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

Analgesic Efficacy of Epidural Neuroplasty Using Racz Catheter During Lumbar Fixation in Situ for Lumbosacral Spondylolisthesis: A Randomized Controlled Trial

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

Study Overview

• Status: Completed
• Conditions: Analgesic Efficacy; Epidural; Racz Catheter; Neuroplasty; Lumbar Fixation; Lumbosacral Spondylolisthesis
• Intervention / Treatment: Procedure: Racz catheter; Procedure: Classic lumber fixation

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Racz catheter group; Patients will undergo epidural neuroplasty using Racz catheter during lumber fixation.	Procedure: Racz catheter; Patients will undergo epidural neuroplasty using Racz catheter during lumber fixation.
Active Comparator: Control group; Patients will undergo classic lumber fixation.	Procedure: Classic lumber fixation; Patients will undergo classic lumber fixation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of Disability	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	6 month post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of pain	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	6 month post-procedure
Degree of patient satisfaction	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)	6 month post-procedure
Incidence of complications	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.	6 month post-procedure

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2024
• Primary Completion (Actual): April 17, 2025
• Study Completion (Actual): April 17, 2025

Study Registration Dates

• First Submitted: November 11, 2024
• First Submitted That Met QC Criteria: November 11, 2024
• First Posted (Actual): November 12, 2024

Study Record Updates

• Last Update Posted (Actual): April 23, 2025
• Last Update Submitted That Met QC Criteria: April 22, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Spondylolysis; Spondylosis; Spondylolisthesis
• Other Study ID Numbers: 36264PR903/10/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No