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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06153290
Acronym
SHA
Enrollment
30
Registered
2023-12-01
Start date
2024-01-04
Completion date
2024-08-26
Last updated
2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subluxation

Keywords

randomized, sham-controlled, chiropractic, blinding

Brief 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.

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.

Interventions

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)

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)

Sponsors

Life University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Masking description

Single-blinded

Intervention model description

Randomized, sham-controlled, proof-of-concept trial

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Participant blindingImmediately after interventionThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026