Prospective, Double Blind, Randomized Control Trial Comparing the Efficacy of Intra-articular Injections for the Treatment of Primary Glenohumeral Osteoarthritis
概览
- 阶段
- 不适用
- 干预措施
- Glenohumeral Injection
- 疾病 / 适应症
- Arthritis Shoulder
- 发起方
- Rush University Medical Center
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Visual Analog Scale-Pain (VAS)
- 状态
- 招募中
- 最后更新
- 2个月前
概览
简要总结
The purpose of this study is to compare the efficacy of intra-articular corticosteroid injections versus platelet-rich plasma injections for non-operative treatment of primary glenohumeral osteoarthritis. The efficacy of intra-articular injections, outside of hyaluronic acid, for the treatment of glenohumeral OA is not known, yet these treatments are commonly used with hopes of providing patients with symptomatic relief that can hopefully delay or prevent the need for shoulder arthroplasty. This study will help elucidate the therapeutic benefit of corticosteroid and Platelet Rich Plasma (PRP) injections in this patient population.
研究者
入排标准
入选标准
- •Patient ≥18y.o. of age
- •Primary glenohumeral arthritis (bone on bone or near bone on bone) that has been previously diagnosed on radiographs and clinical evaluation.
- •Baseline pain level of VAS \>4
排除标准
- •Secondary causes of arthritis (i.e. septic arthritis, rheumatoid arthritis, rotator cuff arthropathy, post-traumatic arthritis)
- •Ipsilateral shoulder surgery within 1 year
- •Any glenohumeral joint injection within 3 months
- •Allergy to lidocaine
- •Known pregnancy
- •Workers compensation case regarding shoulder
研究组 & 干预措施
Corticosteroid Injection Group
80mg Depo-Medrol and 8cc Lidocaine ultrasound-guided intra-articular injection
干预措施: Glenohumeral Injection
Platelet-Rich Plasma Injection Group
15cc blood draw in Arthrex Autologous Conditioned Plasma (ACP) kit and processed per manufacturer instructions Ultrasound-guided intra-articular injection of isolated PRP
干预措施: Glenohumeral Injection
结局指标
主要结局
Visual Analog Scale-Pain (VAS)
时间窗: 12 weeks
Validated patient-reported metric scale of pain: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm)