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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06275529
Enrollment
160
Registered
2024-02-23
Start date
2024-03-15
Completion date
2025-01-15
Last updated
2025-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

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.

Sponsors

Başakşehir Çam & Sakura City Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change of the pain severity scorePre-intervention, post-intervention 1th month and post-intervention 3rd monthPain 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 scorePre-intervention, post-intervention 1th month and post-intervention 3rd monthDisability 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026