Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2026-01-01 @ 3:53 PM
Study NCT ID:
NCT05390359
Status:
COMPLETED
Last Update Posted:
2023-05-03
First Post:
2022-04-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioimpedance and Sensorimotor Effects of Percutaneous Electrolysis Protocols on the Patellar Tendon
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The order of the interventions will be randomized by a third person not involved in the treatment, assessment or statistical analysis. Once the care provider has inserted the needle in each subject, the investigator that apply the treatment will choose the treatment protocol assigned on the stimulator, previously programmed and codified. Thus, nobody (participant, care provider, investigator and the outcome assessor) will know what intervention is applied.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomized intervention of repeated measures, quadruple-blinded'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-05-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-02', 'studyFirstSubmitDate': '2022-04-06', 'studyFirstSubmitQcDate': '2022-05-21', 'lastUpdatePostDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in pain evoked with Von Frey Filaments.', 'timeFrame': 'Pre-intervention and immediately after the intervention', 'description': "We will use Von Frey Filaments to apply a 300g pressure in the evaluated areas (tibialis anterior muscle, inferior pole of the patella and patellar tendon). The subject will report the pain intensity verbally administered Numeric rate scale (NRS): 0 will be any pain and 10 will be the maximal perception of pain). The test will be performed with subject's eyes closed."}], 'secondaryOutcomes': [{'measure': 'Change in transcutaneous electrical detection threshold.', 'timeFrame': 'Pre-intervention and immediately after the intervention', 'description': 'We will use a transcutaneous active electrode to evaluate electrical detection threshold on the medial region of the tibia. We will apply an alternating current with a frequency of 2 Hz, a pulse duration of 150 msec and the intensity will be increased progressively. When the subjects perceives the electrical current, the evaluator will record the current intensity as the electrical detection threshold.'}, {'measure': 'Change in percutaneous electrical detection threshold.', 'timeFrame': 'Pre-intervention and immediately after the intervention', 'description': 'We will use the intervention needle as an active electrode to evaluate electrical detection threshold on the patellar tendon. The parameters of the electric current will be 2 Hz and 150 msec of pulse duration and the intensity will be increased progressively. When the subjects perceives the electrical current, the evaluator will record the current intensity as the electrical detection threshold.'}, {'measure': 'Change in pain evoked with a transcutaneous electrical stimulus.', 'timeFrame': 'Pre-intervention and immediately after the intervention', 'description': 'We will use a transcutaneous active electrode to evaluate pain evoked with electrical stimulus on the medial side of the tibia. The parameters of electric current will be 2 hz and 150 msec of pulse duration and the intensity will be x3-4 respect to the electrical detection threshold determined using an electrical transcutaneous stimulus. The subject will report the pain intensity with a verbally administered numeric rate scale (NRS): 0 will be no pain and 10 will be the maximal perception of pain.'}, {'measure': 'Change in pain evoked with a percutaneous electrical stimulus.', 'timeFrame': 'Pre-intervention and immediately after the intervention', 'description': 'We will use the intervention needle as an active electrode to evaluate electrical detection threshold on the patellar tendon. The parameters of electric current will be 2 Hz and 150 msec of pulse duration and the intensity will be x4-6 respect to the electrical detection threshold determined using an electrical percutaneous simulus. The subject will report the pain intensity with a verbally administered numeric rate scale (NRS): 0 will be no pain and 10 will be the maximal perception of pain.'}, {'measure': 'Change in maximum strength during knee extension with dynamometer', 'timeFrame': 'Pre-intervention and immediately after the intervention', 'description': 'The subject will be sitting with 90 degrees knee flexion and the dynamometer located at the ankle. He/she will must extend the knee executing maximal isometric force during 5 seconds, 2 times with 1 minute to rest between them.'