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

February 21, 2024 updated by: Life University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Recruiting
        • Dr. Sid E. Williams Center for Chiropractic Research
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Genuine/real
15 participants receiving genuine/real chiropractic adjustment
Procedure: 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)
Sham Comparator: Simulated/sham
15 participants receiving simulated/sham "adjustment"
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Immediately after intervention
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.
48 hours after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Life University

Investigators

  • Principal Investigator: Tyson Perez, DC, PhD, Life University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2024

Primary Completion (Estimated)

April 7, 2024

Study Completion (Estimated)

July 7, 2024

Study Registration Dates

First Submitted

November 22, 2023

First Submitted That Met QC Criteria

November 22, 2023

First Posted (Actual)

December 1, 2023

Study Record Updates

Last Update Posted (Estimated)

February 22, 2024

Last Update Submitted That Met QC Criteria

February 21, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • I-0026

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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