Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-26 @ 3:09 AM
Study NCT ID:
NCT04352920
Status:
COMPLETED
Last Update Posted:
2021-02-02
First Post:
2020-04-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Vacuum Myofascial Therapy Device in Treatment of Muscle Fibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Outcomes assesor'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Medical Doctor diagnosed muscle fibrosis'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2019-10-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-28', 'studyFirstSubmitDate': '2020-04-15', 'studyFirstSubmitQcDate': '2020-04-15', 'lastUpdatePostDateStruct': {'date': '2021-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The intensity of pain in muscle fibrosis', '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."}], 'secondaryOutcomes': [{'measure': 'The intensity of pain in muscle fibrosis', 'timeFrame': 'Two 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."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['negative pressure', 'cupping', 'physical therapy modalities'], 'conditions': ['Muscle Injury']}, 'referencesModule': {'references': [{'pmid': '23070932', 'type': 'RESULT', 'citation': 'Bhatia K, Tong CS, Cho CC, Yuen EH, Lee J, Ahuja AT. Reliability of shear wave ultrasound elastography for neck lesions identified in routine clinical practice. Ultraschall Med. 2012 Oct;33(5):463-8. doi: 10.1055/s-0032-1325330. Epub 2012 Oct 15.'}, {'pmid': '23645834', 'type': 'RESULT', 'citation': 'Ekstrand J, Askling C, Magnusson H, Mithoefer K. Return to play after thigh muscle injury in elite football players: implementation and validation of the Munich muscle injury classification. Br J Sports Med. 2013 Aug;47(12):769-74. doi: 10.1136/bjsports-2012-092092. Epub 2013 May 5.'}, {'pmid': '24784885', 'type': 'RESULT', 'citation': 'Hallen A, Ekstrand J. Return to play following muscle injuries in professional footballers. J Sports Sci. 2014;32(13):1229-36. doi: 10.1080/02640414.2014.905695. Epub 2014 May 1.'}, {'pmid': '21119022', 'type': 'RESULT', 'citation': 'Fousekis K, Tsepis E, Poulmedis P, Athanasopoulos S, Vagenas G. Intrinsic risk factors of non-contact quadriceps and hamstring strains in soccer: a prospective study of 100 professional players. Br J Sports Med. 2011 Jul;45(9):709-14. doi: 10.1136/bjsm.2010.077560. Epub 2010 Nov 30.'}]}, 'descriptionModule': {'briefSummary': 'We present the case of a 24-year-old professional soccer player, with no personal history of interest, who came to the X-Ray diagnosis service due to severe pain in the right quadriceps muscle after a 10-month evolution of muscle rupture occurred during sports practice.', 'detailedDescription': 'PHYSIUM System® provides standardized negative pressure massage for 15 minutes with the analgesic program and 15 minutes with the trigger points program at 80 millibars with eight adjustable arms, both in the entire muscle and in muscle fibrosis.\n\nSeven days later, after PHYSIUM System® session with the same parameters of the previous treatment, ultrasound elastography was performed.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '24 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria.\n\n* 24-year-old professional soccer player.\n* No personal medical history of interest'}, 'identificationModule': {'nctId': 'NCT04352920', 'acronym': 'Physium', 'briefTitle': 'Vacuum Myofascial Therapy Device in Treatment of Muscle Fibrosis', 'organization': {'class': 'OTHER', 'fullName': 'University of Cadiz'}, 'officialTitle': 'Vacuum Myofascial Therapy Device in Treatment of Muscle Fibrosis', 'orgStudyIdInfo': {'id': '27/19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'PHYSIUM System® provides standardized negative pressure massage for 15 minutes with the analgesic program and 15 minutes with the trigger points program at 80 millibars with eight adjustable arms both in the entire muscle and in muscle fibrosis.', 'interventionNames': ['Other: Experimental group']}], 'interventions': [{'name': 'Experimental group', 'type': 'OTHER', 'description': 'PHYSIUM System® provides standardized negative pressure massage for 15 minutes with the analgesic program and 15 minutes with the trigger points program at 80 millibars with eight adjustable arms both in the entire muscle and in muscle fibrosis.', 'armGroupLabels': ['Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11008', 'city': 'Cadiz', 'state': 'Cádiz', 'country': 'Spain', 'facility': 'Manuel Rodríguez Huguet', 'geoPoint': {'lat': 36.52672, 'lon': -6.2891}}], 'overallOfficials': [{'name': 'Manuel Rodriguez Huguet, Physiotherapy', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cádiz'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cadiz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Manuel Rodriguez Huguet', 'investigatorAffiliation': 'University of Cadiz'}}}}