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

NCT ID: NCT06275529

Last Updated: 2025-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-15
• Study Completion Date: 2025-01-15

Brief Summary

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MSU Classification 1A

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

Group Type: EXPERIMENTAL

Transforaminal Epidural Steroid Injection

Intervention Type: PROCEDURE

Epidural injections have been used since about 1900 for the treatment of low back and lower extremity pain, with steroids added to local anesthetics in about 1950. The epidural space can be entered by 3 approaches: caudal, interlaminar, and transforaminal. Transforaminal Epidural Steroid Injections:

After the patient is monitored in pron position and asepsis is ensured, the epidural space is entered with the appropriate needle through the transforaminal space by giving the necessary angles to the fluoroscopy. Then the location is confirmed with radiopaque agent and steroid injection is performed. The procedure takes 15-20 minutes.

MSU Classification 1B

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

Group Type: EXPERIMENTAL

Transforaminal Epidural Steroid Injection

Intervention Type: PROCEDURE

Epidural injections have been used since about 1900 for the treatment of low back and lower extremity pain, with steroids added to local anesthetics in about 1950. The epidural space can be entered by 3 approaches: caudal, interlaminar, and transforaminal. Transforaminal Epidural Steroid Injections:

After the patient is monitored in pron position and asepsis is ensured, the epidural space is entered with the appropriate needle through the transforaminal space by giving the necessary angles to the fluoroscopy. Then the location is confirmed with radiopaque agent and steroid injection is performed. The procedure takes 15-20 minutes.

MSU Classification 1C

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

Group Type: EXPERIMENTAL

Transforaminal Epidural Steroid Injection

Intervention Type: PROCEDURE

Epidural injections have been used since about 1900 for the treatment of low back and lower extremity pain, with steroids added to local anesthetics in about 1950. The epidural space can be entered by 3 approaches: caudal, interlaminar, and transforaminal. Transforaminal Epidural Steroid Injections:

After the patient is monitored in pron position and asepsis is ensured, the epidural space is entered with the appropriate needle through the transforaminal space by giving the necessary angles to the fluoroscopy. Then the location is confirmed with radiopaque agent and steroid injection is performed. The procedure takes 15-20 minutes.

MSU Classification 2A

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

Group Type: EXPERIMENTAL

Transforaminal Epidural Steroid Injection

Intervention Type: PROCEDURE

Epidural injections have been used since about 1900 for the treatment of low back and lower extremity pain, with steroids added to local anesthetics in about 1950. The epidural space can be entered by 3 approaches: caudal, interlaminar, and transforaminal. Transforaminal Epidural Steroid Injections:

After the patient is monitored in pron position and asepsis is ensured, the epidural space is entered with the appropriate needle through the transforaminal space by giving the necessary angles to the fluoroscopy. Then the location is confirmed with radiopaque agent and steroid injection is performed. The procedure takes 15-20 minutes.

MSU Classification 2B

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

Group Type: EXPERIMENTAL

Transforaminal Epidural Steroid Injection

Intervention Type: PROCEDURE

Epidural injections have been used since about 1900 for the treatment of low back and lower extremity pain, with steroids added to local anesthetics in about 1950. The epidural space can be entered by 3 approaches: caudal, interlaminar, and transforaminal. Transforaminal Epidural Steroid Injections:

After the patient is monitored in pron position and asepsis is ensured, the epidural space is entered with the appropriate needle through the transforaminal space by giving the necessary angles to the fluoroscopy. Then the location is confirmed with radiopaque agent and steroid injection is performed. The procedure takes 15-20 minutes.

MSU Classification 2C

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

Group Type: EXPERIMENTAL

Transforaminal Epidural Steroid Injection

Intervention Type: PROCEDURE

Epidural injections have been used since about 1900 for the treatment of low back and lower extremity pain, with steroids added to local anesthetics in about 1950. The epidural space can be entered by 3 approaches: caudal, interlaminar, and transforaminal. Transforaminal Epidural Steroid Injections:

After the patient is monitored in pron position and asepsis is ensured, the epidural space is entered with the appropriate needle through the transforaminal space by giving the necessary angles to the fluoroscopy. Then the location is confirmed with radiopaque agent and steroid injection is performed. The procedure takes 15-20 minutes.

