Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-24 @ 5:05 PM
Study NCT ID:
NCT04325750
Status:
COMPLETED
Last Update Posted:
2020-09-29
First Post:
2020-03-23
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Energy Transfer Therapy in Treatment of Medial Gastrocnemius
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-08-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-28', 'studyFirstSubmitDate': '2020-03-23', 'studyFirstSubmitQcDate': '2020-03-25', 'lastUpdatePostDateStruct': {'date': '2020-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': '30 minutes', 'description': 'Visual analogue scale (VAS) of pain'}], 'secondaryOutcomes': [{'measure': 'Back flexion', 'timeFrame': '30 minutes', 'description': 'LUNGE Test'}, {'measure': 'Thermographic evaluation', 'timeFrame': '30 minutes', 'description': 'Ymiko Wifi Digital Weather Station with FLIR E60 camera and interpreted with FLIR tools software.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Strain of Gastrocnemius Muscle (Diagnosis)', 'Diathermy Plate Burn', 'Thermography', 'Sports Physical Therapy']}, 'descriptionModule': {'briefSummary': 'This study develops the effects of Capacitive and Resistive Energy Transfer Therapy (TECAR) on medial gastrocnemius using thermographic cameras, algometry and lunge tests, in a pre-post study with basketball players using a control group to which placebo is applied. (simulated technique) and an intervention group to which the technique is performed. The main objective of the study is to establish whether the TECAR produces physiological and mechanical changes in the subjects that improve muscle recovery.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '39 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male players\n* Semi-professional players who are currently active\n* Not have suffered a lower limb injury in the last 6 months before the study\n* Not having suffered a rupture of the triceps surae\n* Contain a latent trigger point in the medial gastrocnemius\n\nExclusion Criteria:\n\n* Players suffering from any disease that could alter the study or be contradictory'}, 'identificationModule': {'nctId': 'NCT04325750', 'briefTitle': 'Energy Transfer Therapy in Treatment of Medial Gastrocnemius', 'organization': {'class': 'OTHER', 'fullName': 'Fundación Universidad Católica de Valencia San Vicente Mártir'}, 'officialTitle': 'Effects of Capacitive and Resistive Energy Transfer Therapy in Pre and Post-treatment Medial Gastrocnemius in National Level Basketball Players', 'orgStudyIdInfo': {'id': 'UCV2017-2018-40'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'The simulated mode technique is applied (machine off)', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'TECAR THERAPY', 'description': 'The intervention will be performed with the T-Care TECAR® therapy machine at the latent trigger points of both gastrocnemius. The professional will apply the therapy with the generator that emits radio frequency signals of 0.5 MHz at a variable power with a maximum of 300W. The frequency to be used will be 500MHz with an intensity of 40% and with direct current.', 'interventionNames': ['Procedure: TECAR Therapy']}], 'interventions': [{'name': 'TECAR Therapy', 'type': 'PROCEDURE', 'description': 'The intervention will be performed with the T-Care TECAR® therapy machine at the latent trigger points of both gastrocnemius. The professional will apply the therapy with the generator that emits radio frequency signals of 0.5 MHz at a variable power with a maximum of 300W. The frequency to be used will be 500MHz with an intensity of 40% and with direct current.', 'armGroupLabels': ['TECAR THERAPY']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'simulated TECAR Therapy (machine off)', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46001', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Universidad Católica de Valencia San Vicente Mártir', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'Carlos Barrios, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universidad Católica de Valencia San Vicente Mártir'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación Universidad Católica de Valencia San Vicente Mártir', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD. Dean of Faculty of Medicine and Health Sciences', 'investigatorFullName': 'Carlos Barrios Pitarque', 'investigatorAffiliation': 'Fundación Universidad Católica de Valencia San Vicente Mártir'}}}}