Comparison of intradiscal platelet rich plasma vs steroid in patients undergoing biacuplasty for discogenic low back pain.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- To compare the analgesic efficacy of biaculoplasty + intradiscal leucocyte poor PRP and biaculoplasty + intradiscal steroid in patients with chronic discogenic low back pain at 3,6 and 12 months after the procedure using NRS (Numerical rating scale)
研究概览
简要总结
Biaculoplasty has shown to be significantly beneficial in improving patient outcomes. This study aims to combine biaculoplasty with leucocyte poor PRP and steroid intradiscal injections. We hypothesize that combining and comparing both has better results when compared with biaculoplasty alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults aged between 18–65 years Patients with chronic low back pain for more than 3 months MRI evidence showing disc degeneration or annular tear Patients with failed conservative therapy of at least 3 months.
排除标准
- •Patients with radiculopathy or spinal canal stenosis Patients who have undergone prior lumbar surgery Patients with spinal infection, tumors, fractures, or instability Currently on anti-coagulants or patients with coagulopathy Pregnant or lactating women Patients with known allergy to drugs and materials used .
结局指标
主要结局
To compare the analgesic efficacy of biaculoplasty + intradiscal leucocyte poor PRP and biaculoplasty + intradiscal steroid in patients with chronic discogenic low back pain at 3,6 and 12 months after the procedure using NRS (Numerical rating scale)
时间窗: To compare the analgesic efficacy of biaculoplasty + intradiscal leucocyte poor PRP and biaculoplasty + intradiscal steroid in patients with chronic discogenic low back pain at 3,6 and 12 months after the procedure using NRS (Numerical rating scale)
次要结局
- Compare functional improvement using the Oswestry Disability Index (ODI) in(patients with chronic discogenic low back pain after biaculoplasty + intradiscal leucocyte poor PRP and biaculoplasty + intradiscal steroid at 3,6 and 12 months after the procedure.)
研究者
Anuj Jain
All India Institute Of Medical Sciences, Bhopal