Does Synovitis Affect Treatment Efficacy in Intra-articular Injection Therapy to Osteoarthritis
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- visual analog scale(VAS)
研究概览
简要总结
To determine whether platelet-rich-plasma (PRP) or HA (hyaluronic acid)injection into synovitis in osteoarthritis(OA) knee can achieve improvement in knee function and reduce synovitis.
详细描述
Methods:
sixty patients with OA knee having unilateral or bilateral synovitis validated by ultrasound (N=40) were studied. All the patients were randomized to receive PRP (N=40) or Hyaluronic acid(HA)(N=40) injection twice at 2-week intervals; Clinical assessments were performed using a visual analog scale(VAS) and The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC index) before injection at baseline, 4 weeks(first evaluation) and 12 weeks(secondary evaluation). Imaging evaluation based on color Doppler ultrasound(CDUS) and the depth of synovial fluid accumulation ,and the width of synovial hypertrophy was performed simultaneously.
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
- None
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed with OA knee according to ACR guideline
- •stiffness less than 30min
- •cracking sound during activity
- •more than 30min pain for last 2 months
- •non-bed ridden patients
- •no structure abnormality
- •synovitis was proved by US
排除标准
- •OA knee secondary to other disease 2 . more than 10 years after diagnosing OA
- •under knee surgery within 3 months
- •autoimmune disease
- •refuses inform/consent process
研究组 & 干预措施
PRP group
the patients received PRP(platelet-rich-plasma) injection twice at 2-week intervals
干预措施: platelet rich plasma (Drug)
HA group
the patients received HA(hyaluronic acid) injection twice at 2-week intervals
干预措施: Hyaluronic acid (Drug)
结局指标
主要结局
visual analog scale(VAS)
时间窗: 12 weeks(secondary evaluation)
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC index)
时间窗: 12 weeks(secondary evaluation)
次要结局
- Imaging evaluation based on color Doppler ultrasound(CDUS) and the depth of synovial fluid accumulation ,and the width of synovial hypertrophy was performed simultaneously.(before injection at baseline)
- Imaging evaluation based on color Doppler ultrasound(CDUS) and the depth of synovial fluid accumulation ,and the width of synovial hypertrophy was performed(12 weeks(secondary evaluation))