MSU Classification 3A

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

Group Type: EXPERIMENTAL

Transforaminal Epidural Steroid Injection

Intervention Type: PROCEDURE

Epidural injections have been used since about 1900 for the treatment of low back and lower extremity pain, with steroids added to local anesthetics in about 1950. The epidural space can be entered by 3 approaches: caudal, interlaminar, and transforaminal. Transforaminal Epidural Steroid Injections:

After the patient is monitored in pron position and asepsis is ensured, the epidural space is entered with the appropriate needle through the transforaminal space by giving the necessary angles to the fluoroscopy. Then the location is confirmed with radiopaque agent and steroid injection is performed. The procedure takes 15-20 minutes.

MSU Classification 3B

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

Group Type: EXPERIMENTAL

Transforaminal Epidural Steroid Injection

Intervention Type: PROCEDURE

Epidural injections have been used since about 1900 for the treatment of low back and lower extremity pain, with steroids added to local anesthetics in about 1950. The epidural space can be entered by 3 approaches: caudal, interlaminar, and transforaminal. Transforaminal Epidural Steroid Injections:

After the patient is monitored in pron position and asepsis is ensured, the epidural space is entered with the appropriate needle through the transforaminal space by giving the necessary angles to the fluoroscopy. Then the location is confirmed with radiopaque agent and steroid injection is performed. The procedure takes 15-20 minutes.

MSU Classification 2AB

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

Group Type: EXPERIMENTAL

Transforaminal Epidural Steroid Injection

Intervention Type: PROCEDURE

Epidural injections have been used since about 1900 for the treatment of low back and lower extremity pain, with steroids added to local anesthetics in about 1950. The epidural space can be entered by 3 approaches: caudal, interlaminar, and transforaminal. Transforaminal Epidural Steroid Injections:

After the patient is monitored in pron position and asepsis is ensured, the epidural space is entered with the appropriate needle through the transforaminal space by giving the necessary angles to the fluoroscopy. Then the location is confirmed with radiopaque agent and steroid injection is performed. The procedure takes 15-20 minutes.

MSU Classification 3AB

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

Group Type: EXPERIMENTAL

Transforaminal Epidural Steroid Injection

Intervention Type: PROCEDURE

Epidural injections have been used since about 1900 for the treatment of low back and lower extremity pain, with steroids added to local anesthetics in about 1950. The epidural space can be entered by 3 approaches: caudal, interlaminar, and transforaminal. Transforaminal Epidural Steroid Injections:

After the patient is monitored in pron position and asepsis is ensured, the epidural space is entered with the appropriate needle through the transforaminal space by giving the necessary angles to the fluoroscopy. Then the location is confirmed with radiopaque agent and steroid injection is performed. The procedure takes 15-20 minutes.

Interventions

Transforaminal Epidural Steroid Injection

Epidural injections have been used since about 1900 for the treatment of low back and lower extremity pain, with steroids added to local anesthetics in about 1950. The epidural space can be entered by 3 approaches: caudal, interlaminar, and transforaminal. Transforaminal Epidural Steroid Injections:

After the patient is monitored in pron position and asepsis is ensured, the epidural space is entered with the appropriate needle through the transforaminal space by giving the necessary angles to the fluoroscopy. Then the location is confirmed with radiopaque agent and steroid injection is performed. The procedure takes 15-20 minutes.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Başakşehir Çam & Sakura City Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Burak Erken

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tuba Tanyel Saraçoğlu, MD

Role: PRINCIPAL_INVESTIGATOR

Başakşehir Çam & Sakura City Hospital

Locations

Başakşehir Çam and Sakura City Hospital

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

27.12.2023.685

Identifier Type: -

Identifier Source: org_study_id