Metabolic Syndrome
Conditions
Keywords
Chiropractic, Metabolic syndrome, Spinal manipulation, autonomic nervous system, EEG, patient reported outcomes
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: 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 \[ECG\]
Interventions
PROCEDUREChiropractic 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.
Sponsors
Life University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Single-arm pilot
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 9-item acceptability questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Impedance cardiogram (ICG) pre-ejection period (PEP) | Day 1 | 2 sensors on chest and 2 sensors on back |
| ECG mean interbeat interval | Day 1 | 3 sensors on torso |
| ECG respiratory sinus arrhythmia (RSA) | Day 1 | 3 sensors on torso |
| ECG de-trended fluctuation analysis | Day 1 | 3 sensors on torso |
| Impedance cardiogram (ICG) initial systolic time interval (ISTI) | Day 1 | 2 sensors on chest and 2 sensors on back |
| EEG resting state broadband power | Day 1 | 64-channel hydronet cap |
| Electrodermal activity (EDA) power spectral density (PSD) | Day 1 | 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 |
| Patient-Reported Outcomes Measurement Information System Cognitive Abilities and Cognitive Concerns Scale (PROMIS-Cog) | Day 0 | 8-item questionnaire |
| Perceived Stress Scale (PSS) | Day 0 | 10-item questionnaire |
| Electrodermal activity (EDA) non-specific skin conductance responses (SCR) | Day 1 | 2 sensors on first and second digits of non-dominant hand |
| EEG resting state functional connectivity | Day 1 | 64-channel hydronet cap |
| EEG evoked latency | Day 1 | 64-channel hydronet cap during auditory oddball task |
| EEG evoked amplitude | Day 1 | 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 |
Countries
United States
Outcome results
None listed