Instantaneous EEG Changes Following Chiropractic Adjustment or Sham

NCT05864703 | Suspended

• 1 other identifier: I-0024
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The project is a randomized, two-arm trial assessing the immediate impact of upper and lower cervical chiropractic adjustments on brain and heart patterns. Thirty individuals (15 per arm) will be recruited from the general population to participate in the study. Qualified participants will undergo a chiropractic physical exam, assessing for cervical subluxations, and a health history review with a Georgia licensed chiropractor. Individuals will be randomized to either an adjustment group or sham group. The adjustment group will receive an upper and lower cervical adjustment with an instrument designed to provide a gentle, targeted adjustment. The sham group will receive a touch sham at similar cervical locations with the same instrument. Both groups will have a 1-hour recording session with an EEG and ECG set-up plus a series of baseline recordings, interventions, and post recordings.

Conditions

Subluxation

Keywords

Chiropractic; EEG; ECG; sham

Outcome Measures

Primary Outcomes (4)

• EEG resting state effective connectivity

  Baseline EEG recording for the first intervention or sham procedure. A 64-channel hydronet will be on the head to capture EEG.

  0 minutes

• EEG resting state effective connectivity

  EEG recording immediately after the first intervention or sham procedure. A 64-channel hydronet will be on the head to capture EEG.

  8 minutes

• EEG resting state effective connectivity

  Baseline EEG recording for the second intervention or sham procedure. A 64-channel hydronet will be on the head to capture EEG.

  15 minutes

• EEG resting state effective connectivity

  EEG recording immediately after the second intervention or sham procedure. A 64-channel hydronet will be on the head to capture EEG.

  23 minutes

Secondary Outcomes (4)

• ECG R-R interval

  0 minutes

• ECG R-R interval

  8 minutes

• ECG R-R interval

  15 minutes

• ECG R-R interval

  23 minutes

Study Arms (2)

Adjustment

EXPERIMENTAL

Individuals with a subluxation who receive a true chiropractic adjustment

Procedure: Adjustment

Sham

SHAM COMPARATOR

Individuals with a subluxation who receive a light touch-only sham

Procedure: Sham

Interventions

Adjustment PROCEDURE

Instrument-assisted, high velocity, low amplitude adjustment

Adjustment

Sham PROCEDURE

Instrument-assisted light touch to neck

Sham

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Individuals between the ages of 18 and 50
• Individuals who can wear an EEG net for 60 minutes Individuals who can sit quietly for at least 20 minutes
• Individuals who can rest on their knees on a massage chair.
• Individuals who have not had a chiropractic adjustment within the last two weeks
• Individuals who have not received any other interventions, such as osteopathic spinal manipulation, physical therapy rehabilitation or manipulation, massage, body movement therapies, or acupuncture within the last two weeks

You may not qualify if:

• Individuals who have been diagnosed with a serious mental disorder such as schizophrenia or major depressive disorder that could influence EEG results
• Individuals who do not feel they can sit quietly with limited movement for roughly 20 minutes
• Individuals who cannot rest on their knees on a massage chair.
• Individuals who are on psychotropic medications (e.g. Benzodiazepine medications) that influence EEG readings (Benzodiazepine medications include but are not limited to: alprazolam, chlordiazepoxide, clobazam, clonazepam, clorazepate, diazepam, estazolam, flurazepam, lorazepam, midazolam, oxazepam, temazepam, triazolam, etc.)
• Individuals with any injury or surgery to the skull in the last 6 months, or a history of trauma to the head such as a concussion or stroke
• Individuals who are currently pregnant
• Individuals with a current litigation related to a physical, health-related injury Individuals with untreated diagnosed osteoporosis or articular instability, such as atlanto-axial instability
• Individuals who may require x-rays. Since a single session of chiropractic care is being performed, if at any point the attending chiropractor has any concerns about the ability of the participant to tolerate care or require x-rays, the chiropractor will have the authority to remove the participant from the study.
• Individuals who do not present with a subluxation in the upper cervical region (C1/C2) and in the lower cervical region (C3-C7). The attending chiropractor will determine the presence of the two subluxations during the chiropractic physical exam.
• Individuals with a known heart condition that results in an aberrant ECG recording

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

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries

Study Officials

• Stephanie Sullivan, DC, PhD

  Life University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Blind to intervention
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, sham-controlled trial

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: May 18, 2023
• Study Start: June 29, 2024
• Primary Completion: July 1, 2025
• Study Completion: December 16, 2025
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)