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

NCT06153290 — Not applicable, Completed, 30 participants, Life University

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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

RegistryNCT06153290, acronym SHA
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: single, other
Enrollment30 (Actual)
SponsorLife University (Other)
ConditionsSubluxation
InterventionsChiropractic adjustment, Sham adjustment (Procedure)
Datesstart 2024-01-04, primary completion 2024-08-26, completion 2024-08-26, first posted 2023-12-01, last updated 2025-01-27
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Subluxation All trials of Chiropractic adjustment All trials of Sham adjustment

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Genuine/realExperimentalProcedure: Chiropractic adjustment15 participants receiving genuine/real chiropractic adjustment
Simulated/shamSham comparatorProcedure: Sham adjustment15 participants receiving simulated/sham "adjustment"
  • 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)

+Outcome measures

Primary outcomes

  • Participant blinding [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.
  • Participant blinding [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.

+Eligibility

Sex: All, ages: 18 Years to 60 Years, accepts healthy volunteers

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

+Locations (1)

FacilityCityCountryStatus
Dr. Sid E. Williams Center for Chiropractic ResearchMarietta, GeorgiaUnited States

+Study documents

+Investigators