Back to resultsThe Effects of Chiropractic in Adults With Metabolic Syndrome
Primary Purpose
Metabolic Syndrome
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Chiropractic adjustment
Sponsored by
About this trial
This is an interventional other trial for Metabolic Syndrome focused on measuring Chiropractic, Metabolic syndrome, Spinal manipulation, autonomic nervous system, EEG, patient reported outcomes
Eligibility Criteria
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 have been diagnosed with metabolic syndrome by their primary healthcare provider OR individuals who suspect they meet 3 of the 5 following criteria for metabolic syndrome: 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 Individuals who suspect they have metabolic syndrome and have been taking medications for criteria 2-5 (or for other reasons) must have been on a stable dose for a minimum of 12 weeks with no plans to change the medication during the study 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 who are unable to do fasting glucose in lab or at home Individuals who are unwilling to wash their hair/head, remove hair products, accessories, braids, or wigs for the EEG recording only
Sites / Locations
- Dr. Sid E. Williams Center for Chiropractic Research
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Chiropractic
Arm Description
Chiropractic adjustment
Outcomes
Primary Outcome Measures
Recruitment rate
Length of time needed to recruit target number of participants
Participant adherence rate
Proportion of participants able to adhere to the testing & treatment schedule
Participant tolerability rate
Proportion of participants able to perform all aspects of the testing regimen
Participant retention rate
Proportion of enrolled participants who complete the full testing regimen
Acceptability of treatment regimen for participants
8-item Theoretical Framework for Acceptability questionnaire
Secondary Outcome Measures
EEG resting state broadband power
64-channel hydronet cap
EEG resting state broadband power
64-channel hydronet cap
EEG resting state broadband power
64-channel hydronet cap
EEG resting state functional connectivity
64-channel hydronet cap
EEG resting state functional connectivity
64-channel hydronet cap
EEG resting state functional connectivity
64-channel hydronet cap
EEG evoked latency
64-channel hydronet cap during auditory oddball task
EEG evoked latency
64-channel hydronet cap during auditory oddball task
EEG evoked latency
64-channel hydronet cap during auditory oddball task
EEG evoked amplitude
64-channel hydronet cap during auditory oddball task
EEG evoked amplitude
64-channel hydronet cap during auditory oddball task
EEG evoked amplitude
64-channel hydronet cap during auditory oddball task
skin conductance level (SCL)
2 electrodermal activity (EDA) sensors on first and second digits of non-dominant hand
skin conductance level (SCL)
2 electrodermal activity (EDA) sensors on first and second digits of non-dominant hand
skin conductance level (SCL)
2 electrodermal activity (EDA) sensors on first and second digits of non-dominant hand
Impedance cardiogram (ICG) pre-ejection period (PEP)
2 sensors on chest and 2 sensors on back
Impedance cardiogram (ICG) pre-ejection period (PEP)
2 sensors on chest and 2 sensors on back
Impedance cardiogram (ICG) pre-ejection period (PEP)
2 sensors on chest and 2 sensors on back
ECG mean interbeat interval
3 sensors on torso
ECG mean interbeat interval
3 sensors on torso
ECG mean interbeat interval
3 sensors on torso
ECG respiratory sinus arrhythmia (RSA)
3 sensors on torso
ECG respiratory sinus arrhythmia (RSA)
3 sensors on torso
ECG respiratory sinus arrhythmia (RSA)
3 sensors on torso
ECG de-trended fluctuation analysis
3 sensors on torso
ECG de-trended fluctuation analysis
3 sensors on torso
ECG de-trended fluctuation analysis
3 sensors on torso
Impedance cardiogram (ICG) initial systolic time interval (ISTI)
2 sensors on chest and 2 sensors on back
Impedance cardiogram (ICG) initial systolic time interval (ISTI)
2 sensors on chest and 2 sensors on back
Impedance cardiogram (ICG) initial systolic time interval (ISTI)
2 sensors on chest and 2 sensors on back
Electrodermal activity (EDA) non-specific skin conductance responses (SCR)
2 sensors on first and second digits of non-dominant hand
Electrodermal activity (EDA) non-specific skin conductance responses (SCR)
2 sensors on first and second digits of non-dominant hand
Electrodermal activity (EDA) non-specific skin conductance responses (SCR)
2 sensors on first and second digits of non-dominant hand
Electrodermal activity (EDA) power spectral density (PSD)
2 sensors on first and second digits of non-dominant hand
Electrodermal activity (EDA) power spectral density (PSD)
2 sensors on first and second digits of non-dominant hand
Electrodermal activity (EDA) power spectral density (PSD)
2 sensors on first and second digits of non-dominant hand
Composite Autonomic Symptom Score (COMPASS-31)
31-item questionnaire
Composite Autonomic Symptom Score COMPASS-31)
31-item questionnaire
Composite Autonomic Symptom Score (COMPASS-31)
31-item questionnaire
Composite Autonomic Symptom Score (COMPASS-31)
