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

T

Tanta University

Status

Completed

Conditions

Racz Catheter
Epidural
Steroid Injection
Low Back Pain
Lumbar
Conventional

Treatments

Drug: Conventional lumbar steroid injections
Procedure: Racz catheter

Study type

Interventional

Funder types

Other

Identifiers

NCT06599723
36264PR800/8/24

Details and patient eligibility

About

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.

Full description

Low back pain (LBP) is defined as a localized discomfort sensation below the costal margin and above the inferior gluteal folds, with or without leg pain. Conservative treatment for LBP is focused on delaying or preventing the need for surgery. Indeed, LBP can improve spontaneously or with non-surgical treatment. However, cases that fail to improve with conservative management may need to be considered for a surgical approach.

The epidural injection is a well-founded anesthetic and analgesic technique; moreover, nowadays, new technological devices can help anesthesiologists to learn and to administer it. One of these devices is Racz catheter epidural adhesiolysis. Racz catheter epidural adhesiolysis treatment addresses two issues, the injectate always reaches the area being targeted also the injections are likely to loosen fibrotic adhesions which may be the main cause of the pain in some cases.

Enrollment

60 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 persistent lumbar pain, grade 1 spondylolisthesis, facet osteoarthropathy, and small disc on radiological findings.

Exclusion criteria

  • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 2 patient groups

Conventional lumbar steroid injections group
Active Comparator group
Description:
Patients will receive conventional lumbar steroid injections.
Treatment:
Drug: Conventional lumbar steroid injections
Racz catheter group
Experimental group
Description:
Patients will receive lumbar epidural steroid using Racz catheter.
Treatment:
Procedure: Racz catheter

Trial contacts and locations

1

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Central trial contact

Mohammed S Elsharkawy, MD

Data sourced from clinicaltrials.gov

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