Treatment for Sacroiliac Joint Pain Using Platelet-rich Plasma (PRP) Regenerative Therapy: A Randomized Controlled Trial in Comparison With Steroid/Anesthetic Injection With Advanced MR Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Numeric Rating Scale
研究概览
简要总结
The purpose of this study is to determine if platelet-rich plasma is superior to steroid/anesthetic for the treatment of sacroiliac joint pain.
详细描述
All patients with sacroiliac joint pain diagnosed by a back pain specialist will undergo physical examination maneuvers and a test lidocaine injection of the joint. Patients who meet eligibility requirements will be randomized in a single-blind randomized controlled manner with a 50% chance of receiving platelet-rich plasma versus steroid/anesthetic injection of the sacroiliac joint(s).
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
- Single (Participant)
盲法说明
Patients will be blinded to which injectate they received.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (>18 y/o) males and females referred for therapeutic injection to the investigators spine interventional service by a physiatrist or pain anesthesiologist with a clinical diagnosis of SIJ pain confirmed by history
- •50% or greater reduction in pain by a diagnostic anesthetic block using no more than 1.5 cc 2% lidocaine performed under imaging guidance by a pain interventionalist (PM&R, Pain Anesthesia, or Neuroradiology Spine Intervention).
- •Baseline pain must be >/=4 by numeric rating scale (NRS), at least 6 weeks in chronicity, and must not be multi-factorial (related to radiculopathy or axial pain localizing elsewhere) by physical examination or confounding medical history (infection, inflammatory spondyloarthropathy, or osseous metastatic disease).
排除标准
- •SIJ steroid treatment within the prior 6 months.
- •Patients with a history of infection currently on antibiotic therapy
- •Usage of systemic immunosuppressants
- •Pregnancy
研究组 & 干预措施
Platelet-rich Plasma
Patients will receive an intra-articular injection 3 mL of autologous platelet-rich plasma in the sacroiliac joint.
干预措施: Sacroiliac intra-articular injection (Procedure)
Steroid/Anesthetic
Patients will receive an intra-articular injection 40 mg Depo-medrol mixed with 2 mL 0.25% bupivicaine in the sacroiliac joint.
干预措施: Sacroiliac intra-articular injection (Procedure)
结局指标
主要结局
Numeric Rating Scale
时间窗: Change between baseline and 3-months post-intervention
Validated pain scale rating pain on a scale of 0 through 10. 0 for no pain, and 10 for the highest pain the patient can imagine.
次要结局
- Functional testing(Change between baseline and 3-months post-intervention)
- Short-Form 12 Survey(Change between baseline and 3-months post-intervention)
- Modified Oswestry Disability Questionnaire(Change between baseline and 3-months post-intervention)
- Opiate/pain medication usage questionnaire(Change between baseline and 3-months post-intervention)
研究者
Miriam Peckham
Assistant Professor
University of Utah