Ultrasound-Guided Platelet Rich Plasma Versus Whole Blood Injection for the Treatment of Gluteus Medius Tendinopathy: A Double-Blind Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Improvement in Pain
研究概览
简要总结
Gluteus medius tendinopathy, which is often referred to as Greater Trochanteric Pain Syndrome, is characterized by pain in the lateral aspect of the hip that is aggravated by side lying, stair climbing, and walking. Treatment is currently limited to lifestyle modifications, corticosteroid injections, physical therapy, and open and endoscopic surgical repair. Platelet rich plasma (PRP) injections contain important growth factors that are essential in the healing and tissue formation processes. However, the extent to which PRP is more efficacious than whole blood in tendinopathy remains unclear. In this double-blind randomized trial, patients will be allocated to receive either a PRP or whole-blood injection. Post-procedure assessments will occur at 6 weeks, 3 months, 6 months, 9 months, and 1 year.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate to severe lateral hip pain for greater than 3 months
- •Symptoms are refractory to conservative treatment, including at least 8 weeks of traditional physical therapy for this condition
- •Moderate to severe gluteus medius tendinosis with or without partial tear <1 cm
- •Normal neurologic exam except for hip abductor weakness on the affected side
排除标准
- •Severe (Tonnis grade >1) hip osteoarthritis with active synovitis or bone edema
- •Active lumbar radiculopathy with pain, numbness or weakness in a dermatomal distribution
- •No evidence of fatty atrophy, denervation, or complete tears of gluteus medius seen on MRI
- •Any condition that requires anti-platelet or anti-coagulation therapy, including aspirin therapy for cardiac conditions
- •Non-English speaking
研究组 & 干预措施
PRP
干预措施: Ultrasound (Device)
Whole Blood
干预措施: Whole Blood (Biological)
PRP
干预措施: PRP (Biological)
结局指标
主要结局
Improvement in Pain
时间窗: Up to 1 year post-injection
The Numerical Rating Scale for Pain will be used, where 0=no pain and 10=worst pain. A higher number represents more pain.
Improvement in Function
时间窗: Up to 1 year post-injection
The Non-Arthritic Hip Score and Veterans RAND 12-Item Health Survey will be used to assess improvement in function.
Patient Satisfaction
时间窗: Up to 1 year post-injection
The 10-cm Visual Analog Scale for patient satisfaction will be used. This scale will range from "very dissatisfied" to "extremely satisfied".
次要结局
- Quality of Movement During the Forward Step-down Test(Up to 1 year post-injection)
- Pain During Side-lying Hip Abduction(Up to 1 year post-injection)
- Pain During Forward Step-down Test(Up to 1 year post-injection)