Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-25 @ 9:27 PM
Study NCT ID:
NCT03888456
Status:
COMPLETED
Last Update Posted:
2019-07-24
First Post:
2019-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of OMT on ANS: a Thermography Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D026301', 'term': 'Manipulation, Osteopathic'}, {'id': 'C005703', 'term': 'salicylhydroxamic acid'}], 'ancestors': [{'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'participants will be blindly assigned to study or control arm using a computer-based random sequence generation and seal envelop'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'randomised placebo controlled crossover study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-07-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-23', 'studyFirstSubmitDate': '2019-03-21', 'studyFirstSubmitQcDate': '2019-03-22', 'lastUpdatePostDateStruct': {'date': '2019-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'temperature', 'timeFrame': '1 week', 'description': 'variability of the autonomic nervous system measured by temperature variability of the face'}], 'secondaryOutcomes': [{'measure': 'skin conductance', 'timeFrame': '1 week', 'description': 'pre-post changes of physiological parameter of electrodermal skin response'}, {'measure': 'heart rate variability', 'timeFrame': '1 week', 'description': 'pre-post changes of HRV'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Autonomic Nervous System Imbalance', 'Healthy']}, 'referencesModule': {'references': [{'pmid': '33013294', 'type': 'DERIVED', 'citation': 'Cerritelli F, Cardone D, Pirino A, Merla A, Scoppa F. Does Osteopathic Manipulative Treatment Induce Autonomic Changes in Healthy Participants? A Thermal Imaging Study. Front Neurosci. 2020 Aug 18;14:887. doi: 10.3389/fnins.2020.00887. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'the study will investigate the effect of a specific type of touch intervention on the activity of autonomic nervous system measured using thermography'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adults above 18y and below 35y\n* without any congenital, genetical and chronic disease\n* without any symptomatology\n\nExclusion Criteria:\n\n* congenital, genetical and chronic disease\n* neurological, cardiovascular, psychiatric disease\n* acute pain\n* paediatric patients\n* adults over 35 years old'}, 'identificationModule': {'nctId': 'NCT03888456', 'briefTitle': 'Effects of OMT on ANS: a Thermography Study', 'organization': {'class': 'OTHER', 'fullName': 'Come Collaboration'}, 'officialTitle': 'Effects of Osteopathic Manipulative Treatment on Autonomic Nervous System: a Thermography Study', 'orgStudyIdInfo': {'id': 'COME-02-18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'study', 'description': 'participants will receive a single touch intervention based on osteopathic assessment and treatment', 'interventionNames': ['Other: osteopathic treatment', 'Other: sham']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control', 'description': 'participants will receive a single touch sham intervention mimicking the intervention', 'interventionNames': ['Other: osteopathic treatment', 'Other: sham']}], 'interventions': [{'name': 'osteopathic treatment', 'type': 'OTHER', 'description': 'the intervention will be based on 2 phases: 1) assessment to identify areas with somatic dysfunction, 2) treatment to improve the function of the area identified', 'armGroupLabels': ['Control', 'study']}, {'name': 'sham', 'type': 'OTHER', 'description': 'the sham intervention will consists of 2 overlapping phases as the intervention group but without applying any technique', 'armGroupLabels': ['Control', 'study']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66100', 'city': 'Chieti', 'country': 'Italy', 'facility': 'University of Chieti', 'geoPoint': {'lat': 42.34827, 'lon': 14.16494}}], 'overallOfficials': [{'name': 'Francesco Cerritelli', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Come Collaboration'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Come Collaboration', 'class': 'OTHER'}, 'collaborators': [{'name': "Università degli Studi 'G. d'Annunzio' Chieti e Pescara", 'class': 'OTHER'}, {'name': 'Chinesis IFOP', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}