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临床试验/NCT01781130
NCT01781130已完成不适用

Effect of Steroid Injection Which is Added to Percutaneous Trigger Finger Release: a Double-blinded Randomized Controlled Trial.

Samsung Medical Center2 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2013年1月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Min Jong Park

Professor

Samsung Medical Center

研究点 (2)

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