Comparing Short-term Function and Pain After Treatment With Collagenase Clostridium Histolyticum or Percutaneous Needle Aponeurotomy for Dupuytren's Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Daily Pain and Function Scales
研究概览
简要总结
This study will evaluate short-term pain and function associated with percutaneous needle aponeurotomy (PNA) and injections of the enzyme collagenase clostridium histolyticum in patients with Dupuytren's disease. Scores on outcome measures will be compared between groups to determine whether treatments differ in terms of hand function and pain during the early post-treatment period.
详细描述
Percutaneous needle aponeurotomy (PNA) and injections of the enzyme collagenase clostridium histolyticum are two non-invasive treatment options for patients with Dupuytren's disease. While PNA has been offered for decades, injectable collagenase is relatively new. The effectiveness of each treatment has been compared in the literature; however, recovery, in terms of pain and short-term function has not been formally evaluated. The objective of this study is to objectively compare short-term function and pain outcomes associated with each of these two procedures in patients presenting with untreated Dupuytren's disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Dupuytren's disease diagnosis
- •Consented to either percutaneous needle aponeurotomy or Xiaflex injection (patient choice)
- •Able to read/write/speak English
- •Must have an email address
排除标准
- •Previous treatment for Dupuytren's disease
- •Type 2 Diabetes Mellitus
- •Pre-existing hand condition, previous hand surgery or trauma
研究组 & 干预措施
Percutaneous Needle Aponeurotomy
Patients who choose to undergo percutaneous needle aponeurotomy (PNA) for primary treatment of Dupuytren's disease
干预措施: Percutaneous Needle Aponeurotomy (Procedure)
Xiaflex
Patients who choose to receive Collagenase clostridium histolyticum injection (drug name Xiaflex) for primary treatment of Dupuytren's disease.
干预措施: Collagenase clostridium histolyticum (Drug)
结局指标
主要结局
Daily Pain and Function Scales
时间窗: Day 28
Brief Michigan Hand Questionnaire (brief MHQ)
时间窗: Day 28
Unite Rhumatologique des Affections de la Main (URAM) scale
时间窗: Day 28
次要结局
未报告次要终点