HealthyNCT04475133
Effects of Percutaneous Neuromodulation on Plasticity in the Somatosensory System in Healthy Subjects
A study testing Ultrasound guided percutaneous neuromodulation in people with Healthy, run by Clinica Francisco Ortega Rehabilitacion Avanzada SL at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Ultrasound guided percutaneous neuromodulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteSpain
- Study dates
- 13 Aug 2020to 29 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy.
- more than 18 years old
- amateur athlete.
Who cannot join
- 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.
Show all 10Show fewer
- belonephobia.
- professional athlete
- to be pregnant
- to suffer immunodepression
Trial locations and contacts
1 site in 1 country.
Spain1 site
Clínica Francisco Ortega Rehabilitación Avanzada, S.L.
Elche, Alicante, 03203
About this study
Official title: Effects of Percutaneous Neuromodulation on Plasticity in the Somatosensory System
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.
Read the 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:
- - 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.
- - 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.
- - 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
- Healthy
- Being tested
- Ultrasound guided percutaneous neuromodulation
- Keywords
- Echography guided percutaneous neuromodulation, Plasticity, somatomotor system, Peripheral nerve stimulation, Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided percutaneous neuromodulationOther
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
| Study group | Role | What they receive |
|---|---|---|
| Low-frequency and high-intensity | Experimental | 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. Receives: Other: Ultrasound guided percutaneous neuromodulation |
| High-frequency and low-intensity | Experimental | 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. Receives: Other: Ultrasound guided percutaneous neuromodulation |
| Control group | Sham comparator | The intervention of ultrasound guided percutaneous neuromodulation is applied over the median nerve without current during 16 minutes. Receives: Other: Ultrasound guided percutaneous neuromodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mechanical Threshold elicited with Von Frey Filaments
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
Measured: Pre-intervention / baseline
Mechanical Threshold elicited with Von Frey Filaments
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.
Measured: Immediately after the intervention
Mechanical Threshold elicited with Von Frey Filaments
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.
Measured: 24 hours after the intervention
Pinprick pain threshold elicited with Von Frey Filaments
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
Measured: pre-intervention / baseline
Pinprick pain threshold elicited with Von Frey Filaments
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
Measured: Immediately after the intervention
Pinprick pain threshold elicited with Von Frey Filaments
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
Measured: 24 hours after the intervention
Pain evocated with Von Frey Filaments.
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.
Measured: Pre-intervention / baseline
Pain evocated with Von Frey Filaments.
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.
Measured: Immediately after the intervention
Pain evocated with Von Frey Filaments.
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.
Measured: 24 hours after the intervention
Pressure pain threshold with algometer.
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.
Measured: pre-intervention / baseline
Change in pressure pain threshold with algometer.
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.
Measured: Immediately after the intervention
Change in pressure pain threshold with algometer.
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.
Measured: 24 hours after the intervention
Maximum grip force with dynamometer
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.
Measured: pre-intervention / baseline
Change in maximum grip force with dynamometer
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.
Measured: Immediately after the intervention
Change in maximum grip force with dynamometer.
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.
Measured: 24 hours after the intervention
Maximum grip force with surface electromyography.
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.
Measured: pre-intervention / baseline
Change in maximum grip force with surface electromyography.
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.
Measured: Immediately after the intervention
Change in maximum grip force with surface electromyography.
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.
Measured: 24 hours after the intervention
Arterial peak systolic velocity with Color Doppler Ultrasonography
On the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial peak systolic during 5 cardiac cycles.
Measured: pre-intervention / baseline
Change in arterial peak systolic velocity with Color Doppler Ultrasonography in placebo group
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.
Measured: Immediately after the needle insertion
Change in arterial peak systolic velocity with Color Doppler Ultrasonography
On the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial peak systolic during 5 cardiac cycles.
Measured: Immediately after the intervention
Arterial volume flow with Color Doppler Ultrasonography
On the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial volume flow during 5 cardiac cycles.
Measured: pre-intervention / baseline
Change in arterial volume flow with Color Doppler Ultrasonography
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.
Measured: Immediately after the needle insertion
Change in arterial volume flow with Color Doppler Ultrasonography
On the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial volume flow during 5 cardiac cycles.
Measured: Immediately after the intervention
Secondary outcomes (30)
Electric current threshold of perception with low frequency
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.
Measured: pre-intervention / baseline
Change in Electric current threshold of perception with low frequency
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.
