Surgery Versus Standardized Non-operative Care for the Treatment of Lumbar Disc Herniations: A Canadian Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Visual Analogue Scale for leg pain intensity
研究概览
简要总结
The objective of this study is to determine if surgery is superior to non-operative care for sciatica caused by a lumbar disc herniation. This study will include patients that have had severe sciatica for greater than 4 months which reflects the wait time of the Canadian health care system. This study is an opportunity to make an important contribution to medical science as there is no "top tier" evidence for or against this highly prevalent surgery. Although there have been several recent randomized trials in the field, all have been marred by a large number of patient crossing over from non-operative to operative treatment. Due to the wait for spine surgery, the Canadian system has a built-in delay that prevents such a cross over of patients. This study capitalizes on this unique opportunity to perform a high caliber surgical trial. Patients consenting to be in the study will be randomly assigned to expedited surgery within three weeks or standardized non-operative care while they wait on the surgeons list for consultation and then surgery (minimum wait of 9 months). The study will assess pain, function, quality of life, satisfaction, and work status to determine if one treatment is superior.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 - 60 years old
- •Unilateral, single L5 or S1 radiculopathy (leg pain following dermatomal distribution of L5 or S1)
- •Leg dominant pain over central back pain
- •Positive straight leg raise <70 degrees
- •MRI with corresponding L4-5 or L5-S1 posterolateral disc herniation*
- •Radicular symptom duration greater than 4 months and less than 12 months. May be recurrent if first episode occurred within 12 months and duration of presenting episode is greater than 4 months.
- •Agree to possible discectomy
排除标准
- •Radiculopathy secondary to foraminal stenosis
- •Radiculopathy secondary to intra-foraminal or far lateral disc herniation
- •Radiculopathy secondary to lumbar central or lateral recess stenosis not caused by a posterolateral disc herniation
- •Previous lumbar surgery at involved level
- •Lumbar spondylolisthesis or lateral listhesis at level of disc herniation
- •Lumbar Scoliosis greater than 10 degrees
结局指标
主要结局
Visual Analogue Scale for leg pain intensity
时间窗: 6 months
(Scale 0-10: 0 = no pain, 10 worst pain)
次要结局
- Visual Analogue Scale for central back pain intensity(enrollment, 6 weeks, 3 months, 6 months, 1 year)
- Visual Analogue Scale for leg pain frequency(enrollment, 6 weeks, 3 months, 6 months, 1 year)
- Visual Analogue Scale for central back pain frequency(enrollment, 6 weeks, 3 months, 6 months, 1 year)
- Visual Analogue Scale for leg pain intensity(enrollment, 6 weeks, 3 months, 6 months, 1 year)
- Satisfaction with treatment (% of patients satisfied with treatment)(6 weeks, 3 months, 6 months, 1 year)
- Oswestry Disability Index(enrollment, 6 weeks, 3 months, 6 months, 1 year)
- SF36 - Generic Health Outcome Measure(enrollment, 6 weeks, 3 months, 6 months, 1 year)
- Return to Work Status (% of patients employed)(enrollment, 6 weeks, 3 months, 6 months, 1 year)