The Effects of Chiropractic in Adults With Metabolic Syndrome

NCT ID: NCT05884437

Last Updated: 2024-08-27

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2025-12-16

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]

Conditions

Metabolic Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Chiropractic

Chiropractic adjustment

Group Type: EXPERIMENTAL

Chiropractic adjustment

Intervention Type: 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.

Interventions

Chiropractic 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.

Intervention Type: PROCEDURE

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 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Life University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tyson Perez, DC, PhD

Role: PRINCIPAL_INVESTIGATOR

Life University

Locations

Dr. Sid E. Williams Center for Chiropractic Research

Marietta, Georgia, United States

Countries

United States

Other Identifiers

I-0023

Identifier Type: -

Identifier Source: org_study_id