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Clinical Trials/NCT06275529
NCT06275529
Completed
Not Applicable

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

Başakşehir Çam & Sakura City Hospital1 site in 1 country160 target enrollmentMarch 15, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Radiculopathy Lumbar
Sponsor
Başakşehir Çam & Sakura City Hospital
Enrollment
160
Locations
1
Primary Endpoint
Change of the disability score
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 15, 2024
End Date
January 15, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Başakşehir Çam & Sakura City Hospital
Responsible Party
Principal Investigator
Principal Investigator

Burak Erken

Medical Doctor

Başakşehir Çam & Sakura City Hospital

Eligibility Criteria

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,

Outcomes

Primary Outcomes

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.

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.

Study Sites (1)

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