Ignite Creation Date:
2025-12-24 @ 2:06 PM
Ignite Modification Date:
2025-12-30 @ 9:17 PM
Study NCT ID:
NCT05465395
Status:
SUSPENDED
Last Update Posted:
2023-05-03
First Post:
2022-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Upper Cervical and Thoracic Chiropractic Adjustment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'whyStopped': 'Prioritizing other studies', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2021-10-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-01', 'studyFirstSubmitDate': '2022-03-07', 'studyFirstSubmitQcDate': '2022-07-15', 'lastUpdatePostDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Caretaker Heart Rate Variability', 'timeFrame': 'Through study completion, an average of 1 week', 'description': 'HRV allows for an understanding of Autonomic (parasympathetic) function, via measuring the interval of R peaks in QRS complexes.'}, {'measure': 'Galvanic Skin Response', 'timeFrame': 'Through study completion, an average of 1 week', 'description': 'Galvanic Skin response gives a strong measure of Sympathetic response via electrical conductivity of perspiration.'}, {'measure': 'Hamilton Anxiety Rating Scale', 'timeFrame': 'Through study completion, an average of 1 week', 'description': 'Measures the severity of anxiety symptoms'}, {'measure': 'NSESSS', 'timeFrame': 'Through study completion, an average of 1 week', 'description': 'Measures PTSD symptoms in people 18 and up.'}, {'measure': 'CD-RISC-25', 'timeFrame': 'Through study completion, an average of 1 week', 'description': 'Measure of adaptability'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Heart Rate Varability', 'Autonomic Nervious System', 'Chiropractic Adjustment'], 'conditions': ['Stress']}, 'descriptionModule': {'briefSummary': "The proposed study examines the differences in how the ANS responds to cervical adjustments in comparison to thoracic adjustments. This study is the continuation of a previous study titled Perceived stress and patterns of autonomic function: a protocol development study. Autonomic tests such as HRV, GSR, and the stress surveys will be the primary method of measurement. CareTaker and Biopac devices will provide continual data collection of ECG (for HRV analysis) and GSR throughout the exam and adjustment. Participant's subjective stress levels will be measured through the use of stress questionnaires including the National Stressful Events Survey Acute Stress Disorder Short Scale, the Hamilton Anxiety Rating Scale, and the Connor-Davidson Resilience Scale. The objective of the study is to determine if the location of a chiropractic adjustment will affect the autonomic nervous system in such a way that PNS or SNS activation increases or decreases after the adjustment. Further, the study will continue to examine how the chiropractic adjustment affects the subjective stress response."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Over the age of 19\n* In good health\n* Willing to have blood pressure taken\n* Willinig to shave a small area of chest hair for placement of a ECG patch\n* Consent to a physical exam\n* Consent ot chiropractic evaluationa nd 2 adjustments'}, 'identificationModule': {'nctId': 'NCT05465395', 'briefTitle': 'Upper Cervical and Thoracic Chiropractic Adjustment', 'organization': {'class': 'OTHER', 'fullName': 'Life University'}, 'officialTitle': 'Effects of Upper Cervical and Thoracic Chiropractic Adjustments on the Autonomic Nervous System and Perceived Stress Response', 'orgStudyIdInfo': {'id': 'I-0020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Upper Cervical Adjustment', 'description': 'Upper cervical adjustemnt', 'interventionNames': ['Procedure: Upper Cervical Adjustemnt', 'Procedure: Thoracic Adjustemnt']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Thoracic Adjustment', 'description': 'Thoracic adjustment', 'interventionNames': ['Procedure: Upper Cervical Adjustemnt', 'Procedure: Thoracic Adjustemnt']}], 'interventions': [{'name': 'Upper Cervical Adjustemnt', 'type': 'PROCEDURE', 'description': 'Upper cervical adjustement', 'armGroupLabels': ['Thoracic Adjustment', 'Upper Cervical Adjustment']}, {'name': 'Thoracic Adjustemnt', 'type': 'PROCEDURE', 'description': 'Thoracic adjustment', 'armGroupLabels': ['Thoracic Adjustment', 'Upper Cervical Adjustment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Dr. Sid E. Williams Center for Chiropractic Research', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Stephanie Sullivan', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Life Univeristy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Life University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}