HealthyFVTNCT05249530
Chiropractic Force Versus Touch
A study testing Chiropractic spinal adjustment and Non-force simulation in people with Healthy, run by Life University at 1 site in United States.
Trial summary
The Life University Center for Chiropractic Research is conducting a research study to better understand the physiologic and brain-based differences between the touch and force components of the chiropractic adjustment. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Chiropractic spinal adjustment and Non-force simulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2021to 1 Aug 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- You are between the age of 18 and 50.
- You have not had a chiropractic adjustment in the past 2 weeks.
- You are not currently receiving care such as acupuncture or physical therapy.
- You are currently not taking any medication that may change your brain patterns.
Who cannot join
- You do not have a history of recent spinal surgery or trauma.
- You do not have any other health conditions that may prevent you from receive chiropractic care. This could include diagnosed osteoporosis.
- You are not pregnant.
- You do not have a severe mental health condition.
- You do not have a known heart condition.
Trial locations and contacts
1 site in 1 country.
United States1 site
Life University Center for Chiropractic Research
Atlanta, Georgia, 30308
About this study
Official title: Comparison of EEG Changes Over Time Following Application of Chiropractic Adjustive Force vs Non-force Simulation
The Life University Center for Chiropractic Research is conducting a research study to better understand the physiologic and brain-based differences between the touch and force components of the chiropractic adjustment. Eligible individuals will either receive a chiropractic adjustment with force or a non-force stimulation. Individuals in the force stimulation group will receive an active spinal adjustment with a handheld instrument called an Activator. Individuals in the non-force stimulation group will have one Activator placed on the spine and another Activator clicked away from the spine. This study is not randomized. The first participant will receive an active spinal adjustment, and the second participant will receive a non-force stimulation at the same locations as the first participant. This pattern repeats until all individuals have been recruited (n=30). Outcome assessments include resting state electroencephalography (EEG), electrocardiography (ECG), and blood pressure. Outcome assessments will be captured prior to the adjustment or non-force stimulation, after the adjustment or non-force stimulation, and one week later. Individuals will also undergo a standard health history and chiropractic physical exam at the start of participation.
- Conditions
- Healthy
- Being tested
- Chiropractic spinal adjustment, Non-force simulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chiropractic spinal adjustmentOther
Chiropractic spinal adjustment
Non-force simulationOther
Non-force simulation
| Study group | Role | What they receive |
|---|---|---|
| Force | Experimental | Chiropractic spinal adjustment with force Receives: Other: Chiropractic spinal adjustment |
| Touch | Active comparator | non-force stimulation Receives: Other: Non-force simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electroencephalography (EEG) Power spectrum
64 channels of EEG will be recorded. A fast Fourier transform will be computed to provide a power spectrum of frequencies 1-50.
Measured: Baseline, beginning of the study
Electroencephalography (EEG) Power spectrum
64 channels of EEG will be recorded. A fast Fourier transform will be computed to provide a power spectrum of frequencies 1-50.
Measured: through study completion, an average of 1 year
Electroencephalography (EEG) Power spectrum
64 channels of EEG will be recorded. A fast Fourier transform will be computed to provide a power spectrum of frequencies 1-50.
Measured: One week follow up
Electrocardiogram (ECG) R-R intervals
Three leads will be placed on the torso to capture a Lead II ECG. R-R intervals will be calculated.
Measured: Baseline, beginning of the study
Electrocardiogram (ECG) R-R intervals
Three leads will be placed on the torso to capture a Lead II ECG. R-R intervals will be calculated.
Measured: through study completion, an average of 1 year
Electrocardiogram (ECG) R-R intervals
Three leads will be placed on the torso to capture a Lead II ECG. R-R intervals will be calculated.
Measured: one-week follow up
Blood pressure
Blood pressure will be captured using an automatic blood pressure cuff
Measured: Baseline, beginning of the study
Blood pressure
Blood pressure will be captured using an automatic blood pressure cuff
Measured: through study completion, an average of 1 year
Blood pressure
Blood pressure will be captured using an automatic blood pressure cuff
Measured: one-week follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start28 Sep 2021
- Primary completion1 Aug 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Life University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephanie Sullivan, PhD, DC, Principal investigator, Life Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05249530
- Sponsor's protocol ID
- I-0015
- Acronym
- FVT
- Status last verified
- Feb 2024
- First submitted
- 27 Jan 2022
- Last updated
- 2 Feb 2024
- Results posted
- 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 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of EEG Changes Over Time Following Application of Chiropractic Adjustive Force vs Non-force Simulation
- ClinicalTrials.gov ID
- NCT05249530
- Acronym / sponsor ID
- FVT / I-0015
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Life UniversityUniversity, hospital or other
- Study start
- 28 Sep 2021 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 21 Feb 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.
