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临床试验/NCT05763017
NCT05763017已完成不适用

A Randomized Comparative Trial of Relative Motion Splint Versus Metacarpophalangeal Joint Blocking Splint in the Management of Trigger Finger

National University of Malaysia2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2022年6月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
36
试验地点
2
主要终点
Stages of Stenosing Tenosynovitis (SST)

研究概览

简要总结

The purpose of this study is to compare the effectiveness of relative motion splint and metacarpophalangeal joint blocking splints in terms of sign and symptoms, hand function, occupational performance, and perception of splint wearability (comfort and satisfaction) after six weeks of TF management.

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
None

入排标准

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

入选标准

  • single or multiple trigger finger
  • unilateral or bilateral trigger finger
  • neutral metacarpophalangeal joint position can be attained during passive isolated metacarpophalangeal joint extension of the affected finger

排除标准

  • trigger thumb
  • steroid injection of the affected finger within last six months
  • A1 pulley release of the affected finger.
  • history of fracture, tendon injury, nerve injury, Dupuytren's contracture, and other soft tissue injuries of the affected finger or adjacent fingers.

结局指标

主要结局

Stages of Stenosing Tenosynovitis (SST)

时间窗: Baseline, 6 weeks after splint wear

SST is a grading system that divides trigger finger into six stages. Stage 1 is normal; Stage 2 is uneven finger movement; Stage 3 is triggering or clicking or catching; Stage 4 is locking of finger in flexion or extension, which can be unlocked by active finger movement; Stage 5 is locking of finger in flexion or extension, which requires application of passive force to unlock; and Stage 6 is locked finger in flexion or extension

次要结局

  • Visual Analog Scale (VAS) for pain(Baseline, 6 weeks after splint wear)
  • Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure(Baseline, 6 weeks after splint wear)
  • Canadian Occupational Performance Measure (COPM)(Baseline, 6 weeks after splint wear)
  • Number of triggering events in ten active fists(Baseline, 6 weeks after splint wear)
  • Visual Analog Scale (VAS) for splint comfort(Baseline, 3 and 6 weeks after splint wear)
  • Visual Analog Scale (VAS) for splint satisfaction(Baseline, 3 and 6 weeks after splint wear)

研究者

发起方
National University of Malaysia
申办方类型
Other
责任方
Sponsor

研究点 (2)

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