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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT05465395
Other study ID # I-0020
Secondary ID
Status Suspended
Phase N/A
First received
Last updated
Start date October 12, 2021
Est. completion date November 1, 2023

Study information

Verified date May 2023
Source Life University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The proposed study examines the differences in how the ANS responds to cervical adjustments in comparison to thoracic adjustments. This study is the continuation of a previous study titled Perceived stress and patterns of autonomic function: a protocol development study. Autonomic tests such as HRV, GSR, and the stress surveys will be the primary method of measurement. CareTaker and Biopac devices will provide continual data collection of ECG (for HRV analysis) and GSR throughout the exam and adjustment. Participant's subjective stress levels will be measured through the use of stress questionnaires including the National Stressful Events Survey Acute Stress Disorder Short Scale, the Hamilton Anxiety Rating Scale, and the Connor-Davidson Resilience Scale. The objective of the study is to determine if the location of a chiropractic adjustment will affect the autonomic nervous system in such a way that PNS or SNS activation increases or decreases after the adjustment. Further, the study will continue to examine how the chiropractic adjustment affects the subjective stress response.


Recruitment information / eligibility

Status Suspended
Enrollment 40
Est. completion date November 1, 2023
Est. primary completion date November 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Over the age of 19 - In good health - Willing to have blood pressure taken - Willinig to shave a small area of chest hair for placement of a ECG patch - Consent to a physical exam - Consent ot chiropractic evaluationa nd 2 adjustments

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Upper Cervical Adjustemnt
Upper cervical adjustement
Thoracic Adjustemnt
Thoracic adjustment

Locations

Country Name City State
United States Dr. Sid E. Williams Center for Chiropractic Research Atlanta Georgia

Sponsors (1)

Lead Sponsor Collaborator
Life University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Caretaker Heart Rate Variability HRV allows for an understanding of Autonomic (parasympathetic) function, via measuring the interval of R peaks in QRS complexes. Through study completion, an average of 1 week
Primary Galvanic Skin Response Galvanic Skin response gives a strong measure of Sympathetic response via electrical conductivity of perspiration. Through study completion, an average of 1 week
Primary Hamilton Anxiety Rating Scale Measures the severity of anxiety symptoms Through study completion, an average of 1 week
Primary NSESSS Measures PTSD symptoms in people 18 and up. Through study completion, an average of 1 week
Primary CD-RISC-25 Measure of adaptability Through study completion, an average of 1 week
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