Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2026-02-28 @ 10:02 AM
Study NCT ID:
NCT04475133
Status:
COMPLETED
Last Update Posted:
2022-02-02
First Post:
2020-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Percutaneous Neuromodulation on Plasticity in the Somatosensory System in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': '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.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomized intervention of repeated measures, quadruple-blinded'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2020-10-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-19', 'studyFirstSubmitDate': '2020-07-08', 'studyFirstSubmitQcDate': '2020-07-16', 'lastUpdatePostDateStruct': {'date': '2022-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mechanical Threshold elicited with Von Frey Filaments', 'timeFrame': 'Pre-intervention / baseline', 'description': "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"}, {'measure': 'Mechanical Threshold elicited with Von Frey Filaments', 'timeFrame': 'Immediately after the intervention', 'description': "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."}, {'measure': 'Mechanical Threshold elicited with Von Frey Filaments', 'timeFrame': '24 hours after the intervention', 'description': "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."}, {'measure': 'Pinprick pain threshold elicited with Von Frey Filaments', 'timeFrame': 'pre-intervention / baseline', 'description': "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"}, {'measure': 'Pinprick pain threshold elicited with Von Frey Filaments', 'timeFrame': 'Immediately after the intervention', 'description': "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"}, {'measure': 'Pinprick pain threshold elicited with Von Frey Filaments', 'timeFrame': '24 hours after the intervention', 'description': "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"}, {'measure': 'Pain evocated with Von Frey Filaments.', 'timeFrame': 'Pre-intervention / baseline', 'description': "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."}, {'measure': 'Pain evocated with Von Frey Filaments.', 'timeFrame': 'Immediately after the intervention', 'description': "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."}, {'measure': 'Pain evocated with Von Frey Filaments.', 'timeFrame': '24 hours after the intervention', 'description': "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."}, {'measure': 'Pressure pain threshold with algometer.', 'timeFrame': 'pre-intervention / baseline', 'description': '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.'}, {'measure': 'Change in pressure pain threshold with algometer.', 'timeFrame': 'Immediately after the intervention', 'description': '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.'}, {'measure': 'Change in pressure pain threshold with algometer.', 'timeFrame': '24 hours after the intervention', 'description': '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.'}, {'measure': 'Maximum grip force with dynamometer', 'timeFrame': 'pre-intervention / baseline', 'description': '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.'}, {'measure': 'Change in maximum grip force with dynamometer', 'timeFrame': 'Immediately after the intervention', 'description': '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.'}, {'measure': 'Change in maximum grip force with dynamometer.', 'timeFrame': '24 hours after the intervention', 'description': '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.'}, {'measure': 'Maximum grip force with surface electromyography.', 'timeFrame': 'pre-intervention / baseline', 'description': '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.'}, {'measure': 'Change in maximum grip force with surface electromyography.', 'timeFrame': 'Immediately after the intervention', 'description': '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.'}, {'measure': 'Change in maximum grip force with surface electromyography.', 'timeFrame': '24 hours after the intervention', 'description': '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.'}, {'measure': 'Arterial peak systolic velocity with Color Doppler Ultrasonography', 'timeFrame': 'pre-intervention / baseline', 'description': 'On the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial peak systolic during 5 cardiac cycles.'}, {'measure': 'Change in arterial peak systolic velocity with Color Doppler Ultrasonography in placebo group', 'timeFrame': 'Immediately after the needle insertion', 'description': '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.'}, {'measure': 'Change in arterial peak systolic velocity with Color Doppler Ultrasonography', 'timeFrame': 'Immediately after the intervention', 'description': 'On the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial peak systolic during 5 cardiac cycles.'}, {'measure': 'Arterial volume flow with Color Doppler Ultrasonography', 'timeFrame': 'pre-intervention / baseline', 'description': 'On the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial volume flow during 5 cardiac cycles.'}, {'measure': 'Change in arterial volume flow with Color Doppler Ultrasonography', 'timeFrame': 'Immediately after the needle insertion', 'description': '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.'}, {'measure': 'Change in arterial volume flow with Color Doppler Ultrasonography', 'timeFrame': 'Immediately after the intervention', 'description': 'On the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial volume flow during 5 cardiac cycles.'}], 'secondaryOutcomes': [{'measure': 'Electric current threshold of perception with low frequency', 'timeFrame': 'pre-intervention / baseline', 'description': '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.'