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临床试验/NCT02104531
NCT02104531已完成不适用

Shoulder Motion Guided Patient Diagnostic and Treatment Classification

University of Minnesota1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2015年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Rotator cuff tendon predicted disease location

研究概览

简要总结

The investigators purpose is to determine the ability of a low cost, currently available imaging technique to predict shoulder movement disorders and the location of shoulder disease based on motion analysis of subjects with known shoulder disorders.

详细描述

Shoulder disorders account for the second largest number of musculoskeletal cases in the United States with a large health care burden. The current standard for diagnosis of shoulder disorders is a clinical exam, visual motion assessment and in some cases, costly magnetic resonance (MR) imaging. However, specific tissue pathologies are not always accurately identified, and often not directly linked to the magnitude of dysfunction. There is a need for categorizing or sub-grouping patients based on the underlying movement dysfunctions with which they present. Video fluoroscopy is a common clinical tool that can improve the accuracy of motion analysis. The investigators are using 2-D fluoroscopy, combined with 3-D MR imaging to measure shoulder motion. From the motion analysis we can predict areas of potential soft tissue disease, and compare these to disease locations from MR imaging. The investigators hypotheses is that our motion based predicted disease locations will be significantly associated with disease locations from MR imaging.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Normal subjects with normal normal shoulder movement and function will be included, age and gender matched to symptomatic subjects.
  • Symptomatic subjects will be included if visual shoulder movement deviates from what might be considered normal; they are experiencing shoulder pain with movement, and clinical examination is consistent with soft tissue cumulative trauma to the soft tissues (rotator cuff disease).
  • Clinical MR imaging will be used to confirm rotator cuff disease, subacromial bursitis, and/or bicipital tendinitis.

排除标准

  • Age outside the accepted range. Contraindications to radiation exposure (pregnancy or possible pregnancy, other recent substantive radiation exposures (CT scanning, treatments involving radiation). Subjects unable to move through at least 90 degrees of shoulder motion will also be excluded.

结局指标

主要结局

Rotator cuff tendon predicted disease location

时间窗: baseline

Measures will predict presence/absence of rotator cuff disease in each of the supraspinatus, infraspinatus, and subscapularis muscles (rotator cuff). Subjects are not followed, there is no intervention. The assessment timeframe is dependent on subjects volunteering for the study and can range from 1 month to 10 years from initial onset of their condition.

次要结局

  • Shoulder Motion(baseline)
  • Shoulder functional status(baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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