Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2026-02-22 @ 9:39 AM
Study NCT ID:
NCT03852212
Status:
COMPLETED
Last Update Posted:
2019-02-25
First Post:
2019-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ninth Dorsal Osteopathic Visceral Manipulation D9
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001847', 'term': 'Bone Diseases'}], 'ancestors': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 87}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-21', 'studyFirstSubmitDate': '2019-02-20', 'studyFirstSubmitQcDate': '2019-02-21', 'lastUpdatePostDateStruct': {'date': '2019-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Basal insulin laboratory value change', 'timeFrame': '10 minutes', 'description': 'The normal values of basal insulin measured with the imunoanalysis method are ˂ at 25.0 mU / l. If these values are exceeded, the effect of the manipulation in the study is verified'}, {'measure': 'Basal glycemia laboratory value change', 'timeFrame': '10 minutes', 'description': 'The normal values of basal glycemia measured with the enzymatic method vary between 60 - 105 mg / dl. The change of these values according to the reference laboratory has been the basis of the study.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Thrust technique', 'Blood levels', 'Pancreas', 'Ninth vertebra', 'Manipulation'], 'conditions': ['Osteopathia', 'Manipulation']}, 'descriptionModule': {'briefSummary': 'The aims of this study is to verify that the vertebral manipulation of dorsal level D9 influences the pancreas biochemical and endocrinology blood values.', 'detailedDescription': 'A longitudinal experimental study was conducted in which the osteopathic thrust maneuver was applied. In this research, 87 healthy subjects participated, of which 56.3% (n = 49) are men and 43.7% (n = 38) are women aged 19-29 who study at the Catholic University of Murcia.The blood analytical values of insulin and glycemia have been measured in 4 different times: at baseline, after 2,5 and 10 minutes of the technique application with the purpose to verify any possible change.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '27 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* students between 18-27 years old\n* healthy persons\n* Acceptance of informed consent\n\nExclusion Criteria:\n\n* pancreatitis\n* diabetes I,II type\n* anemia\n* Alcohol intake for 12 hours prior.'}, 'identificationModule': {'nctId': 'NCT03852212', 'briefTitle': 'Ninth Dorsal Osteopathic Visceral Manipulation D9', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Católica San Antonio de Murcia'}, 'officialTitle': 'Ninth Dorsal Osteopathic Visceral Manipulation D9 Affects Pancreas Blood Levels', 'orgStudyIdInfo': {'id': '5548'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'The control group did not received any treatment'}, {'type': 'EXPERIMENTAL', 'label': 'Manipulation', 'description': 'Experimental group received the osteopathic maneuver and the blood value were measured at baseline, after 2,5 and 10 minutes.', 'interventionNames': ['Other: Manipulation']}], 'interventions': [{'name': 'Manipulation', 'type': 'OTHER', 'description': 'Thrust technique application', 'armGroupLabels': ['Manipulation']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Católica San Antonio de Murcia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jasemin Todri', 'investigatorAffiliation': 'Universidad Católica San Antonio de Murcia'}}}}