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

Not Applicable

Completed

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

• Registration Number: NCT06275529
• Lead Sponsor: Başakşehir Çam & Sakura City Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-17
• Study First Submitted QC: 2024-02-17
• Study First Posted: 2024-02-23
• Study Start: 2024-03-15
• Primary Completion: 2024-10-15
• Status Verified: 2025-01
• Study Completion: 2025-01-15
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change of the disability score	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.
Change of the pain severity score	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.

Trial Locations

Locations (1)

Başakşehir Çam and Sakura City Hospital; 🇹🇷 İstanbul, Turkey