JPRN-jRCTs043190014已完成2 期
Intradiscal injection therapy of platelet-rich plasma (PRP) - releasate for the patients with discogenic low back pain: Randomized control study - IDTPRCS
Akeda Koji0 个研究点目标入组 16 人开始时间: 2019年4月10日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
研究概览
简要总结
The intradiscal injection of PRPr showed clinically significant improvements in LBP intensity (more than 30% reduction) in patients with discogenic LBP, similar to those injected with glucocorticoid at eight weeks post-injection. PRPr treatment was safe and maintained improvements in pain, disability, and QOL during 60 weeks follow-up.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Having low back pain more than three month
- •Visual analogue scare (VAS): more than 40% at baseline
- •ODI: more than 40% at bassline
- •Disc degeneration evaluated by MRI (more than grade II by Pfirrmann grading) from L3/4 to L4/5 lumbar disc
- •Less than 50% decrease of disc height measurement by lumbar radiograph
- •Discogenic pain evaluated by provocative discography
- •Written informed consent is obtained from the participant of this study
排除标准
- •Having remarkable cauda equine and neuropathy symptom
- •Having systematic or spinal infection
- •Past-history of lumbar surgeries
- •Past-history of interventional intervertebral disc therapy
- •Having intervertebral instability evaluated by lumbar radiograph
- •Patients having spondylolisthesis (more than grade I by Meyerding classification)
- •Having neuro-muscular diseases, cerebral diseases, malignant tumor and blood coagulation disorders
- •High risk for infectious diseases after the treatment
- •Having anti-coagulant drugs at the time of treatment
- •Pregnant patient
- •Difficulty in participating throughout the evaluation period
- •More than 10-points of BS-POS questionnaire test
- •Contraindication for MRI
- •Inappropriate patient for clinical study evaluate by doctors
研究者
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