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

NCT ID: NCT05925439

Last Updated: 2023-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

284 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-30

Study Completion Date

2025-06-22

Brief Summary

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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

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Conditions

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S1 Transforaminal Epidural Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel assignment
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Double

Study Groups

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Tuohy needle group

Ultrasound-guided S1 transforaminal epidural block with Touhy needle

Group Type EXPERIMENTAL

Tuohy needle group

Intervention Type DEVICE

Ultrasound-guided S1 transforaminal epidural block with Touhy needle

Quincke needle group

Ultrasound-guided S1 transforaminal epidural block with Quincke needle

Group Type ACTIVE_COMPARATOR

Quincke needle group

Intervention Type DEVICE

Ultrasound-guided S1 transforaminal epidural block with Quincke needle

Interventions

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Tuohy needle group

Ultrasound-guided S1 transforaminal epidural block with Touhy needle

Intervention Type DEVICE

Quincke needle group

Ultrasound-guided S1 transforaminal epidural block with Quincke needle

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gangnam Severance Hospital

OTHER

Sponsor Role lead

Responsible Party

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Do-Hyeong Kim

Clinical assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Do-Hyeong Kim

Role: PRINCIPAL_INVESTIGATOR

Yonsei University

Locations

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GangnamSeverance Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Do-Hyeong Kim

Role: CONTACT

0220196691

Facility Contacts

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jiyeong kim

Role: primary

82-2-2019-4601

Other Identifiers

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3-2023-0145

Identifier Type: -

Identifier Source: org_study_id

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