NCT06384859尚未招募4 期
Effectiveness of Extracorporeal Shockwave Therapy Combined With Platelet-rich Plasma in the Treatment of Chronic Insertional Achilles Tendinopathy
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- VAS
研究概览
简要总结
The goal of this clinical trial is to learn about the effectiveness of extracorporeal shockwave(ESWT) combined with platelet-rich plasma(PRP) to treat chronic insertional tendinopathy. The main questions it aims to answer are:
Does ESWT combined with PRP treatment reduce the symptom and improve functional score after treatment? What medical complication do participants have when receive the treatment?
Researchers will compare ESWT combined with PRP to ESWT treatment alone to see if ESWT combined with PRP works to treat chronic insertional tendinopathy.
Participants will:
- Receive ESWT once a week for 4 weeks then receive PRP injection at a week later or ESWT once a week for 4 weeks
- Visit the clinic at 6 weeks, 3 months, 6 months and 1 year after treatment for checkups and record functional score
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with insertional Achilles tendinopathy
- •Had symptom more than 6 months
- •Failed other standard conservative treatment (rest, medication, activity modification, stretching exercise, and heel lift orthosis)
排除标准
- •Receive corticosteroid injection at the Achilles insertion
- •History of infection around ankle and heel
- •Has neurological deficit
- •Has a contraindication for ESWT(hemophilia, coagulopathy or foot and ankle malignancy)
结局指标
主要结局
VAS
时间窗: 6 week, 3 months, 6 months and 1 year after treatment
Visual Analogue Scale
次要结局
- VAS-FA(6 week, 3 months, 6 months and 1 year after treatment)
- FFI(6 week, 3 months, 6 months and 1 year after treatment)
- FAAM(6 week, 3 months, 6 months and 1 year after treatment)
研究者
研究点 (2)
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