Treatment of Pain in Patients With Lumbar Spinal Stenosis By Epidural Intervention of Spinal Nerves With Local Anesthetic, Steroids and Tumor Necrosis Factor-Alpha Inhibitor Respectively：a Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 主要终点
- Oswestry Disability Index
研究概览
简要总结
This study is to assess the clinical efficacy of epidural injections with Tumor Necrosis Factor-Alpha(TNF-α) Inhibitor in patients with chronic radicular pain caused by lumbar spinal stenosis.
详细描述
This study is to assess the clinical efficacy of epidural injections with Tumor Necrosis Factor-Alpha(TNF-α) Inhibitor in patients with chronic radicular pain caused by lumbar spinal stenosis.Ninety patients were diagnosed with lumbar spinal stenosis and were randomly assigned to 3 groups, for each group 30 cases. Patients in Group A received epidural injection of spinal nerve with 2.0 ml of lidocaine and 10 mg of Tumor Necrosis Factor-Alpha Inhibitor (etanercept) onto the affected spinal nerve, Group B patients received epidural injection with lidocaine 2ml mixed with 2ml of steroid(Diprospan), and group C patients received epidural injections with 4.0 ml of lidocaine only. All the 3 groups were evaluated by VAS and ODI, and received 6 months' follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of spinal stenosis with radicular pain at least 5 scores of VAS(ranging from 0 to 10).
- •Failed to improve symptom significantly through conservative treatment, including physiotherapy, chiropractic therapy, exercise, medication and bed rest.
排除标准
- •lumbar surgery history,
- •spinal stenosis without radicular pain,
- •uncontrollable or unstable use of opioids,
- •uncontrolled mental illness,
- •pregnant or lactating women,
- •patients with a history of adverse reactions or possible adverse reactions to local anesthetics, etanercept or Steroids.
结局指标
主要结局
Oswestry Disability Index
时间窗: 6 months
Oswestry Disability Index is for movement function, Questionnaire examines
visual analog scale
时间窗: 6 months
visual analog scale(0-10 scores) is for pain, 0 represent no pain, 10 score represent the severe pain.
次要结局
未报告次要终点