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

Tanta University

Status: Completed

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

Treatments: Procedure: Classic lumber fixation; Procedure: Racz catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT06684821

36264PR903/10/24

Details and patient eligibility

About

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

Full 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

Enrollment: 50 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Racz catheter group

Experimental group

Description:

Patients will undergo epidural neuroplasty using Racz catheter during lumber fixation.

Treatment:

Procedure: Racz catheter

Control group

Active Comparator group

Description:

Patients will undergo classic lumber fixation.

Treatment:

Procedure: Classic lumber fixation