Collagenase Chemonucleolysis vs Percutaneous Endoscopic Lumbar Discectomy (PELD) for Lumbar Disc Herniation, a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale/Score of leg
研究概览
简要总结
Lumbar disc herniation compressed the nerve cause pain, numbness, weak legs called sciatica, which seriously decrease the quality of life and work efficiency. Both collagenase chemonucleolysis(CCNL) and percutaneous endoscopic lumbar discectomy (PELD) was effective to treat lumbar disc herniation(LDH) requires surgery. whether functional clinical outcomes of CCNL vs PELD effect on LDH was superior, and no study provided convincing evidence.
详细描述
Lumbar disc herniation (LDH) is a common disease with an incidence of 1%-3%, usually manifested as low back pain radiating to the lower extremities, which seriously affects patients' quality of life. Collagen hydrolysis was effective in treating LDH, it makes the protrusion smaller or disappeared, relieving or resolving the compression of nerve root by the protrusion.Percutaneous endoscopic lumbar discectomy (PELD) is a less invasive techniques to treat LDH. However, the outcomes of collagen hydrolysis vs PELD effect was still unknown.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •at least six weeks of excessive radiating leg pain with no tendency for any clinical improvement despite conservative therapy
- •have a nerve root compression by a lumbar disc herniation proven by magnetic resonance imaging
排除标准
- •previous surgery at the same or adjacent disc level;
- •isthmic or degenerative spondylolisthesis
- •pregnancy
- •severe comorbid medical or psychiatric disorder (American Society of Anesthesiologists' classification >2);
- •severe caudal or cranial sequestration of disc fragments, defined as sequestration towards more than half of the adjacent vertebra;
- •contraindication for surgery
结局指标
主要结局
Visual Analogue Scale/Score of leg
时间窗: up to 12 months
Visual Analogue Scale pain assess for leg. Use a ruler about 10cm long, one side is marked with "0" and the other "10" respectively. A score of 0 indicates no pain, 10 indicates the most unbearable pain.
Visual Analogue Scale/Score of lumbar
时间窗: up to 12 months
Visual Analogue Scale pain assess for lumbar. Use a ruler about 10cm long, one side is marked with "0" and the other "10" respectively. A score of 0 indicates no pain, 10 indicates the most unbearable pain.
reoperation
时间窗: up to 12 months
The percentage of reoperation rate. 0 represents the minimum and 100% represents the maximum.
Recurrence rate
时间窗: up to 12 months
The percentage of disc herniation recurrence appearance. 0 represents the minimum and 100% represents the maximum.
次要结局
- Length of stay in the hospital(up to 12 month)
- the EuroQoL-5D (EQ-5D)(up to 12 month)
- Duration of operation(up to 12 month)
- Major complications(up to 12 month)
- hospital fees(up to 12 month)
- the Oswestry Disability Index (ODI)(up to 12 month)
- the Medical Outcomes Study 12-item short-form health survey (SF-12) scale(up to 12 month)
- cost-effectiveness(up to 12 month)
- The Roland-Morris Disability Questionnaire(up to 12 month)
- modified MacNab(up to 12 month)