Effects of Percutaneous Neuromodulation on Plasticity in the Somatosensory System in Healthy Subjects
- Conditions
- Healthy
- Interventions
- Other: Ultrasound guided percutaneous neuromodulation
- Registration Number
- NCT04475133
- Lead Sponsor
- Clinica Francisco Ortega Rehabilitacion Avanzada SL
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 29
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Low-frequency and high-intensity Ultrasound guided percutaneous neuromodulation 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. Control group Ultrasound guided percutaneous neuromodulation The intervention of ultrasound guided percutaneous neuromodulation is applied over the median nerve without current during 16 minutes. High-frequency and low-intensity Ultrasound guided percutaneous neuromodulation 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.
- Primary Outcome Measures
Name Time Method Mechanical Threshold elicited with Von Frey Filaments 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 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 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. 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. 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. 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. 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 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. 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. 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 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 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 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 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 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.
- Secondary Outcome Measures
Name Time Method Change in Force grip resistance with surface electromyography. 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.
Change in arterial end-diastolic velocity with Color Doppler Ultrasonography 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.
Arterial end-diastolic velocity with Color Doppler Ultrasonography 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.
Arterial time average maximun velocity during cardiac cycle with Color Doppler 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.
Electric current threshold of perception with high frequency 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.
Change electric current threshold of perception with high frequency 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.
Change in Force grip resistance with dynamometer. 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.
Neural tension test (ROM) 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
Change in neural tension test (ROM) 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
Change in arterial time average mean velocity during cardiac cycle with Color Doppler Ultrasonography 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.
Arterial arterial resistivity index during cardiac cycle with Color Doppler 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.
Force grip resistance with surface electromyography. 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.
Arterial time average mean velocity during cardiac cycle with Color Doppler Ultrasonography 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.
Arterial pulsatility index during cardiac cycle with Color Doppler 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.
Change in Electric current threshold of perception with low frequency 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.
Change in arterial time average mean velocity during cardiac cycle with Color Doppler 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.
Electric current threshold of perception with low frequency 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.
Force grip resistance with dynamometer 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.
Change in arterial time average maximun velocity during cardiac cycle with Color Doppler 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.
Change in arterial pulsatility index during cardiac cycle with Color Doppler 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.
Change in arterial resistivity index during cardiac cycle with Color Doppler 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.
Trial Locations
- Locations (1)
ClÃnica Francisco Ortega Rehabilitación Avanzada, S.L.
🇪🇸Elche, Alicante, Spain