Chiropractic T Cell Study

Study Overview
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Brief Summary
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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.

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

Conditions
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Intervention, Waitlist Control

Intervention / Treatment
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* Procedure: full spine corrective protocol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: parallel-arm randomized control trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>experimental group will receive 36 chiropractic treatments designed to correct vertebral subluxation over  12 weeks | Procedure: full spine corrective protocol<br>* 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<br>|
| No Intervention: waitlist control<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in CD25+ Regulatory T Cell | 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 | CD4+ and CD8+ T cell count measured by surface staining using flow cytometry | 12 weeks |