NCT05362084

Brief Summary

The purpose of this study is to compare using oblique fluoroscopic angle has any advantage in reducing the incidence of vascular punture and technical easiness during lumbar medial branch block

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

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

September 3, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 2, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 5, 2022

Completed
Last Updated

May 23, 2022

Status Verified

May 1, 2022

Enrollment Period

8 months

First QC Date

May 2, 2022

Last Update Submit

May 19, 2022

Conditions

Intravascular Injection

Keywords

intravascular injection

Outcome Measures

Primary Outcomes (1)

  • incidence of intravasuclar injection

    incidence of intravasuclar injection

    1 minute after finishing lumbar medial branch block

Secondary Outcomes (2)

  • time required to complete lumbar medial branch block

    1 second after finishing lumbar medial branch block

  • radiation amount to complete lumbar medial branch block

    1 second after finishing lumbar medial branch block

Study Arms (2)

Oblique group

ACTIVE COMPARATOR

medial branch block with oblique group

Procedure: lumbar medial branch block

Anteroposterior group

PLACEBO COMPARATOR

medial branch block with anteroposterior group

Procedure: lumbar medial branch block

Interventions

lumbar medial branch blockPROCEDURE

lumbar medial branch block

Anteroposterior groupOblique group

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • facet joint arthropathy

You may not qualify if:

  • allergy to local anesthetics or contrast medium
  • pregnancy
  • spine deformity
  • neurologic abnormality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hong ji HEE

Daegu, 42601, South Korea

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 2, 2022

First Posted

May 5, 2022

Study Start

September 3, 2021

Primary Completion

April 30, 2022

Study Completion

April 30, 2022

Last Updated

May 23, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)