"Platelet-Rich Plasma" Transforaminal Epidural Injection an Emerging Strategy in Lumbar Disc Herniation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- VAS of leg pain
研究概览
简要总结
To evaluate the efficacy of platelet-rich plasma (PRP; double-spin) in treatment of single-level lumbar herniated nucleus pulposus (HNP) in comparison to triamcinolone. RCT was conducted with 30 patients included.
详细描述
The study was a randomized controlled trial, triple-blind, single-center/surgeon/assessor. The study was conducted between April 2019 to May 2021. We evaluated 30 patients (both genders) aged 20-55 years, having failed conservative treatment of unilateral HNP undergone for at least 6 weeks, with visual analogue scale (VAS) of greater than 30, and confirmed a single-level HNP, corelated to clinical, by MRI. The exclusion criteria included previous spine surgery or epidural injection, progressive neurological deficit, cauda equina, coagulopathy-related conditions, associated cervical myelopathy, systemic bone and joint diseases. All patients had to have been exempted from NSAIDs for at least one week. Patients were treated by transforaminal epidural injections. Fifteen patients were in triamcinolone and PRP groups each. PRP was obtained from 24 ml venous blood through standardized double-spin protocol. Participants were fifteen patients each in triamcinolone and PRP groups. The same postoperative protocols and medications were applied. The visual analogue scale of leg (LegVAS), collected at baseline, 2, 6, 12, and 24 weeks, was the primary outcome. The BackVAS, Oswestry Disability Index (ODI), adverse event, and treatment failure were the secondary endpoints. All subjects were analyzed according to the intention-to-treat principle. All statistical analyses were performed with STATA 17.
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 (Participant, Investigator, Outcomes Assessor)
盲法说明
all patient were masked. Surgeon was blinded by leukostrip around injection syringe. Assessor was blinded from operative information.
入排标准
- 年龄范围
- 20 Years 至 55 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 20-55 years
- •Having failed conservative treatment for at least 6 weeks
- •Visual analogue scale (VAS) of greater than 30
- •Confirmed a single-level HNP, corelated to clinical, by MRI.
排除标准
- •Previous spine surgery or epidural injection
- •Progressive neurological deficit
- •Cauda equina
- •Coagulopathy-related conditions
- •Associated cervical myelopathy
- •Systemic bone and joint diseases
研究组 & 干预措施
Triamcinolone group
Patients were placed in the prone position. Transforaminal triamcinolone injections were performed under a C-arm fluoroscopy.
干预措施: Triamcinolone (Drug)
Platelet-rich plasma
Patients were placed in the prone position. Transforaminal PRPinjections were performed under a C-arm fluoroscopy.
干预措施: platelet rich plasma (Drug)
结局指标
主要结局
VAS of leg pain
时间窗: at 24 weeks
0-100 (visual analog score, 0 is the minimum and 100 is the maximum)
次要结局
- VAS of back(at 24 weeks)
- ODI(at 24 weeks)
- Rate of treatment failure [participant who require reinjection or operation](up to 24 weeks)
- adverse event(up to 24 weeks)