}, {'measure': 'Change in surface electromyography signal during knee extension', 'timeFrame': 'Pre-intervention and immediately after the intervention', 'description': 'The subject will be sitting with 90 degrees knee flexion and the dynamometer located at the ankle and a surface electromyography located at the muscles vastus medialis and lateralis, from the muscle quadriceps femoris. He/she will must extend the knee executing maximal isometric force during 5 seconds, 2 times with 1 minute to rest between them.'}, {'measure': 'Questionnaire Victorian Institute of Sport Assessment - Patella (VISA-P)', 'timeFrame': 'One week before intervention', 'description': 'The subject will fulfil the visa-p questionnaire, that assess symptoms, simple test of function, and the ability to play sports, to control that the sample recruited are healthy subjects.'}, {'measure': 'Change in patellar tendon bioimpedance', 'timeFrame': 'pre-intervention / baseline, immediately after the introduction the intervention needle and immediately after the intervention', 'description': 'We will use four needles in the patellar tendon as electrodes to measure bioimpedance with a specific device (ImpediMed´s SFB7). We will measure using 256 frequences ranging from 3 Kilohertz (KHz) to 1 Megahertz (MHz) in different time frames. Firstly, we will measure three times prior to the introduction of the intervention needle. Then we will measure once more after the introduction of the intervention needle. Finally, we will performed four repeated measures after the intervention (immediately, 5, 10 and 15 minutes after of the intervention).'}, {'measure': 'Pain induced during bioimpedance measurement.', 'timeFrame': 'Immediately after the intervention, immediately after the introduction the intervention needle and immediately after of the intervention.', 'description': 'We will continuously measure pain intensity produced by the bioimpedance recording using a digital visual analogue scale (VAS) integrated in a potentiometer: 0 will be no pain and 10 will be the maximal perception of pain.'}, {'measure': 'Conditioned pain modulation', 'timeFrame': 'One week before the intervention', 'description': 'First, we will measure pressure pain threshold with an algometer on the patellar tendon. Then, we will repeat the assesment of the pressure pain threshold on the patellar tendon meanwhile we apply a moderate painful pressure on the contralateral arm (5/10 on a numeric rate scale NRS: 0 will be no pain and 10 will be the maximal perception of pain) with a pressure cuff. The change between both pressure pain threshold will assess the conditioned pain modulation. After, we will repeat the same procedure but using cutaneous electrical threshold instead of pressure.'}, {'measure': 'International Physical Activity Questionnaire (IPAQ)', 'timeFrame': 'One week before the intervention', 'description': 'The subjects will answer International Physical Activity Questionnaire to assess the level of physical activity.'}, {'measure': 'Questionnaire about intervention effects past 24 hours.', 'timeFrame': '24 hours after the intervention', 'description': 'The subjects will answer a questionnaire about the intervention effects and the possible side effects.'}, {'measure': 'Pain induced during intervention', 'timeFrame': 'During the 16 minutes of intervention', 'description': 'We will continuously measure pain intensity produced by the intervention using a digital visual analogue scale (VAS) integrated in a potentiometer: 0 will be no pain and 10 will be the maximal perception of pain.'}, {'measure': 'Change in threshold to elicit mechanical perception with Von Frey Filaments', 'timeFrame': 'Pre-intervention and immediately after the intervention', 'description': "We will use Von Frey Filaments of increasing caliber to apply different pressure forces in the evaluated areas (tibialis anterior muscle, inferior pole of the patella and patellar tendon). The evaluator will score the caliber of the filament that produce a mechanical perception in the subject as the mechanical pressure threshold. The test will be performed with subject's eyes closed."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Percutaneous electrolysis', 'Patellar tendon', 'Bioimpedance', 'Sensorimotor system', 'Percutaneous electrical stimulation'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Segura León J.M., Medina i Mirapeix F., Valera Garrido F. Adverse effects of percutaneous needle electrolysis in carpal tunnel syndrome. Rev Fisioter Invasiva 2019;2:130'}, {'type': 'BACKGROUND', 'citation': 'Valera Garrido F., Minaya Muñoz F., Ramírez Martínez P., Medina i Mirapeix F. Adverse effects associated to the application of ultrasound-guided percutaneous needle electrolysis. Rev Fisioter Invasiva 2019; 02(02): 115-116.'