Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-25 @ 5:18 PM
Study NCT ID:
NCT03572803
Status:
UNKNOWN
Last Update Posted:
2018-06-28
First Post:
2018-06-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparative Research Among 3 Action Protocol in Other to Approach Chronic Lateral Epicondyle Tendinopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D052256', 'term': 'Tendinopathy'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D013708', 'term': 'Tendon Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-04-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2020-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-06-27', 'studyFirstSubmitDate': '2018-06-14', 'studyFirstSubmitQcDate': '2018-06-27', 'lastUpdatePostDateStruct': {'date': '2018-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in quality of life by DASH', 'timeFrame': 'Pre-intervention; Post-intervention (1 week after); Follow up (26 and 52 weeks after)', 'description': 'The Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure is a 30-item, self-report questionnaire designed to help describe the disability experienced by people with upper-limb disorders and also to monitor changes in symptoms and function over time. The DASH Outcome Measure contains one optional, four-item modules intended to measure symptoms and function in workers whose jobs require a high degree of physical performance.'}], 'secondaryOutcomes': [{'measure': 'Pain, as measured by Visual Analog Scale', 'timeFrame': 'Pre-intervention; Intervention (4 weeks); Post-intervention (1 week after), Follow up (26 and 52 weeks after)', 'description': 'Participants will be explained that a score of 0 indicates the absence of pain whereas a score of 10 represents the maximum tolerable pain.'}, {'measure': 'Pressure pain thresholds (PPTs)', 'timeFrame': 'Pre-intervention; Intervention (4 weeks); Post-intervention (1 week after), Follow up (26 and 52 weeks after)', 'description': 'Level of pressure tolerated by the patient just before feeling pain. The pressure is done with a digital algometer Type II(Somedic). PPTS will be assessed bilaterally in extensor carpi radialis brevis tendon and tibialis anterior muscle.'}, {'measure': 'Pain free grip strength', 'timeFrame': 'Pre-intervention; Intervention (4 weeks); Post-intervention (1 week after), Follow up (26 and 52 weeks after)', 'description': 'Grip strength before feeling pain. The tool used is a hydraulic hand dynamometer (Baseline). Subjects will be asked to gradually increase the grip strength while the elbow is extended and pronated and arm alongside of the body. They will be asked to stop when pain is felt. We will take three measures with each elbow.'}, {'measure': 'Thickness of the tendon, as measured by ultrasound scan', 'timeFrame': 'Pre-intervention; Post-intervention (1 week after); Follow up (26 and 52 weeks after)', 'description': 'Tendon structure'}, {'measure': 'Hypervascularity, as measured by ultrasound scan', 'timeFrame': 'Pre-intervention; Post-intervention (1 week after); Follow up (26 and 52 weeks after)', 'description': 'Tendon structure'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ntratissue Percutaneous Electrolysis', 'Dry needling', 'Eccentric exercise', 'Lateral epicondyle'], 'conditions': ['Tendinopathy']}, 'descriptionModule': {'briefSummary': 'The accomplishment of a treatment with Intratissue Percutaneous Electrolysis of additional form to the accomplishment of eccentric exercises and stretching program in patients with chronic lateral epicondyle tendinopathy is more effective than the accomplishment of an additional treatment with dry needling or eccentric exercises program realized of isolated form.', 'detailedDescription': 'Experimental study randomized with double blind, whose purpose is to compare three protocols in those who apply different protocols of physical therapy to themselves in three groups of intervention with patients with chronic lateral epicondyle tendinopathy.\n\nThere take part in this study people of both sexes, with ages between 18 and 65 years, all of them present chronic lateral epicondyle tendinopathy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age between 18 and 65 years.\n* Patients diagnosed of chronic lateral epicondyle tendinopathy with a minimum of 3 months of evolution.\n* Pain when palpating the lateral epicondyle area.\n* Positive test in at least 1 of the following 3 clinical tests: Cozen, Thomson or Mill's\n* Have the capacity to perform all clinical tests, understand the study process, and obtain informed consent.