ClinicalTrials.gg
SuspendedNCT06931600SHAUpdated Mar 30, 2026

Simulated vs Genuine Manual Chiropractic Adjustments

An interventional study of Sham adjustment and Chiropractic adjustment in Subluxation, sponsored by Life University. Suspended at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-30.

Sponsored by Life University · Not applicable, Interventional, and Other

Why this study was suspended
Funding
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Subluxation

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Keywords

  • randomized
  • sham-controlled
  • chiropractic
  • blinding
  • gait analysis
  • impedance cardiography
  • movement parameters
  • electrocardiography
  • autonomic nervous system
  • Heart Rate Variability
03

In context

Joint Dislocations

98 studies on the registry are indexed under Joint Dislocations; 21 are open to participants now.

This study's planned enrollment of 60 is above the median of 50 across 60 interventional studies indexed under Joint Dislocations.

Browse Joint Dislocations studies →

Lead sponsor

Life University is the lead sponsor of 29 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

  • No history of stroke or 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)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Sham comparator
    Simulated/sham

    30 individuals receiving simulated/sham chiropractic interventions

    Procedure: Sham adjustment

  • Experimental
    Genuine/real

    30 individuals receiving genuine/real chiropractic interventions

    Procedure: Chiropractic adjustment

Interventions

  • ProcedureSham adjustment

    Two manual high velocity, low amplitude (HVLA) simulated/sham chiropractic interventions in the cervical, thoracic, and/or lumbopelvic regions

  • ProcedureChiropractic adjustment

    Two manual high velocity, low amplitude (HVLA) genuine/real chiropractic interventions in the cervical, thoracic, and/or lumbopelvic regions

06

What researchers measure

Primary outcomes

  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.

    Time frame: Immediately post-session 1 (day 1)

  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.

    Time frame: Immediately pre-session 2 (day 2)

  3. 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.

    Time frame: Immediately post-session 2 (day 2)

Secondary outcomes

  1. 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

    Time frame: baseline

  2. 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.

    Time frame: post-session 2 (day 2)

  3. 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).

    Time frame: baseline

  4. 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).

    Time frame: post-session 2 (day 2)

  5. 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

    Time frame: baseline

  6. 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

    Time frame: post-session 2 (day 2)

  7. 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

    Time frame: baseline

  8. 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

    Time frame: post-session 2 (day 2)

  9. Gait symmetry will be assessed at baseline as part of the gait analysis.

    16 inertial measurement unit (IMU) sensors (noraxon)

    Time frame: baseline

  10. Gait symmetry will be assessed again at post-session 2 as part of the gait analysis.

    16 inertial measurement unit (IMU) sensors (noraxon)

    Time frame: post-session 2 (day 2)

  11. 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.

    Time frame: baseline

  12. 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.

    Time frame: post-session 2 (day 2)

07

Study locations

1 site
  • Dr. Sid E. Williams Center for Chiropractic Research
    Marietta, Georgia 30067, United States
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06931600
Lead sponsor
Life University
Responsible party
Tyson Perez, DC, PhD (Principal Investigator, Life University) — Principal investigator
First posted
Apr 17, 2025
Start date
May 5, 2025
Primary completion
Apr 2026 (estimated)
Completion
May 2026 (estimated)
Last update
Mar 30, 2026

Study contacts

Tyson Perez, DC, PhD
principal investigator · Life University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is suspended, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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