Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2026-01-17 @ 2:13 AM
Study NCT ID:
NCT01908920
Status:
COMPLETED
Last Update Posted:
2013-09-10
First Post:
2013-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Osteopathic Manipulative Treatment Effects on High Frequency Parameters in Healthy Subjects
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']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-08', 'studyFirstSubmitDate': '2013-07-19', 'studyFirstSubmitQcDate': '2013-07-23', 'lastUpdatePostDateStruct': {'date': '2013-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline high frequency (HF) value at 1 week', 'timeFrame': 'baseline and 1 week'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in low frequency (LF) value at 1 week', 'timeFrame': 'baseline and 1 week'}, {'measure': 'Change from baseline LF/HF ratio value at 1 week', 'timeFrame': 'baseline and 1 week'}, {'measure': 'Change from baseline very low frequency (VLF) value at 1 week', 'timeFrame': 'baseline and 1 week'}, {'measure': 'Change from baseline standard deviation beat-to-beat (SDNN) value at 1 week', 'timeFrame': 'baseline and 1 week'}, {'measure': 'Changes from baseline square root of the mean squared difference of successive beat-to-beat (RMSSD) at 1 week', 'timeFrame': 'baseline and 1 week'}, {'measure': 'Change from baseline proportion of beat-to-beat50 divided by total number of beat-to-beats in (pNN50) at 1 week', 'timeFrame': 'baseline and 1 week'}, {'measure': 'Change from baseline detrended fluctuation scaling exponent (DFAa1) value at 1 week', 'timeFrame': 'baseline and 1 week'}, {'measure': 'Change in LF value', 'timeFrame': 'during treatment session'}, {'measure': 'Change in LF/HF ratio value', 'timeFrame': 'during treatment session'}, {'measure': 'Change in VLF value', 'timeFrame': 'during treatment session'}, {'measure': 'Change in SDNN value', 'timeFrame': 'during treatment session'}, {'measure': 'Change in RMSSD value', 'timeFrame': 'during treatment session'}, {'measure': 'Change in pNN50 value', 'timeFrame': 'during treatment session'}, {'measure': 'Change in DFAa1 value', 'timeFrame': 'during treatment session'}, {'measure': 'Change from baseline intrasubject HF value at 1 week', 'timeFrame': 'baseline and 1 week'}, {'measure': 'Change from baseline heart rate variability parameters between smokers and no-smokers at 1 week', 'timeFrame': 'baseline and 1 week'}, {'measure': 'Change from baseline 15D questionnaire at 1 week', 'timeFrame': 'baseline and 1 week'}, {'measure': 'Differences in skin conductance value between groups', 'timeFrame': '1 week'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Healthy Subject', 'Heart Rate Variability']}, 'referencesModule': {'references': [{'pmid': '26300719', 'type': 'DERIVED', 'citation': "Ruffini N, D'Alessandro G, Mariani N, Pollastrelli A, Cardinali L, Cerritelli F. Variations of high frequency parameter of heart rate variability following osteopathic manipulative treatment in healthy subjects compared to control group and sham therapy: randomized controlled trial. Front Neurosci. 2015 Aug 4;9:272. doi: 10.3389/fnins.2015.00272. eCollection 2015."}]}, 'descriptionModule': {'briefSummary': 'The aim of the present study is to determine the extend to which osteopathic manipulative treatment (OMT) is effective on a sample of healthy subjects in changing high frequency (HF) parameters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 45;\n* No chronic symptomatology;\n* No acute symptomatology during the last 72 hours before intervention;\n* No pathologies\n\nExclusion Criteria:\n\n* Age below 18 or over 45;\n* Pregnancy;\n* Menopause;\n* Abuse of alcool during the last 48 hours;\n* Chronic pain;\n* Acute pain during the last 72 hours;\n* Conclamate pathologies;\n* Use of drugs during the last 72 hours ;\n* Use of ortothic devices during the last 3 months;\n* Any type of surgery;\n* Osteopathic treatment during the last 3 months.'}, 'identificationModule': {'nctId': 'NCT01908920', 'briefTitle': 'Osteopathic Manipulative Treatment Effects on High Frequency Parameters in Healthy Subjects', 'organization': {'class': 'OTHER', 'fullName': 'European Institute for Evidence Based Osteopathic Medicine'}, 'orgStudyIdInfo': {'id': 'HRVOST'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'OMT', 'description': 'Each osteopathic session is based on structural evaluation and treatment using indirect techniques.', 'interventionNames': ['Other: Osteopathic manipulative treatment']}, {'type': 'OTHER', 'label': 'SHAM', 'description': 'Sham therapy was administered with subjects lying supine on the treatment table while the operator used light manual contact to "treat" the subject. A pre-determined protocol has been used. The practitioner\'s attention was distracted by subtracting calculation in silence.', 'interventionNames': ['Other: SHAM']}, {'type': 'OTHER', 'label': 'CONTROL', 'description': 'No intervention', 'interventionNames': ['Other: CONTROL']}], 'interventions': [{'name': 'Osteopathic manipulative treatment', 'type': 'OTHER', 'armGroupLabels': ['OMT']}, {'name': 'SHAM', 'type': 'OTHER', 'armGroupLabels': ['SHAM']}, {'name': 'CONTROL', 'type': 'OTHER', 'armGroupLabels': ['CONTROL']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Pescara', 'country': 'Italy', 'facility': 'Accademia Italiana Osteopatia Tradizionale', 'geoPoint': {'lat': 42.4584, 'lon': 14.20283}}], 'overallOfficials': [{'name': 'Francesco Cerritelli, MS, DO', 'role': 'STUDY_CHAIR', 'affiliation': 'Italian Academy of Traditional Osteopathy - AIOT'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Institute for Evidence Based Osteopathic Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MS, DO', 'investigatorFullName': 'Francesco Cerritelli', 'investigatorAffiliation': 'European Institute for Evidence Based Osteopathic Medicine'}}}}