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临床试验/NCT03521856
NCT03521856已完成不适用

Trial for Shoulder Pathology and Pain in Chronic SCI

University of Miami2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2012年5月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
35
试验地点
2
主要终点
Change in shoulder pathology

研究概览

简要总结

This research study will investigate in a 12-week home exercise program to see whether it is effective in improving shoulder pathology and reducing shoulder pain in persons with chronic spinal cord injury. The research study will involve ultrasound shoulder examinations of your shoulders using a non-invasive medical ultrasound machine, as well as clinical shoulder examinations and completion of a number of pain questionnaires.

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

  • Candidates will be men or women, 18 years of age or older.
  • Candidates must have an SCI and be at least 1 year post-diagnosis
  • Candidates must use a wheelchair (manual or electric) for at least the majority of the time.
  • Candidates must be able to transfer themselves without the help of others.
  • The presence of at least moderate shoulder pain (rating of >= 4 on a 0-10 rating scale for average pain intensity) for 3 or more months.

排除标准

  • Patients younger than 18 years of age.
  • Patients who have a history of pre-injury rotator cuff tears or shoulder injury.
  • Patients who do not use a wheelchair (manual or electric) at least 50% of the time.

结局指标

主要结局

Change in shoulder pathology

时间窗: Baseline to week 12

Quantitative ultrasound measures of the supraspinatus tendon

次要结局

  • Change in shoulder pathology(Baseline to week 16)
  • Change in shoulder pain using the WUSPI(Baseline to week 16)
  • Change in shoulder pain using the numerical rating scale(Baseline to week 16)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elizabeth Roy Felix

Associate Professor

University of Miami

研究点 (2)

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