A Pilot Trial Evaluating the Feasibility of Using Platelet-Rich Plasma (PRP) for Treatment of Symptomatic Osteoarthritis of the Lumbar Facet Joint(s) of the Spine
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Change in pain Visual Analog Score with back flexion and at rest from baseline after intervention over time.
研究概览
简要总结
The purpose of this study is to investigate the feasibility of standardized autologous platelet rich plasma injections into osteoarthritic lumbar facet joints to treat back pain and improve patient function.
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
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suspicion of z-joint mediated low back pain
- •Pain rating of ≥4/10 on a VAS scale
- •Symptom duration of 3 or more months
- •Failed conservative therapy (minimum of PT and pain medications)
- •Have diagnosis of lumbar facet syndrome after MRI, X-ray, or CT imaging of any severity and a medial branch block with local anesthetic that confirms lumbar facet pathology.
排除标准
- •Inability to undergo fluoroscopically guided procedures
- •Current pregnancy
- •Prior spinal surgery with hardware
- •Intolerance to local anesthesia, contrast medium, or blood derivatives
- •Local or systemic infection or spinal infection
- •Irreversible coagulopathy
- •Patients that require strict anticoagulation and cannot be off antiplatelet medication for at least a week
- •Less than 18 years of age
- •Corticosteroid shot within last 3 months into affected lumbar facet joint because of concern of damage to cartilage in the joint in that time period.
- •Patients with workman compensation related back pain
- •Patients with rheumatic cause of lumbar facet arthritis.
- •Patients who have had a radiofrequency neurotomy of the nerves innervating their affected facet joints within the last year
结局指标
主要结局
Change in pain Visual Analog Score with back flexion and at rest from baseline after intervention over time.
时间窗: Baseline, immediately after intervention, 1 week, 1 month, and 3 months post intervention
Pain as assessed from 0-10. Where 10 is severe pain and 0 is no pain. Improvement of pain by 50% after intervention is defined as treatment success
PROMIS Survey for Low Back Pain Function (PROMIS-29)
时间窗: Baseline, immediately after intervention, 1 week, 1 month, and 3 months post intervention
NIH validated PROMIS score for physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social activities, pain interference, and pain intensity (PROMIS- 29 Profile v2.0). A higher PROMIS T-score represents more of the concept being measured.For negatively-worded concepts like Anxiety,a T-score of 60 is one SD worse than average.By comparison,an Anxiety T-score of 40 is one SD better than average.However,for positively-worded concepts like Physical Function-Mobility,a T-score of 60 is one SD better than average while a T-score of 40 is one SD worse than average.
次要结局
- Length of enrollment of 10 patients and attrition rate(3 months)
- Degree of improvement in pain and function based on severity of lumbar facet OA.(3 months)
- Safety as measured by number of subjects with at least one adverse event(3 months)