The Life University Center for Chiropractic Research is conducting a research study to better understand the physiologic and brain-based differences between the touch and force components of the chiropractic adjustment. Eligible individuals will either receive a chiropractic adjustment with force or a non-force stimulation. Individuals in the force stimulation group will receive an active spinal adjustment with a handheld instrument called an Activator. Individuals in the non-force stimulation group will have one Activator placed on the spine and another Activator clicked away from the spine. This study is not randomized. The first participant will receive an active spinal adjustment, and the second participant will receive a non-force stimulation at the same locations as the first participant. This pattern repeats until all individuals have been recruited (n=30). Outcome assessments include resting state electroencephalography (EEG), electrocardiography (ECG), and blood pressure. Outcome assessments will be captured prior to the adjustment or non-force stimulation, after the adjustment or non-force stimulation, and one week later. Individuals will also undergo a standard health history and chiropractic physical exam at the start of participation.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Force | Experimental | Other: Chiropractic spinal adjustmentChiropractic spinal adjustment with force |
| Touch | Active comparator | Other: Non-force simulationnon-force stimulation |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- You are between the age of 18 and 50.
- You have not had a chiropractic adjustment in the past 2 weeks.
- You are not currently receiving care such as acupuncture or physical therapy.
- You are currently not taking any medication that may change your brain patterns.
Key exclusion criteria (5 listed)
- You do not have a history of recent spinal surgery or trauma.
- You do not have any other health conditions that may prevent you from receive chiropractic care. This could include diagnosed osteoporosis.
- You are not pregnant.
- You do not have a severe mental health condition.
- You do not have a known heart condition.
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 |
|---|---|---|
| Chiropractic spinal adjustmentChiropractic spinal adjustment | Other | Force |
| Non-force simulationNon-force simulation | Other | Touch |
Primary outcome
Electroencephalography (EEG) Power spectrum
Time frame: Baseline, beginning of the study
64 channels of EEG will be recorded. A fast Fourier transform will be computed to provide a power spectrum of frequencies 1-50.
Electroencephalography (EEG) Power spectrum
Time frame: through study completion, an average of 1 year
64 channels of EEG will be recorded. A fast Fourier transform will be computed to provide a power spectrum of frequencies 1-50.
Electroencephalography (EEG) Power spectrum
Time frame: One week follow up
64 channels of EEG will be recorded. A fast Fourier transform will be computed to provide a power spectrum of frequencies 1-50.
Electrocardiogram (ECG) R-R intervals
Time frame: Baseline, beginning of the study
Three leads will be placed on the torso to capture a Lead II ECG. R-R intervals will be calculated.
Electrocardiogram (ECG) R-R intervals
Time frame: through study completion, an average of 1 year
Three leads will be placed on the torso to capture a Lead II ECG. R-R intervals will be calculated.
Electrocardiogram (ECG) R-R intervals
Time frame: one-week follow up
Three leads will be placed on the torso to capture a Lead II ECG. R-R intervals will be calculated.
Blood pressure
Time frame: Baseline, beginning of the study
Blood pressure will be captured using an automatic blood pressure cuff
Blood pressure
Time frame: through study completion, an average of 1 year
Blood pressure will be captured using an automatic blood pressure cuff
Blood pressure
Time frame: one-week follow up
Blood pressure will be captured using an automatic blood pressure cuff
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 2 Feb 2024.
- 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.
Stephanie Sullivan, PhD, DC principal investigator
Life Univeristy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chiropractic spinal adjustment and Non-force simulation in people with Healthy, run by Life University at 1 site in United States.
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 4 inclusion and 5 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 2 Feb 2024. 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 United States. 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?
Electroencephalography (EEG) Power spectrum (time frame: Baseline, beginning of the study). The study lists 9 primary outcomes in all. 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 2 Feb 2024.