SubluxationSHANCT06931600

Simulated vs Genuine Manual Chiropractic Adjustments

A study testing Chiropractic adjustment in people with Subluxation, run by Life University at 1 site in United States.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Subluxation
What is being tested?: Chiropractic adjustment
Type of treatment: Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 1 siteUnited States
Study dates: 5 May 2025to May 2026
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 60 years
All sexes
Healthy volunteers accepted
Adult

No history of stroke or transient ischemic attack or current symptoms including: Dizziness or vertigo; Tinnitus (ringing in the ears); Visual, sensory, or motor disturbances
No new pattern headache complaint
No recent whiplash injury (within 3 mo)
No spinal fractures/dislocations
No disc problems with radiating symptoms to the arms or legs
No severe degenerative joint disease in the spine
No connective tissue disorders
No primary fibromyalgia
No metabolic or metaplastic bone disease
No diagnosed condition that causes fainting during postural changes, such as POTS or orthostatic hypotension
No history of cervical, thoracic, or lumbar spine surgery
No uncontrolled high blood pressure or vascular disease
No current use of anticoagulant therapy
No current use of short-acting benzodiazepines, including midazolam \& triazolam
No change in medications in the past 6 weeks or intentions to change medications during the study
Inability to walk unassisted on a treadmill
No pacemakers or known heart conditions that influence the electrical or mechanical function of the heart, such as severe heart valve disease
Not a DC or a DC student enrolled 4th quarter or above
No present, self-reported pregnancy
No chiropractic care in the 2 weeks prior to participation
Did not participate in the feasibility study for this pilot (Perceptions and experiences following a single session of simulated or genuine high velocity, low amplitude (HVLA) manual chiropractic adjustments)

Trial locations and contacts

1 site in 1 country.

United States1 site

Dr. Sid E. Williams Center for Chiropractic Research
Marietta, Georgia, 30067

Other trials in United States

About this study

Official title: Blinding Integrity Following Multiple Sessions of Simulated or Genuine High Velocity, Low Amplitude (HVLA) Manual Chiropractic Adjustments: a Pilot Study

Our primary aim with this trial is to measure participant blinding following two simulated/sham or genuine/real high velocity, low amplitude (HVLA) manual chiropractic adjustments to assess if participants are able to identify their un-disclosed treatment group. Our secondary aims with this trial are to utilize electrocardiography (ECG), impedance cardiography (ICG), and gait analysis before either treatment session and after both treatment sessions to assess if there are any changes with the participants' measurements before and after a sham or genuine HVLA chiropractic treatment.

Read the detailed description

The primary aim of this trial is to assess blinding following simulated/sham or genuine/real high velocity, low amplitude (HVLA) manual chiropractic adjustments. Briefly, 60 eligible participants will be randomized (1:1 ratio) to receive two sessions of either simulated/sham or genuine/real chiropractic spinal adjustments with a 1 week washout between each treatment. The participants will be given a brief survey immediately following their first and second sessions, as well as immediately prior to the second session. This survey captures their perceptions and experiences regarding the intervention they received. The participants will also complete a pre- and post-electrocardiogram (ECG), impedance cardiography (ICG), and gait analysis. The participant will wear electrical diodes to assess ECG and ICG. Additional sensors will be placed on the participant to assess gait patterns while walking on a treadmill.

Conditions: Subluxation
Being tested: Sham adjustment, Chiropractic adjustment
Keywords: randomized, sham-controlled, chiropractic, blinding, gait analysis, impedance cardiography, movement parameters, electrocardiography, autonomic nervous system, Heart Rate Variability
Medical subject headings: Joint Dislocations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sham adjustmentProcedure or surgery
Two manual high velocity, low amplitude (HVLA) simulated/sham chiropractic interventions in the cervical, thoracic, and/or lumbopelvic regions
Chiropractic adjustmentProcedure or surgery
Two manual high velocity, low amplitude (HVLA) genuine/real chiropractic interventions in the cervical, thoracic, and/or lumbopelvic regions

Study groups in NCT06931600
Study group	Role	What they receive
Simulated/sham	Sham comparator	30 individuals receiving simulated/sham chiropractic interventions Receives: Procedure: Sham adjustment
Genuine/real	Experimental	30 individuals receiving genuine/real chiropractic interventions Receives: Procedure: Chiropractic adjustment

What is being measured

The primary outcome is the main question the study is designed to answer.

