Chiropractic T Cell Study

Intervention Clinical Trial

Official title:

Impact of a Corrective Model of Chiropractic Care on Immune Cell Phenotype and Function

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05412602
• Other study ID #: H21-00643
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 25, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: December 2023
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 38
• Est. completion date: December 31, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Intervention
• Waitlist Control

Intervention

Procedure:
• full spine corrective protocol
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

Locations

Country	Name	City	State
Canada	University of British Columbia Okanagan	Kelowna	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in body mass	Body mass in kilograms will be measured by a scale	12 weeks
Other	Change in Blood Pressure	Manual blood pressure (systolic and diastolic) in millimetres mercury assessed in the clinic	12 weeks
Other	Change in vertebral subluxation	Absolute rotation angle (ARA) of the cervical spine assessed by X-ray	12 weeks
Other	Quality of Life Assessment	Differences in quality of life as measured via Oswestry	12 weeks
Other	Quality of Life Assessment	Differences in quality of life as measured via SF36	12 weeks
Other	Quality of Life Assessment	Differences in quality of life as measured via Neck Disability Index.	12 weeks
Other	Change in Posture	Posture analysis as measured by JTech Digital Inclinometer	12 weeks
Primary	Change in CD25+ Regulatory T Cell	CD25+ Regulatory T Cell count will be measured by surface staining using flow cytometry	12 weeks
Secondary	Change in CD4+ and CD8+ T cell	CD4+ and CD8+ T cell count measured by surface staining using flow cytometry	12 weeks