Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:34 AM
Study NCT ID:
NCT05412602
Status:
COMPLETED
Last Update Posted:
2025-02-10
First Post:
2022-06-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Chiropractic T Cell Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'parallel-arm randomized control trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-05', 'studyFirstSubmitDate': '2022-06-06', 'studyFirstSubmitQcDate': '2022-06-06', 'lastUpdatePostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Changes in TNF alpha secretion', 'timeFrame': '12 weeks', 'description': 'Ex-vivo whole blood culture for either 4 hours in LPS or 24 hours in Poly I:C.'}, {'measure': 'Changes in IFN gamma secretion', 'timeFrame': '12 weeks', 'description': 'Ex-vivo whole blood culture for either 4 hours in LPS or 24 hours in Poly I:C.'}, {'measure': 'Change in body mass', 'timeFrame': '12 weeks', 'description': 'Body mass in kilograms will be measured by a scale'}, {'measure': 'Change in Blood Pressure', 'timeFrame': '12 weeks', 'description': 'Manual blood pressure (systolic and diastolic) in millimetres mercury assessed in the clinic'}, {'measure': 'Change in vertebral subluxation', 'timeFrame': '12 weeks', 'description': 'Absolute rotation angle (ARA) of the cervical spine assessed by X-ray'}, {'measure': 'Quality of Life Assessment', 'timeFrame': '12 weeks', 'description': 'Differences in quality of life as measured via Oswestry'}, {'measure': 'Quality of Life Assessment', 'timeFrame': '12 weeks', 'description': 'Differences in quality of life as measured via SF36'}, {'measure': 'Quality of Life Assessment', 'timeFrame': '12 weeks', 'description': 'Differences in quality of life as measured via Neck Disability Index.'}, {'measure': 'Change in Posture', 'timeFrame': '12 weeks', 'description': 'Posture analysis as measured by JTech Digital Inclinometer'}], 'primaryOutcomes': [{'measure': 'Change in CD25+ Regulatory T Cell', 'timeFrame': '12 weeks', 'description': 'CD25+ Regulatory T Cell count will be measured by surface staining using flow cytometry'}], 'secondaryOutcomes': [{'measure': 'Change in CD4+ and CD8+ T cell', 'timeFrame': '12 weeks', 'description': 'CD4+ and CD8+ T cell count measured by surface staining using flow cytometry'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intervention', 'Waitlist Control']}, 'descriptionModule': {'briefSummary': 'Some studies suggest that specific chiropractic care (techniques known as "spinal manipulation therapy") can have benefits to the immune system but studies are scarce, sample sizes small, and methodology and analyses often not of the highest scientific standards. The investigators will example how 36 sessions of chiropractic care over 9-12 weeks can impact immune cell function using a randomized clinical trial design.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Must be between the ages of 18-70.\n* Must exhibit vertebral subluxation as measured by a misalignment between one or more vertebrae in relation to normal spinal alignment.\n* Have not been sick for the past 3 weeks (immune function).\n* Non-smoker.\n* Must be able to fast for 10-12 hours.\n\nExclusion Criteria:\n\n* To have had a chiropractic intervention within the past 6 months.\n* To have a condition that may limit the ability to apply a high velocity, low amplitude (HVLA) thrust to the spine such as but not limited to ligament damage, reduced bone density, or other factors that weaken the body's ability to withstand reasonable care (bone cancer, fractures, osteoporosis, etc.)\n* To have excessive scoliotic curvature of the spine (\\> 30ยบ) as measured by identifying the first vertebrae, and the most laterally displaced vertebrae that exhibits tilt below it."}, 'identificationModule': {'nctId': 'NCT05412602', 'briefTitle': 'Chiropractic T Cell Study', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'Impact of a Corrective Model of Chiropractic Care on Immune Cell Phenotype and Function', 'orgStudyIdInfo': {'id': 'H21-00643'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'experimental group will receive 36 chiropractic treatments designed to correct vertebral subluxation over \\~12 weeks', 'interventionNames': ['Procedure: full spine corrective protocol']}, {'type': 'NO_INTERVENTION', 'label': 'waitlist control', 'description': 'waitlist control will receive no chiropractic interventions and will be reminded that to successfully complete their condition, they do not seek alternative chiropractic treatments'}], 'interventions': [{'name': 'full spine corrective protocol', 'type': 'PROCEDURE', 'description': '36 chiropractic adjustments over 12 weeks (3 visits per week) with in office spinal traction on the 3D Denneroll Traction Table, as well as supplemental home exercises', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V1V 1V7', 'city': 'Kelowna', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'University of British Columbia Okanagan', 'geoPoint': {'lat': 49.88307, 'lon': -119.48568}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jonathan Little', 'investigatorAffiliation': 'University of British Columbia'}}}}