Caudal Neuroplasty Using Epidural Catheter Combined with Pulsed Radiofrequency (versus Pulsed Radiofrequency Alone
Launched by ASSIUT UNIVERSITY · Nov 27, 2024
Trial Information
Current as of July 09, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a treatment for patients experiencing pain from a herniated disc in their lower back, specifically looking at the effectiveness of two different procedures. One group of participants will receive a combination of a procedure called caudal neuroplasty (which involves placing a small tube in the epidural space of the spine) along with pulsed radiofrequency therapy, while another group will receive pulsed radiofrequency therapy alone. The goal is to see which method better reduces pain and improves quality of life over a six-month period.
To be eligible for this trial, participants need to be adults aged 20 to 80 who have moderate to severe leg pain (rated 4 or higher on a scale of 0 to 10) due to nerve issues in the lower back. They should have already tried other treatments, like physical therapy or medications, without success. MRI scans must confirm they have a herniated disc. Participants will be monitored closely during the study and can expect to receive either treatment, with the hope of finding a more effective option for managing their pain. It’s important to note that individuals with certain health conditions or those who have recently had specific injections may not qualify for this trial.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Adult patients aged 20-80 years old complaining with lumbosacral radicular pain.
- • pain intensity ≥4 out of 10 on the numerical rating scale (NRS).
- • dominant leg pain with less intense back pain.
- • previous failure of conservative management such as physiotherapy, exercise therapy, or analgesic medications.
- • Epidural injections administered ≥12 weeks prior to recruitment were permitted because most of the patients visiting our clinic had a history of interlaminar or transforaminal epidural injections.
- • Magnetic resonance imaging (MRI) was obtained in all patients and the diagnosis of lumbar disc prolapse was confirmed.
- Exclusion Criteria:
- • patient refusal to participate in the study,
- • age \<20 years,
- • unbearable pain \>9-points on NRS, pain \<4-points on NRS.
- • signs of progressive motor weakness or neurologic deficits.
- • Instability of the spine
- • allergies to steroids or contrast dyes.5
- • coagulopathy.
- • steroid injection within the previous 12 weeks.
- • systemic infection, injection site infection.
- • malignancy.
- • unstable medical or psychiatric condition
About Assiut University
Assiut University, a prominent academic institution located in Egypt, is dedicated to advancing medical research and clinical trials that enhance healthcare outcomes. With a strong emphasis on innovation and collaboration, the university engages in a wide array of clinical studies across various disciplines, aiming to contribute valuable insights into disease prevention, diagnosis, and treatment. Assiut University's commitment to ethical research practices and rigorous scientific methodology ensures the integrity and reliability of its clinical trials, ultimately benefiting both the local community and the global medical landscape.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Trial Officials
Kilani Ali Abdel-salam, PROF
Study Chair
Assiut University
Saeid Metwally El Sawy, DR
Study Director
Assiut University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported