Patient Perceptions and Experiences Following Multiple Sessions of Simulated or Genuine HVLA Manual Chiropractic Adjustments

NCT ID: NCT06931600

Last Updated: 2025-10-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-05
• Study Completion Date: 2026-05-31

Brief Summary

Our primary aim with this trial is to measure participant blinding following two simulated/sham or genuine/real high velocity, low amplitude (HVLA) manual chiropractic adjustments to assess if participants are able to identify their un-disclosed treatment group. Our secondary aims with this trial are to utilize electrocardiography (ECG), impedance cardiography (ICG), and gait analysis before either treatment session and after both treatment sessions to assess if there are any changes with the participants' measurements before and after a sham or genuine HVLA chiropractic 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, 60 eligible participants will be randomized (1:1 ratio) to receive two sessions of either simulated/sham or genuine/real chiropractic spinal adjustments with a 1 week washout between each treatment. The participants will be given a brief survey immediately following their first and second sessions, as well as immediately prior to the second session. This survey captures their perceptions and experiences regarding the intervention they received. The participants will also complete a pre- and post-electrocardiogram (ECG), impedance cardiography (ICG), and gait analysis. The participant will wear electrical diodes to assess ECG and ICG. Additional sensors will be placed on the participant to assess gait patterns while walking on a treadmill.

Conditions

Subluxation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Simulated/sham

30 individuals receiving simulated/sham chiropractic interventions

Group Type: SHAM_COMPARATOR

Sham adjustment

Intervention Type: PROCEDURE

Two manual high velocity, low amplitude (HVLA) simulated/sham chiropractic interventions in the cervical, thoracic, and/or lumbopelvic regions

Genuine/real

30 individuals receiving genuine/real chiropractic interventions

Group Type: EXPERIMENTAL

Chiropractic adjustment

Intervention Type: PROCEDURE

Two manual high velocity, low amplitude (HVLA) genuine/real chiropractic interventions in the cervical, thoracic, and/or lumbopelvic regions

Interventions

Sham adjustment

Two manual high velocity, low amplitude (HVLA) simulated/sham chiropractic interventions in the cervical, thoracic, and/or lumbopelvic regions

Intervention Type: PROCEDURE

Chiropractic adjustment

Two manual high velocity, low amplitude (HVLA) genuine/real chiropractic interventions in the cervical, thoracic, and/or lumbopelvic regions

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• No history of stroke or transient ischemic attack or current symptoms including: Dizziness or vertigo; Tinnitus (ringing in the ears); Visual, sensory, or motor disturbances
• No new pattern headache complaint
• No recent whiplash injury (within 3 mo)
• No spinal fractures/dislocations
• No disc problems with radiating symptoms to the arms or legs
• No severe degenerative joint disease in the spine
• No connective tissue disorders
• No primary fibromyalgia
• No metabolic or metaplastic bone disease
• No diagnosed condition that causes fainting during postural changes, such as POTS or orthostatic hypotension
• No history of cervical, thoracic, or lumbar spine surgery
• No uncontrolled high blood pressure or vascular disease
• No current use of anticoagulant therapy
• No current use of short-acting benzodiazepines, including midazolam & triazolam
• No change in medications in the past 6 weeks or intentions to change medications during the study
• Inability to walk unassisted on a treadmill
• No pacemakers or known heart conditions that influence the electrical or mechanical function of the heart, such as severe heart valve disease
• Not a DC or a DC student enrolled 4th quarter or above
• No present, self-reported pregnancy
• No chiropractic care in the 2 weeks prior to participation
• Did not participate in the feasibility study for this pilot (Perceptions and experiences following a single session of simulated or genuine high velocity, low amplitude (HVLA) manual chiropractic adjustments)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Life University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Margaret Sliwka, DC

Role: PRINCIPAL_INVESTIGATOR

Life University

Locations

Dr. Sid E. Williams Center for Chiropractic Research

Marietta, Georgia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Daekiara Smith-Ireland, MPH

Role: CONTACT

research.studies@life.edu

770-426-2639

Facility Contacts

Daekiara Smith-Ireland, MPH

Role: primary

research.studies@life.edu

770-426-2639

Other Identifiers

I-0032

Identifier Type: -

Identifier Source: org_study_id