NCT03487120已完成不适用
Open Facet Joint Denervation in the Treatment of Low Back Pain -A Randomized Control Trial.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Change in Visual analog scale for pain (VAS)
研究概览
简要总结
A single blinded RCT for adult patients with spine pain. One group had a lumbar laminectomy with denervation of the facet joint at the level decompressed. The other group had a lumbar laminectomy without facet joint denervation. Both groups had their back pain and functional limitations measured using a 10 cm visual analogue scale and the Oswestry disability index (ODI). All measures were taken before surgery and at patients' 6, 12 and 24 week follow-up clinic visit.
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 (Participant)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 19 or older
- •a diagnosis of spinal stenosis
- •having neurogenic claudication
- •complained of back pain for at least 3 months
排除标准
- •previous surgery on their spine,
- •fracture, systemic inflammatory disease,
- •malignancies or an infection affecting their spine
结局指标
主要结局
Change in Visual analog scale for pain (VAS)
时间窗: change from baseline score at 24 weeks
10 centimeter scale with a minimum of 0 indicating no pain and a maximum of 10 indicating worst pain.
次要结局
- Change in Modified Oswestry Disability score (ODI)(change from baseline score at 24 weeks)
研究者
Dr. David Yen
Principal Investigator
Queen's University
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