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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 160
- Locations
- 2
- Primary Endpoint
- Change of the disability score
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
MSU Classification 3AB
Transforaminal Epidural Steroid Injection, MSU classification according to MRI images 3AB
Intervention: Transforaminal Epidural Steroid Injection (Procedure)
MSU Classification 1A
Transforaminal Epidural Steroid Injection, MSU classification according to MRI images 1A
Intervention: Transforaminal Epidural Steroid Injection (Procedure)
MSU Classification 1B
Transforaminal Epidural Steroid Injection, MSU classification according to MRI images 1B
Intervention: Transforaminal Epidural Steroid Injection (Procedure)
MSU Classification 1C
Transforaminal Epidural Steroid Injection, MSU classification according to MRI images 1C
Intervention: Transforaminal Epidural Steroid Injection (Procedure)
MSU Classification 2A
Transforaminal Epidural Steroid Injection, MSU classification according to MRI images 2A
Intervention: Transforaminal Epidural Steroid Injection (Procedure)
MSU Classification 2B
Transforaminal Epidural Steroid Injection, MSU classification according to MRI images 2B
Intervention: Transforaminal Epidural Steroid Injection (Procedure)
MSU Classification 2C
Transforaminal Epidural Steroid Injection, MSU classification according to MRI images 2C
Intervention: Transforaminal Epidural Steroid Injection (Procedure)
MSU Classification 3A
Transforaminal Epidural Steroid Injection, MSU classification according to MRI images 3A
Intervention: Transforaminal Epidural Steroid Injection (Procedure)
MSU Classification 3B
Transforaminal Epidural Steroid Injection, MSU classification according to MRI images 3B
Intervention: Transforaminal Epidural Steroid Injection (Procedure)
MSU Classification 2AB
Transforaminal Epidural Steroid Injection, MSU classification according to MRI images 2AB
Intervention: Transforaminal Epidural Steroid Injection (Procedure)
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Burak Erken
Medical Doctor
Başakşehir Çam & Sakura City Hospital