Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT03762720
Status:
UNKNOWN
Last Update Posted:
2019-06-20
First Post:
2018-12-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment of Muscle Injuries With Physium Therapy.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Blind researcher'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'RANDOMIZED CLINICAL TRIAL WITH BLIND EVALUATION BY THIRD PARTIES, LONGITUDINAL AND PROSPECTIVE.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-07-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2019-08-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-06-18', 'studyFirstSubmitDate': '2018-12-02', 'studyFirstSubmitQcDate': '2018-12-02', 'lastUpdatePostDateStruct': {'date': '2019-06-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time necessary to return to full sport participation.', 'timeFrame': 'Baseline', 'description': 'Time necessary to return to full sport participation.'}], 'secondaryOutcomes': [{'measure': 'Time necessary to return to full sport participation.', 'timeFrame': 'Four weeks.', 'description': 'Time necessary to return to full sport participation.'}, {'measure': 'Range of motion.', 'timeFrame': 'Baseline and four weeks', 'description': 'Measured by goniometer.'}, {'measure': 'The intensity of pain', 'timeFrame': 'Baseline and four 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 pain, and the worst and lowest level of pain experienced in the preceding week in the area."}, {'measure': 'Pressure pain thresholds in cervical trigger points', 'timeFrame': 'Baseline and four weeks', 'description': 'Pressure pain thresholds (PPTs) will be measured with a pressure algometer'}, {'measure': 'Questionnaire SF 12', 'timeFrame': 'Baseline and four weeks', 'description': 'The multidimensional health related quality of life'}, {'measure': 'the extent of sports-related muscle injuries', 'timeFrame': 'Baseline and four weeks', 'description': 'Imaging is crucial to confirm and assess the extent of sports-related muscle injuries and may help to guide management.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Manual Therapy', 'Massage', 'physium', 'pain', 'range of motion', 'quality of life', 'muscle injuries'], 'conditions': ['Injuries; Muscle, Nontraumatic']}, 'referencesModule': {'references': [{'pmid': '23536466', 'type': 'BACKGROUND', 'citation': 'Askling CM, Tengvar M, Thorstensson A. Acute hamstring injuries in Swedish elite football: a prospective randomised controlled clinical trial comparing two rehabilitation protocols. Br J Sports Med. 2013 Oct;47(15):953-9. doi: 10.1136/bjsports-2013-092165. Epub 2013 Mar 27.'}, {'pmid': '29155622', 'type': 'BACKGROUND', 'citation': 'Guermazi A, Roemer FW, Robinson P, Tol JL, Regatte RR, Crema MD. Imaging of Muscle Injuries in Sports Medicine: Sports Imaging Series. Radiology. 2017 Dec;285(3):1063. doi: 10.1148/radiol.2017174038. No abstract available.'}, {'pmid': '22496067', 'type': 'BACKGROUND', 'citation': 'Lee JC, Mitchell AW, Healy JC. Imaging of muscle injury in the elite athlete. Br J Radiol. 2012 Aug;85(1016):1173-85. doi: 10.1259/bjr/84622172. Epub 2012 Apr 11.'}, {'pmid': '23045734', 'type': 'BACKGROUND', 'citation': 'Sporea I, Lie I. Shear wave elastography. Ultraschall Med. 2012 Aug;33(4):393-4. No abstract available.'}, {'pmid': '19130648', 'type': 'BACKGROUND', 'citation': 'Kinser AM, Sands WA, Stone MH. Reliability and validity of a pressure algometer. J Strength Cond Res. 2009 Jan;23(1):312-4. doi: 10.1519/jsc.0b013e31818f051c.'}, {'type': 'BACKGROUND', 'citation': 'Bonilla D, Hortalá G, Temporal D, CarréLlopis C. PHYSIUM in thetreatment of pain in patientswithchroniclow back pain. FisioGlía. 2015;2(3):50-55.'}, {'pmid': '14987620', 'type': 'BACKGROUND', 'citation': 'Maquet D, Croisier JL, Demoulin C, Crielaard JM. Pressure pain thresholds of tender point sites in patients with fibromyalgia and in healthy controls. Eur J Pain. 2004 Apr;8(2):111-7. doi: 10.1016/S1090-3801(03)00082-X.'