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Prioritizing other studies
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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.
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:
Each assessment will consist of the following recordings:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chiropractic | Experimental | Chiropractic adjustment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chiropractic adjustment | Procedure | 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. |
| 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 |
| 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 |
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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 meet 3 of the 5 following criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tyson Perez, DC, PhD | Life University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Sid E. Williams Center for Chiropractic Research | Marietta | Georgia | 30067 | United States |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D026882 | Manipulation, Chiropractic |
| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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Single-arm pilot
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| 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 |
| D009750 |
| Nutritional and Metabolic Diseases |