Measured: Immediately after the intervention
Change in Electric current threshold of perception with low frequency
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.
Measured: 24 hours after the intervention
Electric current threshold of perception with high frequency
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.
Measured: pre-intervention / baseline
Change electric current threshold of perception with high frequency
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.
Measured: Immediately after the intervention
Change electric current threshold of perception with high frequency
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.
Measured: 24 hours after the intervention
Force grip resistance with dynamometer
The subject is standing with the dynamometer in his hand. He/she must press the dynamometer during one minute trying to maintain maximal force.
Measured: Pre-intervention / Baseline
Change in Force grip resistance with dynamometer.
The subject is standing with the dynamometer in his hand. He/she must press the dynamometer during one minute trying to maintain maximal force.
Measured: Immediately after the intervention
Change in Force grip resistance with dynamometer.
The subject is standing with the dynamometer in his hand. He/she must press the dynamometer during one minute trying to maintain maximal force.
Measured: 24 hours after the intervention
Force grip resistance with surface electromyography.
The subject is standing with the dynamometer in his hand. He/she must press the dynamometer during one minute trying to maintain maximal force.
Measured: Pre-intervention / Baseline
Change in Force grip resistance with surface electromyography.
The subject is standing with the dynamometer in his hand. He/she must press the dynamometer during one minute trying to maintain maximal force.
Measured: Immediately after the intervention
Change in Force grip resistance with surface electromyography.
The subject is standing with the dynamometer in his hand. He/she must press the dynamometer during one minute trying to maintain maximal force.
Measured: 24 hours after the intervention
Neural tension test (ROM)
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
Measured: pre-intervention / baseline
Change in neural tension test (ROM)
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
Measured: Immediately after the intervention
Change in neural tension test (ROM)
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
Measured: 24 hours after the intervention
Change in arterial end-diastolic velocity with Color Doppler Ultrasonography
In the placebo group, on the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial end-diastolic velocity during 5 cardiac cycles.
Measured: Immediately after the needle insertion
Arterial time average mean velocity during cardiac cycle with Color Doppler Ultrasonography
On the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial time average mean velocity during 5 cardiac cycles.
Measured: pre-intervention / baseline
Change in arterial time average mean velocity during cardiac cycle with Color Doppler Ultrasonography
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.
Measured: Immediately after the needle insertion
Arterial end-diastolic velocity with Color Doppler Ultrasonography
On the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial end-diastolic velocity during 5 cardiac cycles.
Measured: pre-intervention / baseline
Change in arterial end-diastolic velocity with Color Doppler Ultrasonography
On the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial end-diastolic velocity during 5 cardiac cycles.
Measured: Immediately after the intervention
Change in arterial time average mean velocity during cardiac cycle with Color Doppler
On the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial time average mean velocity during 5 cardiac cycles.
Measured: Immediately after the intervention
Arterial time average maximun velocity during cardiac cycle with Color Doppler
On the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial time average maximun velocity during 5 cardiac cycles.
Measured: pre-intervention / baseline
Change in arterial time average maximun velocity during cardiac cycle with Color Doppler
In placebo group, on the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial time average maximun velocity during 5 cardiac cycles.
Measured: Immediately after the needle insertion
Change in arterial time average maximun velocity during cardiac cycle with Color Doppler
On the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial time average maximun velocity during 5 cardiac cycles.
Measured: Immediately after the intervention
Arterial pulsatility index during cardiac cycle with Color Doppler
On the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial pulsatility index during 5 cardiac cycles.
Measured: pre-intervention / baseline
Change in arterial pulsatility index during cardiac cycle with Color Doppler
In placebo group, on the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial pulsatility index during 5 cardiac cycles.
Measured: Immediately after the needle insertion
Change in arterial pulsatility index during cardiac cycle with Color Doppler
On the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial pulsatility index during 5 cardiac cycles.
Measured: Immediately after the intervention
Arterial arterial resistivity index during cardiac cycle with Color Doppler
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.
Measured: pre-intervention / baseline
Change in arterial resistivity index during cardiac cycle with Color Doppler
On the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial resistivity index during 5 cardiac cycles.
Measured: Immediately after the needle insertion
Change in arterial resistivity index during cardiac cycle with Color Doppler
On the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial resistivity index during 5 cardiac cycles.
