Effect of needle angle on epidural steroid injection outcomes
The Effect of Needle Insertion Angle on Contrast Distribution and Treatment Outcomes in S1 Transforaminal Epidural Steroid Injections
This study is testing whether changing the angle of the needle during epidural steroid injections can help people with low back pain and nerve issues feel better and recover more effectively.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Marmara University Academic / other |
| Locations | 1 site (Istanbul, Maltepe) |
| Trial ID | NCT06801990 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates how the angle of needle insertion during S1 transforaminal epidural steroid injections affects the distribution of contrast and treatment outcomes for patients suffering from low back pain and lumbar radiculopathy. The study aims to optimize injection techniques to improve pain relief and functional recovery in patients with nerve compression due to disc herniation. Participants will receive injections of dexamethasone, and their responses will be monitored to assess the effectiveness of different needle angles. The trial seeks to provide insights that could enhance the efficacy of this common interventional procedure.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with S1 nerve root compression due to L5-S1 disc herniation who have not responded to conservative treatments.
Not a fit: Patients who have undergone lumbosacral surgery or have conditions such as spinal stenosis or progressive motor deficits may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management and recovery for patients with low back pain and lumbar radiculopathy.
How similar studies have performed: While there have been studies on epidural steroid injections, the specific focus on needle angle and its impact on contrast distribution is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Being over 18 years of age * Having S1 nerve root compression due to paravertebral disc herniation at the L5-S1 level detected by MRI * Having history and physical examination findings consistent with S1 root compression * Patients with low back and leg pain who have not responded to conservative treatment methods * Being willing to participate in the study and having signed a consent form Exclusion Criteria: * Having undergone lumbosacral surgery * Presence of transitional vertebra * Presence of progressive motor deficit * Presence of local and/or systemic infection * History of malignancy * Patients with lumbar disc herniation causing root compression outside the L5/S1 level on MRI * Patients with bilateral S1 root compression on MRI * Presence of spinal stenosis * Pregnancy * Presence of known coagulopathy * Presence of known psychiatric disease diagnosis * History of allergy to any of the injection materials * Having received an epidural steroid injection within the last 3 months * Receiving systemic steroid treatment for any reason
Where this trial is running
Istanbul, Maltepe
- Marmara Üniversitesi Tıp Fakültesi — Istanbul, Maltepe, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Berat A Polat, Assistant Doctor
- Email: beratasmpolat@gmail.com
- Phone: +905303669700
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.