Comparison of Tuohy Needle and Quincke Needle During S1 T... | NCT05925439

Studies
Comparison of Tuohy Needle and Quincke Needle During S1 Transforaminal Epidural Injection

NCT05925439

Sponsor

Gangnam Severance Hospital

Status

Unknown status

Last Update Posted

Jul 28, 2023Actual

Enrollment

284Estimated

Phase

Not Applicable

Conditions

S1 Transforaminal Epidural Block

Interventions

Tuohy needle group
Quincke needle group

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 30, 2023Actual

Primary Completion Date

Jun 22, 2025Estimated

Completion Date

Jun 22, 2025Estimated

First Submitted Date

Jun 21, 2023

First Submission Date that Met QC Criteria

Jun 21, 2023

First Posted Date

Jun 29, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 26, 2023

Last Update Posted Date

Jul 28, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Do-Hyeong Kim, Clinical assistant professor, Gangnam Severance HospitalPrincipal Investigator

Lead Sponsor

Gangnam Severance HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Recently, Park et al. introduced a new technique for performing S1 TFESI using ultrasound. S1 TFESI using ultrasound can be considered to overcome the disadvantages of exposure to radiation. We hypothesized that the frequency of intravascular injection differs depending on the type of needle during S1 TFESI under ultrasound guidance.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

284Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tuohy needle group	Experimental	Ultrasound-guided S1 transforaminal epidural block with Touhy needle	Device: Tuohy needle group
Quincke needle group	Active Comparator	Ultrasound-guided S1 transforaminal epidural block with Quincke needle	Device: Quincke needle group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tuohy needle group	Device	Ultrasound-guided S1 transforaminal epidural block with Touhy needle	Tuohy needle group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
incidence of intravascular injection	incidence of intravascular injection during S1 transforaminal epidural block	1 minute after finishing the procedure

Secondary Outcomes

Measure	Description	Time Frame
time required to complete S1 transforaminal epidural block	time required to complete S1 transforaminal epidural block	Baseline, 1 second after the completion of the procedure

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1. Patient diagnosed with S1 radiculopathy because S1 root compression was confirmed on MRI and related symptoms 2. NRS of back and/or radiating pain score of 4 or more 3. Patients aged 19 years or older

Exclusion Criteria:

1. Cases in which lumbar count is expected to be difficult due to lumbarization, sacralization, or lumbosacral transition 2. When the S1 posterior foramen is not clearly identified on ultrasound 3. Malignancy 4. Systemic infections 5. Bleeding tendency 6. Contrast allergy 7. Pregnant Women 8. If you cannot read or agree to the consent form 9. If you are unable to sign the consent form yourself

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Do-Hyeong Kim	Contact	0220196691		breadfans@yuhs.ac

Overall Officials

Name	Affiliation	Role
Do-Hyeong Kim	Yonsei University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
GangnamSeverance Hospital	Recruiting	Seoul			South Korea