Platelet Rich Plasma and Bone Marrow Aspirate for Lumbar Intradiscal Injections: A Multicenter Prospective Randomized Controlled Trial in Patients With Internal Disc Disruption
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 8
- 主要终点
- Worsening of Disc Pathology with Injection of Biologics
研究概览
简要总结
The condition being studied is chronic low back or leg pain in patients with internal disc disruption (IDD). The intervention to be studied is the intradiscal delivery of autologous Platelet Rich Plasma (PRP) or bone marrow concentrate (BMC) into the nucleus pulposus of the disrupted disc(s).
详细描述
This multi-center randomized controlled pilot trial will be the first to evaluate the response of PRP and BMC for discogenic pain by direct comparison. The investigators propose to incorporate a crossover design that compares placebo to two treatment modalities (i.e. Neutrophil-Poor PRP [NP-PRP] and BMC).
If the investigators can demonstrate statistically significant and clinically meaningful improvements in study's primary and secondary outcome measures, this study will have identified a natural, effective and sustainable treatment for discogenic back pain that currently accounts for the highest level of disability in US. This will help guide physicians in the choice of care between surgical and conservative treatment options when treating patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A high index of suspicion for discogenic pain, i.e. painful degenerative discs with or without contained protrusions
- •Age greater than 18 and less than 70 years
- •Maintained intervertebral disc heights of at least 50%
- •Pain not generated from facet joints, sacro-iliac joints or any pathology other than discogenic origin.
- •Pain is not responsive to conservative treatment measures (oral medications, epidural steroid injections, physical therapy)
- •Pain persists for an extended period of time (i.e., at least 3 months)
- •High intensity zone (HIZ) in annular fissure detected on T2 or STIR MRI, degenerated discs or contained disc protrusions.
- •No evidence of contraindications to undergo procedure such as pregnancy, active infection, bleeding disorder, or metastatic cancer
- •English speaking
排除标准
- •Disc extrusions, disc sequestrations, severe spinal stenosis, or severe disc degeneration with grade 5 Pfirmann index or with Modic 3 level change.
- •Patient refusal
- •Presence of a known bleeding disorder
- •Pregnancy
- •Systemic or local infection
- •Presence of an unstable medical or psychiatric condition
- •Prior intradiscal procedure (ie. IDET, Nucleoplasty)
- •Inaccessibility to discs such as fusion
- •Non-English speaking
- •Prior fusion surgery
结局指标
主要结局
Worsening of Disc Pathology with Injection of Biologics
时间窗: 24 weeks post procedure
Pre and post op discs will be examined and compared for worsening pathology.
Improvement in Disc Pain with Injection of Biologics
时间窗: 24 weeks post procedure
Pre and post op Pain will be measured and compared by Numeric Rating Scale (NRS) Numeric Pain Rating Scale (NRS): Measured from 0-10, 0 minimum score (better outcome) and 10 maximum score (worse outcome) Oswestry Low back disability (ODS): Measured from 0-50, 0 minimum score and 10 maximum score. The numbers are then calculated into percentages between 0% (minimum disability- better outcome)-100% (maximum disability- worse outcome) NASS Patient satisfaction Index (NASS): Measured from 0-4, 0 (better outcome) and 4 (worse outcome)
Improvement in Function in Patients with Injection of Biologics
时间窗: 24 weeks post procedure
Pre and post op function will be measured and compared by Oswestry Disability Index (ODI)
次要结局
- Hospitalization(Pre injection, 1 month post op, 3 months post op, 6 months post op, 1 year.)
- Spine Surgery(Pre injection, 1 month post op, 3 months post op, 6 months post op, 1 year.)
- Medications(Pre injection, 1 month post op, 3 months post op, 6 months post op, 1 year.)
- Patient Satisfaction(Pre injection, 1 month post op, 3 months post op, 6 months post op, 1 year.)
研究者
Annu Navani
Principal Investigator
Comprehensive Spine & Sports Center, Campbell, CA