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临床试验/NCT01874821
NCT01874821终止不适用

Adhesive Capsulitis and Dynamic Splinting: a Randomized, Controlled Trial

Dynasplint Systems, Inc.1 个研究点 分布在 1 个国家目标入组 5 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
终止
入组人数
5
试验地点
1
主要终点
Efficacy

研究概览

简要总结

The purpose of this study is to examine the efficacy of dynamic splinting in reducing contracture following diagnosis of adhesive capsulitis.

详细描述

This randomized controlled trial will explore the efficacy of dynamic splinting in conjunction with the current standard of care as compared to standard of care 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
None

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

  • Greater than 25% reduction in maximal external rotation plus greater than 25% reduction in at least one other plane of motion (elevation or abduction), as compared to the asymptomatic shoulder, measure supine with humerus abducted to 90º
  • Duration from onset less than 12 months.
  • Pain that is worsened by moving the arm in that direction

排除标准

  • Any previous shoulder surgery.
  • Brachial plexus injuries
  • Neurologically mediated pain and fibromatosis-like contracture
  • Concomitant neurologic complaints or abnormalities
  • Glenohumeral impingement or mechanical blockage
  • Oncological process affecting the shoulder
  • Previous total mastectomy
  • Glenohumeral arthritis

结局指标

主要结局

Efficacy

时间窗: 6 months

The primary measures are full arc ROM and changes in the Disabilities of the Arm Shoulder Hand pain survey (DASH).

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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