}, {'measure': 'Change in Electric current threshold of perception with low frequency', 'timeFrame': 'Immediately after the intervention', 'description': '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.'}, {'measure': 'Change in Electric current threshold of perception with low frequency', 'timeFrame': '24 hours after the intervention', 'description': '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.'}, {'measure': 'Electric current threshold of perception with high frequency', 'timeFrame': 'pre-intervention / baseline', 'description': '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.'}, {'measure': 'Change electric current threshold of perception with high frequency', 'timeFrame': 'Immediately after the intervention', 'description': '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.'}, {'measure': 'Change electric current threshold of perception with high frequency', 'timeFrame': '24 hours after the intervention', 'description': '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.'}, {'measure': 'Force grip resistance with dynamometer', 'timeFrame': 'Pre-intervention / Baseline', 'description': 'The subject is standing with the dynamometer in his hand. He/she must press the dynamometer during one minute trying to maintain maximal force.'}, {'measure': 'Change in Force grip resistance with dynamometer.', 'timeFrame': 'Immediately after the intervention', 'description': 'The subject is standing with the dynamometer in his hand. He/she must press the dynamometer during one minute trying to maintain maximal force.'}, {'measure': 'Change in Force grip resistance with dynamometer.', 'timeFrame': '24 hours after the intervention', 'description': 'The subject is standing with the dynamometer in his hand. He/she must press the dynamometer during one minute trying to maintain maximal force.'}, {'measure': 'Force grip resistance with surface electromyography.', 'timeFrame': 'Pre-intervention / Baseline', 'description': 'The subject is standing with the dynamometer in his hand. He/she must press the dynamometer during one minute trying to maintain maximal force.'}, {'measure': 'Change in Force grip resistance with surface electromyography.', 'timeFrame': 'Immediately after the intervention', 'description': 'The subject is standing with the dynamometer in his hand. He/she must press the dynamometer during one minute trying to maintain maximal force.'}, {'measure': 'Change in Force grip resistance with surface electromyography.', 'timeFrame': '24 hours after the intervention', 'description': 'The subject is standing with the dynamometer in his hand. He/she must press the dynamometer during one minute trying to maintain maximal force.'}, {'measure': 'Neural tension test (ROM)', 'timeFrame': 'pre-intervention / baseline', 'description': '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'}, {'measure': 'Change in neural tension test (ROM)', 'timeFrame': 'Immediately after the intervention', 'description': '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'}, {'measure': 'Change in neural tension test (ROM)', 'timeFrame': '24 hours after the intervention', 'description': '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'}, {'measure': 'Change in arterial end-diastolic velocity with Color Doppler Ultrasonography', 'timeFrame': 'Immediately after the needle insertion', 'description': '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.'}, {'measure': 'Arterial time average mean velocity during cardiac cycle with Color Doppler Ultrasonography', 'timeFrame': 'pre-intervention / baseline', 'description': 'On the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial time average mean velocity during 5 cardiac cycles.'}, {'measure': 'Change in arterial time average mean velocity during cardiac cycle with Color Doppler Ultrasonography', 'timeFrame': 'Immediately after the needle insertion', 'description': '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.'}, {'measure': 'Arterial end-diastolic velocity with Color Doppler Ultrasonography', 'timeFrame': 'pre-intervention / baseline', 'description': 'On the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial end-diastolic velocity during 5 cardiac cycles.'}, {'measure': 'Change in arterial end-diastolic velocity with Color Doppler Ultrasonography', 'timeFrame': 'Immediately after the intervention', 'description': 'On the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial end-diastolic velocity during 5 cardiac cycles.'}, {'measure': 'Change in arterial time average mean velocity during cardiac cycle with Color Doppler', 'timeFrame': 'Immediately after the intervention', 'description': 'On the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial time average mean velocity during 5 cardiac cycles.'}, {'measure': 'Arterial time average maximun velocity during cardiac cycle with Color Doppler', 'timeFrame': 'pre-intervention / baseline', 'description': 'On the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial time average maximun velocity during 5 cardiac cycles.'}, {'measure': 'Change in arterial time average maximun velocity during cardiac cycle with Color Doppler', 'timeFrame': 'Immediately after the needle insertion', 'description': '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.'}, {'measure': 'Change in arterial time average maximun velocity during cardiac cycle with Color Doppler', 'timeFrame': 'Immediately after the intervention', 'description': 'On the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial time average maximun velocity during 5 cardiac cycles.'}, {'measure': 'Arterial pulsatility index during cardiac cycle with Color Doppler', 'timeFrame': 'pre-intervention / baseline', 'description': 'On the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial pulsatility index during 5 cardiac cycles.'