NCT02838654

Brief Summary

The purpose of this study is to analyze the reliability of epidural wave form during cerivical epidural injection.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2016

Shorter than P25 for all trials

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

Study Start

First participant enrolled

July 1, 2016

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

July 12, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 20, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

November 30, 2017

Status Verified

November 1, 2017

Enrollment Period

10 months

First QC Date

July 12, 2016

Last Update Submit

November 28, 2017

Conditions

Analysis, Event History

Keywords

cervical epidural spacewave form analysis

Outcome Measures

Primary Outcomes (1)

  • epidural wave form reliability (sensitivity, specificity) analysis

    1 minute after the completion of the epidural injection

Study Arms (1)

cervical epidural injection group

cervical epidural injection group

Procedure: cervical epidural injection

Interventions

cervical epidural injectionPROCEDURE

sensitivity, specificity, positive predictive value, negative predictive value

cervical epidural injection group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who complain chronic neck pain due to cervical spinal disease or acute herpes zoster

You may qualify if:

  • Cerivical Herniated nucleusus
  • Cerivical spinal stenosis
  • acute herpes zoster

You may not qualify if:

  • Coagulopathy
  • Infectious cervical disease
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • JiHEE Hong, MD, PhD

    Keimyung University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

July 12, 2016

First Posted

July 20, 2016

Study Start

July 1, 2016

Primary Completion

May 1, 2017

Study Completion

June 1, 2017

Last Updated

November 30, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share