color Doppler Ultrasonography
timeFrame: Immediately after the intervention
measure: Change in arterial time average mean velocity during cardiac cycle with Color Doppler
timeFrame: Immediately after the intervention
measure: Arterial time average maximun velocity during cardiac cycle with Color Doppler
timeFrame: pre-intervention / baseline
measure: Change in arterial time average maximun velocity during cardiac cycle with Color Doppler
timeFrame: Immediately after the needle insertion
measure: Change in arterial time average maximun velocity during cardiac cycle with Color Doppler
timeFrame: Immediately after the intervention
measure: Arterial pulsatility index during cardiac cycle with Color Doppler
timeFrame: pre-intervention / baseline
measure: Change in arterial pulsatility index during cardiac cycle with Color Doppler
timeFrame: Immediately after the needle insertion
measure: Change in arterial pulsatility index during cardiac cycle with Color Doppler
timeFrame: Immediately after the intervention
measure: Arterial arterial resistivity index during cardiac cycle with Color Doppler
timeFrame: pre-intervention / baseline
measure: Change in arterial resistivity index during cardiac cycle with Color Doppler
timeFrame: Immediately after the needle insertion
measure: Change in arterial resistivity index during cardiac cycle with Color Doppler
timeFrame: Immediately after the intervention
Other outcomes:
Locations:
city: Elche
country: Spain
facility: Clínica Francisco Ortega Rehabilitación Avanzada, S.L.
state: Alicante
Study officials:
affiliation: Clínica Francisco Javier Ortega Puebla
name: Patricia Beltrá López
role: PRINCIPAL_INVESTIGATOR
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