Clinical trial NCT05249530: Chiropractic Force Versus Touch
Official title: Comparison of EEG Changes Over Time Following Application of Chiropractic Adjustive Force vs Non-force Simulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Life University
Sponsor class: OTHER
First posted: 2022-02-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Electroencephalography (EEG) Power spectrum
timeFrame: Baseline, beginning of the study
measure: Electroencephalography (EEG) Power spectrum
timeFrame: through study completion, an average of 1 year
measure: Electroencephalography (EEG) Power spectrum
timeFrame: One week follow up
measure: Electrocardiogram (ECG) R-R intervals
timeFrame: Baseline, beginning of the study
measure: Electrocardiogram (ECG) R-R intervals
timeFrame: through study completion, an average of 1 year
measure: Electrocardiogram (ECG) R-R intervals
timeFrame: one-week follow up
measure: Blood pressure
timeFrame: Baseline, beginning of the study
measure: Blood pressure
timeFrame: through study completion, an average of 1 year
measure: Blood pressure
timeFrame: one-week follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Life University Center for Chiropractic Research
state: Georgia
Study officials:
affiliation: Life Univeristy
name: Stephanie Sullivan, PhD, DC
role: PRINCIPAL_INVESTIGATOR
References: