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Completed

NCT Number: NCT05249530

Chiropractic Force Versus Touch

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.

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Life University Center for Chiropractic Research

Atlanta, Georgia, 30308, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Chiropractic spinal adjustment

Other

Chiropractic spinal adjustment

Non-force simulation

Other

Non-force simulation

Primary outcomes

  1. Electroencephalography (EEG) Power spectrum

    Time frame: Baseline, beginning of the study

    64 channels of EEG will be recorded. A fast Fourier transform will be computed to provide a power spectrum of frequencies 1-50.

  2. Electroencephalography (EEG) Power spectrum

    Time frame: through study completion, an average of 1 year

    64 channels of EEG will be recorded. A fast Fourier transform will be computed to provide a power spectrum of frequencies 1-50.

  3. Electroencephalography (EEG) Power spectrum

    Time frame: One week follow up

    64 channels of EEG will be recorded. A fast Fourier transform will be computed to provide a power spectrum of frequencies 1-50.

  4. Electrocardiogram (ECG) R-R intervals

    Time frame: Baseline, beginning of the study

    Three leads will be placed on the torso to capture a Lead II ECG. R-R intervals will be calculated.

  5. Electrocardiogram (ECG) R-R intervals

    Time frame: through study completion, an average of 1 year

    Three leads will be placed on the torso to capture a Lead II ECG. R-R intervals will be calculated.

  6. Electrocardiogram (ECG) R-R intervals

    Time frame: one-week follow up

    Three leads will be placed on the torso to capture a Lead II ECG. R-R intervals will be calculated.

  7. Blood pressure

    Time frame: Baseline, beginning of the study

    Blood pressure will be captured using an automatic blood pressure cuff

  8. Blood pressure

    Time frame: through study completion, an average of 1 year

    Blood pressure will be captured using an automatic blood pressure cuff

  9. Blood pressure

    Time frame: one-week follow up

    Blood pressure will be captured using an automatic blood pressure cuff

Sponsors and collaborators

Lead sponsor

Life University

Other

Registry information

Official study title

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

Acronym: FVT

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 21, 2022
Registry last updated
Feb 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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