StressNCT05465395
Upper Cervical and Thoracic Chiropractic Adjustment
A study testing Upper Cervical Adjustemnt and Thoracic Adjustemnt in people with Stress, run by Life University at 1 site in United States.
Trial summary
The proposed study examines the differences in how the ANS responds to cervical adjustments in comparison to thoracic adjustments. This study is the continuation of a previous study titled Perceived stress and patterns of autonomic function: a protocol development study. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Upper Cervical Adjustemnt and Thoracic Adjustemnt
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2021to 1 Nov 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over the age of 19
- In good health
- Willing to have blood pressure taken
- Willinig to shave a small area of chest hair for placement of a ECG patch
- Consent to a physical exam
- Consent ot chiropractic evaluationa nd 2 adjustments
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dr. Sid E. Williams Center for Chiropractic Research
Atlanta, Georgia, 30308
About this study
Official title: Effects of Upper Cervical and Thoracic Chiropractic Adjustments on the Autonomic Nervous System and Perceived Stress Response
The proposed study examines the differences in how the ANS responds to cervical adjustments in comparison to thoracic adjustments. This study is the continuation of a previous study titled Perceived stress and patterns of autonomic function: a protocol development study. Autonomic tests such as HRV, GSR, and the stress surveys will be the primary method of measurement. CareTaker and Biopac devices will provide continual data collection of ECG (for HRV analysis) and GSR throughout the exam and adjustment. Participant's subjective stress levels will be measured through the use of stress questionnaires including the National Stressful Events Survey Acute Stress Disorder Short Scale, the Hamilton Anxiety Rating Scale, and the Connor-Davidson Resilience Scale. The objective of the study is to determine if the location of a chiropractic adjustment will affect the autonomic nervous system in such a way that PNS or SNS activation increases or decreases after the adjustment. Further, the study will continue to examine how the chiropractic adjustment affects the subjective stress response.
- Conditions
- Stress
- Being tested
- Upper Cervical Adjustemnt, Thoracic Adjustemnt
- Keywords
- Heart Rate Varability, Autonomic Nervious System, Chiropractic Adjustment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper Cervical AdjustemntProcedure or surgery
Upper cervical adjustement
Thoracic AdjustemntProcedure or surgery
Thoracic adjustment
| Study group | Role | What they receive |
|---|---|---|
| Upper Cervical Adjustment | Experimental | Upper cervical adjustemnt Receives: Procedure: Upper Cervical Adjustemnt; Procedure: Thoracic Adjustemnt |
| Thoracic Adjustment | Active comparator | Thoracic adjustment Receives: Procedure: Upper Cervical Adjustemnt; Procedure: Thoracic Adjustemnt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caretaker Heart Rate Variability
HRV allows for an understanding of Autonomic (parasympathetic) function, via measuring the interval of R peaks in QRS complexes.
Measured: Through study completion, an average of 1 week
Galvanic Skin Response
Galvanic Skin response gives a strong measure of Sympathetic response via electrical conductivity of perspiration.
Measured: Through study completion, an average of 1 week
Hamilton Anxiety Rating Scale
Measures the severity of anxiety symptoms
Measured: Through study completion, an average of 1 week
NSESSS
Measures PTSD symptoms in people 18 and up.
Measured: Through study completion, an average of 1 week
CD-RISC-25
Measure of adaptability
Measured: Through study completion, an average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start12 Oct 2021
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
Why it stopped: Prioritizing other studies
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Life University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephanie Sullivan, Study director, Life Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05465395
- Sponsor's protocol ID
- I-0020
- Status last verified
- May 2023
- First submitted
- 7 Mar 2022
- Last updated
- 3 May 2023
- 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 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Upper Cervical and Thoracic Chiropractic Adjustments on the Autonomic Nervous System and Perceived Stress Response
- ClinicalTrials.gov ID
- NCT05465395
- Acronym / sponsor ID
- I-0020
- Conditions
- Stress
- Keywords
- Heart Rate Varability, Autonomic Nervious System, Chiropractic Adjustment
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Prioritizing other studies
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Life UniversityUniversity, hospital or other
- Study start
- 12 Oct 2021 (actual)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 19 Jul 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 proposed study examines the differences in how the ANS responds to cervical adjustments in comparison to thoracic adjustments. This study is the continuation of a previous study titled Perceived stress and patterns of autonomic function: a protocol development study. Autonomic tests such as HRV, GSR, and the stress surveys will be the primary method of measurement. CareTaker and Biopac devices will provide continual data collection of ECG (for HRV analysis) and GSR throughout the exam and adjustment. Participant's subjective stress levels will be measured through the use of stress questionnaires including the National Stressful Events Survey Acute Stress Disorder Short Scale, the Hamilton Anxiety Rating Scale, and the Connor-Davidson Resilience Scale. The objective of the study is to determine if the location of a chiropractic adjustment will affect the autonomic nervous system in such a way that PNS or SNS activation increases or decreases after the adjustment. Further, the study will continue to examine how the chiropractic adjustment affects the subjective stress response.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Upper Cervical Adjustment | Experimental | Procedure: Upper Cervical Adjustemnt, Procedure: Thoracic AdjustemntUpper cervical adjustemnt |
| Thoracic Adjustment | Active comparator | Procedure: Upper Cervical Adjustemnt, Procedure: Thoracic AdjustemntThoracic adjustment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Over the age of 19
- In good health
- Willing to have blood pressure taken
- Willinig to shave a small area of chest hair for placement of a ECG patch
- Consent to a physical exam
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Upper Cervical AdjustemntUpper cervical adjustement | Procedure or surgery | Thoracic Adjustment, Upper Cervical Adjustment |
| Thoracic AdjustemntThoracic adjustment | Procedure or surgery | Thoracic Adjustment, Upper Cervical Adjustment |
Primary outcome
Caretaker Heart Rate Variability
Time frame: Through study completion, an average of 1 week
HRV allows for an understanding of Autonomic (parasympathetic) function, via measuring the interval of R peaks in QRS complexes.
Galvanic Skin Response
Time frame: Through study completion, an average of 1 week
Galvanic Skin response gives a strong measure of Sympathetic response via electrical conductivity of perspiration.
Hamilton Anxiety Rating Scale
Time frame: Through study completion, an average of 1 week
Measures the severity of anxiety symptoms
NSESSS
Time frame: Through study completion, an average of 1 week
Measures PTSD symptoms in people 18 and up.
CD-RISC-25
Time frame: Through study completion, an average of 1 week
Measure of adaptability
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- 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 study director
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 Upper Cervical Adjustemnt and Thoracic Adjustemnt in people with Stress, 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 6 inclusion and 0 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: paused, as of the sponsor's last update on 3 May 2023. 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?
Results are not available in the source record.
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?
Caretaker Heart Rate Variability (time frame: Through study completion, an average of 1 week). The study lists 5 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 3 May 2023.