Outcomes Following Single Injections of Low-dose Platelet-rich Plasma (PRP), High-dose PRP, or Saline in Patients With Glenohumeral OA: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- American Shoulder and Elbow Surgeons (ASES) Shoulder Score
研究概览
简要总结
The glenohumeral joint is the third most common large joint to be affected by OA. Conservative treatments include physical activity, corticosteroid injections, and medications. PRP is an emerging treatment that has shown efficacy in different musculoskeletal conditions. The use of PRP for glenohumeral OA has been described sparingly in the literature but has shown efficacy in a couple studies and case reports. However, all of the previous studies investigating PRP for glenohumeral OA have focused on low-dose PRP preparations (~3X), and none have compared PRP treatment to saline treatment. This study aims to compare outcomes following single injections of low-dose PRP, high-dose PRP, or saline in patients with glenohumeral osteoarthritis.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-100 years old
- •Average NRS pain greater than or equal to 5/10 as a direct result of glenohumeral osteoarthritis (any severity: mild, moderate, or severe) and/or chondral lesion or loss
- •At least 3 months of pain after onset of symptoms that has failed conservative treatments, including physical therapy
- •MRI of the affected joint
- •Transient relief of symptoms after a diagnostic intra-articular injection into the joint
- •Email address or network access
排除标准
- •Inability to hold non-steroidal anti-inflammatory drugs for 2 weeks prior and 1 month after the injection
- •Prior platelet-rich plasma injection
- •Steroid injection within 3 months of the initial injection
- •Hyaluronic acid within 6 months of the initial injection
- •Involved in workers' compensation or active litigation involving the affected joint
- •History of Plavix use
- •Known uncontrolled systemic illness (uncontrolled diabetes, HIV, vasculitis, autoimmune/autoinflammatory disease)
- •Presence of acute fractures or gross mechanical deformities
- •Concurrent "uncontrolled" cervical disorders
研究组 & 干预措施
Saline control
Patients will receive a single injection of 6 ml saline into the glenohumeral joint.
干预措施: Saline (Other)
High-dose PRP
Patients will receive a single injection of 6 ml high-dose platelet-rich plasma (PRP) into the glenohumeral joint. High-dose is defined as a platelet yield of 12X (i.e., 12-fold increase in platelets in PRP compared to whole blood).
干预措施: High-dose PRP (Biological)
Low-dose PRP
Patients will receive a single injection of 6 ml low-dose platelet-rich plasma (PRP) into the glenohumeral joint. Low-dose is defined as a platelet yield of 3X (i.e., 3-fold increase in platelets in PRP compared to whole blood).
干预措施: Low-dose PRP (Biological)
结局指标
主要结局
American Shoulder and Elbow Surgeons (ASES) Shoulder Score
时间窗: 3 months post-injection
The ASES measures pain and function in activities of daily living related to the shoulder. On a 100-point scale, a higher score represents less pain/higher function.
次要结局
- PROMIS-Upper Extremity computer adaptive test (CAT)(Up to 12 months post-injection)
- Medication use(Up to 12 months post-injection)
- Average numerical rating scale (NRS) pain score(Up to 12 months post-injection)
- Patient-Reported Outcomes Measurement Information System (PROMIS)-10 Global Health measure(Up to 12 months post-injection)
- PROMIS Sleep Disturbance(Up to 12 months post-injection)
- Patient satisfaction(Up to 12 months post-injection)