The Effects of Chiropractic in Adults With Metabolic Syndrome

Sponsor

Life University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05884437

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the feasibility of our study procedures/protocols and to look at the potential effects of chiropractic care on people with metabolic syndrome.

Condition or Disease	Intervention/Treatment	Phase
Metabolic Syndrome	Procedure: Chiropractic adjustment	N/A

Detailed Description

After providing informed consent, individuals will undergo 6 weeks of chiropractic care. Throughout these 6 weeks there will be three assessments (Day 0, Week 2, and Week 6) that each include the following:

Seated resting recording
Auditory oddball task
Isometric hand grip
Postural challenge
Treadmill walking
Patient-reported outcome surveys

Each assessment will consist of the following recordings:

Electroencephalography [EEG]
Electrodermal activity [EDA]
Impedance cardiography [ICG]
Electrocardiogram [ECG]

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Single-arm pilotSingle-arm pilot

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

The Effects of Chiropractic on the Brain, Autonomic Nervous System, Clinical Outcomes, and Patient Reported Outcomes: a Single-arm Pilot Trial in Adults With Metabolic Syndrome

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Chiropractic Chiropractic adjustment	Procedure: Chiropractic adjustment Participants will receive 6 weeks of chiropractic care. The frequency of care will be determined by the field clinician. Participants will have their spine assessed for the presence of vertebral subluxations per their clinician's normal and customary procedures. The adjustment technique(s) utilized by the field clinician will be at their discretion.

Arm

Intervention/Treatment

Experimental: Chiropractic

Chiropractic adjustment

Procedure: Chiropractic adjustment

Participants will receive 6 weeks of chiropractic care. The frequency of care will be determined by the field clinician. Participants will have their spine assessed for the presence of vertebral subluxations per their clinician's normal and customary procedures. The adjustment technique(s) utilized by the field clinician will be at their discretion.

Outcome Measures

Primary Outcome Measures

Recruitment rate [through study completion, an average of 1 year]
Length of time needed to recruit target number of participants
Participant adherence rate [through study completion, an average of 1 year]
Proportion of participants able to adhere to the testing & treatment schedule
Participant tolerability rate [through study completion, an average of 1 year]
Proportion of participants able to perform all aspects of the testing regimen
Participant retention rate [through study completion, an average of 1 year]
Proportion of enrolled participants who complete the full testing regimen
Acceptability of treatment regimen for participants [Week 6]
8-item Theoretical Framework for Acceptability questionnaire

