A Prospective, Randomized, Single Blind Study Comparing Transforaminal Epidural Steroid Injections at the Level of MRI Pathology vs Clinical Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Visual Analog Scale
研究概览
简要总结
Patients are being asked to participate in a research study because the patients are being treated for low back pain and the patients have decided to have an epidural steroid injection.
Low back pain has a tremendous impact on the individual and society. It not only affects the individuals quality of life, it also contributes to lost productivity and increased health care costs.
Epidural steroid injections (ESIs) are a common treatment option for many forms of low back pain. They have been used for low back problems since 1952 and are still being used as a non-surgical form of treatment for low back pain. The goal of the injections is reduction of pain, increased quality of life and improved function.
This study is being conducted to determine the outcomes of injections given at the "level of MRI Pathology" versus at the "level of clinical symptoms" to see if one is more effective than the other and to learn more about the characteristics of the two different injections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Single
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Single level spinal stenosis.
- •Single level radiculopathy with MRI findings at a different level than clinical pattern.
- •Chronic low back pain with radicular symptoms of > 4 weeks, but < 6 months.
- •Failure of conservative therapy to include physical and pharmacotherapy.
- •Patient is at least 21 years of age.
- •Patient is willing to be blinded to treatment until after the 3-month follow up visit.
- •Patient is willing and able to review and sign the study's informed consent form.
排除标准
- •Patient has a mental or physical condition that would invalidate evaluation results.
- •Patient has had prior lumbar surgery at any level.
- •Patient is pregnant.
- •Patient has systemic infection or infection at the proposed injection site.
结局指标
主要结局
Visual Analog Scale
时间窗: 2 weeks to 6months
次要结局
- Oswestry Disability Index(2 weeks to 6months)
- Short Form 36 Health Survey(2 weeks to 6months)