Racz Catheter Technique Versus Conventional Technique in Lumbar Epidural Steroid Injection for Management of Low Back Pain

NCT06599723 | Completed

• 1 other identifier: 36264PR800/8/24
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare Racz catheter technique and conventional technique in lumbar epidural steroid injection for the management of low back pain.

Conditions

Racz Catheter; Conventional; Lumbar; Epidural; Steroid Injection; Low Back Pain

Outcome Measures

Primary Outcomes (1)

• Oswestry score

  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 Outcomes (4)

• Degree of pain

  6 month post-procedure

• Patient satisfaction

  6 month post-procedure

• Procedure technique time

  Intraoperatively

• Incidence of complications

  6 month post-procedure

Study Arms (2)

Conventional lumbar steroid injections group

ACTIVE COMPARATOR

Patients will receive conventional lumbar steroid injections.

Drug: Conventional lumbar steroid injections

Racz catheter group

EXPERIMENTAL

Patients will receive lumbar epidural steroid using Racz catheter.

Procedure: Racz catheter

Interventions

Conventional lumbar steroid injections DRUG

Patients will receive conventional lumbar steroid injections.

Conventional lumbar steroid injections group

Racz catheter PROCEDURE

Patients will receive lumbar epidural steroid using Racz catheter.

Racz catheter group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age from 18 to 65 years.
• Both sexes.
• Patients suffering from persistent lumbar pain, grade 1 spondylolisthesis, facet osteoarthropathy, and small disc on radiological findings.

You may not qualify if:

• Uncooperative patients.
• Contraindications to perform the proper technique e.g., coagulopathy and skin infection.
• History of allergy to contrast medium.
• Rupture disc.
• Lumbar canal stenosis.
• Previously operated traditional spine surgeries.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: September 19, 2024
• Study Start: September 17, 2024
• Primary Completion: March 6, 2025
• Study Completion: March 6, 2025
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author

Locations

EG (1)