Precision Treatment of Lumbar Spine Surgery Through Advanced Nerve Root Blockade
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Minimum clinically important difference (MCID)
研究概览
简要总结
The overall purpose of the study is to investigate whether selective spinal nerve root blocks can improve diagnostics of radiculopathy due to lumbar disc herniation (LDH), foraminal stenosis (FS), and recess stenosis (RS), and hence identify the patients that will benefit from surgical intervention.
详细描述
The study is designed as a prospective randomized controlled trial, using a two-group stratified block-randomization, evaluating the effect of adding the outcome of a diagnostic SNRB to surgical decision-making. Stratification will be based on the study site. Block size will be 4, 6, or 8 and in random order.
All patients referred to our departments with suspected radiculopathy and radiological evidence of root compression are eligible for inclusion. Patients will be randomized to either standard care or SNRB after the consultation. Results of the SNRB will be available to the surgeon before deciding finally whether to operate or not. Hence, the intervention adds the outcome of the diagnostic SNRB to the shared surgical decision-making.
Study outline:
Baseline:
Demographics, Oswestry Disability Index, Eq5D, SF-36, NRS-LP, and NRS-BP will be recorded
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years old
- •Suspected lumbar radiculopathy persistent ≥ 8 weeks
- •Radiological evidence of lumbar nerve root compression (herniated disc, recess stenosis, foraminal stenosis)
排除标准
- •Prior lumbar spine surgery
- •Mental illness
- •Language barrier in Danish
- •Severe physical co-morbidity
- •Known allergies to medicine used in the study
- •Plans to move abroad during the next 12-months
结局指标
主要结局
Minimum clinically important difference (MCID)
时间窗: 3 months after surgery/decision not to operate
Difference in mean change on numerical rating scale for leg pain (NRS-LP) 3 months after surgery. The margin of non-inferiority will be set to = 1.6 points. Comparison will be made between patients in the SNRB group and patients in the control group surgery.
次要结局
- EQ5D (EuroQol 5D)(3 months after surgery/decision not to operate)
- Leg pain(3 months after surgery/decision not to operate)
- Back pain(3 months after surgery/decision not to operate)
- SF-36 (Short form 36)(3 months after surgery/decision not to operate)
- ODI(3 months after surgery/decision not to operate)
- Subanalysis(3 months after surgery)