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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-14

Study Completion Date

2025-04-17

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Aim of Study is to Identify the Predictive Factors for the Success of Transforaminal Epidural Injection in Treatment of Patients with Lumbosacral Radiculopathy

NCT06795542

Lumbar Radiculopathy

ENROLLING_BY_INVITATION PHASE2

The Effect of Additional Transforaminal Epidural Blocks in Percutaneous Epidural Neuroplasty

NCT03867630

Lumbar Spinal Stenosis

UNKNOWN

LUMBAR & SACROILIAC FUSION STUDY

NCT07204288

Fusion of Spine Sacroiliac; Fusion

RECRUITING NA

Platelet Rich Plasma Injection Versus Surgical Fixation Procedure in Management of Spondylolisthesis grade1.

NCT04808336

Degenerative Spondylolisthesis G1

COMPLETED NA

Two Different Approaches During Fluoroscopically Guided Interlaminar Lumbar Epidural Steroid Injection

NCT01760317

Unilateral Lumbosacral Radiculopathy Pain

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Analgesic Efficacy Epidural Neuroplasty Racz Catheter Lumbar Fixation Lumbosacral Spondylolisthesis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Racz catheter group

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

Group Type EXPERIMENTAL

Racz catheter

Intervention Type PROCEDURE

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

Control group

Patients will undergo classic lumber fixation.

Group Type ACTIVE_COMPARATOR

Classic lumber fixation

Intervention Type PROCEDURE

Patients will undergo classic lumber fixation.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Racz catheter

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

Intervention Type PROCEDURE

Classic lumber fixation

Patients will undergo classic lumber fixation.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No