Trial for Shoulder Pathology and Pain in Chronic SCI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 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
- 否
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.
研究组 & 干预措施
shoulder exercise intervention
A home exercise intervention for strengthening and stretching the shoulders - Strengthening and Optimal Movement for Painful Shoulders (STOMPS) - performed 3 times per week for 12 weeks.
干预措施: shoulder exercise (Behavioral)
education-only control
Subjects watched a 1 hour educational video on shoulder anatomy, mechanisms of shoulder injury and pain, and hints for managing shoulder pain
干预措施: education (Behavioral)
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)
- Change in shoulder pain using the numerical rating scale(Baseline to week 12)
- Change in shoulder pain using the WUSPI(Baseline to week 12)
研究者
Elizabeth Roy Felix
Associate Professor
University of Miami