Simulated vs Genuine Manual Chiropractic Adjustments

NCT06931600 | Suspended

• 1 other identifier: I-0032
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Subluxation

Keywords

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

Outcome Measures

Primary Outcomes (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.

  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.

  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.

  Immediately post-session 2 (day 2)

Secondary Outcomes (12)

• High-frequency Heart Rate Variability (HF-HRV)

  baseline

• High-frequency Heart Rate Variability (HF-HRV)

  post-session 2 (day 2)

• Pre-ejection period (PEP)

  baseline

• Pre-ejection period (PEP)

  post-session 2 (day 2)

• The speed of the participants will be assessed at baseline as part of the gait analysis.

  baseline

Study Arms (2)

Simulated/sham

SHAM COMPARATOR

30 individuals receiving simulated/sham chiropractic interventions

Procedure: Sham adjustment

Genuine/real

EXPERIMENTAL

30 individuals receiving genuine/real chiropractic interventions

Procedure: Chiropractic adjustment

Interventions

Sham adjustment PROCEDURE

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

Simulated/sham

Chiropractic adjustment PROCEDURE

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

Genuine/real

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

* 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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Life University: lead

Study Sites (1)

Dr. Sid E. Williams Center for Chiropractic Research

Marietta, Georgia, 30067, United States

Location

Related Publications (1)

• 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.

  PMID: 41894654 DERIVED

MeSH Terms

Conditions

Joint Dislocations

Interventions

Manipulation, Chiropractic

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics

Study Officials

• Tyson Perez, DC, PhD

  Life University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Lab coordinator
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: randomized, sham-controlled, pilot study

Study Record Dates

• First Submitted: March 28, 2025
• First Posted: April 17, 2025
• Study Start: May 5, 2025
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)