Chiropractic Force Versus Touch

NCT05249530 | Completed

• 1 other identifier: I-0015
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (2)

Force

EXPERIMENTAL

Chiropractic spinal adjustment with force

Other: Chiropractic spinal adjustment

Touch

ACTIVE COMPARATOR

non-force stimulation

Other: Non-force simulation

Interventions

Chiropractic spinal adjustment OTHER

Chiropractic spinal adjustment

Force

Non-force simulation OTHER

Non-force simulation

Touch

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Life University: lead

Study Sites (1)

Life University Center for Chiropractic Research

Atlanta, Georgia, 30308, United States

Location

MeSH Terms

Interventions

Manipulation, Chiropractic

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics

Study Officials

• Stephanie Sullivan, PhD, DC

  Life Univeristy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be masked to whether they are receiving an adjustment with force or a non-force stimulation
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: February 21, 2022
• Study Start: September 28, 2021
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: February 2, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)