The Effects of Chiropractic in Adults With Metabolic Syndrome

Study Overview
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Brief Summary
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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
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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]

Official Title
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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

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Procedure: Chiropractic adjustment


Participation Criteria
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Eligibility Criteria
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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 with moderate to severe pain on a daily basis Individuals who are unwilling to wash their hair/head, remove hair products, accessories, braids, or wigs for the EEG recording only

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Single-arm pilot
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chiropractic<br>Chiropractic adjustment | Procedure: Chiropractic adjustment<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment rate | Length of time needed to recruit target number of participants | through study completion, an average of 1 year | 
| Participant adherence rate | Proportion of participants able to adhere to the testing & treatment schedule | through study completion, an average of 1 year | 
| Participant tolerability rate | Proportion of participants able to perform all aspects of the testing regimen | through study completion, an average of 1 year | 
| Participant retention rate | Proportion of enrolled participants who complete the full testing regimen | through study completion, an average of 1 year | 
| Acceptability of treatment regimen for participants | 9-item acceptability questionnaire | Week 6 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EEG, Chiropractic, Metabolic syndrome, Spinal manipulation, autonomic nervous system, patient reported outcomes