Ultrasonication-mediated Microbubbles Dressings Increase the Therapeutic Efficacy of Piroxicam Gel for Hand Arthritis: Assessments Using Conventional and Ultrafast Power Doppler Imaging
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Clinical response
研究概览
简要总结
The goal of this clinical trial is to learn if ultrasonication-mediated microbubbles dressing works to treat hand arthritis in adults. It will also learn about the safety of ultrasonication-mediated microbubbles dressing. The main questions it aims to answer are:
Does ultrasonication-mediated microbubbles dressing increase the therapeutic efficacy of piroxicam gel for hand arthritis?
Researchers will compare "ultrasonication-mediated microbubbles dressing + piroxicam gel " to "ultrasonication + piroxicam gel" and "piroxicam gel alone" to see if ultrasonication-mediated microbubbles dressing works to treat hand arthritis.
Participants will:
Take "ultrasonication-mediated microbubbles dressing (day 1,3,5) + piroxicam gel (day 2,4,6,7) ", "ultrasonication (day 1,3,5) + piroxicam gel (day 2.4.6.7)", and "piroxicam gel alone (day 1-7)" for 1 week.
Visit the clinic on day 1 and day 8 for checkups and tests Keep a diary of their symptoms
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of hand arthritis
- •Have at least three symptomatic joints over wrist, metacarpophalangeal joints, and interphalangeal joints
排除标准
- •Infectious arthritis
- •Acute gout
结局指标
主要结局
Clinical response
时间窗: day 8
A decrease in pain visual analogue scale (VAS) score of ≥2 on day 8 relative to day 1, or an absolute VAS score of ≤1 on day 8. \[Pain VAS score range: 0-10, higher scores mean a worse outcome\]
B-mode response
时间窗: day 8
A ≥20% decrease in synovial area on day 8 relative to day 1
Conventional power Doppler (PD) response
时间窗: day 8
A ≥20% decrease in synovial PD area on day 8 relative to day 1 on conventional PD image
次要结局
- Ultrafast PD response(day 8)
研究者
Kuo-Lung Lai
Doctor
National Taiwan University