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Completed

NCT Number: NCT05412602

Chiropractic T Cell Study

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.

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Key information

Conditions

Intervention Waitlist Control

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of British Columbia Okanagan

Kelowna, British Columbia, V1V 1V7, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

full spine corrective protocol

Procedure

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

Primary outcomes

  1. Change in CD25+ Regulatory T Cell

    Time frame: 12 weeks

    CD25+ Regulatory T Cell count will be measured by surface staining using flow cytometry

Secondary outcomes

  1. Change in CD4+ and CD8+ T cell

    Time frame: 12 weeks

    CD4+ and CD8+ T cell count measured by surface staining using flow cytometry

Other outcomes

  1. 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.

  2. 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.

  3. Change in body mass

    Time frame: 12 weeks

    Body mass in kilograms will be measured by a scale

  4. Change in Blood Pressure

    Time frame: 12 weeks

    Manual blood pressure (systolic and diastolic) in millimetres mercury assessed in the clinic

  5. Change in vertebral subluxation

    Time frame: 12 weeks

    Absolute rotation angle (ARA) of the cervical spine assessed by X-ray

  6. Quality of Life Assessment

    Time frame: 12 weeks

    Differences in quality of life as measured via Oswestry

  7. Quality of Life Assessment

    Time frame: 12 weeks

    Differences in quality of life as measured via SF36

  8. Quality of Life Assessment

    Time frame: 12 weeks

    Differences in quality of life as measured via Neck Disability Index.

  9. Change in Posture

    Time frame: 12 weeks

    Posture analysis as measured by JTech Digital Inclinometer

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 9, 2022
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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