Effects of Percutaneous Neuromodulation on Plasticity in the Somatosensory System in Healthy Subjects
NCT ID: NCT04475133
Last Updated: 2022-02-02
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
29 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-08-13
Study Completion Date
2020-10-29
Brief Summary
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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.
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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Detailed Description
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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.
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
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Healthy
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
CROSSOVER
Randomized intervention of repeated measures, quadruple-blinded
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
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.
Study Groups
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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.
Group Type
EXPERIMENTAL
Ultrasound guided percutaneous neuromodulation
Intervention Type
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
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.
Group Type
EXPERIMENTAL
Ultrasound guided percutaneous neuromodulation
Intervention Type
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
The intervention of ultrasound guided percutaneous neuromodulation is applied over the median nerve without current during 16 minutes.
Group Type
SHAM_COMPARATOR
Ultrasound guided percutaneous neuromodulation
Intervention Type
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
Interventions
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Ultrasound guided percutaneous neuromodulation
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
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
* healthy.
* more than 18 years old
* amateur athlete.
* 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
* 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
Minimum Eligible Age
18 Years
Maximum Eligible Age
40 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Clinica Francisco Ortega Rehabilitacion Avanzada SL
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Patricia Beltrá López
Role: PRINCIPAL_INVESTIGATOR
Clínica Francisco Javier Ortega Puebla
Locations
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Clínica Francisco Ortega Rehabilitación Avanzada, S.L.
Elche, Alicante, Spain
Site Status
Countries
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Spain
References
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Other Identifiers
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NMP19/20-FREMPI
Identifier Type: -
Identifier Source: org_study_id
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