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临床试验/NCT01886157
NCT01886157Unknown不适用

Treatment of Trigger Finger With Steroid Injection Versus Steroid Injection and Splinting: A Randomized Controlled Trial

The Philadelphia & South Jersey Hand Center2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2013年5月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
2
主要终点
Stage of finger triggering

研究概览

简要总结

Hypothesis: Treatment of trigger finger by corticosteroid injection and splinting is superior to corticosteroid treatment alone.

详细描述

Stenosing tenosynovitis, or more commonly "trigger finger" is a disease that can severely impact a patient's quality of life. Its incidence is said to be 28 persons per 100,000 annually. The disease is manifested in one or more fingers by finger locking in flexion or extension, leading to pain, discomfort and at times, loss of function. Patients frequently report having to snap their fingers back in position to alleviate symptoms. The pathophysiology relates to thickening of the flexor tendon sheath, which can impair tendon gliding within it.

Although multiple treatment strategies are available, it is not entirely clear which treatment offers the best outcome, especially when the finger has not reached end stage locking. In general, corticosteroid injection into the tendon sheath is offered as the first line of treatment. Splinting alone has also been described as a reliable method treatment. However, Patel and Bassini indicated that steroid injection results in fewer recurrences than splinting alone. Surgery is typically reserved for recurrent triggering, cases refractory to injection, or digits locked in flexion. The effects of steroid injection followed by splinting however have not been reported in a comprehensive fashion. It may be that this form of treatment could result in a synergistic effect, which can offer a treatment modality superior to either injection or splinting alone. The purpose of this research study is to determine whether steroid injection followed by splinting is superior to injection alone.

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 (Care Provider)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Trigger finger in one or more trigger fingers, in stages 2 to 5 (inclusive)
  • Adult patient aged over 18 years.
  • No prior treatment (splinting, injection or surgery) to the involved finger OR at least 1 year since last treatment of the involved finger.

排除标准

  • Exclude Trigger thumbs because they appear to be respond very favorably or unfavorably to treatment3
  • Exclude locked digits because surgery is indicated in these cases
  • Pregnant patients
  • Prisoners
  • Patients with impaired decision-making capacity
  • Patients that do not speak English and cannot fill in English language questionnaires.

结局指标

主要结局

Stage of finger triggering

时间窗: 1, 2, 4-6, and 12 months

Trigger Finger Stage: 1. Normal 2. Painful palpable nodule 3. Triggering = Clicking = Catching 4. Locking of finger in flexion or extension unlocked by active finger movement 5. Locking of finger in flexion or extension unlocked by passive finger movement 6. Locked finger in flexion or extension (Each stage may be painless or painful)

次要结局

  • Failed treatment: surgical intervention required(1,2, 4-6, 12months)
  • Patient rated functional outcome(1, 2, 4-6, 12months)
  • Pain(1, 2, 4-6, 12 months)

研究者

发起方
The Philadelphia & South Jersey Hand Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sidney M. Jacoby

Associate Professor

The Philadelphia & South Jersey Hand Center

研究点 (2)

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