31-item questionnaire
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
29-item questionnaire
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
29-item questionnaire
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
29-item questionnaire
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
29-item questionnaire
Patient-Reported Outcomes Measurement Information System Cognitive Abilities and Cognitive Concerns Scale (PROMIS-Cog)
8-item questionnaire
Patient-Reported Outcomes Measurement Information System Cognitive Abilities and Cognitive Concerns Scale (PROMIS-Cog)
8-item questionnaire
Patient-Reported Outcomes Measurement Information System Cognitive Abilities and Cognitive Concerns Scale (PROMIS-Cog)
8-item questionnaire
Patient-Reported Outcomes Measurement Information System Cognitive Abilities and Cognitive Concerns Scale (PROMIS-Cog)
8-item questionnaire
Perceived Stress Scale (PSS)
10-item questionnaire
Perceived Stress Scale (PSS)
10-item questionnaire
Perceived Stress Scale (PSS)
10-item questionnaire
Perceived Stress Scale (PSS)
10-item questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05884437
Brief Title
The Effects of Chiropractic in Adults With Metabolic Syndrome
Official Title
The Effects of Chiropractic Care on the Brain, Autonomic Nervous System, Gait, and Patient Reported Outcomes in Adults With Diagnosed or Suspected Metabolic Syndrome: a Proof-of-concept Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Life University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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]
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
Chiropractic, Metabolic syndrome, Spinal manipulation, autonomic nervous system, EEG, patient reported outcomes
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single-arm pilot
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Chiropractic
Arm Type
Experimental
Arm Description
Chiropractic adjustment
Intervention Type
Procedure
Intervention Name(s)
Chiropractic adjustment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recruitment rate
Description
Length of time needed to recruit target number of participants
Time Frame
through study completion, an average of 1 year
Title
Participant adherence rate
Description
Proportion of participants able to adhere to the testing & treatment schedule
Time Frame
through study completion, an average of 1 year
Title
Participant tolerability rate
Description
Proportion of participants able to perform all aspects of the testing regimen
Time Frame
through study completion, an average of 1 year
Title
Participant retention rate
Description
Proportion of enrolled participants who complete the full testing regimen
Time Frame
through study completion, an average of 1 year
Title
Acceptability of treatment regimen for participants
Description
8-item Theoretical Framework for Acceptability questionnaire
Time Frame
Week 6
Secondary Outcome Measure Information:
Title
EEG resting state broadband power
Description
64-channel hydronet cap
Time Frame
Day 1
Title
EEG resting state broadband power
Description
64-channel hydronet cap
Time Frame
Week 2
Title
EEG resting state broadband power
Description
64-channel hydronet cap
Time Frame
Week 6
Title
EEG resting state functional connectivity
Description
64-channel hydronet cap
Time Frame
Day 1
Title
EEG resting state functional connectivity
Description
64-channel hydronet cap
Time Frame
Week 2
Title
EEG resting state functional connectivity
Description
64-channel hydronet cap
Time Frame
Week 6
Title
EEG evoked latency
Description
64-channel hydronet cap during auditory oddball task
Time Frame
Day 1
Title
EEG evoked latency
Description
64-channel hydronet cap during auditory oddball task
Time Frame
Week 2
Title
EEG evoked latency
Description
64-channel hydronet cap during auditory oddball task
Time Frame
Week 6
Title
EEG evoked amplitude
Description
64-channel hydronet cap during auditory oddball task
Time Frame
Day 1
Title
EEG evoked amplitude
Description
64-channel hydronet cap during auditory oddball task
Time Frame
Week 2
Title
EEG evoked amplitude
Description
64-channel hydronet cap during auditory oddball task
Time Frame
Week 6
Title
skin conductance level (SCL)
Description
2 electrodermal activity (EDA) sensors on first and second digits of non-dominant hand
Time Frame
Day 1
Title
skin conductance level (SCL)
Description
2 electrodermal activity (EDA) sensors on first and second digits of non-dominant hand
Time Frame
Week 2
Title
skin conductance level (SCL)
Description
2 electrodermal activity (EDA) sensors on first and second digits of non-dominant hand
Time Frame
Week 6
Title
Impedance cardiogram (ICG) pre-ejection period (PEP)
Description
2 sensors on chest and 2 sensors on back
Time Frame
Day 1
Title
Impedance cardiogram (ICG) pre-ejection period (PEP)
Description
2 sensors on chest and 2 sensors on back
Time Frame
Week 2
Title
Impedance cardiogram (ICG) pre-ejection period (PEP)
Description
2 sensors on chest and 2 sensors on back
Time Frame
Week 6
Title
ECG mean interbeat interval
Description
3 sensors on torso
Time Frame
Day 1
Title
ECG mean interbeat interval
Description
3 sensors on torso
Time Frame
