Chiropractic Force Versus Touch (FVT)

Comparison of EEG Changes Over Time Following Application of Chiropractic Adjustive Force vs Non-force Simulation

The Life University Center for Chiropractic Research is conducting a research study to better understand the physiologic and brain-based differences between the touch and force components of the chiropractic adjustment. Eligible individuals will either receive a chiropractic adjustment with force or a non-force stimulation. Individuals in the force stimulation group will receive an active spinal adjustment with a handheld instrument called an Activator. Individuals in the non-force stimulation group will have one Activator placed on the spine and another Activator clicked away from the spine. This study is not randomized. The first participant will receive an active spinal adjustment, and the second participant will receive a non-force stimulation at the same locations as the first participant. This pattern repeats until all individuals have been recruited (n=30). Outcome assessments include resting state electroencephalography (EEG), electrocardiography (ECG), and blood pressure. Outcome assessments will be captured prior to the adjustment or non-force stimulation, after the adjustment or non-force stimulation, and one week later. Individuals will also undergo a standard health history and chiropractic physical exam at the start of participation.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Chiropractic spinal adjustment; Other: Non-force simulation

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Life University Center for Chiropractic Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• You are between the age of 18 and 50.
• You have not had a chiropractic adjustment in the past 2 weeks.
• You are not currently receiving care such as acupuncture or physical therapy.
• You are currently not taking any medication that may change your brain patterns.

Exclusion Criteria:

• You do not have a history of recent spinal surgery or trauma.
• You do not have any other health conditions that may prevent you from receive chiropractic care. This could include diagnosed osteoporosis.
• You are not pregnant.
• You do not have a severe mental health condition.
• You do not have a known heart condition.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Force; Chiropractic spinal adjustment with force	Other: Chiropractic spinal adjustment; Chiropractic spinal adjustment
Active Comparator: Touch; non-force stimulation	Other: Non-force simulation; Non-force simulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electroencephalography (EEG) Power spectrum	64 channels of EEG will be recorded. A fast Fourier transform will be computed to provide a power spectrum of frequencies 1-50.	Baseline, beginning of the study
Electroencephalography (EEG) Power spectrum	64 channels of EEG will be recorded. A fast Fourier transform will be computed to provide a power spectrum of frequencies 1-50.	through study completion, an average of 1 year
Electroencephalography (EEG) Power spectrum	64 channels of EEG will be recorded. A fast Fourier transform will be computed to provide a power spectrum of frequencies 1-50.	One week follow up
Electrocardiogram (ECG) R-R intervals	Three leads will be placed on the torso to capture a Lead II ECG. R-R intervals will be calculated.	Baseline, beginning of the study
Electrocardiogram (ECG) R-R intervals	Three leads will be placed on the torso to capture a Lead II ECG. R-R intervals will be calculated.	through study completion, an average of 1 year
Electrocardiogram (ECG) R-R intervals	Three leads will be placed on the torso to capture a Lead II ECG. R-R intervals will be calculated.	one-week follow up
Blood pressure	Blood pressure will be captured using an automatic blood pressure cuff	Baseline, beginning of the study
Blood pressure	Blood pressure will be captured using an automatic blood pressure cuff	through study completion, an average of 1 year
Blood pressure	Blood pressure will be captured using an automatic blood pressure cuff	one-week follow up

Collaborators and Investigators

• Sponsor: Life University
• Investigators: Principal Investigator: Stephanie Sullivan, PhD, DC, Life Univeristy

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2021
• Primary Completion (Actual): August 1, 2023
• Study Completion (Actual): August 1, 2023

Study Registration Dates

• First Submitted: January 27, 2022
• First Submitted That Met QC Criteria: February 18, 2022
• First Posted (Actual): February 21, 2022

Study Record Updates

• Last Update Posted (Actual): February 2, 2024
• Last Update Submitted That Met QC Criteria: February 1, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: I-0015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No