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start13 Aug 2020
- Primary completion29 Oct 2020
- Study completion29 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (50)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized intervention of repeated measures, quadruple-blinded
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Francisco Ortega Rehabilitacion Avanzada SL
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patricia Beltrá López, Principal investigator, Clínica Francisco Javier Ortega Puebla
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04475133
- Sponsor's protocol ID
- NMP19/20-FREMPI
- Status last verified
- Jan 2022
- First submitted
- 8 Jul 2020
- Last updated
- 2 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wilson RD, Harris MA, Gunzler DD, Bennett ME, Chae J. Percutaneous peripheral nerve stimulation for chronic pain in subacromial impingement syndrome: a case series. Neuromodulation. 2014 Dec;17(8):771-6; discussion 776. doi: 10.1111/ner.12152. Epub 2014 Feb 11.
PubMed 24512114Toprak U, Selvi NA, Ates A, Erhuner Z, Bostanoglu S, Karademir MA, Karaaslan Y. Dynamic Doppler evaluation of the hand arteries of the patients with Raynaud's disease. Clin Rheumatol. 2009 Jun;28(6):679-83. doi: 10.1007/s10067-009-1131-1. Epub 2009 Feb 24.
PubMed 19238503Barlas P, Ting SL, Chesterton LS, Jones PW, Sim J. Effects of intensity of electroacupuncture upon experimental pain in healthy human volunteers: a randomized, double-blind, placebo-controlled study. Pain. 2006 May;122(1-2):81-9. doi: 10.1016/j.pain.2006.01.012. Epub 2006 Mar 9.
PubMed 16527396Bliss TV, Collingridge GL. A synaptic model of memory: long-term potentiation in the hippocampus. Nature. 1993 Jan 7;361(6407):31-9. doi: 10.1038/361031a0.
PubMed 8421494Bliss TV, Lomo T. Long-lasting potentiation of synaptic transmission in the dentate area of the anaesthetized rabbit following stimulation of the perforant path. J Physiol. 1973 Jul;232(2):331-56. doi: 10.1113/jphysiol.1973.sp010273.
PubMed 4727084Borg-Stein J, Simons DG. Focused review: myofascial pain. Arch Phys Med Rehabil. 2002 Mar;83(3 Suppl 1):S40-7, S48-9. doi: 10.1053/apmr.2002.32155.
PubMed 11973695Chae J, Wilson RD, Bennett ME, Lechman TE, Stager KW. Single-lead percutaneous peripheral nerve stimulation for the treatment of hemiplegic shoulder pain: a case series. Pain Pract. 2013 Jan;13(1):59-67. doi: 10.1111/j.1533-2500.2012.00541.x. Epub 2012 Mar 26.
PubMed 22448759Chapman CR, Gavrin J. Suffering: the contributions of persistent pain. Lancet. 1999 Jun 26;353(9171):2233-7. doi: 10.1016/S0140-6736(99)01308-2.
PubMed 10393002Chan AW, MacFarlane IA, Bowsher D, Campbell JA. Weighted needle pinprick sensory thresholds: a simple test of sensory function in diabetic peripheral neuropathy. J Neurol Neurosurg Psychiatry. 1992 Jan;55(1):56-9. doi: 10.1136/jnnp.55.1.56.
PubMed 1312581Corneil BD, Goonetilleke SC, Peel TR, Green KA, Welch ID. Ultrasound-guided insertion of intramuscular electrodes into suboccipital muscles in the non-human primate. J Electromyogr Kinesiol. 2012 Aug;22(4):553-9. doi: 10.1016/j.jelekin.2012.02.014. Epub 2012 Mar 22.
PubMed 22445030Dommerholt J. Dry needling - peripheral and central considerations. J Man Manip Ther. 2011 Nov;19(4):223-7. doi: 10.1179/106698111X13129729552065.
PubMed 23115475Domingo A, Mayoral O, Monterde S, Santafe MM. Neuromuscular damage and repair after dry needling in mice. Evid Based Complement Alternat Med. 2013;2013:260806. doi: 10.1155/2013/260806. Epub 2013 Apr 9.
PubMed 23662122Dubuisson D. Effect of dorsal-column stimulation on gelatinosa and marginal neurons of cat spinal cord. J Neurosurg. 1989 Feb;70(2):257-65. doi: 10.3171/jns.1989.70.2.0257.
PubMed 2913223Falowski S, Celii A, Sharan A. Spinal cord stimulation: an update. Neurotherapeutics. 2008 Jan;5(1):86-99. doi: 10.1016/j.nurt.2007.10.066.
