Effects of Percutaneous Neuromodulation on Plasticity in the Somatosensory System
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 29
- Locations
- 1
- Primary Endpoint
- Mechanical Threshold elicited with Von Frey Filaments
Study Overview
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:
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- 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.
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- 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.
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- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Arms & Interventions
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.
Intervention: Ultrasound guided percutaneous neuromodulation (Other)
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.
Intervention: Ultrasound guided percutaneous neuromodulation (Other)
Control group
The intervention of ultrasound guided percutaneous neuromodulation is applied over the median nerve without current during 16 minutes.
Intervention: Ultrasound guided percutaneous neuromodulation (Other)
Outcomes
Primary Outcomes
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.
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.
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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.
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
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
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.
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.
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.
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.
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.
Secondary Outcomes
- Change in arterial time average maximun velocity during cardiac cycle with Color Doppler(Immediately after the intervention)
- Change in Force grip resistance with surface electromyography.(24 hours after the intervention)
- Change in arterial end-diastolic velocity with Color Doppler Ultrasonography(Immediately after the intervention)
- Arterial end-diastolic velocity with Color Doppler Ultrasonography(pre-intervention / baseline)
- Arterial time average maximun velocity during cardiac cycle with Color Doppler(pre-intervention / baseline)
- Electric current threshold of perception with high frequency(pre-intervention / baseline)
- Change electric current threshold of perception with high frequency(24 hours after the intervention)
- Change in Force grip resistance with dynamometer.(24 hours after the intervention)
- Neural tension test (ROM)(pre-intervention / baseline)
- Change in neural tension test (ROM)(24 hours after the intervention)
- Change in arterial time average mean velocity during cardiac cycle with Color Doppler Ultrasonography(Immediately after the needle insertion)
- Arterial arterial resistivity index during cardiac cycle with Color Doppler(pre-intervention / baseline)
- Force grip resistance with surface electromyography.(Pre-intervention / Baseline)
- Arterial time average mean velocity during cardiac cycle with Color Doppler Ultrasonography(pre-intervention / baseline)
- Arterial pulsatility index during cardiac cycle with Color Doppler(pre-intervention / baseline)
- Change in Electric current threshold of perception with low frequency(24 hours after the intervention)
- Change in arterial time average mean velocity during cardiac cycle with Color Doppler(Immediately after the intervention)
- Electric current threshold of perception with low frequency(pre-intervention / baseline)
- Force grip resistance with dynamometer(Pre-intervention / Baseline)
- Change in arterial pulsatility index during cardiac cycle with Color Doppler(Immediately after the intervention)
- Change in arterial resistivity index during cardiac cycle with Color Doppler(Immediately after the intervention)
- Change in Electric current threshold of perception with low frequency(Immediately after the intervention)
- Change electric current threshold of perception with high frequency(Immediately after the intervention)
- Change in Force grip resistance with dynamometer.(Immediately after the intervention)
- Change in Force grip resistance with surface electromyography.(Immediately after the intervention)
- Change in neural tension test (ROM)(Immediately after the intervention)
- Change in arterial end-diastolic velocity with Color Doppler Ultrasonography(Immediately after the needle insertion)
- Change in arterial time average maximun velocity during cardiac cycle with Color Doppler(Immediately after the needle insertion)
- Change in arterial pulsatility index during cardiac cycle with Color Doppler(Immediately after the needle insertion)
- Change in arterial resistivity index during cardiac cycle with Color Doppler(Immediately after the needle insertion)