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

NCT ID: NCT06153290

Last Updated: 2025-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-04

Study Completion Date

2024-08-26

Brief Summary

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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

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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.

Conditions

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Subluxation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, sham-controlled, proof-of-concept trial
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants
Single-blinded

Study Groups

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Genuine/real

15 participants receiving genuine/real chiropractic adjustment

Group Type EXPERIMENTAL

Chiropractic adjustment

Intervention Type 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)

Simulated/sham

15 participants receiving simulated/sham "adjustment"

Group Type SHAM_COMPARATOR

Sham adjustment

Intervention Type 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)

Interventions

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Chiropractic 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)

Intervention Type PROCEDURE

Sham 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)

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Life University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tyson Perez, DC, PhD

Role: PRINCIPAL_INVESTIGATOR

Life University

Locations

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Dr. Sid E. Williams Center for Chiropractic Research

Marietta, Georgia, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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I-0026

Identifier Type: -

Identifier Source: org_study_id

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