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OpenTrials
Completed

NCT Number: NCT06153290

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

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

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Sid E. Williams Center for Chiropractic Research

Marietta, Georgia, 30067, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-60 years of age

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

Treatment and study plan

Chiropractic adjustment

Procedure

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)

Sham adjustment

Procedure

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)

Primary outcomes

  1. Participant blinding

    Time frame: Immediately after intervention

    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.

  2. Participant blinding

    Time frame: 48 hours after intervention

    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.

Sponsors and collaborators

Lead sponsor

Life University

Other

Registry information

Official study title

Blinding Integrity Following a Single Session of Simulated or Genuine High Velocity, Low Amplitude (HVLA) Manual Chiropractic Adjustments: a Randomized Controlled Proof-of-concept Trial

Acronym: SHA

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 1, 2023
Registry last updated
Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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