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.
age >18 and a diagnosis of rotator cuff syndrome which is being treated non-operatively.
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.
Parallel
MedCline Shoulder Relief System
DevicePatients will receive a customized pillow to aid with sleep
Change in Sleep Difficulty as Assessed as Assessed Using the Insomnia Severity Index (ISI)
The ISI assesses sleep difficulty using a 5 point Likert Scale, where a lower score is better
Change from Baseline in Pain Scores on the Visual Analog Scale (VAS)
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)
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 American Shoulder and Elbow Surgeons Shoulder Score (ASES)
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
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Rhode Island Hospital
Lead sponsor
Amenity Health, Inc.
Collaborator
