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

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.

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Key information

Conditions

Radiculopathy Lumbar Back Pain Bone Diseases Disc Herniation Hernia Injections, Epidural Intervertebral Disc Displacement Low Back Pain Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Başakşehir Çam and Sakura City Hospital

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transforaminal Epidural Steroid Injection

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.

Primary outcomes

Change of the pain severity score

Time frame: Pre-intervention, post-intervention 1th month and post-intervention 3rd month

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.
Change of the disability score

Time frame: Pre-intervention, post-intervention 1th month and post-intervention 3rd month

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.

Sponsors and collaborators

Lead sponsor

Başakşehir Çam & Sakura City Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2025
First posted: Feb 23, 2024
Registry last updated: Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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