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CompletedNCT04475133

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

Effects of Percutaneous Neuromodulation on Plasticity in the Somatosensory System

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
29 (actual)
Sponsor
Clinica Francisco Ortega Rehabilitacion Avanzada SL · Academic / Other
Sex
All
Age
18 Years – 40 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERUltrasound guided percutaneous neuromodulationIt 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

Timeline

Start date
2020-08-13
Primary completion
2020-10-29
Completion
2020-10-29
First posted
2020-07-17
Last updated
2022-02-02

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT04475133. Inclusion in this directory is not an endorsement.

Effects of Percutaneous Neuromodulation on Plasticity in the Somatosensory System in Healthy Subjects (NCT04475133) · Clinical Trials Directory