NCT05020509

Brief Summary

The purpose of this study is to compare using Toughy needle has an advantage of reducing the incidence of vasucular puncture 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 Aug 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

August 12, 2021

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

August 19, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 25, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2021

Completed
Last Updated

November 2, 2021

Status Verified

August 1, 2021

Enrollment Period

3 months

First QC Date

August 19, 2021

Last Update Submit

October 30, 2021

Conditions

Intravascular Injection

Keywords

intravascular injection

Outcome Measures

Primary Outcomes (1)

  • incidence of intravascular injection

    incidence of intravascular injection during lumbar medial branch block

    1 minute after finishing lumbar medial branch block

Secondary Outcomes (2)

  • time required to complete lumbar medial branch block

    Baseline, 1 second after the completion of lumbar medial branch block

  • radiation amout to complete lumbar medial branch block

    Baseline, 1 second after the completion of lumbar medial branch block

Study Arms (2)

Touhy needle group

ACTIVE COMPARATOR

medial branch block with touhy needle

Procedure: medial branch block

Quincke needle group

PLACEBO COMPARATOR

medial branch block with Quincke needle

Procedure: medial branch block

Interventions

medial branch blockPROCEDURE

lumbar medial branch block

Also known as: lumbar medial branch block
Quincke needle groupTouhy needle 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

August 19, 2021

First Posted

August 25, 2021

Study Start

August 12, 2021

Primary Completion

October 30, 2021

Study Completion

October 30, 2021

Last Updated

November 2, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)