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

Low Back Pain Clinical Trial

Official 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06275529
• Other study ID #: 27.12.2023.685
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 15, 2024
• Est. completion date: August 15, 2024

Study information

• Verified date: February 2024
• Source: Basaksehir Cam & Sakura Sehir Hospital
• Contact: Burak Erken, MD
• Phone: +0902129096000
• Email: burak_erken[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: August 15, 2024
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Disc Herniation
• Hernia
• Intervertebral Disc Displacement
• Low Back Pain
• Radiculopathy
• Radiculopathy Lumbar

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Basaksehir Cam & Sakura Sehir Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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