Simulated vs Genuine Manual Chiropractic Adjustments (SHA)

March 25, 2026 updated by: Tyson Perez, DC, PhD, Life University

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Simulated/sham
30 individuals receiving simulated/sham chiropractic interventions
Procedure: Sham adjustment
Two manual high velocity, low amplitude (HVLA) simulated/sham chiropractic interventions in the cervical, thoracic, and/or lumbopelvic regions
Experimental: Genuine/real
30 individuals receiving genuine/real chiropractic interventions
Procedure: Chiropractic adjustment
Two manual high velocity, low amplitude (HVLA) genuine/real chiropractic interventions in the cervical, thoracic, and/or lumbopelvic regions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Immediately post-session 1 (day 1)
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.
Immediately pre-session 2 (day 2)
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.
Immediately post-session 2 (day 2)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
High-frequency Heart Rate Variability (HF-HRV)
Time Frame: baseline
3 sensors on torso. HF-HRV indexes fluctuations in the heart period that occur within the 0.12 to 0.5 Hz frequency range
baseline
High-frequency Heart Rate Variability (HF-HRV)
Time Frame: post-session 2 (day 2)
3 sensors on torso. HF-HRV indexes fluctuations in the heart period that occur within the 0.12 to 0.5 Hz frequency range.
post-session 2 (day 2)
Pre-ejection period (PEP)
Time Frame: baseline
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).
baseline
Pre-ejection period (PEP)
Time Frame: post-session 2 (day 2)
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).
post-session 2 (day 2)
The speed of the participants will be assessed at baseline as part of the gait analysis.
Time Frame: baseline
16 inertial measurement unit (IMU) sensors (noraxon) and treadmill output measurements
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)
16 inertial measurement unit (IMU) sensors (noraxon) and treadmill output measurements
post-session 2 (day 2)
Force measurements generated during walking will be assessed at baseline as part of the gait analysis.
Time Frame: baseline
16 inertial measurement unit (IMU) sensors (noraxon) and treadmill output measurements
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)
16 inertial measurement unit (IMU) sensors (noraxon) and treadmill output measurements
post-session 2 (day 2)
Gait symmetry will be assessed at baseline as part of the gait analysis.
Time Frame: baseline
16 inertial measurement unit (IMU) sensors (noraxon)
baseline
Gait symmetry will be assessed again at post-session 2 as part of the gait analysis.
Time Frame: post-session 2 (day 2)
16 inertial measurement unit (IMU) sensors (noraxon)
post-session 2 (day 2)
Root Mean Square of Successive Differences (RMSSD)
Time Frame: baseline
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.
baseline
Root Mean Square of Successive Differences (RMSSD)
Time Frame: post-session 2 (day 2)
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.
post-session 2 (day 2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Life University

Investigators

  • Principal Investigator: Tyson Perez, DC, PhD, Life University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2025

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

March 28, 2025

First Submitted That Met QC Criteria

April 15, 2025

First Posted (Actual)

April 17, 2025

Study Record Updates

Last Update Posted (Actual)

March 30, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I-0032

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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