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临床试验/NCT05234840
NCT05234840已完成不适用

"Platelet-Rich Plasma" Transforaminal Epidural Injection an Emerging Strategy in Lumbar Disc Herniation

Queen Savang Vadhana Memorial Hospital, Thailand1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年4月1日最近更新:
适应症
干预措施

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

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

Active Comparator

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

Experimental

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)

研究者

发起方
Queen Savang Vadhana Memorial Hospital, Thailand
申办方类型
Other
责任方
Sponsor

研究点 (1)

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