The Efficacy of Ultrasound Guided Glenohumeral Joint Injections of Platelet Rich Plasma (PRP) Versus Hyaluronic Acid (HA) in the Treatment of Glenohumeral Osteoarthritis: a Randomized, Double-blind Control Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Shoulder Pain and Disability Index (SPADI) Score
研究概览
简要总结
This study seeks to expand the current literature in demonstrating potentially efficacious, conservative treatments in the management of glenohumeral osteoarthritis (OA) and will compare ultrasound-guided injections of hyaluronic acid vs. platelet-rich plasma. We aim to obtain information measuring potential benefits of these interventions and to observe for any adverse events.
详细描述
Glenohumeral OA accounts for approximately 2-5% of all chronic shoulder pain and may be classified into primary and secondary forms. Primary glenohumeral OA is caused by degenerative joint disease, inflammatory arthropathies, and neuropathic arthropathy secondary to syringomyelia or diabetes. Secondary glenohumeral OA is caused by trauma, postoperative changes after arthroscopy or capulorraphy, and osteonecrosis. Hyaluronic acid is found in synovial joint fluid and has viscoelastic, chondroprotective, and possibly anti-inflammatory properties. It has been shown to increase joint lubrication. Platelet-rich plasma contains growth factors that have been shown to promote tissue regeneration. The aim of this study is to determine whether injections of hyaluronic acid or platelet-rich plasma can be used reliably to decrease pain, restore function, and improve quality of life in patients suffering from glenohumeral OA. Patients will be randomized to receive either an injection of hyaluronic acid or an injection of platelet-rich plasma. Outcomes will be assessed via questionnaires for up to 52 weeks post-procedure.
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, Investigator, 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
- •English speaking/literate
- •Age 18-100 years
- •Visual analog score pain >= 5
- •Greater than or equal to 3 months of pain after onset of symptoms that has failed conservative treatments
- •Confirmation of glenohumeral OA via routine imaging (MRI and x-ray; must be recent and within the past year)
- •Transient relief of symptoms after diagnostic intra-articular injection into the glenohumeral joint
排除标准
- •Non-English speaking/illiterate
- •Painful active, concurrent cervical spine conditions
- •Current non-steroidal anti-inflammatory drug (NSAID) use
- •History of taking coumadin or similar anticoagulant, have a known coagulopathy, bleeding dyscrasia, or platelet count < 150,000/cubic mm
- •Allergic reaction to poultry or previous viscosupplementation
- •Involved in workers' compensation or active litigation involving affected shoulder
- •Inability to refrain from NSAID use for 5 days prior to and 6 weeks after injection
- •History of corticosteroid injection to affected shoulder within the last 3 months
- •History of viscosupplementation or platelet-rich plasma to affected shoulder within the last 6 months
- •Presence of acute fracture
- •History of shoulder tumor
- •Known uncontrolled systemic illness (uncontrolled diabetes, human immunodeficiency virus, vasculitis, autoimmune/inflammatory disease)
- •Psychiatric and somatoform disorders
研究组 & 干预措施
Hyaluronic Acid
Patients will receive an injection of hyaluronic acid.
干预措施: Ultrasound (Device)
Platelet-rich plasma (PRP)
Patients will receive an injection of PRP.
干预措施: PRP (Biological)
Platelet-rich plasma (PRP)
Patients will receive an injection of PRP.
干预措施: Ultrasound (Device)
Hyaluronic Acid
Patients will receive an injection of hyaluronic acid.
干预措施: Hyaluronic Acid (Drug)
结局指标
主要结局
Shoulder Pain and Disability Index (SPADI) Score
时间窗: Up to 52 weeks post-procedure
Score ranges from 0-100, with a higher score representing higher disability.
次要结局
- Shoulder Function(Up to 52 weeks post-procedure)
- Number of Patients Who Were Satisfied After Treatment(Up to 52 weeks post-procedure)
- Number of Patients With Complication Events After the Procedure(Up to 52 weeks post-procedure)