Epidural Neuroplasty Using Racz Catheter During Lumbar Fixation in Situ for Lumbosacral Spondylolisthesis

Not Applicable

Completed

• Conditions: Analgesic Efficacy; Epidural; Neuroplasty; Racz Catheter; Lumbar Fixation; Lumbosacral Spondylolisthesis

• Registration Number: NCT06684821
• Lead Sponsor: Tanta University

Brief Summary

This study aims to evaluate the analgesic efficacy of epidural neuroplasty using a Racz catheter during lumber fixation in situ for lumbosacral spondylolisthesis.

Detailed Description

Lumbosacral spondylolisthesis, a common neurosurgical disorder, involves the anterior displacement of a vertebra in relation to the one below it. It often leads to back pain and neurologic symptoms.

Epidural lysis of adhesions is a procedure which treat chronic LBP in patients which didn't respond to medical treatments.The technique of Radiofrequency ablation (RFA) uses high-frequency current to produce tissue coagulation and heat. It involves the use of radio waves, applied through a percutaneous probe to generate heat and create a lesion in a spinal sensory nerve

Study Timeline

• Study First Submitted: 2024-11-11
• Study First Submitted QC: 2024-11-11
• Study First Posted: 2024-11-12
• Study Start: 2024-11-14
• Status Verified: 2025-04
• Primary Completion: 2025-04-17
• Study Completion: 2025-04-17
• Last Update Submitted: 2025-04-22
• Last Update Posted: 2025-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Age from 18 to 65 years.
• Both sexes.
• Patients suffering from spondylolisthesis grade 0, 1, 2 complaining of low back pain and/or sciatica.

Exclusion Criteria

• Uncooperative patients.
• Patients in need of discectomy for lumber disc prolapse.
• Patients with severe canal stenosis and in need of spinal laminectomy.
• Contraindications to perform the proper technique e.g., coagulopathy and skin infection.
• Body mass index (BMI) ≥35 kg/m2.
• History of allergy to contrast medium.
• Previously operated traditional spine surgeries.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Degree of Disability	6 month post-procedure	Degree of Disability will be assessed using Oswestry Low Back Disability Questionnaire: This questionnaire has been designed to give us information as to how back pain has affected a patient's ability to manage everyday life. It consists of 10 questions for each question, there is a possible 5 points (0 for the first answer, 1 for the second answer, etc). Add up the total for the 10 questions and rate them on the scale (0-4 no disability, 5-14 mild disability, 15-24 moderate disability, 25-34 severe disability, 35-50 complete disability). It will be assisted pre-procedure as a baseline, after 1, 2, 4, 6 month post-procedure

Secondary Outcome Measures

Name	Time	Method
Degree of pain	6 month post-procedure	Each patient will be instructed about postoperative pain assessment with the visual analogue scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable"). VAS will be assessed pre-procedure as baseline, immediately post-procedure, 1, 2, 4, 6 month post-procedure
Degree of patient satisfaction	6 month post-procedure	Degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied)
Incidence of complications	6 month post-procedure	Incidence of complications that may occur during the technique such as (bending of the tip of the needle, shearing of the catheter, misplacement of the catheter, blocking of the catheter, blood aspiration and bleeding in the epidural space, hypotension, migration of the catheter, paresthesia, headache and infection) will be recorded.

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El-Gharbia, Egypt