S1 Transforaminal Epidural BlockNCT05925439
Comparison of Tuohy Needle and Quincke Needle During S1 Transforaminal Epidural Injection
A study testing Tuohy needle group and Quincke needle group in people with S1 Transforaminal Epidural Block, run by Gangnam Severance Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- S1 Transforaminal Epidural Block
- What is being tested?
- Tuohy needle group and Quincke needle group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 284 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Jun 2023to 22 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
GangnamSeverance Hospital
Seoul
jiyeong kim, 82-2-2019-4601, gsirb@yuhs.ac
About this study
Official title: 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
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.
- Conditions
- S1 Transforaminal Epidural Block
- Being tested
- Tuohy needle group, Quincke needle group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tuohy needle groupDevice
Ultrasound-guided S1 transforaminal epidural block with Touhy needle
Quincke needle groupDevice
Ultrasound-guided S1 transforaminal epidural block with Quincke needle
| Study group | Role | What they receive |
|---|---|---|
| Tuohy needle group | Experimental | Ultrasound-guided S1 transforaminal epidural block with Touhy needle Receives: Device: Tuohy needle group |
| Quincke needle group | Active comparator | Ultrasound-guided S1 transforaminal epidural block with Quincke needle Receives: Device: Quincke needle group |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of intravascular injection
incidence of intravascular injection during S1 transforaminal epidural block
Measured: 1 minute after finishing the procedure
Secondary outcomes (1)
time required to complete S1 transforaminal epidural block
time required to complete S1 transforaminal epidural block
Measured: Baseline, 1 second after the completion of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start30 Jun 2023
- Primary completion22 Jun 2025 (estimated)
- Study completion22 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for S1 Transforaminal Epidural BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 284 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Do-Hyeong Kim, Gangnam Severance Hospital
- Investigators
- Do-Hyeong Kim, Principal investigator, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05925439
- Sponsor's protocol ID
- 3-2023-0145
- Status last verified
- Jul 2023
- First submitted
- 21 Jun 2023
- Last updated
- 28 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05925439
- Acronym / sponsor ID
- 3-2023-0145
- Conditions
- S1 Transforaminal Epidural Block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 284 participants (estimated)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 30 Jun 2023 (actual)
- Primary completion
- 22 Jun 2025 (estimated)
- Study completion
- 22 Jun 2025 (estimated)
- First posted
- 29 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Tuohy needle group | Experimental | Device: Tuohy needle groupUltrasound-guided S1 transforaminal epidural block with Touhy needle |
| Quincke needle group | Active comparator | Device: Quincke needle groupUltrasound-guided S1 transforaminal epidural block with Quincke needle |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tuohy needle groupUltrasound-guided S1 transforaminal epidural block with Touhy needle | Device | Tuohy needle group |
| Quincke needle groupUltrasound-guided S1 transforaminal epidural block with Quincke needle | Device | Quincke needle group |
Primary outcome
incidence of intravascular injection
Time frame: 1 minute after finishing the procedure
incidence of intravascular injection during S1 transforaminal epidural block
1 secondary outcome
time required to complete S1 transforaminal epidural block
Time frame: Baseline, 1 second after the completion of the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Do-Hyeong Kim principal investigator
Yonsei University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tuohy needle group and Quincke needle group in people with S1 Transforaminal Epidural Block, run by Gangnam Severance Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Do-Hyeong Kim (0220196691, breadfans@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of intravascular injection (time frame: 1 minute after finishing the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2023.