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

NCT06153290 | Completed

• 1 other identifier: I-0026
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Subluxation

Keywords

randomized; sham-controlled; chiropractic; blinding

Outcome Measures

Primary Outcomes (2)

• Participant blinding

  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

  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

Study Arms (2)

Genuine/real

EXPERIMENTAL

15 participants receiving genuine/real chiropractic adjustment

Procedure: Chiropractic adjustment

Simulated/sham

SHAM COMPARATOR

15 participants receiving simulated/sham "adjustment"

Procedure: Sham adjustment

Interventions

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)

Genuine/real

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)

Simulated/sham

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years of age

You may not qualify if:

• 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

Sponsors & Collaborators

• Life University: lead

Study Sites (1)

Dr. Sid E. Williams Center for Chiropractic Research

Marietta, Georgia, 30067, United States

Location

MeSH Terms

Conditions

Joint Dislocations

Interventions

Manipulation, Chiropractic

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics

Study Officials

• Tyson Perez, DC, PhD

  Life University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single-blinded
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, sham-controlled, proof-of-concept trial

Study Record Dates

• First Submitted: November 22, 2023
• First Posted: December 1, 2023
• Study Start: January 4, 2024
• Primary Completion: August 26, 2024
• Study Completion: August 26, 2024
• Last Updated: January 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)