Comparing two types of needles for S1 epidural injections
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
This study is testing whether using different types of needles for epidural injections can reduce complications and improve pain relief for patients with S1 radiculopathy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 284 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Gangnam Severance Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05925439 on ClinicalTrials.gov |
What this trial studies
This clinical trial compares the effectiveness of Tuohy and Quincke needles during S1 transforaminal epidural injections (TFESI) using ultrasound guidance. The study aims to determine if the type of needle affects the frequency of intravascular injections, which can lead to complications. By utilizing ultrasound, the trial seeks to minimize radiation exposure while providing effective pain relief for patients with S1 radiculopathy. Participants will be randomly assigned to receive either type of needle during the procedure.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 and older diagnosed with S1 radiculopathy confirmed by MRI and experiencing significant pain.
Not a fit: Patients with conditions such as malignancy, systemic infections, or those who cannot provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer and more effective epidural injection techniques for patients suffering from S1 radiculopathy.
How similar studies have performed: While the specific comparison of needle types in this context may be novel, similar studies using ultrasound guidance for epidural injections have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seoul
- GangnamSeverance Hospital — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Principal investigator: Do-Hyeong Kim — Yonsei University
- Study coordinator: Do-Hyeong Kim
- Email: breadfans@yuhs.ac
- Phone: 0220196691
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.