Ignite Creation Date:
2025-12-24 @ 5:51 PM
Ignite Modification Date:
2025-12-25 @ 3:16 PM
Study NCT ID:
NCT03273868
Status:
COMPLETED
Last Update Posted:
2019-03-05
First Post:
2017-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of a Single Spinal Manipulation on Cardiovascular Autonomic Activity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-01', 'studyFirstSubmitDate': '2017-08-09', 'studyFirstSubmitQcDate': '2017-09-02', 'lastUpdatePostDateStruct': {'date': '2019-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Heart rate variability (HRV)', 'timeFrame': 'Baseline, + 5 minutes, + 15 minutes, + 30 minutes', 'description': 'Frequency and Time-domain analyses of HRV from 5-minutes ECG recording'}, {'measure': 'Local (T5) and distal (L4) Pressure pain thresholds (PPT)', 'timeFrame': 'Baseline, immediatly after intervention, + 12 minutes, + 25 minutes, + 35 minutes', 'description': 'The mean of 3 successives PPT in kilopascal'}], 'secondaryOutcomes': [{'measure': 'Systolic blood pressure variability', 'timeFrame': 'Baseline, + 5 minutes, + 15 minutes, + 30 minutes', 'description': 'Frequency analysis in the low frequency band of systolic blood pressure variability from 5-minutes recording'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Manipulation, Spinal']}, 'referencesModule': {'references': [{'pmid': '31988711', 'type': 'DERIVED', 'citation': 'Picchiottino M, Honore M, Leboeuf-Yde C, Gagey O, Cottin F, Hallman DM. The effect of a single spinal manipulation on cardiovascular autonomic activity and the relationship to pressure pain threshold: a randomized, cross-over, sham-controlled trial. Chiropr Man Therap. 2020 Jan 20;28(1):7. doi: 10.1186/s12998-019-0293-4. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the effect of a single high-velocity low-amplitude spinal manipulation on both cardiovascular autonomic activity and pressure pain thresholds.\n\nIt is a cross-over study, thus each participant will undergo both interventions (spinal manipulation and sham manipulation). Both interventions will be separated by a 48 h wash-out period.', 'detailedDescription': 'Several systematic reviews have shown that spinal manipulations may have an immediate effect on autonomic nervous system activity (e.g. increase in skin sympathetic nerve activity) and on sensitivity to experimentally-induced pain (e.g. increase in pressure pain threshold).\n\nIt is generally unknown i) if these supposed effects last after the immediate post intervention period and ii) if there is a statistical relationship between them, considering that pain and autonomic networks are closely connected and interact at the peripheral, spinal and supra-spinal levels.\n\nThe primary aim of the study is to assess every single effect immediatly and at short-term after the intervention.\n\nThe secondary aim is to assess the bivariate statistical relationship between cardiovascular autonomic activity and sensitivity to experimentally-induced pain after the intervention.\n\nCardiovascular autonomic nervous system activity is assessed with both heart rate and systolic blood variabilities\n\nSensitivity to experimentally-induced pain is measured using pressure pain threshold.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* First-year chiropractic student at IFEC\n* Volunteer\n* Healthy (no pain, no disease)\n\nExclusion Criteria:\n\n* Counter indications to spinal manipulation\n* Drugs intakes (pain killers or beta-blockers)\n* Food, Caffeine and tobacco intakes during the previous hour\n* Alcohol intake and performance of strenuous physical activity the day of the experimentation'}, 'identificationModule': {'nctId': 'NCT03273868', 'briefTitle': 'The Effect of a Single Spinal Manipulation on Cardiovascular Autonomic Activity', 'organization': {'class': 'OTHER', 'fullName': 'Institut Franco Europeen de Chiropratique'}, 'officialTitle': 'The Effect of a Single Spinal Manipulation on Cardiovascular Autonomic Activity in Healthy Subjects: a Randomized, Cross-over, Sham-controlled Trial', 'orgStudyIdInfo': {'id': 'Protocole IFEC 2017-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High velocity low amplitude manipulation', 'interventionNames': ['Other: High velocity low amplitude manipulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham manipulation', 'interventionNames': ['Other: Sham manipulation']}], 'interventions': [{'name': 'High velocity low amplitude manipulation', 'type': 'OTHER', 'description': 'The researcher manually applies a preload force on the T5/T6 level followed by a single posterior to anterior thrust.', 'armGroupLabels': ['High velocity low amplitude manipulation']}, {'name': 'Sham manipulation', 'type': 'OTHER', 'description': 'The researcher manually applies a preload force on the right scapula followed by a single lateral thrust.', 'armGroupLabels': ['Sham manipulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94220', 'city': 'Ivry-sur-Seine', 'state': 'Val De Marne', 'country': 'France', 'facility': 'Institut Franco Européen de Chiropraxie', 'geoPoint': {'lat': 48.81568, 'lon': 2.38487}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Franco Europeen de Chiropratique', 'class': 'OTHER'}, 'collaborators': [{'name': 'French chiropractic research fund', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chiropractor, PhD student', 'investigatorFullName': 'Mathieu Picchiottino', 'investigatorAffiliation': 'Institut Franco Europeen de Chiropratique'}}}}