NCT03245294

Brief Summary

The purpose of this study is to evaluate the decrease pattern of lumbar epidural pressure from ligamentum flavum to epidural space and analyzing factors contributing this pressure change pattern.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

August 1, 2017

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 3, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 10, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 11, 2018

Completed
Last Updated

April 17, 2018

Status Verified

April 1, 2018

Enrollment Period

8 months

First QC Date

August 3, 2017

Last Update Submit

April 13, 2018

Conditions

Analysis, Event History

Keywords

cervical epidural spaceabrupt pressure decrease

Outcome Measures

Primary Outcomes (1)

  • pattern of epidural pressure decrease

    abrupt or gradual decrease of epidural pressure

    1 second after the completion of entry from ligamentum flavum to epidural space

Secondary Outcomes (1)

  • factors contributing the epidural pressure pattern

    60 minutes after the completion of entry from ligamentum flavum to epidural space

Study Arms (2)

Lumbar ESI with paramedian approach

ACTIVE COMPARATOR

Lumbar ESI with paramedian approach

Procedure: lumbar epidural injection

Lumbar ESI with midline approach

ACTIVE COMPARATOR

Lumbar ESI with midline approach

Procedure: lumbar epidural injection

Interventions

lumbar epidural injectionPROCEDURE

the pattern of pressure decrease from ligamentum flavum to epidural space

Lumbar ESI with midline approachLumbar ESI with paramedian approach

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • lumbar herniated nucleus
  • lumbar spinal stenosis
  • internal disc disruption
  • NRS \> 5
  • ODI \> 20

You may not qualify if:

  • coagulopathy
  • allergy to contrast media
  • infection at needle insertion site
  • absence of lumbar MRI
  • Pregnancy
  • previous lumbar spine surgery
  • neurological symptoms requiring prompt reevalution

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ji Hee Hong

Daegu, 700712, South Korea

Location

Study Officials

  • Ji Hee Hong, PhD

    Keimyung University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 3, 2017

First Posted

August 10, 2017

Study Start

August 1, 2017

Primary Completion

April 11, 2018

Study Completion

April 11, 2018

Last Updated

April 17, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)