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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Change of the disability score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
MSU Classification 3AB
Transforaminal Epidural Steroid Injection, MSU classification according to MRI images 3AB
干预措施: Transforaminal Epidural Steroid Injection (Procedure)
MSU Classification 1A
Transforaminal Epidural Steroid Injection, MSU classification according to MRI images 1A
干预措施: Transforaminal Epidural Steroid Injection (Procedure)
MSU Classification 1B
Transforaminal Epidural Steroid Injection, MSU classification according to MRI images 1B
干预措施: Transforaminal Epidural Steroid Injection (Procedure)
MSU Classification 1C
Transforaminal Epidural Steroid Injection, MSU classification according to MRI images 1C
干预措施: Transforaminal Epidural Steroid Injection (Procedure)
MSU Classification 2A
Transforaminal Epidural Steroid Injection, MSU classification according to MRI images 2A
干预措施: Transforaminal Epidural Steroid Injection (Procedure)
MSU Classification 2B
Transforaminal Epidural Steroid Injection, MSU classification according to MRI images 2B
干预措施: Transforaminal Epidural Steroid Injection (Procedure)
MSU Classification 2C
Transforaminal Epidural Steroid Injection, MSU classification according to MRI images 2C
干预措施: Transforaminal Epidural Steroid Injection (Procedure)
MSU Classification 3A
Transforaminal Epidural Steroid Injection, MSU classification according to MRI images 3A
干预措施: Transforaminal Epidural Steroid Injection (Procedure)
MSU Classification 3B
Transforaminal Epidural Steroid Injection, MSU classification according to MRI images 3B
干预措施: Transforaminal Epidural Steroid Injection (Procedure)
MSU Classification 2AB
Transforaminal Epidural Steroid Injection, MSU classification according to MRI images 2AB
干预措施: Transforaminal Epidural Steroid Injection (Procedure)
结局指标
主要结局
Change of the disability score
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Burak Erken
Medical Doctor
Başakşehir Çam & Sakura City Hospital