\n\nExclusion Criteria:\n\n* Previous history of direct trauma, fractures, joint instability, surgery or rheumatic alterations of the lateral epicondyle area.\n* Full elbow extension limited.\n* Alterations at cervical level such as: cervical radiculopathy (C4-C7), degenerative pathology in the cervical spine, exacerbated pain increase with neck movements or cervical compression.\n* Symptoms compatible with entrapment of the posterior interosseous nerve.\n* NSAID intake the week before the intervention;\n* Have received treatment with infiltration in the last year;\n* Have received physiotherapy treatment during the last month."}, 'identificationModule': {'nctId': 'NCT03572803', 'briefTitle': 'Comparative Research Among 3 Action Protocol in Other to Approach Chronic Lateral Epicondyle Tendinopathy', 'organization': {'class': 'OTHER', 'fullName': 'Universidad San Jorge'}, 'officialTitle': 'Comparative Research Among 3 Action Protocol in Other to Approach Chronic Lateral Epicondyle Tendinopathy', 'orgStudyIdInfo': {'id': 'C3P_CLET'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group of Dry Needling', 'description': "They will receive a treatment of dry needling, guided by ultrasound, together with a self-treatment program at home based on eccentric exercises and stretching.\n\nThe needle will get in the relevant zone of treatment. The punction will be realized using Hong's technique (fast in-out). Three needle insertions will be carried out in the target area during 3 seconds", 'interventionNames': ['Other: Group of Dry Needling']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group of electrolysis', 'description': "They will receive a treatment of Intratissue Percutaneous Electrolysis, guided by ultrasound, together with a self-treatment program at home based on eccentric exercises and stretching.\n\nThe needle will get in the relevant zone of treatment. The punction will be realized simulating Hong's technique (fast in-out). Three needle insertions will be carried out in the target area during 3 seconds and 3mA each one.", 'interventionNames': ['Other: Group of Electrolysis']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control Group', 'description': 'They will receive a treatment of punction sham, guided by ultrasound, together with a self-treatment program at home based on eccentric exercises and stretching.', 'interventionNames': ['Other: Control Group']}], 'interventions': [{'name': 'Group of Dry Needling', 'type': 'OTHER', 'description': 'Every group will receive a total of 3 treatment sessions distributed throughout 4 weeks of treatment. The program of eccentric exercises will be done by participants at home 5 days a week, two times a day.', 'armGroupLabels': ['Group of Dry Needling']}, {'name': 'Group of Electrolysis', 'type': 'OTHER', 'description': 'Every group will receive a total of 3 treatment sessions distributed throughout 4 weeks of treatment. The program of eccentric exercises will be done by participants at home 5 days a week, two times a day.', 'armGroupLabels': ['Group of electrolysis']}, {'name': 'Control Group', 'type': 'OTHER', 'description': 'Every group will receive a total of 3 treatment sessions distributed throughout 4 weeks of treatment. The program of eccentric exercises will be done by participants at home 5 days a week, two times a day.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50639', 'city': 'Figueruelas', 'state': 'Zaragoza', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Rita Mª Galán Díaz, MD', 'role': 'CONTACT', 'email': 'rmgalan@usj.es', 'phone': '+34660222284'}], 'facility': 'Opel España', 'geoPoint': {'lat': 41.76651, 'lon': -1.17473}}], 'centralContacts': [{'name': 'Rita Mª Galán Díaz, MD', 'role': 'CONTACT', 'email': 'rmgalan@usj.es', 'phone': '+34660222284'}, {'name': 'Pablo Herrero Gallego, PhD', 'role': 'CONTACT', 'email': 'pherrero@usj.es', 'phone': '+976060100'}], 'overallOfficials': [{'name': 'Rita Mª Galán Díaz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad San Jorge'}, {'name': 'Pablo Herrero Gallego, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universidad San Jorge'}, {'name': 'Cleofas Rodríguez Blanco, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Seville'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad San Jorge', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Seville', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}