}, {'type': 'BACKGROUND', 'citation': 'Valera-Garrido, Polidori F, Canet, Botet J, Ramírez F, Calvo P, et al. Clinical criteria for the application of percutaneous needle electrolysis in tendinopathies: An expert Consensus cocument and cross-sectional study among physical therapists. Revista Fisioterapia Invasiva / Journal of Invasive Techniques in Physical Therapy. 2019; 02. 055-061. 10.1055/s-0039-3402789.'}, {'pmid': '25897404', 'type': 'RESULT', 'citation': 'Abat F, Valles SL, Gelber PE, Polidori F, Jorda A, Garcia-Herreros S, Monllau JC, Sanchez-Ibanez JM. An experimental study of muscular injury repair in a mouse model of notexin-induced lesion with EPI(R) technique. BMC Sports Sci Med Rehabil. 2015 Apr 17;7:7. doi: 10.1186/s13102-015-0002-0. eCollection 2015.'}, {'pmid': '24821478', 'type': 'RESULT', 'citation': 'Abat F, Valles SL, Gelber PE, Polidori F, Stitik TP, Garcia-Herreros S, Monllau JC, Sanchez-Ibanez JM. 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Ultrasound-guided percutaneous needle electrolysis in chronic lateral epicondylitis: short-term and long-term results. Acupunct Med. 2014 Dec;32(6):446-54. doi: 10.1136/acupmed-2014-010619. Epub 2014 Aug 13.'}, {'pmid': '17899675', 'type': 'RESULT', 'citation': 'Ylinen J. Pressure algometry. Aust J Physiother. 2007;53(3):207. doi: 10.1016/s0004-9514(07)70032-6. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Percutaneous electrolysis is a physical therapy technique, whose main objective is the treatment of the signs and symptoms associated with tendinopathies by applying a galvanic current through a blunt dry needle. Despite its clinical use being already stablished, the physiological mechanisms underlying this therapy are still unknown and thus, the optimal parameterization. The present study proposes to perform different stimulation protocols of percutaneous electrolysis on healthy subjects patellar tendon to answer those questions.', 'detailedDescription': 'Intervention will be performed in the middle of the patellar tendon, using ultrasonography to guide the needle insertion, without risk of affecting any adjacent structure. The theoretical basis of the technique is to produce specific controlled changes in the intervened tissue, and the pathological symptoms, through the accumulation of an electric charge. For this reason, the protocols will be the following:\n\n1. High-intensity and short-duration: 3 squared pulses of a high intensity galvanic current (3 mA) for 3 seconds with 3 seconds rests between pulses and 1 second of pulses ramp. The current will be off during the first 348 seconds of the intervention and the last 18 seconds it will be on. The total intervention time will be 366 seconds.\n2. Low-intensity and long-duration: 3 squared pulses of a low intensity galvanic current (0.1 mA) during 90 seconds, with 3 seconds rests between pulses and 30 seconds of pulses ramp. The total intervention time will be 366 seconds.\n3. High-intensity, short-duration and 20 Hertz (Hz): 3 squared pulses of a high intensity compensated biphasic squared current (3 mA), during 3 seconds with 3 seconds rests between pulses and 1 second of pulses ramp. The alternative frequency of 20 Hz and the pulse width of 50 ms. The current will be off during the first 348 seconds of the intervention and the last 18 seconds it will be on. The total intervention time will be 366 seconds.\n4. Sham electrolysis group will got the same intervention, but without applying electrical current.\n\nThe study design will be an crossover clinical trial, with randomized order of intervention with repeated measurements. Therefore, each subject will be have the four protocols at randomized order, with a gap of at least one week between them. The study will be full blinded.\n\nThe capacity to recruit the inhibitory system will be evaluated by means of conditioned pain modulation. Moreover, somatosensory thresholds will be evaluated in the knee, as well as knee extension strength. In addition, we will undertake continuous measures of the electrical bioimpedance of the patellar tendon, to study the changes produced by the intervention in the different intra and extracellular tissue components.\n\nThe conditioned modulation of pain assesment will take place one week before to the intervention, and the remaining measurements will be measured pre-intervention and post-intervention for each protocol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy.\n* Between 18 and 45 years old.\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 needling, as coagulation deficit, etc.