Upper Cervical and Thoracic Chiropractic Adjustment

May 1, 2023 updated by: Life University

Effects of Upper Cervical and Thoracic Chiropractic Adjustments on the Autonomic Nervous System and Perceived Stress Response

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Dr. Sid E. Williams Center for Chiropractic Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Upper Cervical Adjustment
Upper cervical adjustemnt
Procedure: Upper Cervical Adjustemnt
Upper cervical adjustement
Procedure: Thoracic Adjustemnt
Thoracic adjustment
Active Comparator: Thoracic Adjustment
Thoracic adjustment
Procedure: Upper Cervical Adjustemnt
Upper cervical adjustement
Procedure: Thoracic Adjustemnt
Thoracic adjustment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caretaker Heart Rate Variability
Time Frame: Through study completion, an average of 1 week
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
Galvanic Skin Response
Time Frame: Through study completion, an average of 1 week
Galvanic Skin response gives a strong measure of Sympathetic response via electrical conductivity of perspiration.
Through study completion, an average of 1 week
Hamilton Anxiety Rating Scale
Time Frame: Through study completion, an average of 1 week
Measures the severity of anxiety symptoms
Through study completion, an average of 1 week
NSESSS
Time Frame: Through study completion, an average of 1 week
Measures PTSD symptoms in people 18 and up.
Through study completion, an average of 1 week
CD-RISC-25
Time Frame: Through study completion, an average of 1 week
Measure of adaptability
Through study completion, an average of 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Life University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 12, 2021

Primary Completion (Anticipated)

November 1, 2023

Study Completion (Anticipated)

November 1, 2023

Study Registration Dates

First Submitted

March 7, 2022

First Submitted That Met QC Criteria

July 15, 2022

First Posted (Actual)

July 19, 2022

Study Record Updates

Last Update Posted (Actual)

May 3, 2023

Last Update Submitted That Met QC Criteria

May 1, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • I-0020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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