Participant blinding
The blinding index is scaled to an internal of -1 to +1, +1 being complete lack of blinding, 0 being consistent with perfect blinding, -1 indicating opposite guessing which may be related to unblinding.
Measured: Immediately post-session 1 (day 1)
Participant blinding
The blinding index is scaled to an internal of -1 to +1, +1 being complete lack of blinding, 0 being consistent with perfect blinding, -1 indicating opposite guessing which may be related to unblinding.
Measured: Immediately pre-session 2 (day 2)
Participant blinding
The blinding index is scaled to an internal of -1 to +1, +1 being complete lack of blinding, 0 being consistent with perfect blinding, -1 indicating opposite guessing which may be related to unblinding.
Measured: Immediately post-session 2 (day 2)

Secondary outcomes (12)

High-frequency Heart Rate Variability (HF-HRV)
3 sensors on torso. HF-HRV indexes fluctuations in the heart period that occur within the 0.12 to 0.5 Hz frequency range
Measured: baseline
High-frequency Heart Rate Variability (HF-HRV)
3 sensors on torso. HF-HRV indexes fluctuations in the heart period that occur within the 0.12 to 0.5 Hz frequency range.
Measured: post-session 2 (day 2)
Pre-ejection period (PEP)
3 ECG sensors on the torso + 4 ICG sensors (2 sensors on chest and 2 sensors on back). The PEP is the time interval between the electrical depolarization of the heart (Q-wave on ECG) and the beginning of blood ejection from the heart (B-point on ICG).
Measured: baseline
Pre-ejection period (PEP)
3 ECG sensors on the torso + 4 ICG sensors (2 sensors on chest and 2 sensors on back). The PEP is the time interval between the electrical depolarization of the heart (Q-wave on ECG) and the beginning of blood ejection from the heart (B-point on ICG).
Measured: post-session 2 (day 2)
The speed of the participants will be assessed at baseline as part of the gait analysis.
16 inertial measurement unit (IMU) sensors (noraxon) and treadmill output measurements
Measured: baseline
The speed of the participants will be assessed again at post-session 2 as part of the gait analysis.
16 inertial measurement unit (IMU) sensors (noraxon) and treadmill output measurements
Measured: post-session 2 (day 2)
Force measurements generated during walking will be assessed at baseline as part of the gait analysis.
16 inertial measurement unit (IMU) sensors (noraxon) and treadmill output measurements
Measured: baseline
Force measurements generated during walking will be assessed again at post-session 2 as part of the gait analysis.
16 inertial measurement unit (IMU) sensors (noraxon) and treadmill output measurements
Measured: post-session 2 (day 2)
Gait symmetry will be assessed at baseline as part of the gait analysis.
16 inertial measurement unit (IMU) sensors (noraxon)
Measured: baseline
Gait symmetry will be assessed again at post-session 2 as part of the gait analysis.
16 inertial measurement unit (IMU) sensors (noraxon)
Measured: post-session 2 (day 2)
Root Mean Square of Successive Differences (RMSSD)
3 sensors on torso. RMSSD is a measure of heart rate variability (HRV) that focuses on short-term beat-to-beat changes in the heart period.
Measured: baseline
Root Mean Square of Successive Differences (RMSSD)
3 sensors on torso. RMSSD is a measure of heart rate variability (HRV) that focuses on short-term beat-to-beat changes in the heart period.
Measured: post-session 2 (day 2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 May 2025May 2026

First posted17 Apr 2025
Study start5 May 2025
Primary completionApr 2026 (estimated)
Study completionMay 2026 (estimated)

Why it stopped: Funding

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for SubluxationStudies 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: Other
Allocation: Randomised
Intervention model: Parallel groups
Model description: randomized, sham-controlled, pilot study
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 60 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06931600
Sponsor's protocol ID: I-0032
Acronym: SHA
Status last verified: Mar 2026
First submitted: 28 Mar 2025
Last updated: 30 Mar 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Sliwka M, Perez T, Qazi A, Sullivan S. Spinal Manipulative Therapy on a Healthy Population: Protocol for a Randomized Blinding Feasibility Trial. JMIR Res Protoc. 2026 Mar 27;15:e85956. doi: 10.2196/85956.
PubMed 41894654

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Assessment of Posterior Subluxation of the Humeral Head Using Biplanar Imaging in the Upright Position in Patients Scheduled for Total Shoulder Arthroplasty
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Validation of an Upper Extremity Physical Performance Test Battery in Patients After Shoulder Dislocation
Return to Sport, Shoulder Dislocation or Subluxation
Not yet recruitingObservational study
Investigation of the Relationship Between Shoulder Alpha Angle and Humeral Head Displacement Percentage Measured by Ultrasonography in Neonatal Brachial Plexus Palsy Infants With Clinical Parameters
Glenohumeral Subluxation, Neonatal Brachial Plexus Palsy
Active, not recruitingObservational study
Multicenter Study on the Use of Intraoperative OCT in the Diagnosis and Management of Lens Diseases
Lens Diseases, Cataract

