CClinicalTrials.gg
CompletedNCT06153290SHAUpdated Jan 27, 2025

Patient Perceptions Following a Single Session of Simulated or Genuine HVLA Manual Chiropractic Adjustments

An interventional study of Chiropractic adjustment and Sham adjustment in Subluxation, sponsored by Life University. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-27.

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

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
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Study summary

The primary aim of this trial is to assess blinding following simulated/sham or genuine/real high velocity, low amplitude (HVLA) manual chiropractic adjustments.

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, 30 eligible participants will be randomized (1:1 ratio) to receive a single session of either simulated/sham or genuine/real chiropractic spinal adjustments and be given a brief survey immediately following their session and 48 hours later that captures their perceptions and experiences regarding the intervention they received. This study is intended to inform a future multi-session, randomized, sham-controlled trial.

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Conditions studied

  • Subluxation

Keywords

  • randomized
  • sham-controlled
  • chiropractic
  • blinding
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In context

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.

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Who can participate

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

Inclusion criteria

  • 18-60 years of age

Exclusion criteria

Exclusion Criteria:

  • History of stroke or transient ischemic attack or current symptoms including dizziness or vertigo, tinnitus (ringing in the ears), or visual, sensory, or motor disturbances
  • New pattern headache complaint
  • Recent whiplash injury (within 12 months)
  • Cervical fracture/dislocation
  • Disc problem with radiating symptoms to the arms or legs
  • Severe degenerative joint disease in the spine
  • Connective tissue disorder
  • Primary fibromyalgia
  • Metabolic or metaplastic bone disease
  • History of cervical, thoracic, or lumbar spine surgery
  • Uncontrolled high blood pressure or vascular disease
  • Current use of anticoagulant therapy
  • Doctor of Chiropractic (DC) or a DC student in 5th quarter or above
  • Present, self-reported pregnancy
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Genuine/real

    15 participants receiving genuine/real chiropractic adjustment

    Procedure: Chiropractic adjustment

  • Sham comparator
    Simulated/sham

    15 participants receiving simulated/sham "adjustment"

    Procedure: Sham adjustment

Interventions

  • ProcedureChiropractic adjustment

    A single-session of genuine/real high-velocity, low-amplitude (HVLA) manual chiropractic adjustments to various regions of the spine (i.e., cervical, thoracic, lumbo-pelvic)

  • ProcedureSham adjustment

    A single-session of simulated/sham high-velocity, low-amplitude (HVLA) manual chiropractic adjustments to various regions of the spine (i.e., cervical, thoracic, lumbo-pelvic)

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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 after intervention

  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: 48 hours after intervention

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Study locations

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

Study documents

  • Informed consent form · Jun 12, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06153290
Lead sponsor
Life University
Responsible party
Sponsor
First posted
Dec 1, 2023
Start date
Jan 4, 2024
Primary completion
Aug 26, 2024
Completion
Aug 26, 2024
Last update
Jan 27, 2025

Study contacts

Tyson Perez, DC, PhD
principal investigator · Life University

Oversight

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

Not currently enrolling

This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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