跳至主要内容
临床试验/NCT04855942
NCT04855942撤回不适用

Focused Extracorporeal Shock Wave Therapy (ESWT) Versus Traditional Physiotherapy in the Treatment of Trigger Finger: a Randomized Controlled Study

Cheng-Hsin General Hospital0 个研究点开始时间: 2021年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Quinnell stages of triggering

研究概览

简要总结

Trigger finger is the common name of stenosing tenosynovitis of fingers, caused by repetitive trauma. Conservative treatment includes NSAIDs or other analgesic agents, activity modification, splint, and physiotherapy. Operation could be considered if conservative treatments fails. With literature reviewed, there is no treatment which is both non-invasive and effective, and also could avoid recurrence well.

Extracorporeal shock wave therapy could induce angiogenesis, anti-inflammatory reaction, and recruitment of fibroblast. Although extracorporeal shock wave has been utilized in musculoskeletal diseases for more than twenty years, there is no well-designed clinical trial to prove the effectiveness of extracorporeal shock wave in treating trigger finger. The purpose of this study is to compare the effectiveness of extracorporeal shock wave therapy with traditional physical therapy for the management of trigger finger.

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 (Investigator, 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

  • Quinnel classification grade 2 or 3
  • who has only one trigger

排除标准

  • who had ever treated the trigger finger
  • who has other musculoskeletal disease of the upper limb
  • who has severe coagulopathy disease
  • who is pregnant
  • who has arrhythmia or has a pacemaker
  • there is sensory impairment, scar, edema at the trigger finger
  • who has cognitive dysfunction

结局指标

主要结局

Quinnell stages of triggering

时间窗: 15 weeks

Quinnell stages of triggering classifies the trigger finger using five types during flexion and extension: normal movement (Type 0), uneven movement (Type I), actively correctable (Type II), passively correctable (Type III) and fixed deformity (Type IV).

sonographic image

时间窗: 15 weeks

The investigators would record the characteristics of acquired sonographic images, such like the thickness of finger flexor tendon and A1 pulley, the presence of tendon sheath effusion, and the presence of increased vascularity by Doppler images.

11-point numeric scale of pain

时间窗: 15 weeks

The 11-point numeric scale of pain requires the patient to rate their pain on a defined scale. 0 is no pain and 10 is the worst pain imaginable.

Chinese quick DASH (disabilities of the Arm, Shoulder, and Hand questionnaire)

时间窗: 15 weeks

This questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The investigators chose the first two components: the disability and symptom section (11 items, scored 1-5). The lower score means better condition of upper limbs, and vice versa.

strength of hand grip

时间窗: 15 weeks

The strength of hand grip is to measure the maximum isometric strength of the hand and forearm muscles by a electicial grip strength device.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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