}, {'pmid': '27073401', 'type': 'BACKGROUND', 'citation': 'Ko SJ, Kim H, Kim SK, Park K, Lee J, Lee BJ, Oh J, Lee K, Park JW. Reliability and Validity of Modified Algometer in Abdominal Examination. Evid Based Complement Alternat Med. 2016;2016:3052954. doi: 10.1155/2016/3052954. Epub 2016 Mar 17.'}, {'pmid': '12583868', 'type': 'BACKGROUND', 'citation': 'Chesterton LS, Barlas P, Foster NE, Baxter DG, Wright CC. Gender differences in pressure pain threshold in healthy humans. Pain. 2003 Feb;101(3):259-266. doi: 10.1016/S0304-3959(02)00330-5.'}, {'pmid': '18570798', 'type': 'BACKGROUND', 'citation': 'Vilagut G, Valderas JM, Ferrer M, Garin O, Lopez-Garcia E, Alonso J. [Interpretation of SF-36 and SF-12 questionnaires in Spain: physical and mental components]. Med Clin (Barc). 2008 May 24;130(19):726-35. doi: 10.1157/13121076. Spanish.'}, {'pmid': '6226917', 'type': 'BACKGROUND', 'citation': 'Price DD, McGrath PA, Rafii A, Buckingham B. The validation of visual analogue scales as ratio scale measures for chronic and experimental pain. Pain. 1983 Sep;17(1):45-56. doi: 10.1016/0304-3959(83)90126-4.'}, {'pmid': '24405028', 'type': 'BACKGROUND', 'citation': "Ayala F, De Ste Croix M, Sainz de Baranda P, Santonja F. Acute effects of static and dynamic stretching on hamstrings' response times. J Sports Sci. 2014;32(9):817-25. doi: 10.1080/02640414.2013.861606. Epub 2014 Jan 10."}, {'pmid': '27699732', 'type': 'BACKGROUND', 'citation': 'Ohno Y, Fujimoto T, Shibata Y. A New Era in Diagnostic Ultrasound, Superb Microvascular Imaging: Preliminary Results in Pediatric Hepato-Gastrointestinal Disorders. Eur J Pediatr Surg. 2017 Feb;27(1):20-25. doi: 10.1055/s-0036-1593381. Epub 2016 Oct 3.'}]}, 'descriptionModule': {'briefSummary': 'Muscle injuries are currently particularly frequent among people who participate in sports.\n\nThe diagnosis is easily made with an ultrasound study and Shear Wave Elastography.', 'detailedDescription': 'Patients of the experimental group, after diagnosis by ultrasound and Shear Wave Elastography , will receive five sessions of physium therapy at 80 millibars during one month.\n\nThe measurements of the variables visual analog scale, joint mobility through the double inclinometer device, elasticity and tissue vascularization through the ultrasound, quality of life through SF-12 questionnaire and pressure algometry will be made before, after, month and three months after the end of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of both sexes, aged between 20 and 60 years, in an active state of pain and diagnosed with muscle breakdown.\n\nExclusion Criteria:\n\n* Patients who are pregnant, have pacemakers and surgically operated in the area to be treated.'}, 'identificationModule': {'nctId': 'NCT03762720', 'acronym': 'Physium', 'briefTitle': 'Treatment of Muscle Injuries With Physium Therapy.', 'organization': {'class': 'OTHER', 'fullName': 'University of Cadiz'}, 'officialTitle': 'Treatment of Muscle Injuries With Physium Therapy.', 'orgStudyIdInfo': {'id': 'Muscle injuries'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Physium treatment', 'description': 'Patients will receive five sessions of physium therapy at 80 millibars in 30 minutes for a month', 'interventionNames': ['Device: Physium treatment']}], 'interventions': [{'name': 'Physium treatment', 'type': 'DEVICE', 'description': 'patients will receive five sessions of physium therapy at 80 millibars in 30 minutes for one month in muscle injury and diagnosed by ultrasound and Shear Wave Elastography.', 'armGroupLabels': ['Physium treatment']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Manuel Rodriguez Huguet, Physiotherapy', 'role': 'CONTACT', 'email': 'manuel.rodriguez@uca.es', 'phone': '+34606176814'}], 'overallOfficials': [{'name': 'Manuel Rodriguez Huguet, Physiotherapy', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cadiz'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cadiz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Manuel Rodriguez Huguet', 'investigatorAffiliation': 'University of Cadiz'}}}}