Comparison of Tuohy Needle and Quincke Needle During S1 Transforaminal Epidural Injection
Comparison of the Incidence of Intravascular Injection Using the Tuohy and Quincke Needles During Ultrasound-guided S1 Transforaminal Epidural Injection: a Prospective Randomized Controlled Study
1 other identifier
interventional
284
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 21, 2023
CompletedFirst Posted
Study publicly available on registry
June 29, 2023
CompletedStudy Start
First participant enrolled
June 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 22, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 22, 2025
CompletedJuly 28, 2023
July 1, 2023
2 years
June 21, 2023
July 26, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
incidence of intravascular injection
incidence of intravascular injection during S1 transforaminal epidural block
1 minute after finishing the procedure
Secondary Outcomes (1)
time required to complete S1 transforaminal epidural block
Baseline, 1 second after the completion of the procedure
Study Arms (2)
Tuohy needle group
EXPERIMENTALUltrasound-guided S1 transforaminal epidural block with Touhy needle
Quincke needle group
ACTIVE COMPARATORUltrasound-guided S1 transforaminal epidural block with Quincke needle
Interventions
Ultrasound-guided S1 transforaminal epidural block with Touhy needle
Ultrasound-guided S1 transforaminal epidural block with Quincke needle
Eligibility Criteria
You may qualify if:
- \. 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
You may not qualify if:
- \. 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
GangnamSeverance Hospital
Seoul, South Korea
Study Officials
- PRINCIPAL INVESTIGATOR
Do-Hyeong Kim
Yonsei University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Double
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical assistant professor
Study Record Dates
First Submitted
June 21, 2023
First Posted
June 29, 2023
Study Start
June 30, 2023
Primary Completion
June 22, 2025
Study Completion
June 22, 2025
Last Updated
July 28, 2023
Record last verified: 2023-07