Effect of Steroid Injection Which is Added to Percutaneous Trigger Finger Release: a Double-blinded Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- pain VAS
研究概览
简要总结
Background
Present treatment strategies for trigger finger when conservative management including steroid injection was failed include percutaneous or open A1 pulley release, but some people showed prolonged swelling and delay of complete healing.
We aimed to test the hypothesis that an improved outcome can be achieved by employing steroid injection simultaneously with percutaneous release compared with conventional percutaneous release alone
Methods
We designed a double-blind, randomized controlled trial.
Inclusion criteria is the patient who has symptom of trigger finger warranted surgical release after sufficient time of conservative treatment.
Exclusion criteria are as follow: 1) multiple fingers at presentation; 2) Rheumatoid arthritis patients; 3) Pregnant or lactating patients; 4) Younger than 18 years old; 5) Previous surgery history of finger 6); the patients who got steroid injection more than 4 time previously; 7) coagulation abnormality including usage of anti-thrombotic agent.
After power analysis by a statistician, total 40 patients would be required for each group (percutaneous alone group versus percutaneous alone + steroid injection group).
The surgery will be performed by outpatients clinic basis with local injection. Additional steroid injection will be given to half of patients after allocation with randomized selection by permutaed block randomization.
Primary outcome measure is mean fall in pain visual analogue scale (pVAS) and secondary outcome will be proportion of patients with good response (defined as "Perfect" or "much better" as reported by patients).
Follow-up will be conducted 3 weeks and 3 month after index procedure
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
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Trigger finger patients who require surgical intervention due to failuer of sufficient time of conservative treatment
排除标准
- •Age under 18 years old
- •Rheumatoid arthritis patients
- •Patients who got steroid injection more than 4 times previously
- •Multiple finger affected at presentation
- •Previous surgery history
- •Any recent trauma history of affected hand
结局指标
主要结局
pain VAS
时间窗: 3 month after procedure
次要结局
未报告次要终点
研究者
Min Jong Park
Professor
Samsung Medical Center