All Subluxation trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Blinding Integrity Following Multiple Sessions of Simulated or Genuine High Velocity, Low Amplitude (HVLA) Manual Chiropractic Adjustments: a Pilot Study
ClinicalTrials.gov ID: NCT06931600
Acronym / sponsor ID: SHA / I-0032
Conditions: Subluxation
Keywords: randomized, sham-controlled, chiropractic, blinding, gait analysis, impedance cardiography, movement parameters, electrocardiography
Study type: Interventional
Recruitment status: SuspendedReason stopped: Funding
Enrolment: 60 participants (estimated)
Lead sponsor: Life UniversityUniversity, hospital or other
Study start: 5 May 2025 (actual)
Primary completion: Apr 2026 (estimated)
Study completion: May 2026 (estimated)
First posted: 17 Apr 2025 (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.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2
Model description: randomized, sham-controlled, pilot study

Arm	Type	Receives
Simulated/sham	Sham comparator	Procedure: Sham adjustment30 individuals receiving simulated/sham chiropractic interventions
Genuine/real	Experimental	Procedure: Chiropractic adjustment30 individuals receiving genuine/real chiropractic interventions

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

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
Sham adjustmentTwo manual high velocity, low amplitude (HVLA) simulated/sham chiropractic interventions in the cervical, thoracic, and/or lumbopelvic regions	Procedure or surgery	Simulated/sham
Chiropractic adjustmentTwo manual high velocity, low amplitude (HVLA) genuine/real chiropractic interventions in the cervical, thoracic, and/or lumbopelvic regions	Procedure or surgery	Genuine/real

Primary outcome

Participant blinding
Time frame: Immediately post-session 1 (day 1)
The blinding index is scaled to an internal of -1 to +1, +1 being complete lack of blinding, 0 being consistent with perfect blinding, -1 indicating opposite guessing which may be related to unblinding.
Participant blinding
Time frame: Immediately pre-session 2 (day 2)
The blinding index is scaled to an internal of -1 to +1, +1 being complete lack of blinding, 0 being consistent with perfect blinding, -1 indicating opposite guessing which may be related to unblinding.
Participant blinding
Time frame: Immediately post-session 2 (day 2)
The blinding index is scaled to an internal of -1 to +1, +1 being complete lack of blinding, 0 being consistent with perfect blinding, -1 indicating opposite guessing which may be related to unblinding.

12 secondary outcomes

High-frequency Heart Rate Variability (HF-HRV)
Time frame: baseline
High-frequency Heart Rate Variability (HF-HRV)
Time frame: post-session 2 (day 2)
Pre-ejection period (PEP)
Time frame: baseline
Pre-ejection period (PEP)
Time frame: post-session 2 (day 2)
The speed of the participants will be assessed at baseline as part of the gait analysis.
Time frame: baseline
The speed of the participants will be assessed again at post-session 2 as part of the gait analysis.
Time frame: post-session 2 (day 2)
Force measurements generated during walking will be assessed at baseline as part of the gait analysis.
Time frame: baseline
Force measurements generated during walking will be assessed again at post-session 2 as part of the gait analysis.
Time frame: post-session 2 (day 2)
Gait symmetry will be assessed at baseline as part of the gait analysis.
Time frame: baseline
Gait symmetry will be assessed again at post-session 2 as part of the gait analysis.
Time frame: post-session 2 (day 2)
Root Mean Square of Successive Differences (RMSSD)
Time frame: baseline
Root Mean Square of Successive Differences (RMSSD)
Time frame: post-session 2 (day 2)

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
Derived from this study: PubMed 41894654Sliwka M, Perez T, Qazi A, Sullivan S. Spinal Manipulative Therapy on a Healthy Population: Protocol for a Randomized Blinding Feasibility Trial. JMIR Res Protoc. 2026 Mar 27;15:e85956. doi: 10.2196/85956.
Individual participant dataSharing planned: No

Related trials for Subluxation

Not yet recruitingPhase 1/2
Regenerative Medicine for Joint Hypermobility and Instability
Ehlers-Danlos Syndrome Hypermobility Type (hEDS), Ehlers-Danlos Syndrome (EDS)
Not yet recruiting
Assessment of Posterior Subluxation of the Humeral Head Using Biplanar Imaging in the Upright Position in Patients Scheduled for Total Shoulder Arthroplasty
Shoulder Arthroplasty
Recruiting
Validation of an Upper Extremity Physical Performance Test Battery in Patients After Shoulder Dislocation
Return to Sport, Shoulder Dislocation or Subluxation
Not yet recruitingObservational study
Investigation of the Relationship Between Shoulder Alpha Angle and Humeral Head Displacement Percentage Measured by Ultrasonography in Neonatal Brachial Plexus Palsy Infants With Clinical Parameters
Glenohumeral Subluxation, Neonatal Brachial Plexus Palsy
Active, not recruitingObservational study
Multicenter Study on the Use of Intraoperative OCT in the Diagnosis and Management of Lens Diseases
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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.

Tyson Perez, DC, PhD principal investigator

Life University

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 adjustment in people with Subluxation, 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?

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 30 Mar 2026. 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. Some participants in this study may receive a placebo. 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?

Participant blinding (time frame: Immediately post-session 1 (day 1)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06931600, which also lists 1 linked publication.

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 30 Mar 2026.