The Effects of Chiropractic in Adults With Metabolic Syndrome

Life University10 enrolled

Overview

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.

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: 1. Seated resting recording 2. Auditory oddball task 3. Isometric hand grip 4. Postural challenge 5. Treadmill walking 6. Patient-reported outcome surveys Each assessment will consist of the following recordings: 1. Electroencephalography \[EEG\] 2. Electrodermal activity \[EDA\] 3. Impedance cardiography \[ICG\] 4. Electrocardiogram \[ECG\]

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Metabolic Syndrome

Interventions

Chiropractic adjustmentPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 meet 3 of the 5 following criteria: * Elevated waist circumference (\>40 in/102 cm if male and \>35 in/88cm if female) * Elevated triglycerides (\>150 mg/dL) or drug treatment for elevated triglycerides * Reduced HDL-cholesterol (\<40mg/dL if male and \<50 mg/dL if female) or drug treatment to increase HDL-C * Elevated blood pressure (\>130 mm Hg systolic BP or \>85 mm Hg diastolic BP) or drug treatment to reduce blood pressure * Elevated fasting glucose (\>100 mg/dL) or drug treatment to reduce blood glucose Exclusion Criteria: * Individuals with a known disorder resulting in syncope/fainting during postural changes (e.g., POTS, orthostatic hypotension) * 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 or stroke 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 short-acting benzodiazepines which include midazolam \& triazolam * 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. * Individuals with moderate to severe pain on a daily basis * Pain on the day of testing rated greater than 3/10 on a visual analog scale (VAS)

Locations (1)

Dr. Sid E. Williams Center for Chiropractic Research

Marietta, Georgia, United States

Outcomes

Primary Outcomes

Recruitment rate

Length of time needed to recruit target number of participants

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

Participant adherence rate

Proportion of participants able to adhere to the testing \& treatment schedule

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

Participant tolerability rate

Proportion of participants able to perform all aspects of the testing regimen

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

Participant retention rate

Proportion of enrolled participants who complete the full testing regimen

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

Acceptability of treatment regimen for participants

9-item acceptability questionnaire

Time frame: Week 6

Secondary Outcomes

EEG resting state broadband power

64-channel hydronet cap

Time frame: Day 1

EEG resting state broadband power

64-channel hydronet cap

Time frame: Week 2

EEG resting state broadband power

64-channel hydronet cap

Time frame: Week 6

EEG resting state functional connectivity

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

64-channel hydronet cap

EEG resting state functional connectivity

64-channel hydronet cap

Time frame: Week 2

EEG resting state functional connectivity

64-channel hydronet cap

Time frame: Week 6

EEG evoked latency

64-channel hydronet cap during auditory oddball task

Time frame: Day 1

EEG evoked latency

64-channel hydronet cap during auditory oddball task

Time frame: Week 2

EEG evoked latency

64-channel hydronet cap during auditory oddball task

Time frame: Week 6

EEG evoked amplitude

64-channel hydronet cap during auditory oddball task

Time frame: Day 1

EEG evoked amplitude

64-channel hydronet cap during auditory oddball task

Time frame: Week 2

EEG evoked amplitude

64-channel hydronet cap during auditory oddball task

Time frame: Week 6

skin conductance level (SCL)

2 electrodermal activity (EDA) sensors on first and second digits of non-dominant hand

Time frame: Day 1

skin conductance level (SCL)

2 electrodermal activity (EDA) sensors on first and second digits of non-dominant hand

Time frame: Week 2

skin conductance level (SCL)

2 electrodermal activity (EDA) sensors on first and second digits of non-dominant hand

Time frame: Week 6

Impedance cardiogram (ICG) pre-ejection period (PEP)

2 sensors on chest and 2 sensors on back

Time frame: Day 1

Impedance cardiogram (ICG) pre-ejection period (PEP)

2 sensors on chest and 2 sensors on back

Time frame: Week 2

Impedance cardiogram (ICG) pre-ejection period (PEP)

2 sensors on chest and 2 sensors on back

Time frame: Week 6

ECG mean interbeat interval

3 sensors on torso

Time frame: Day 1

ECG mean interbeat interval

3 sensors on torso

Time frame: Week 2

ECG mean interbeat interval

3 sensors on torso

Time frame: Week 6

ECG respiratory sinus arrhythmia (RSA)

3 sensors on torso

Time frame: Day 1

ECG respiratory sinus arrhythmia (RSA)

3 sensors on torso

Time frame: Week 2

ECG respiratory sinus arrhythmia (RSA)

3 sensors on torso

Time frame: Week 6

ECG de-trended fluctuation analysis

3 sensors on torso

Time frame: Day 1

ECG de-trended fluctuation analysis

3 sensors on torso

Time frame: Week 2

ECG de-trended fluctuation analysis

3 sensors on torso

Time frame: Week 6

Impedance cardiogram (ICG) initial systolic time interval (ISTI)

2 sensors on chest and 2 sensors on back

Time frame: Day 1

Impedance cardiogram (ICG) initial systolic time interval (ISTI)

2 sensors on chest and 2 sensors on back

Time frame: Week 2

Impedance cardiogram (ICG) initial systolic time interval (ISTI)

2 sensors on chest and 2 sensors on back

Time frame: Week 6

Electrodermal activity (EDA) non-specific skin conductance responses (SCR)