PubMed 18164487Finnerup NB, Sindrup SH, Jensen TS. Recent advances in pharmacological treatment of neuropathic pain. F1000 Med Rep. 2010 Jul 14;2:52. doi: 10.3410/M2-52.
PubMed 21170362
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Percutaneous Neuromodulation on Plasticity in the Somatosensory System
- ClinicalTrials.gov ID
- NCT04475133
- Acronym / sponsor ID
- NMP19/20-FREMPI
- Conditions
- Healthy
- Keywords
- Echography guided percutaneous neuromodulation, Plasticity, somatomotor system, Peripheral nerve stimulation, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Clinica Francisco Ortega Rehabilitacion Avanzada SLUniversity, hospital or other
- Study start
- 13 Aug 2020 (actual)
- Primary completion
- 29 Oct 2020 (actual)
- Study completion
- 29 Oct 2020 (actual)
- First posted
- 17 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- - 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.
- - 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.
- - 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized intervention of repeated measures, quadruple-blinded
| Arm | Type | Receives |
|---|---|---|
| Low-frequency and high-intensity | Experimental | Other: Ultrasound guided percutaneous neuromodulationThe 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. |
| High-frequency and low-intensity | Experimental | Other: Ultrasound guided percutaneous neuromodulationThe 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. |
| Control group | Sham comparator | Other: Ultrasound guided percutaneous neuromodulationThe intervention of ultrasound guided percutaneous neuromodulation is applied over the median nerve without current during 16 minutes. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy.
- more than 18 years old
- amateur athlete.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound 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 | Other | Control group, High-frequency and low-intensity, Low-frequency and high-intensity |
Primary outcome
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.
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.
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
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: 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.
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.
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: 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 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.
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.
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.
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: 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 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.
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 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.
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.
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.
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.
30 secondary outcomes
Electric current threshold of perception with low frequency
Time frame: pre-intervention / baseline
Change in Electric current threshold of perception with low frequency
Time frame: Immediately after the intervention
Change in Electric current threshold of perception with low frequency
Time frame: 24 hours after the intervention
Electric current threshold of perception with high frequency
Time frame: pre-intervention / baseline
Change electric current threshold of perception with high frequency
Time frame: Immediately after the intervention
Change electric current threshold of perception with high frequency
Time frame: 24 hours after the intervention
Force grip resistance with dynamometer
Time frame: Pre-intervention / Baseline
Change in Force grip resistance with dynamometer.
Time frame: Immediately after the intervention
Change in Force grip resistance with dynamometer.
Time frame: 24 hours after the intervention
Force grip resistance with surface electromyography.
Time frame: Pre-intervention / Baseline
Change in Force grip resistance with surface electromyography.
Time frame: Immediately after the intervention
Change in Force grip resistance with surface electromyography.
Time frame: 24 hours after the intervention
Neural tension test (ROM)
Time frame: pre-intervention / baseline
Change in neural tension test (ROM)
Time frame: Immediately after the intervention
Change in neural tension test (ROM)
Time frame: 24 hours after the intervention
Change in arterial end-diastolic velocity with Color Doppler Ultrasonography
Time frame: Immediately after the needle insertion
Arterial time average mean velocity during cardiac cycle with Color Doppler Ultrasonography
Time frame: pre-intervention / baseline
Change in arterial time average mean velocity during cardiac cycle with Color Doppler Ultrasonography
Time frame: Immediately after the needle insertion
Arterial end-diastolic velocity with Color Doppler Ultrasonography
Time frame: pre-intervention / baseline
Change in arterial end-diastolic velocity with Color Doppler Ultrasonography
Time frame: Immediately after the intervention
Change in arterial time average mean velocity during cardiac cycle with Color Doppler
Time frame: Immediately after the intervention
Arterial time average maximun velocity during cardiac cycle with Color Doppler
Time frame: pre-intervention / baseline
Change in arterial time average maximun velocity during cardiac cycle with Color Doppler
Time frame: Immediately after the needle insertion
Change in arterial time average maximun velocity during cardiac cycle with Color Doppler
Time frame: Immediately after the intervention
Arterial pulsatility index during cardiac cycle with Color Doppler
Time frame: pre-intervention / baseline
Change in arterial pulsatility index during cardiac cycle with Color Doppler
Time frame: Immediately after the needle insertion
Change in arterial pulsatility index during cardiac cycle with Color Doppler
Time frame: Immediately after the intervention
Arterial arterial resistivity index during cardiac cycle with Color Doppler
Time frame: pre-intervention / baseline
Change in arterial resistivity index during cardiac cycle with Color Doppler
Time frame: Immediately after the needle insertion
Change in arterial resistivity index during cardiac cycle with Color Doppler
Time frame: Immediately after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2022.
