NCT05465395

Brief 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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 12, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 19, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

May 3, 2023

Status Verified

May 1, 2023

Enrollment Period

2.1 years

First QC Date

March 7, 2022

Last Update Submit

May 1, 2023

Conditions

Keywords

Heart Rate VarabilityAutonomic Nervious SystemChiropractic Adjustment

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • Hamilton Anxiety Rating Scale

    Measures the severity of anxiety symptoms

    Through study completion, an average of 1 week

  • NSESSS

    Measures PTSD symptoms in people 18 and up.

    Through study completion, an average of 1 week

  • CD-RISC-25

    Measure of adaptability

    Through study completion, an average of 1 week

Study Arms (2)

Upper Cervical Adjustment

EXPERIMENTAL

Upper cervical adjustemnt

Procedure: Upper Cervical AdjustemntProcedure: Thoracic Adjustemnt

Thoracic Adjustment

ACTIVE COMPARATOR

Thoracic adjustment

Procedure: Upper Cervical AdjustemntProcedure: Thoracic Adjustemnt

Interventions

Upper cervical adjustement

Thoracic AdjustmentUpper Cervical Adjustment

Thoracic adjustment

Thoracic AdjustmentUpper Cervical Adjustment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Sid E. Williams Center for Chiropractic Research

Atlanta, Georgia, 30308, United States

Location

Study Officials

  • Stephanie Sullivan

    Life Univeristy

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2022

First Posted

July 19, 2022

Study Start

October 12, 2021

Primary Completion

November 1, 2023

Study Completion

November 1, 2023

Last Updated

May 3, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations