Effects and Safety of PDRN (Polydeoxyribonucleotide) for Patient With Lumbar Spinal Stenosis Compared With Normal Saline in Randomized Placebo-Controlled Comparative Pilot Study
试验速览
- 阶段
- 4 期
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- visual analogue scale(VAS)
研究概览
简要总结
This is a single-center, randomized, double-blind clinical study to assess the clinical application and outcomes with epidural PDRN versus Normal saline injection in patients with spinal stenosis.
详细描述
Patients who are already planning to receive an Transforaminal epidural block from their clinician will be approached by study members on the day of their injection. If enrolled, the patients will be contacted every 2 weeks for 4 weeks to determine the severity of pain and degree of pain relief from the injection.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged between 19-80 years old
- •Radiological confirmation of spinal stenosis on MRI
- •Neurogenic claudication greater thanVAS 4 of due to spinal stenosis
- •Follow-up possible during 3 months the clinical trial
排除标准
- •Not able to comply fully with the protocol, including treatment, follow-up or study procedures
- •pregnant or feeding women
- •Alcohol/drug abuse
- •Anticoagulant medication
研究组 & 干预措施
Polydeoxyribonucleotide
Polydeoxyribonucleotide(PDRN) 5.625mg/3ml
干预措施: Polydeoxyribonucleotides (Drug)
Polydeoxyribonucleotide, Placebo
Polydeoxyribonucleotide(PDRN) 5.625mg/3ml Placebo (Normal saline)
干预措施: Polydeoxyribonucleotides (Drug)
Polydeoxyribonucleotide, Placebo
Polydeoxyribonucleotide(PDRN) 5.625mg/3ml Placebo (Normal saline)
干预措施: Normal saline (Drug)
Placebo
Placebo (Normal saline)
干预措施: Normal saline (Drug)
结局指标
主要结局
visual analogue scale(VAS)
时间窗: 12 weeks post - injection
This is in pain measurement ranging from 0 when no pain to 10 when there is severe pain(low back pain)
次要结局
- visual analogue scale(VAS)(4, 8 weeks post - injection)
- CGI(Clinicians Global Impression)(4, 8 weeks post - injection)
- treadmill test(8 weeks post - injection)
研究者
Pyung-Bok Lee
Principal Investigator
Seoul National University Hospital