Evaluation of Transforaminal Epidural Steroid Injection in Radicular Low Back Pain According to MSU Classification

Başakşehir Çam & Sakura City Hospital

Status: Completed

Conditions: Disc Herniation; Injections, Epidural; Radiculopathy Lumbar; Low Back Pain

Treatments: Procedure: Transforaminal Epidural Steroid Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT06275529

27.12.2023.685

Details and patient eligibility

About

Low back pain is a common disease in all ages and it effects seriously quality of life. Medical treatment,interventional methods and surgery are the treatment options. Transforaminal epidural steroid injections (TFSI) is one of the interventional method for radiculopathy with low back pain. Michigan State University(MSU) classification is a MRI based disc herniation classification. It helps to classified disc herniation in types, places and sizes.

The aim of this study to evaluate the pain and oswestry disability index in patients who have radiculopathy with low back pain, undergone TFSI according to MSU classification.

Enrollment: 160 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• between the ages of 18-65
• After outpatient evaluation, a decision was made to perform transforaminal steroid injection,
• Low back pain of more than 6 on a numeric rating scale (NRS)
• Radiculopathy for more than 4 weeks and less than one year and straight leg raising <45
• Disc herniation at the L4-L5 or L5-S1 level on MRI
• Failure to respond to medical treatment for at least one month

Exclusion criteria

• Neurological deficit,
• Bleeding problems,
• Localized infection,
• Spinal pathologies (such as tumors),
• Fractures,
• Severe stenosis,
• Uncontrolled diabetes,
• Pregnancy,
• Red flag symptoms (such as motor and/or sphincter dysfunction)
• Patient reluctance,
• Computed tomography (CT) and MRI findings in favor of sequestrated fragments from herniated disc,
• Sphincteric disorders,
• Previous spine surgeries

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 10 patient groups

MSU Classification 1A

Experimental group

Description:

Transforaminal Epidural Steroid Injection, MSU classification according to MRI images 1A

Treatment:

Procedure: Transforaminal Epidural Steroid Injection

MSU Classification 1B

Experimental group

Description:

Transforaminal Epidural Steroid Injection, MSU classification according to MRI images 1B

Treatment:

Procedure: Transforaminal Epidural Steroid Injection

MSU Classification 1C

Experimental group

Description:

Transforaminal Epidural Steroid Injection, MSU classification according to MRI images 1C

Treatment:

Procedure: Transforaminal Epidural Steroid Injection

MSU Classification 2A

Experimental group

Description:

Transforaminal Epidural Steroid Injection, MSU classification according to MRI images 2A

Treatment:

Procedure: Transforaminal Epidural Steroid Injection

MSU Classification 2B

Experimental group

Description:

Transforaminal Epidural Steroid Injection, MSU classification according to MRI images 2B

Treatment:

Procedure: Transforaminal Epidural Steroid Injection

MSU Classification 2C

Experimental group

Description:

Transforaminal Epidural Steroid Injection, MSU classification according to MRI images 2C

Treatment:

Procedure: Transforaminal Epidural Steroid Injection

MSU Classification 3A

Experimental group

Description:

Transforaminal Epidural Steroid Injection, MSU classification according to MRI images 3A

Treatment:

Procedure: Transforaminal Epidural Steroid Injection

MSU Classification 3B

Experimental group

Description:

Transforaminal Epidural Steroid Injection, MSU classification according to MRI images 3B

Treatment:

Procedure: Transforaminal Epidural Steroid Injection

MSU Classification 2AB

Experimental group

Description:

Transforaminal Epidural Steroid Injection, MSU classification according to MRI images 2AB

Treatment:

Procedure: Transforaminal Epidural Steroid Injection

MSU Classification 3AB

Experimental group

Description:

Transforaminal Epidural Steroid Injection, MSU classification according to MRI images 3AB

Treatment:

Procedure: Transforaminal Epidural Steroid Injection