跳至主要内容
临床试验/NCT02972879
NCT02972879Unknown不适用

Effectiveness of Non-surgical Interventions for the Trigger Finger: a Randomized Clinical Trial

Beatriz Sernajoto Cristiani Pedro0 个研究点目标入组 132 人开始时间: 2018年3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
132
主要终点
Changes in the Resolution/cure of the trigger finger until the six months of the treatment

研究概览

简要总结

The aim of this study is to assess the effectiveness of therapeutic modalities (paraffin, ultrasound and orthotics) versus corticosteroid injection for trigger finger.

详细描述

There are several forms of nonsurgical treatment for trigger finger, the most used are:

  • Oral nonsteroidal and steroidal antiinflammatory's drugs use to resolve the inflammatory process
  • Corticosteroids local injection: that proposes to control the inflammation, these injections have shown good effectiveness for trigger finger treatment.
  • Orthotic: with the aim of to immobilize the affected joint until the resolution of the inflammatory process.
  • Electrotherapeutic modalities:
  • Paraffin that increases cellular metabolism and promotes peripheral vasodilatation, favoring the transduction tissue fluid, lymph flow, hyperemia and consequent absorption of exsudato.
  • LASER -Lower Level Laser Therapy (LLLT): the absorption of light through the skin's photoreceptors stimulates mitochondrial chain reactions, promoting adenosine triphosphate (ATP) synthesis, acting on gene expression, which raises the level of growth factors and Tissue repair

Although the non-surgical treatment is often used there is no evidence in the literature of which is the most effective conservative treatment for trigger finger. Thus, it is necessary use appropriate methodology to define the benefits and harms of each treatment modality and assess the effectiveness of these nonsurgical treatments, and may define which one has a higher resolution and lower rates of trigger finger recurrences in short, medium and long term.

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

入选标准

  • 2-3 grade of trigger finger (Quinnell´s classification)
  • Signing the Terms of Consent.

排除标准

  • Presence of finger trigger in children
  • Presence of traumatic finger trigger
  • Secondary causes (patients with tumor of the tendon sheath,
  • synovitis tuberculosis, etc ...)

结局指标

主要结局

Changes in the Resolution/cure of the trigger finger until the six months of the treatment

时间窗: 1, 5, 12 weeks and 6 month

The patient must extend and flex the affected finger 10 times to verify the presence or absence of the trigger finger and determine the degree of commitment.

次要结局

  • Changes in the numbers of the Complications(1, 5, 12 weeks and 6 month)
  • Changes in Visual Analogue Scale (VAS)(1, 5, 12 weeks and 6 month)
  • Changes in Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH)(1, 5, 12 weeks and 6 month)
  • Changes in SF-12 (quality of life)(1, 5, 12 weeks and 6 month)
  • Changes in the numbers of the Relapses(1, 5, 12 weeks and 6 month)

研究者

发起方
Beatriz Sernajoto Cristiani Pedro
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Beatriz Sernajoto Cristiani Pedro

BSCPedro

Federal University of São Paulo

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