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

Evaluation of Pain and Oswestry Disability Index in Different Types of Disc Herniation According to MSU Classification in Patients Undergoing Transforaminal Epidural Steroid Injection for Radicular Low Back Pain

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Low Back Pain; Radiculopathy Lumbar; Disc Herniation; Injections, Epidural
• Intervention / Treatment: Procedure: Transforaminal Epidural Steroid Injection

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Burak Erken, MD; Phone Number: +0902129096000; Email: burak_erken@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

10

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MSU Classification 1A; Transforaminal Epidural Steroid Injection, MSU classification according to MRI images 1A	Procedure: 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.
Experimental: MSU Classification 1B; Transforaminal Epidural Steroid Injection, MSU classification according to MRI images 1B	Procedure: 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.
Experimental: MSU Classification 1C; Transforaminal Epidural Steroid Injection, MSU classification according to MRI images 1C	Procedure: 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.
Experimental: MSU Classification 2A; Transforaminal Epidural Steroid Injection, MSU classification according to MRI images 2A	Procedure: 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.
Experimental: MSU Classification 2B; Transforaminal Epidural Steroid Injection, MSU classification according to MRI images 2B	Procedure: 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.
Experimental: MSU Classification 2C; Transforaminal Epidural Steroid Injection, MSU classification according to MRI images 2C	Procedure: 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.
Experimental: MSU Classification 3A; Transforaminal Epidural Steroid Injection, MSU classification according to MRI images 3A	Procedure: 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.
Experimental: MSU Classification 3B; Transforaminal Epidural Steroid Injection, MSU classification according to MRI images 3B	Procedure: 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.
Experimental: MSU Classification 2AB; Transforaminal Epidural Steroid Injection, MSU classification according to MRI images 2AB	Procedure: 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.
Experimental: MSU Classification 3AB; Transforaminal Epidural Steroid Injection, MSU classification according to MRI images 3AB	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of the pain severity score	Pain severity is assessed by using "Numeric Rating Scale" (NRS). Patients give score of their pain between 0 (no pain) and 10 (worst possible pain). The change in NRS scores between the ten groups will be compared.	Pre-intervention, post-intervention 1th month and post-intervention 3rd month
Change of the disability score	Disability conditions of the patients are assessed by using "Oswestry Disability Index" (ODI). ODI is a patient completed questionnaire which gives a percentage score of disability. The ODI is comprised of 10 items and enquires about functional limitations in various activities of daily living with the index score ranging from 1 (best) to 100 (worst). The change in ODI scores between the ten groups will be compared.	Pre-intervention, post-intervention 1th month and post-intervention 3rd month

Collaborators and Investigators

• Sponsor: Basaksehir Cam & Sakura Şehir Hospital
• Investigators: Principal Investigator: Tuba Tanyel Saraçoğlu, MD, Basaksehir Cam & Sakura Şehir Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 15, 2024
• Primary Completion (Estimated): June 15, 2024
• Study Completion (Estimated): August 15, 2024

Study Registration Dates

• First Submitted: February 17, 2024
• First Submitted That Met QC Criteria: February 17, 2024
• First Posted (Estimated): February 23, 2024

Study Record Updates

• Last Update Posted (Estimated): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 17, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Back Pain; Low Back Pain; Hernia; Intervertebral Disc Displacement; Radiculopathy
• Other Study ID Numbers: 27.12.2023.685

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No