NCT04161677

Brief Summary

This study will seek to describe and understand adverse events (AE) severity ratings.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
161

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

November 10, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 13, 2019

Completed
8 days until next milestone

Study Start

First participant enrolled

November 21, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2020

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

February 16, 2021

Status Verified

February 1, 2021

Enrollment Period

1.1 years

First QC Date

November 10, 2019

Last Update Submit

February 15, 2021

Conditions

Safety Issues

Keywords

Adverse eventElectronic reporting systemChiropracticSpinal manipulation

Outcome Measures

Primary Outcomes (3)

  • Pre-screening questionnaire

    Severity rating based on a series of questionnaire

    5-10 minute

  • Post-survey

    Severity rating based on severity term questionnaire

    Immediately after visit

  • follow-up questionnaire

    Severity rating based on definitions questionnaire

    7-10 days after visit

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A convenience sample of all patients at the Parker University Wellness clinic will be invited to participate in the study.

You may qualify if:

  • Health patients

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Parker University

Dallas, Texas, 75229, United States

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2019

First Posted

November 13, 2019

Study Start

November 21, 2019

Primary Completion

December 20, 2020

Study Completion

December 31, 2020

Last Updated

February 16, 2021

Record last verified: 2021-02

Locations

US(1)