Ignite Creation Date:
2025-12-25 @ 3:05 AM
Ignite Modification Date:
2025-12-31 @ 10:33 PM
Study NCT ID:
NCT04273633
Status:
COMPLETED
Last Update Posted:
2020-12-10
First Post:
2020-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound Supraspinatus Tendon Assessment After 448kilohertz Radiofrequency Stimulation in a Sporty Population.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-12-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-08', 'studyFirstSubmitDate': '2020-02-11', 'studyFirstSubmitQcDate': '2020-02-13', 'lastUpdatePostDateStruct': {'date': '2020-12-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in supraspinatus tendon measured by quantified elastography imaging at 3 months', 'timeFrame': 'Time Frame: time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)]', 'description': 'The elastography is obtained when the anatomic image on grayscale ultrasound overlaps parametric color image that expresses the rate of deformity of the tissues, soft tissues tend to develop greater deformity and tissue deformity have lower rigidity.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ultrasonography', 'Shoulder']}, 'referencesModule': {'references': [{'pmid': '33691576', 'type': 'DERIVED', 'citation': 'Navarro-Ledesma S, Gonzalez-Munoz A. Short-term effects of 448 kilohertz radiofrequency stimulation on supraspinatus tendon elasticity measured by quantitative ultrasound elastography in professional badminton players: a double-blinded randomized clinical trial. Int J Hyperthermia. 2021;38(1):421-427. doi: 10.1080/02656736.2021.1896790.'}]}, 'descriptionModule': {'briefSummary': '448kilohertz capacitive resistive monopolar radiofrequency is a novel technique in physiotherapy and its usefulness and clinical relevance is still to be investigated at both clinical practice and also in performance. Current studies show promising results in different musculoskeletal disorders, however there no studies in the assessment of quality soft tissue in sporty population after the used of this technique.', 'detailedDescription': 'Shoulder pain is is one of the most common musculoskeletal disorders, presenting a high prevalence in primary care centers and sport populations. Many factors have been proposed as the cause of pain, however there are no studies analysing possibilities of preventing shoulder injuries by using a radiofrequency stimulus.\n\nThe use of 448kilohertz capacitive resistive monopolar radiofrequency as the focus of the treatment looking for improve the quality of the tissue is still to be explored.\n\nThe hypothesis of the present project is that focus treatments on 448kilohertz capacitive resistive monopolar radiofrequency on the shoulder will produce better outcomes in terms of ultrasound assessment measured by quantified elastography, and this will decreased the possibilities of get injured.\n\nThe stimulus will be carried out on the shoulder region (suprascapular, axillar, subscapular, long thoracic or pectoralis nerves) and the thoracic region. All interventions will be developed by the same examiner, who is a physiotherapist with 6 years of clinical experience.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18-50 years\n* Sporty people with at least 3 days of training per week and presenting an upper limb dominance.\n\nExclusion Criteria:\n\n* Suffer from any painful shoulder condition.\n* History of significant shoulder trauma, such as fracture or ultrasonography\n* Clinically suspected partial thickness cuff tear, following the classification of Wiener and Seitz.\n* Recent shoulder dislocation in the past two years'}, 'identificationModule': {'nctId': 'NCT04273633', 'briefTitle': 'Ultrasound Supraspinatus Tendon Assessment After 448kilohertz Radiofrequency Stimulation in a Sporty Population.', 'organization': {'class': 'OTHER', 'fullName': 'University of Malaga'}, 'officialTitle': 'Ultrasound Supraspinatus Tendon Assessment After 448kilohertz Capacitive Resistive Radiofrequency Stimulation in a Sporty Population.', 'orgStudyIdInfo': {'id': 'CRMRSPORT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'INTERVENTION', 'description': '448 kilohertz Capacitive Resistive Monopolar Radiofrequency stimulus on the dominant shoulder', 'interventionNames': ['Device: Monopolar 448 kilohertz radiofrequency stimulation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Monopolar Radiofrequency stimulus', 'description': 'To simulate the application of Monopolar Radiofrequency stimulus on the dominant shoulder', 'interventionNames': ['Device: Placebo comparator']}], 'interventions': [{'name': 'Monopolar 448 kilohertz radiofrequency stimulation', 'type': 'DEVICE', 'description': '448kilohertz capacitive resistive monopolar radiofrequency will be applied on the dominant shoulder', 'armGroupLabels': ['INTERVENTION']}, {'name': 'Placebo comparator', 'type': 'DEVICE', 'description': 'To simulate a 448kilohertz capacitive resistive monopolar radiofrequency application on the dominant shoulder', 'armGroupLabels': ['Placebo Monopolar Radiofrequency stimulus']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Málaga', 'country': 'Spain', 'facility': 'Ana González Muñon', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Malaga', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'UNIVERSITY PROFESSOR', 'investigatorFullName': 'SANTIAGO NAVARRO LEDESMA', 'investigatorAffiliation': 'University of Malaga'}}}}