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Search / Trial NCT06711419

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

Pulsed Radio Freqency Caudal Neuroplasty

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.

Locations

Patients applied

0 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