The Effect of Needle Insertion Angle on Contrast Distribution and Treatment Outcomes in S1 Transforaminal Epidural Steroid Injections
Launched by MARMARA UNIVERSITY · Jan 25, 2025
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how the angle at which a needle is inserted during a specific type of injection, called a transforaminal epidural steroid injection (TFESE), affects the spread of the medicine and the overall treatment results for patients with low back pain and leg pain caused by nerve compression from a herniated disc. The goal is to find the best technique to improve patient outcomes and make the procedure safer and more effective.
To be eligible for this study, participants must be at least 18 years old and have been diagnosed with nerve root compression at the L5-S1 level, confirmed by an MRI. They should also be experiencing pain that hasn't improved with other treatments. Participants will receive detailed information about the injection procedure and will answer questions about their pain and daily activities before and after the injection at set times. While there may be some temporary side effects from the injection, trained specialists will be performing the procedure, and safety measures will be in place. Importantly, participation is voluntary, and participants can withdraw at any time without affecting their treatment. There are no costs for participants related to the study.
Gender
ALL
Eligibility 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
About Marmara University
Marmara University is a distinguished academic institution located in Istanbul, Turkey, renowned for its commitment to advancing healthcare through innovative research and clinical trials. With a robust infrastructure and a multidisciplinary approach, the university actively engages in the development and evaluation of new therapeutic interventions, fostering collaboration among researchers, clinicians, and industry partners. Marmara University’s focus on ethical standards and patient safety underscores its dedication to contributing valuable insights to the medical community and improving health outcomes.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
İstanbul, Maltepe, Turkey
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported