Analgesic Efficacy of Epidural Neuroplasty Using Racz Catheter During Lumbar Fixation in Situ for Lumbosacral Spondylolisthesis: A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Analgesic Efficacy
- Sponsor
- Tanta University
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Degree of Disability
- Status
- Completed
- Last Updated
- last year
Overview
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
Investigators
Mohammed Said ElSharkawy
Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.
Tanta University
Eligibility Criteria
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/m
- •History of allergy to contrast medium.
- •Previously operated traditional spine surgeries.
Outcomes
Primary Outcomes
Degree of Disability
Time Frame: 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 Outcomes
- Degree of pain(6 month post-procedure)
- Degree of patient satisfaction(6 month post-procedure)
- Incidence of complications(6 month post-procedure)