The Effect of Platelet Rich Plasma on Osteoarthritis of Knee
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change from baseline of pain on 2nd week, 1st month, 3rd month and 6th month after PRP.
研究概览
简要总结
Although few studies have showed beneficial effect of platelet rich plasma (PRP) for osteoarthritis of knee (OA knee), only one study applied randomized, control method and none of them has the objective measurements such as balance test or muscle strength which were reported as decrease in patients with OA knees. We assess the analgesic effect and the extent of improved muscle strength and balance after PRP in patients with OA knee.
详细描述
Patients with bilateral OA knee will be enrolled and randomized into intervention and control knee. One dose of PRP is applied in the intervention knee and normal saline in control side. Outcome measurements included visual analog scale (VAS)、Lequesne's severity index、Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)、balance test (Biodex) and isokinetic strengthening test at different follow-up frame (2nd week, 1st month, 3rd month and 6th month after treatment).
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, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 35 to 75 y/o.
- •Alert consciousness
- •Symptom of knee osteoarthritis persist at least 6 months and stage I or II scored by Ahlbäck grading system
- •The pain score measured by VAS at least 4 points
排除标准
- •Has received hyaluronic acid or steroid injection within 6 monts
- •Has received NSAIDs or steroid within one week
- •Tumor or metastasis surrounding the knee joint
- •Has received total knee replacement, major surgery in knee, rheumatoid arthritis
- •Patient who cant tolerance the balance or muscle strength test.
研究组 & 干预措施
Platelet rich plasma
Platelet rich plasma (PRP) is a new and potential treatment for patients with kinds of musculoskeletal disorders.
Patients with bilaetral knee osteoarthritis randomized receive on dose of PRP in one knee and placebo with normal saline in the other side.
干预措施: platelet rich plasma (Drug)
normal saline
Normal saline was injected into the other side of knee as the control group.
干预措施: Normal saline (Drug)
结局指标
主要结局
Change from baseline of pain on 2nd week, 1st month, 3rd month and 6th month after PRP.
时间窗: Pre-treatment, 2nd week, 1st month, 3rd month and 6th month after PRP.
Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment.
次要结局
- Change from baseline in balance function on 2nd week, 1st month, 3rd month and 6th month after treatment.(Pre-treatment, 2nd week, 1st month, 3rd month and 6th month after treatment.)
- Change from baseline in severity of symptoms and functional status on 2nd week, 1st month, 3rd month and 6th month after treatment.(Pre-treatment and 2nd week, 1st month, 3rd month and 6th month after treatment.)
- Change from baseline in muscle strength of lower extremities on 2nd week, 1st month, 3rd month and 6th month after treatment.(Pre-treatment, 2nd week, 1st month, 3rd month and 6th month after treatment.)
研究者
Yung-Tsan Wu
Attending Physician
Tri-Service General Hospital