\n* to suffer some severe disease as diabetes mellitus, cancer, neurology disease, depression, fibromyalgia, etc.\n* to suffer some cognitive disorders.\n* to consume drugs as coagulants, anti-depressant, pregabalin, neuropeptide, opioids, etc during investigation or the first week before investigation.\n* to consume NSAIDS the last 48 hours before investigation or during investigation.\n* belonephobia.\n* To consume caffeine 2 hours prior to the investigation or perform intense exercise on the same day as the measurement.\n* To receive concomitant physical therapy treatments or have previously received percutaneous electrolysis treatment.\n* professional athlete\n* To be pregnant.'}, 'identificationModule': {'nctId': 'NCT05390359', 'briefTitle': 'Bioimpedance and Sensorimotor Effects of Percutaneous Electrolysis Protocols on the Patellar Tendon', 'organization': {'class': 'OTHER', 'fullName': 'Clinica Francisco Ortega Rehabilitacion Avanzada SL'}, 'officialTitle': 'Characterization of the Effects on Bioimpedance and the Sensorimotor System After the Application of Percutaneous Electrolysis Protocols on the Patellar Tendon.', 'orgStudyIdInfo': {'id': 'EPTE/2021-BIOZ'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High-intensity and short-duration', 'description': 'The technique consists of the percutaneous electrical stimulation of the tendon applying a galvanic current through a ultrasound-guided needle.', 'interventionNames': ['Other: High-intensity and short-duration']}, {'type': 'EXPERIMENTAL', 'label': 'Low-intensity and long-duration', 'description': 'The technique consists of the percutaneous electrical stimulation of the tendon applying a galvanic current through a ultrasound-guided needle.', 'interventionNames': ['Other: Low-intensity and long-duration']}, {'type': 'EXPERIMENTAL', 'label': 'High-intensity, short-duration and 20 Hz', 'description': 'The technique consists of the percutaneous electrical stimulation of the tendon applying a alternating current through a ultrasound-guided needle.', 'interventionNames': ['Other: High-intensity, short-duration and 20 Hz']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham electrolysis', 'description': 'The technique consists of an introduction ultrasound-guided needle without electrical stimulation.', 'interventionNames': ['Other: Sham electrolysis']}], 'interventions': [{'name': 'High-intensity and short-duration', 'type': 'OTHER', 'description': 'The ultrasound guided percutaneous electrolysis will be applied in the middle of the patellar tendon.\n\nThe parameters will be 3 squared pulses of a high intensity current (3 mA), that will be applied for 3 seconds with 3 seconds rests between pulses and 1 second of pulses ramp.\n\nThe current will be off on the first 348 seconds of the intervention approximately and the last 18 seconds it will be on. The total treatment time will be 366 seconds.', 'armGroupLabels': ['High-intensity and short-duration']}, {'name': 'Low-intensity and long-duration', 'type': 'OTHER', 'description': 'The ultrasound guided percutaneous electrolysis will be applied in the middle of the patellar tendon.\n\nThe parameters will be 3 squared pulses of a low intensity direct current (0.1 mA) during 90 seconds, with 3 seconds rests between pulses and 1 second of pulses ramp.\n\nThe total treatment time will be 366 seconds.', 'armGroupLabels': ['Low-intensity and long-duration']}, {'name': 'High-intensity, short-duration and 20 Hz', 'type': 'OTHER', 'description': 'The ultrasound guided percutaneous electrolysis will be applied in the middle of the patellar tendon.\n\nThe parameters will be 3 pulses of a high intensity compensated biphasic current (3 mA), during 3 seconds with 3 seconds rests between pulses and 1 second of pulses ramp. The alternating frequency will be of 20 Hz and the pulse width of 50 microseconds.\n\nThe current will be off on the first 348 seconds of the intervention approximately and the last 18 seconds it will be on. The total treatment time will be 366 seconds.', 'armGroupLabels': ['High-intensity, short-duration and 20 Hz']}, {'name': 'Sham electrolysis', 'type': 'OTHER', 'description': 'The control ultrasound guided percutaneous electrolysis will be applied in the middle of the patellar tendon, without electrical stimulation during 366 seconds.', 'armGroupLabels': ['Sham electrolysis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Valencia', 'country': 'Spain', 'facility': 'Ionclinics & DEIONICS.', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinica Francisco Ortega Rehabilitacion Avanzada SL', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ionclinics & DEIONICS.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}