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临床试验/NCT03197415
NCT03197415已完成不适用

Intradiscal Injection of Platelet-rich Plasma for Discogenic Pain in L-spine

Pei-Yuan Lee, MD2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年4月22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
2
主要终点
1-month postoperative function evaluated by Oswestry Disability Index

研究概览

简要总结

This study aims to evaluate the effect of platelet-rich plasma (PRP) on discogenic low back pain by comparing the pre- and post-interventional outcomes in patients receiving intradiscal injection of autologous PRP.

详细描述

Intervertebral disc (IVD) degeneration is an important clinical problem that often contributes to low back pain and degenerative disc diseases. Degeneration of the IVD induces anulus tears and fissures, which can cause severe discogenic low back pain. Because the IVD has little potential to self-regenerate, treatment of degenerative disc disease is one of the most challenging clinical problems facing the spine surgeon. Platelet-rich plasma (PRP) is a fraction of plasma that contains platelets and multiple growth factors concentrated at high level. Because activated platelets have the potential to release growth factors, PRP has been clinically used to accelerate wound healing and tissue regeneration in orthopedic and oral surgery. The soluble releasate isolated from PRP has recently been demonstrated to influence the metabolism of intervertebral discs in vitro. Furthermore, an intradiscal injection of autologous PRP has been shown to induce restoration of structural changes in the rabbit annular injection model in vivo. This clinical trial aims to investigate the safety and efficacy of intradiscal PRP injection in patients with discogenic low back pain. The pre- and post-interventional imaging and clinical outcomes will be compared.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 20 and 60 years
  • L-spine disc degeneration diagnosed by MRI
  • Low back pain

排除标准

  • Herniated disc
  • With prior history of spine surgery
  • With current or prior history of cancer
  • With current or prior history of hematological disease
  • Pregnancy
  • Patients who will not cooperate with one-year followup

研究组 & 干预措施

PRP group

Experimental

Intradisc injection of autologous platelet-rich plasma gel

干预措施: Platelet-rich plasma (Other)

结局指标

主要结局

1-month postoperative function evaluated by Oswestry Disability Index

时间窗: 1-month postoperative

Function is evaluated using Oswestry Disability Index.

次要结局

  • 1-month postoperative pain evaluated by visual analogue scale(1-month postoperative)
  • 4-month postoperative pain evaluated by visual analogue scale(4-month postoperative)
  • 4-month postoperative function evaluated by Oswestry Disability Index(4-month postoperative)

研究者

发起方
Pei-Yuan Lee, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Pei-Yuan Lee, MD

Superintendent

Show Chwan Memorial Hospital

研究点 (2)

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