FLO Injection for Discogenic Pain
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Change in patient back pain determined by visual analog scale
研究概览
简要总结
Discogenic pain is pain originating from a damaged vertebral disc and be caused by inflammation, dehydration of the nucleus pulposus, decreased disc height, annular tears and impaired mechanical function of the disc.Non-operative treatment may include traction, steroid therapy, methylene blue injection and ablative therapy. However, there are few high quality studies evaluating these treatments for reducing discogenic low back pain and most clinical trials failed to detect significant differences between treatments and placebo therapies. Hence, there remains an unmet clinical need.
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
- None
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
- •subject (male or female) is at least 18 to 70 years of age
- •diagnosed with single level discogenic back pain confirmed by MRI and positive discography per Spine Interventional Society Guidelines
- •Diagnosis of disc degeneration with Pfirrmann score of 1-3
- •Subject has failed at least six months of conservative care
- •Subject is symptomatic with axial lower back pain greater than lower limb pain at the intensity of >6/10 concordant or partially concordant
- •The subject is able to comply with all post-operative standard of care and follow instructions.
排除标准
- •Subjects has significant disc protrusion, severe lumbar spinal stenosis, spine tumor, severe disc degeneration, or Sacroiliac (SI) joint syndrome
- •Subject had previous surgery at the disc level
- •Patient has previously received injection of FLO within 3 months of screening
- •The subject is unable to comply with follow-up or not appropriate for inclusion based on investigator decision
研究组 & 干预措施
AMUC Dosage 1
25mg amniotic and umbilical cord matrix
干预措施: amniotic and umbilical cord matrix (Other)
AMUC Dosage 2
50mg amniotic and umbilical cord matrix
干预措施: amniotic and umbilical cord matrix (Other)
AMUC Dosage 3
100mg amniotic and umbilical cord matrix
干预措施: amniotic and umbilical cord matrix (Other)
结局指标
主要结局
Change in patient back pain determined by visual analog scale
时间窗: 3 months
0 to 100mm, 100mm worst pain
次要结局
- Change in quality of life determined by SF-36(3 and 6 months)
- Change in patient back pain determined by visual analog scale(6 months)
- Change in Oswestry Disability Index(3 and 6 months)