The Effect of a Custom Pillow on Sleep Quality in Patients With Nonoperative Rotator Cuff Syndrome: a Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change from Baseline in Pain Scores on the Visual Analog Scale (VAS)
研究概览
简要总结
The objective of this study is to determine if a pillow sleep aid improves sleep quality in the short term for patients who have shoulder pain from a rotator cuff injury and are being managed non-operatively.
详细描述
Patients who have shoulder pain from a rotator cuff injury will be identified in the outpatient clinic and offered the chance to enroll in the study. Informed consent will be obtained. There will be two groups of patients in this study; those that receive the pillow sleep aid (the intervention group) and those that do not (the control group). The pillow sleep aid that will be investigated in this project is the "MedCline Shoulder Relief System," a product of Amenity Health Inc.. The pillow will be delivered to the intervention group at no cost. Patients in both groups will be prescribed the same physical therapy protocols. At the end of the trial period, patients in the control group will be offered the option to receive a pillow. Those that accept will be surveyed at similar intervals as the original intervention group.
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
- 否
入选标准
- •age >18 and a diagnosis of rotator cuff syndrome which is being treated non-operatively.
排除标准
- •history of prior shoulder surgery, receiving a corticosteroid injection at initial visit, lack of mailing address, non-English speaking patient, inability to sleep on one's side, preexisting clinical insomnia and obstructive sleep apnea.
研究组 & 干预措施
MedCline Shoulder Relief System
Patients who will receive the MedCline Shoulder Relief System pillow
干预措施: MedCline Shoulder Relief System (Device)
Control
Patients who will not receive the MedCline Shoulder Relief System pillow
干预措施: MedCline Shoulder Relief System (Device)
结局指标
主要结局
Change from Baseline in Pain Scores on the Visual Analog Scale (VAS)
时间窗: Baseline, two weeks, six weeks
The VAS utilizes a scale from 0-10 where a high score indicates more pain
Change in Quality of Life as Assessed Using the Euroqol (EQ-5D)
时间窗: Baseline, two weeks, six weeks
The EQ-5D assesses quality of life with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Change in Shoulder Function as Assessed Using the Single Assessment Numeric Evaluation (SANE)
时间窗: Baseline, two weeks, six weeks
SANE assesses shoulder function via 1 question as a percentage of normal (0-100 scale with 100 being normal)
Change in Shoulder Function as Assessed Using the Western Ontario Rotator Cuff Index (WORC)
时间窗: Baseline, two weeks, six weeks
WORC utilizes 21 questions where each question uses a visual analog scale, a line with a 0-100 scale where 0 represents no difficulty. It asks about shoulder pain in 5 different domains, physical symptoms, sports, work, social, and emotions
Change in Shoulder Function as Assessed Using the American Shoulder and Elbow Surgeons Shoulder Score (ASES)
时间窗: Baseline, two weeks, six weeks
The ASES is a 100-point scale that consists of two dimensions: pain and activities of daily living. There is a pain scale worth 50 points and ten activities of daily living questions worth 50 points
Change in Sleep Difficulty as Assessed as Assessed Using the Insomnia Severity Index (ISI)
时间窗: Baseline, two weeks, six weeks
The ISI assesses sleep difficulty using a 5 point Likert Scale, where a lower score is better
次要结局
未报告次要终点