- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05412602
Chiropractic T Cell Study
February 5, 2025 updated by: Jonathan Little, University of British Columbia
Impact of a Corrective Model of Chiropractic Care on Immune Cell Phenotype and Function
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
38
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
British Columbia
-
Kelowna, British Columbia, Canada, V1V 1V7
- University of British Columbia Okanagan
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Must be between the ages of 18-70.
- Must exhibit vertebral subluxation as measured by a misalignment between one or more vertebrae in relation to normal spinal alignment.
- Have not been sick for the past 3 weeks (immune function).
- Non-smoker.
- Must be able to fast for 10-12 hours.
Exclusion Criteria:
- To have had a chiropractic intervention within the past 6 months.
- 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.)
- To have excessive scoliotic curvature of the spine (> 30º) as measured by identifying the first vertebrae, and the most laterally displaced vertebrae that exhibits tilt below it.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
experimental group will receive 36 chiropractic treatments designed to correct vertebral subluxation over ~12 weeks
|
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
|
|
No Intervention: waitlist control
waitlist control will receive no chiropractic interventions and will be reminded that to successfully complete their condition, they do not seek alternative chiropractic treatments
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in CD25+ Regulatory T Cell
Time Frame: 12 weeks
|
CD25+ Regulatory T Cell count will be measured by surface staining using flow cytometry
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in CD4+ and CD8+ T cell
Time Frame: 12 weeks
|
CD4+ and CD8+ T cell count measured by surface staining using flow cytometry
|
12 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in vertebral subluxation
Time Frame: 12 weeks
|
Absolute rotation angle (ARA) of the cervical spine assessed by X-ray
|
12 weeks
|
|
Change in body mass
Time Frame: 12 weeks
|
Body mass in kilograms will be measured by a scale
|
12 weeks
|
|
Change in Blood Pressure
Time Frame: 12 weeks
|
Manual blood pressure (systolic and diastolic) in millimetres mercury assessed in the clinic
|
12 weeks
|
|
Quality of Life Assessment
Time Frame: 12 weeks
|
Differences in quality of life as measured via Oswestry
|
12 weeks
|
|
Quality of Life Assessment
Time Frame: 12 weeks
|
Differences in quality of life as measured via SF36
|
12 weeks
|
|
Quality of Life Assessment
Time Frame: 12 weeks
|
Differences in quality of life as measured via Neck Disability Index.
|
12 weeks
|
|
Change in Posture
Time Frame: 12 weeks
|
Posture analysis as measured by JTech Digital Inclinometer
|
12 weeks
|
|
Changes in TNF alpha secretion
Time Frame: 12 weeks
|
Ex-vivo whole blood culture for either 4 hours in LPS or 24 hours in Poly I:C.
|
12 weeks
|
|
Changes in IFN gamma secretion
Time Frame: 12 weeks
|
Ex-vivo whole blood culture for either 4 hours in LPS or 24 hours in Poly I:C.
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 25, 2022
Primary Completion (Actual)
September 1, 2023
Study Completion (Actual)
December 31, 2023
Study Registration Dates
First Submitted
June 6, 2022
First Submitted That Met QC Criteria
June 6, 2022
First Posted (Actual)
June 9, 2022
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 5, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- H21-00643
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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