InterventionNCT05412602
Chiropractic T Cell Study
A study testing full spine corrective protocol in people with Intervention and Waitlist Control, run by University of British Columbia at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Intervention, Waitlist Control
- What is being tested?
- full spine corrective protocol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteCanada
- Study dates
- 25 Jul 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of British Columbia Okanagan
Kelowna, British Columbia, V1V 1V7
About this study
Official title: 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.
- Conditions
- Intervention, Waitlist Control
- Being tested
- full spine corrective protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
full spine corrective protocolProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | experimental group will receive 36 chiropractic treatments designed to correct vertebral subluxation over ~12 weeks Receives: Procedure: full spine corrective protocol |
| waitlist control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Change in CD25+ Regulatory T Cell
CD25+ Regulatory T Cell count will be measured by surface staining using flow cytometry
Measured: 12 weeks
Secondary outcomes (1)
Change in CD4+ and CD8+ T cell
CD4+ and CD8+ T cell count measured by surface staining using flow cytometry
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start25 Jul 2022
- Primary completion1 Sep 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InterventionStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- parallel-arm randomized control trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Little, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05412602
- Sponsor's protocol ID
- H21-00643
- Status last verified
- Feb 2025
- First submitted
- 6 Jun 2022
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Corrective Model of Chiropractic Care on Immune Cell Phenotype and Function
- ClinicalTrials.gov ID
- NCT05412602
- Acronym / sponsor ID
- H21-00643
- Conditions
- Intervention, Waitlist Control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 25 Jul 2022 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 9 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- parallel-arm randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: full spine corrective protocolexperimental group will receive 36 chiropractic treatments designed to correct vertebral subluxation over ~12 weeks |
| waitlist control | No intervention | –waitlist control will receive no chiropractic interventions and will be reminded that to successfully complete their condition, they do not seek alternative chiropractic treatments |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| full spine corrective protocol36 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 | Procedure or surgery | Intervention |
Primary outcome
Change in CD25+ Regulatory T Cell
Time frame: 12 weeks
CD25+ Regulatory T Cell count will be measured by surface staining using flow cytometry
1 secondary outcome
Change in CD4+ and CD8+ T cell
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing full spine corrective protocol in people with Intervention and Waitlist Control, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in CD25+ Regulatory T Cell (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.