- Background: PubMed 24512114Wilson RD, Harris MA, Gunzler DD, Bennett ME, Chae J. Percutaneous peripheral nerve stimulation for chronic pain in subacromial impingement syndrome: a case series. Neuromodulation. 2014 Dec;17(8):771-6; discussion 776. doi: 10.1111/ner.12152. Epub 2014 Feb 11.
- Background: PubMed 19238503Toprak U, Selvi NA, Ates A, Erhuner Z, Bostanoglu S, Karademir MA, Karaaslan Y. Dynamic Doppler evaluation of the hand arteries of the patients with Raynaud's disease. Clin Rheumatol. 2009 Jun;28(6):679-83. doi: 10.1007/s10067-009-1131-1. Epub 2009 Feb 24.
- Results publication: PubMed 16527396Barlas P, Ting SL, Chesterton LS, Jones PW, Sim J. Effects of intensity of electroacupuncture upon experimental pain in healthy human volunteers: a randomized, double-blind, placebo-controlled study. Pain. 2006 May;122(1-2):81-9. doi: 10.1016/j.pain.2006.01.012. Epub 2006 Mar 9.
- Results publication: PubMed 8421494Bliss TV, Collingridge GL. A synaptic model of memory: long-term potentiation in the hippocampus. Nature. 1993 Jan 7;361(6407):31-9. doi: 10.1038/361031a0.
- Results publication: PubMed 4727084Bliss TV, Lomo T. Long-lasting potentiation of synaptic transmission in the dentate area of the anaesthetized rabbit following stimulation of the perforant path. J Physiol. 1973 Jul;232(2):331-56. doi: 10.1113/jphysiol.1973.sp010273.
- Results publication: PubMed 11973695Borg-Stein J, Simons DG. Focused review: myofascial pain. Arch Phys Med Rehabil. 2002 Mar;83(3 Suppl 1):S40-7, S48-9. doi: 10.1053/apmr.2002.32155.
- Results publication: PubMed 22448759Chae J, Wilson RD, Bennett ME, Lechman TE, Stager KW. Single-lead percutaneous peripheral nerve stimulation for the treatment of hemiplegic shoulder pain: a case series. Pain Pract. 2013 Jan;13(1):59-67. doi: 10.1111/j.1533-2500.2012.00541.x. Epub 2012 Mar 26.
- Results publication: PubMed 10393002Chapman CR, Gavrin J. Suffering: the contributions of persistent pain. Lancet. 1999 Jun 26;353(9171):2233-7. doi: 10.1016/S0140-6736(99)01308-2.
- Results publication: PubMed 1312581Chan AW, MacFarlane IA, Bowsher D, Campbell JA. Weighted needle pinprick sensory thresholds: a simple test of sensory function in diabetic peripheral neuropathy. J Neurol Neurosurg Psychiatry. 1992 Jan;55(1):56-9. doi: 10.1136/jnnp.55.1.56.
- Results publication: PubMed 22445030Corneil BD, Goonetilleke SC, Peel TR, Green KA, Welch ID. Ultrasound-guided insertion of intramuscular electrodes into suboccipital muscles in the non-human primate. J Electromyogr Kinesiol. 2012 Aug;22(4):553-9. doi: 10.1016/j.jelekin.2012.02.014. Epub 2012 Mar 22.
- Results publication: PubMed 23115475Dommerholt J. Dry needling - peripheral and central considerations. J Man Manip Ther. 2011 Nov;19(4):223-7. doi: 10.1179/106698111X13129729552065.
- Results publication: PubMed 23662122Domingo A, Mayoral O, Monterde S, Santafe MM. Neuromuscular damage and repair after dry needling in mice. Evid Based Complement Alternat Med. 2013;2013:260806. doi: 10.1155/2013/260806. Epub 2013 Apr 9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia Beltrá López principal investigator
Clínica Francisco Javier Ortega Puebla
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided percutaneous neuromodulation in people with Healthy, run by Clinica Francisco Ortega Rehabilitacion Avanzada SL at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mechanical Threshold elicited with Von Frey Filaments (time frame: Pre-intervention / baseline). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04475133, which also lists 50 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2022.