Secondary Outcome Measures

EEG resting state broadband power [Day 1]
64-channel hydronet cap
EEG resting state broadband power [Week 2]
64-channel hydronet cap
EEG resting state broadband power [Week 6]
64-channel hydronet cap
EEG resting state functional connectivity [Day 1]
64-channel hydronet cap
EEG resting state functional connectivity [Week 2]
64-channel hydronet cap
EEG resting state functional connectivity [Week 6]
64-channel hydronet cap
EEG evoked latency [Day 1]
64-channel hydronet cap during auditory oddball task
EEG evoked latency [Week 2]
64-channel hydronet cap during auditory oddball task
EEG evoked latency [Week 6]
64-channel hydronet cap during auditory oddball task
EEG evoked amplitude [Day 1]
64-channel hydronet cap during auditory oddball task
EEG evoked amplitude [Week 2]
64-channel hydronet cap during auditory oddball task
EEG evoked amplitude [Week 6]
64-channel hydronet cap during auditory oddball task
skin conductance level (SCL) [Day 1]
2 electrodermal activity (EDA) sensors on first and second digits of non-dominant hand
skin conductance level (SCL) [Week 2]
2 electrodermal activity (EDA) sensors on first and second digits of non-dominant hand
skin conductance level (SCL) [Week 6]
2 electrodermal activity (EDA) sensors on first and second digits of non-dominant hand
Impedance cardiogram (ICG) pre-ejection period (PEP) [Day 1]
2 sensors on chest and 2 sensors on back
Impedance cardiogram (ICG) pre-ejection period (PEP) [Week 2]
2 sensors on chest and 2 sensors on back
Impedance cardiogram (ICG) pre-ejection period (PEP) [Week 6]
2 sensors on chest and 2 sensors on back
ECG mean interbeat interval [Day 1]
3 sensors on torso
ECG mean interbeat interval [Week 2]
3 sensors on torso
ECG mean interbeat interval [Week 6]
3 sensors on torso
ECG respiratory sinus arrhythmia (RSA) [Day 1]
3 sensors on torso
ECG respiratory sinus arrhythmia (RSA) [Week 2]
3 sensors on torso
ECG respiratory sinus arrhythmia (RSA) [Week 6]
3 sensors on torso
ECG de-trended fluctuation analysis [Day 1]
3 sensors on torso
ECG de-trended fluctuation analysis [Week 2]
3 sensors on torso
ECG de-trended fluctuation analysis [Week 6]
3 sensors on torso
Impedance cardiogram (ICG) initial systolic time interval (ISTI) [Day 1]
2 sensors on chest and 2 sensors on back
Impedance cardiogram (ICG) initial systolic time interval (ISTI) [Week 2]
2 sensors on chest and 2 sensors on back
Impedance cardiogram (ICG) initial systolic time interval (ISTI) [Week 6]
2 sensors on chest and 2 sensors on back
Electrodermal activity (EDA) non-specific skin conductance responses (SCR) [Day 1]
2 sensors on first and second digits of non-dominant hand
Electrodermal activity (EDA) non-specific skin conductance responses (SCR) [Week 2]
2 sensors on first and second digits of non-dominant hand
Electrodermal activity (EDA) non-specific skin conductance responses (SCR) [Week 6]
2 sensors on first and second digits of non-dominant hand
Electrodermal activity (EDA) power spectral density (PSD) [Day 1]
2 sensors on first and second digits of non-dominant hand
Electrodermal activity (EDA) power spectral density (PSD) [Week 2]
2 sensors on first and second digits of non-dominant hand
Electrodermal activity (EDA) power spectral density (PSD) [Week 6]
2 sensors on first and second digits of non-dominant hand
Composite Autonomic Symptom Score (COMPASS-31) [Day 0]
31-item questionnaire
Composite Autonomic Symptom Score COMPASS-31) [Day 1]
31-item questionnaire
Composite Autonomic Symptom Score (COMPASS-31) [Week 2]
31-item questionnaire
Composite Autonomic Symptom Score (COMPASS-31) [Week 6]
31-item questionnaire
Patient-Reported Outcomes Measurement Information System (PROMIS-29) [Day 0]
29-item questionnaire
Patient-Reported Outcomes Measurement Information System (PROMIS-29) [Day 1]
29-item questionnaire
Patient-Reported Outcomes Measurement Information System (PROMIS-29) [Week 2]
29-item questionnaire
Patient-Reported Outcomes Measurement Information System (PROMIS-29) [Week 6]
29-item questionnaire
Patient-Reported Outcomes Measurement Information System Cognitive Abilities and Cognitive Concerns Scale (PROMIS-Cog) [Day 0]
8-item questionnaire
Patient-Reported Outcomes Measurement Information System Cognitive Abilities and Cognitive Concerns Scale (PROMIS-Cog) [Day 1]
8-item questionnaire
Patient-Reported Outcomes Measurement Information System Cognitive Abilities and Cognitive Concerns Scale (PROMIS-Cog) [Week 2]
8-item questionnaire
Patient-Reported Outcomes Measurement Information System Cognitive Abilities and Cognitive Concerns Scale (PROMIS-Cog) [Week 6]
8-item questionnaire
Perceived Stress Scale (PSS) [Day 0]
10-item questionnaire
Perceived Stress Scale (PSS) [Day 1]
10-item questionnaire
Perceived Stress Scale (PSS) [Week 2]
10-item questionnaire
Perceived Stress Scale (PSS) [Week 6]
10-item questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Individuals over the age of 18
Individuals who can wear an EEG net for 30 minutes
Individuals who can sit quietly for at least 15 minutes
Individuals who can walk unassisted for up to 10 minutes
Individuals who can provide informed consent
Individuals who are diagnosed with metabolic syndrome by their primary care provider by meeting 3 of the 5 following criteria:
Excess body fat around the waist
Elevated blood sugar or taking medications to reduce your blood sugar
Elevated blood pressure or taking medications to reduce your blood pressure
Elevated triglycerides or are taking medications to reduce your triglycerides
Reduced HDL-Cholesterol or are taking medications to increase your HDL cholesterol

Exclusion Criteria:

Individuals with impaired function of the dominant hand
Individuals with malignant hypertension
Individuals with a known heart condition such as arrhythmia that results in an aberrant ECG recording
Individuals with any implanted devices (i.e., pacemakers)
Individuals with brain aneurysms
Individuals with a history of epilepsy that would influence EEG readings
Individuals with a diagnosed externalizing or thought disorder (i.e., anti-social disorder, any major personality disorder such as borderline personality disorder, or schizophrenia)
Individuals who are on Benzodiazepine medications which 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 serious injury or surgery to the head or torso, or lower body in the last 6 months
Individuals with a hearing impairment or hearing aids (due to the auditory stimulus recording being performed)
Individuals who are currently pregnant
Individuals with current litigation related to a physical, health-related injury
Individuals who have been diagnosed with rheumatoid arthritis, osteoporosis or instability of the neck.