Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2026-02-20 @ 7:24 PM
Study NCT ID:
NCT03928860
Status:
COMPLETED
Last Update Posted:
2019-04-26
First Post:
2019-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of One Session Osteopathic Manuel Treatment on Femoral Artery Diameter and Flow
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}], 'ancestors': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-23', 'studyFirstSubmitDate': '2019-04-22', 'studyFirstSubmitQcDate': '2019-04-23', 'lastUpdatePostDateStruct': {'date': '2019-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Femoral Artery Diameter Doppler Ultrasonography', 'timeFrame': '10 minutes', 'description': 'Femoral artery diameter evaluated by radiologist. The femoral artery diameter unit is in mm (millimeters).\n\nIn the evaluation, the wall contour characteristics of the vessel to be examined were evaluated and the diameter was measured. Color doppler examination was performed to determine whether the vessel contained color filling, patency, flow direction and turbulence.\n\nPeak systolic and end diastolic flow rates and flow pattern and flow rate were measured by spectral examination.'}, {'measure': 'Femoral Artery Flow Doppler Ultrasonography', 'timeFrame': '10 minutes', 'description': 'Femoral artery flow evaluated by radiologist. The femoral artery flow unit is in ml/sn (milliliter/second).\n\nIn the evaluation, the wall contour characteristics of the vessel to be examined were evaluated and the diameter was measured. Color doppler examination was performed to determine whether the vessel contained color filling, patency, flow direction and turbulence.\n\nPeak systolic and end diastolic flow rates and flow pattern and flow rate were measured by spectral examination'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Peripheral arterial disease', 'Osteopathic manual treatment'], 'conditions': ['Peripheral Arterial Disease']}, 'referencesModule': {'references': [{'pmid': '21147421', 'type': 'BACKGROUND', 'citation': 'Cerritelli F, Carinci F, Pizzolorusso G, Turi P, Renzetti C, Pizzolorusso F, Orlando F, Cozzolino V, Barlafante G. Osteopathic manipulation as a complementary treatment for the prevention of cardiac complications: 12-Months follow-up of intima media and blood pressure on a cohort affected by hypertension. J Bodyw Mov Ther. 2011 Jan;15(1):68-74. doi: 10.1016/j.jbmt.2010.03.005. Epub 2010 May 8.'}, {'pmid': '22863643', 'type': 'BACKGROUND', 'citation': 'Ramos-Gonzalez E, Moreno-Lorenzo C, Mataran-Penarrocha GA, Guisado-Barrilao R, Aguilar-Ferrandiz ME, Castro-Sanchez AM. Comparative study on the effectiveness of myofascial release manual therapy and physical therapy for venous insufficiency in postmenopausal women. Complement Ther Med. 2012 Oct;20(5):291-8. doi: 10.1016/j.ctim.2012.03.005. Epub 2012 May 3.'}, {'pmid': '18824395', 'type': 'BACKGROUND', 'citation': 'Lombardini R, Marchesi S, Collebrusco L, Vaudo G, Pasqualini L, Ciuffetti G, Brozzetti M, Lupattelli G, Mannarino E. The use of osteopathic manipulative treatment as adjuvant therapy in patients with peripheral arterial disease. Man Ther. 2009 Aug;14(4):439-43. doi: 10.1016/j.math.2008.08.002. Epub 2008 Sep 27.'}, {'pmid': '29861222', 'type': 'BACKGROUND', 'citation': 'Thomaz SR, Teixeira FA, de Lima ACGB, Cipriano Junior G, Formiga MF, Cahalin LP. Osteopathic manual therapy in heart failure patients: A randomized clinical trial. J Bodyw Mov Ther. 2018 Apr;22(2):293-299. doi: 10.1016/j.jbmt.2017.07.011. Epub 2017 Jul 29.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study was to investigate the effect of one session OMT on arterial circulation in patients with PAD.', 'detailedDescription': '15 patients with PAD were included in the study. The OMT circulation model was applied to the participants for one session. Before and after the application, femoral artery diameter and flow rate in the patients were evaluated by doppler ultrasound'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with at least 3 months of clinical onset of peripheral vascular disease\n* Patients with ABI between 0.4-1.4\n* Patients up to Stage 2b according to the Fontaine classification system\n\nExclusion Criteria:\n\n* Patients undergoing vascular or endovascular surgery in the last 3 months\n* Patients with unstable angina\n* Patients with myocardial infarction (MI)\n* Patients with stroke\n* Patients with heart failure\n* Patients with significant liver or renal failure (ie, dialysis)\n* Acute infectious diseases\n* Patients with neoplasia'}, 'identificationModule': {'nctId': 'NCT03928860', 'briefTitle': 'The Effect of One Session Osteopathic Manuel Treatment on Femoral Artery Diameter and Flow', 'organization': {'class': 'OTHER', 'fullName': 'Kırıkkale University'}, 'officialTitle': 'The Effect of One Session Osteopathic Manuel Treatment on Femoral Artery Diameter and Flow in Patients With Peripheral Arterial Disease', 'orgStudyIdInfo': {'id': 'PAD AND ONE SESSION OMT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OMT Session and Doppler Ultrasonography', 'description': 'OMT Session Patients with PAD will be received 30 minutes of osteopathic manual treatment for one session. During application, the patient was in the supine position. OMT treatment session include, sub occipital release technique, supraclavicular release technique, sternal mobilization, omentum minus release, liver pumping, diaphragmatic mobilization, grand manevra technique, hip mobilization, knee mobilization and ankle mobilization. Each technique was applied for 3 minutes to patients.\n\nDoppler Ultrasonography Femoral artery diameter and flow evaluated by radiologist.\n\nIn the evaluation, the wall contour characteristics of the vessel to be examined were evaluated and the diameter was measured. Color doppler examination was performed to determine whether the vessel contained color filling, patency, flow direction and turbulence.\n\nPeak systolic and end diastolic flow rates and flow pattern and flow rate were measured by spectral examination', 'interventionNames': ['Other: OMT session']}], 'interventions': [{'name': 'OMT session', 'type': 'OTHER', 'description': 'Patients with PAD will be received 30 minutes of osteopathic manual treatment for one session. During application, the patient was in the supine position. OMT treatment session include, sub occipital release technique, supraclavicular release technique, sternal mobilization, omentum minus release, liver pumping, diaphragmatic mobilization, grand manevra technique, hip mobilization, knee mobilization and ankle mobilization. Each technique was applied for 3 minutes to patients.', 'armGroupLabels': ['OMT Session and Doppler Ultrasonography']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kırıkkale', 'country': 'Turkey (Türkiye)', 'facility': 'Kırıkkale University', 'geoPoint': {'lat': 39.84528, 'lon': 33.50639}}], 'overallOfficials': [{'name': 'Muhammet Ayhan ORAL', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kırıkkale University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kırıkkale University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant', 'investigatorFullName': 'Muhammet Ayhan ORAL', 'investigatorAffiliation': 'Kırıkkale University'}}}}