}, {'measure': 'Change in arterial pulsatility index during cardiac cycle with Color Doppler', 'timeFrame': 'Immediately after the needle insertion', 'description': '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.'}, {'measure': 'Change in arterial pulsatility index during cardiac cycle with Color Doppler', 'timeFrame': 'Immediately after the intervention', 'description': 'On the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial pulsatility index during 5 cardiac cycles.'}, {'measure': 'Arterial arterial resistivity index during cardiac cycle with Color Doppler', 'timeFrame': 'pre-intervention / baseline', 'description': '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.'}, {'measure': 'Change in arterial resistivity index during cardiac cycle with Color Doppler', 'timeFrame': 'Immediately after the needle insertion', 'description': 'On the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial resistivity index during 5 cardiac cycles.'}, {'measure': 'Change in arterial resistivity index during cardiac cycle with Color Doppler', 'timeFrame': 'Immediately after the intervention', 'description': 'On the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial resistivity index during 5 cardiac cycles.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Echography guided percutaneous neuromodulation', 'Plasticity', 'somatomotor system', 'Peripheral nerve stimulation', 'Pain'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '24512114', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '19238503', 'type': 'BACKGROUND', 'citation': "Toprak 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."}, {'pmid': '16527396', 'type': 'RESULT', 'citation': 'Barlas 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.'}, {'pmid': '8421494', 'type': 'RESULT', 'citation': 'Bliss 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.'}, {'pmid': '4727084', 'type': 'RESULT', 'citation': 'Bliss 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.'}, {'pmid': '11973695', 'type': 'RESULT', 'citation': 'Borg-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.'}, {'pmid': '22448759', 'type': 'RESULT', 'citation': 'Chae 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. 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Fisioterapia, 32(6), 271-278.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.', 'detailedDescription': '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.\n\nThe protocols are the following:\n\n1. \\- 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.\n2. \\- 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.\n3. \\- placebo group has got the same intervention, but without current.\n\nThe 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.\n\nSomatomotor 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* healthy.\n* more than 18 years old\n* amateur athlete.\n\nExclusion criteria:\n\n* to suffer or to have suffered any pathology on the arm on the last 30 days.\n* to suffer some disease discouraging current application or needle¡ing, as coagulation deficit, etc.\n* to suffer some disease as diabetes mellitus, cancer, neurology disease, depression, fibromyalgia, etc.\n* to consume drugs as coagulants, anti-depressant, pregabalin, etc during investigation or the first week before investigation.\n* to consume nsaids the last 48 hours before investigation or during investigation.\n* to consume opioids the first week before investigation or during investigation.\n* belonephobia.\n* professional athlete\n* to be pregnant\n* to suffer immunodepression'}, 'identificationModule': {'nctId': 'NCT04475133', 'briefTitle': 'Effects of Percutaneous Neuromodulation on Plasticity in the Somatosensory System in Healthy Subjects', 'organization': {'class': 'OTHER', 'fullName': 'Clinica Francisco Ortega Rehabilitacion Avanzada SL'}, 'officialTitle': 'Effects of Percutaneous Neuromodulation on Plasticity in the Somatosensory System', 'orgStudyIdInfo': {'id': 'NMP19/20-FREMPI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low-frequency and high-intensity', 'description': 'The intervention of ultrasound guided percutaneous neuromodulation is applied over the median nerve.\n\nThe parameters are continuous stimulation of low frequency (2 hz) and high intensity (slightly painful) during 16 minutes.', 'interventionNames': ['Other: Ultrasound guided percutaneous neuromodulation']}, {'type': 'EXPERIMENTAL', 'label': 'High-frequency and low-intensity', 'description': 'The intervention of ultrasound guided percutaneous neuromodulation is applied over the median nerve.\n\nThe 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.\n\nThe current is off on the first 11 minutes and the next 5 minutes it will be on. The total time is 16 minutes.', 'interventionNames': ['Other: Ultrasound guided percutaneous neuromodulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control group', 'description': 'The intervention of ultrasound guided percutaneous neuromodulation is applied over the median nerve without current during 16 minutes.', 'interventionNames': ['Other: Ultrasound guided percutaneous neuromodulation']}], 'interventions': [{'name': 'Ultrasound guided percutaneous neuromodulation', 'type': 'OTHER', 'description': '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', 'armGroupLabels': ['Control group', 'High-frequency and low-intensity', 'Low-frequency and high-intensity']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03203', 'city': 'Elche', 'state': 'Alicante', 'country': 'Spain', 'facility': 'Clínica Francisco Ortega Rehabilitación Avanzada, S.L.', 'geoPoint': {'lat': 38.26218, 'lon': -0.70107}}], 'overallOfficials': [{'name': 'Patricia Beltrá López', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clínica Francisco Javier Ortega Puebla'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinica Francisco Ortega Rehabilitacion Avanzada SL', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}