Week 2
Title
ECG mean interbeat interval
Description
3 sensors on torso
Time Frame
Week 6
Title
ECG respiratory sinus arrhythmia (RSA)
Description
3 sensors on torso
Time Frame
Day 1
Title
ECG respiratory sinus arrhythmia (RSA)
Description
3 sensors on torso
Time Frame
Week 2
Title
ECG respiratory sinus arrhythmia (RSA)
Description
3 sensors on torso
Time Frame
Week 6
Title
ECG de-trended fluctuation analysis
Description
3 sensors on torso
Time Frame
Day 1
Title
ECG de-trended fluctuation analysis
Description
3 sensors on torso
Time Frame
Week 2
Title
ECG de-trended fluctuation analysis
Description
3 sensors on torso
Time Frame
Week 6
Title
Impedance cardiogram (ICG) initial systolic time interval (ISTI)
Description
2 sensors on chest and 2 sensors on back
Time Frame
Day 1
Title
Impedance cardiogram (ICG) initial systolic time interval (ISTI)
Description
2 sensors on chest and 2 sensors on back
Time Frame
Week 2
Title
Impedance cardiogram (ICG) initial systolic time interval (ISTI)
Description
2 sensors on chest and 2 sensors on back
Time Frame
Week 6
Title
Electrodermal activity (EDA) non-specific skin conductance responses (SCR)
Description
2 sensors on first and second digits of non-dominant hand
Time Frame
Day 1
Title
Electrodermal activity (EDA) non-specific skin conductance responses (SCR)
Description
2 sensors on first and second digits of non-dominant hand
Time Frame
Week 2
Title
Electrodermal activity (EDA) non-specific skin conductance responses (SCR)
Description
2 sensors on first and second digits of non-dominant hand
Time Frame
Week 6
Title
Electrodermal activity (EDA) power spectral density (PSD)
Description
2 sensors on first and second digits of non-dominant hand
Time Frame
Day 1
Title
Electrodermal activity (EDA) power spectral density (PSD)
Description
2 sensors on first and second digits of non-dominant hand
Time Frame
Week 2
Title
Electrodermal activity (EDA) power spectral density (PSD)
Description
2 sensors on first and second digits of non-dominant hand
Time Frame
Week 6
Title
Composite Autonomic Symptom Score (COMPASS-31)
Description
31-item questionnaire
Time Frame
Day 0
Title
Composite Autonomic Symptom Score COMPASS-31)
Description
31-item questionnaire
Time Frame
Day 1
Title
Composite Autonomic Symptom Score (COMPASS-31)
Description
31-item questionnaire
Time Frame
Week 2
Title
Composite Autonomic Symptom Score (COMPASS-31)
Description
31-item questionnaire
Time Frame
Week 6
Title
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Description
29-item questionnaire
Time Frame
Day 0
Title
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Description
29-item questionnaire
Time Frame
Day 1
Title
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Description
29-item questionnaire
Time Frame
Week 2
Title
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Description
29-item questionnaire
Time Frame
Week 6
Title
Patient-Reported Outcomes Measurement Information System Cognitive Abilities and Cognitive Concerns Scale (PROMIS-Cog)
Description
8-item questionnaire
Time Frame
Day 0
Title
Patient-Reported Outcomes Measurement Information System Cognitive Abilities and Cognitive Concerns Scale (PROMIS-Cog)
Description
8-item questionnaire
Time Frame
Day 1
Title
Patient-Reported Outcomes Measurement Information System Cognitive Abilities and Cognitive Concerns Scale (PROMIS-Cog)
Description
8-item questionnaire
Time Frame
Week 2
Title
Patient-Reported Outcomes Measurement Information System Cognitive Abilities and Cognitive Concerns Scale (PROMIS-Cog)
Description
8-item questionnaire
Time Frame
Week 6
Title
Perceived Stress Scale (PSS)
Description
10-item questionnaire
Time Frame
Day 0
Title
Perceived Stress Scale (PSS)
Description
10-item questionnaire
Time Frame
Day 1
Title
Perceived Stress Scale (PSS)
Description
10-item questionnaire
Time Frame
Week 2
Title
Perceived Stress Scale (PSS)
Description
10-item questionnaire
Time Frame
Week 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 have been diagnosed with metabolic syndrome by their primary healthcare provider OR individuals who suspect they meet 3 of the 5 following criteria for metabolic syndrome:
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
Individuals who suspect they have metabolic syndrome and have been taking medications for criteria 2-5 (or for other reasons) must have been on a stable dose for a minimum of 12 weeks with no plans to change the medication during the study
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 who are unable to do fasting glucose in lab or at home
Individuals who are unwilling to wash their hair/head, remove hair products, accessories, braids, or wigs for the EEG recording only
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Austin Garlinghouse
Phone
770-426-2639
Email
austin.garlinghouse@life.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tyson Perez, DC, PhD
Organizational Affiliation
Life University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Sid E. Williams Center for Chiropractic Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effects of Chiropractic in Adults With Metabolic Syndrome
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