Ignite Creation Date:
2025-12-24 @ 5:29 PM
Ignite Modification Date:
2025-12-28 @ 5:06 PM
Study NCT ID:
NCT05654168
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-03-28
First Post:
2022-12-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Muscular Morphological Ultrasound Epidemiological Study in Dance Professionals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057925', 'term': 'Femoracetabular Impingement'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-07-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2022-12-08', 'studyFirstSubmitQcDate': '2022-12-08', 'lastUpdatePostDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'One- Way ANCOVA', 'timeFrame': 'Five months', 'description': 'One-way ANCOVA will used to compare quantitative muscle ultrasound (QMUS) variables in hip with or without groin pain, controlling for effects of clinical covariates Regression models will used to study the relationship between time of evolution (and if necessary, logarithmic transform will applied to this variable to correct the absence of a normal distribution) as independent variable and the QMUS parameters as dependent variables'}], 'primaryOutcomes': [{'measure': 'RUSI. (REHABILITATIVE ULTRASOUND IMAGING)', 'timeFrame': 'Five months', 'description': "Taking measurements of the layer thickness of abdominal, lumbar and gluteal muscle groups will be performed, with Toshiba's Nemio XG equipment using a multifrequency convex probe from 3 to 6 MGz."}], 'secondaryOutcomes': [{'measure': 'HAGOS questionnaire', 'timeFrame': 'Five months', 'description': 'Correlate the HAGOS questionnaire with the thicknesses of layer of the different muscle groups analyzed at rest and in contraction in the group with Groin Pain and in the group without Groin pain.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dancing', 'Groin', 'Pain', 'Ultrasonography'], 'conditions': ['Femoracetabular Impingement']}, 'descriptionModule': {'briefSummary': 'This research will determine the presence of groin pain in professional dancers, through a specific questionnaire on the hip joint. Two groups will be formed made up of dancers over 18 years of age, men and women; one with groin pain and one without groin pain. All participants will undergo a functional muscle ultrasound study, where the thickness of the abdominal muscles, lumbar multifidus and gluteus medius and minor will be evaluated, and the relationship between ultrasound neuromuscular changes and groin pain will be verified', 'detailedDescription': 'The objective of the study is to shed light on the to the complexity of the Diagnosis that Groin Pain (GP) encloses, it is proposed to evaluate with Functional Muscular Ultrasonography Rehabilitative Ultrasound Imaging (RUSI), the layer thickness of the gluteal musculature of the hip and the abdominal and lumbar muscles on a sample of professional dancers over 18 years of age with GP to check if there are differences with professional dancers without GP.\n\nExpected goals:\n\n1. Identify the presence of GP in professional dancers.\n2. To compare the ultrasound characteristics of the neuromuscular system between a sample of dancers with GP and a sample of dancers no GP.\n3. Verify the relationship between ultrasound neuromuscular changes with GP.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '• Professional dancers of the National Ballet of Spain', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Volunteer Professional dancers 18 years or older, and no maximum age limits\n\nExclusion Criteria:\n\n* Not signing the informed consent'}, 'identificationModule': {'nctId': 'NCT05654168', 'acronym': 'DancersMUS', 'briefTitle': 'Muscular Morphological Ultrasound Epidemiological Study in Dance Professionals', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Murcia'}, 'officialTitle': 'Muscular Morphological Ultrasound Epidemiological Study in Dance Professionals', 'orgStudyIdInfo': {'id': 'Task BIBDIG-6394'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Professional dancers', 'description': 'Professional dancers with and without groin pain', 'interventionNames': ['Diagnostic Test: Imaging']}], 'interventions': [{'name': 'Imaging', 'type': 'DIAGNOSTIC_TEST', 'description': 'The thickness of the musculature to be studied will be measured with ultrasonography', 'armGroupLabels': ['Professional dancers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28054', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Miguel Angel Alcocer Ojeda', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'MIGUEL ANGEL ALCOCER OJEDA, MSc PT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad de Murcia'}, {'name': 'ANTONIA GOMEZ CONESA, PhD, PT', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universidad de Murcia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Murcia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Master's degree Physiotherapy degree PhD candidate", 'investigatorFullName': 'Miguel Ángel Alcocer Ojeda', 'investigatorAffiliation': 'Universidad de Murcia'}}}}