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
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.
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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Basaksehir Cam & Sakura Sehir Hospital |
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 |
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