Autologous Platelet Rich Plasma in Ultrasound Guided Intervertebral Disk Injection Therapy for Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Visual Analog Scale(VAS)
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of autologous platelet-rich plasma (PRP) injection therapy for low back pain patients. Our hypothesis is that PRP will reduce the pain feeling and benefit for restore of the intervertebral disk.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Chronic low back pain more than 2months
- •Visual analog scale score more than 4
- •Positive X-ray, MRI or CT scan findings
- •Pfirrmann grading I-III
- •Well understanding and communication ability
排除标准
- •History of allergy
- •Hemorrhagic trend or use of anticoagulant therapy
- •Mental diseases
- •Active infection or recent infectious diseases within 3 months
- •Local skin infection near the puncture location
- •Severe lumbar spinal stenosis, lumbar spondylolisthesis, ossification of posterior longitudinal
- •Ligament and lumbar disc herniation（more than 5mm）
- •Immunologic diseases
- •Metastatic disease
- •Recent surgery less than 3 months)
- •Pregnancy
研究组 & 干预措施
PRP Treatment(P)
PRP intra-disk injection therapy combined with NSAIDs medication (Loxoprofen Sodium tablets).
干预措施: PRP Treatment(P) (Other)
PRP Treatment(P)
PRP intra-disk injection therapy combined with NSAIDs medication (Loxoprofen Sodium tablets).
干预措施: Medication Treatment(Loxoprofen Sodium tablets,M) (Drug)
Medication Treatment(M)
NSAIDs medication(Loxoprofen Sodium tablets) therapy only.
干预措施: Medication Treatment(Loxoprofen Sodium tablets,M) (Drug)
结局指标
主要结局
Visual Analog Scale(VAS)
时间窗: 1 year
Pain relief evaluated using change from baseline in Visual Analog Scale (VAS):baseline, 1 week ,and 1 month, 2 months, 6 months, 12 months after intervention.
次要结局
- Functional Rating Index(1 year)
- Oswestry Disability Index (ODI)(1 year)
- Measuring the Quality of life using SF-36 questionnaire(1 year)
- Imaging change(1 year)
- Number of patients with side effect(Within 1 year after injection therapy)
研究者
Xuhua Lu
Vice Director of Spine Surgery
Shanghai Changzheng Hospital