Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2026-01-01 @ 8:57 PM
Study NCT ID:
NCT03225404
Status:
COMPLETED
Last Update Posted:
2022-03-04
First Post:
2017-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Percutaneous Electrolysis in the Treatment of Lateral Epicondylalgia. A Single-Blind Randomized Controlled Trial.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D052256', 'term': 'Tendinopathy'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D013708', 'term': 'Tendon Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Outcomes assesor'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A specialist physician will be diagnosed the epicondylitis'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2018-09-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-16', 'studyFirstSubmitDate': '2017-07-17', 'studyFirstSubmitQcDate': '2017-07-19', 'lastUpdatePostDateStruct': {'date': '2022-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The intensity of pain in epicondylitis', 'timeFrame': 'Baseline', 'description': "A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patients' current level of elbow pain, and the worst and lowest level of pain experienced in the preceding week in the elbow area."}], 'secondaryOutcomes': [{'measure': 'The intensity of pain in epicondylitis', 'timeFrame': 'Four and twelve weeks', 'description': "A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patients' current level of elbow pain, and the worst and lowest level of pain experienced in the preceding week in the elbow area."}, {'measure': 'Active elbow range of motion', 'timeFrame': 'Baseline,four and twelve weeks', 'description': 'Measured by a two branches egoniomter'}, {'measure': 'Pressure pain thresholds in epicondylitis trigger points', 'timeFrame': 'Baseline, four and twelve weeks', 'description': 'Pressure pain thresholds (PPTs) will be measured with a pressure algometer (Baseline)'}, {'measure': 'Questionnaire SF 12', 'timeFrame': 'Baseline,four and twelve weeks', 'description': 'The multidimensional health related quality of life'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tendinopathy', 'Electrolysis', 'Exercise', 'Dry needing'], 'conditions': ['Epicondylitis']}, 'referencesModule': {'references': [{'pmid': '25122629', 'type': 'BACKGROUND', 'citation': 'Valera-Garrido F, Minaya-Munoz F, Medina-Mirapeix F. 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': '24172311', 'type': 'BACKGROUND', 'citation': 'Minaya-Munoz F, Medina-Mirapeix F, Valera-Garrido F. Quality measures for the care of patients with lateral epicondylalgia. BMC Musculoskelet Disord. 2013 Oct 30;14:310. doi: 10.1186/1471-2474-14-310.'}, {'pmid': '19297202', 'type': 'BACKGROUND', 'citation': 'Mintken PE, Glynn P, Cleland JA. Psychometric properties of the shortened disabilities of the Arm, Shoulder, and Hand Questionnaire (QuickDASH) and Numeric Pain Rating Scale in patients with shoulder pain. J Shoulder Elbow Surg. 2009 Nov-Dec;18(6):920-6. doi: 10.1016/j.jse.2008.12.015. Epub 2009 Mar 17.'}, {'pmid': '26649058', 'type': 'BACKGROUND', 'citation': 'Arias-Buria JL, Truyols-Dominguez S, Valero-Alcaide R, Salom-Moreno J, Atin-Arratibel MA, Fernandez-de-Las-Penas C. Ultrasound-Guided Percutaneous Electrolysis and Eccentric Exercises for Subacromial Pain Syndrome: A Randomized Clinical Trial. Evid Based Complement Alternat Med. 2015;2015:315219. doi: 10.1155/2015/315219. Epub 2015 Nov 15.'}]}, 'descriptionModule': {'briefSummary': 'The concept of epicondylitis refers to the manifestation of pain ni the area of insertation of the epicondile muscles, and that it is accompained by limitation funcional.A tendinopathy is characterized as a process of degenaration, with fibroblast proliferation and disorganization of the fibers of collagen. This tendon pathology especially affects the epicondyle extensors and especially the first and second radial and short extensor carpal.', 'detailedDescription': 'Eccentric exercises of the epicondyle muscles were performed in 3 sets of 10 repetitions. Participants were asked to perform the exercise program on an individual basis twice every day for 4 weeks. The eccentric program consisted of 3 exercises, focusing on the epicondyle muscles. Participants were asked to do a normal flexion extension (concentric phase) and a slow return to the initial position (eccentric phase) included first the concentric phase, and the eccentric phase was slowly conducted. The exercise program was taught by a physiotherapist in the first session and monitored in the subsequent sessions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n\\- Patients of both sexes, aged between 18 and 60 years, in an active state of pain and with a diagnosis of one month of evolution.\n\nExclusion Criteria:\n\n\\- Patients who are pregnant, have pacemakers and those surgically operated patients who have been treated with Epte a month earlier'}, 'identificationModule': {'nctId': 'NCT03225404', 'acronym': 'MRH', 'briefTitle': 'Effectiveness of Percutaneous Electrolysis in the Treatment of Lateral Epicondylalgia. A Single-Blind Randomized Controlled Trial.', 'organization': {'class': 'OTHER', 'fullName': 'University of Cadiz'}, 'officialTitle': 'Effectiveness of Percutaneous Electrolysis in the Treatment of Lateral Epicondylalgia. A Single-Blind Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'UCadiz'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'EPTE + EXER Therapeutic Percutaneous Electrolysis once week for four weeks associated with eccentric exercises devices at home.', 'interventionNames': ['Other: Epte group']}, {'type': 'EXPERIMENTAL', 'label': 'Control group', 'interventionNames': ['Other: Dry needling group']}], 'interventions': [{'name': 'Epte group', 'type': 'OTHER', 'otherNames': ['EPTE + EXER'], 'description': 'Therapeutic Percutaneous Electrolysis once week for four weeks associated with eccentric exercises devices at home.', 'armGroupLabels': ['Experimental group']}, {'name': 'Dry needling group', 'type': 'OTHER', 'otherNames': ['DN +EXER'], 'description': 'The intervention for this group consisted of dry needling in trigger points associated with eccentric exercises devices at home.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11008', 'city': 'Cadiz', 'state': 'Cádiz', 'country': 'Spain', 'facility': 'Policlínica Santa maría', 'geoPoint': {'lat': 36.52672, 'lon': -6.2891}}], 'overallOfficials': [{'name': 'Manuel Rodriguez Huguet, Physiotherapy', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cadiz'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cadiz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Manuel Rodriguez Huguet', 'investigatorAffiliation': 'University of Cadiz'}}}}