The Effect of a Custom Pillow on Sleep Quality in Patients With Nonoperative Rotator Cuff Syndrome

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of a Custom Pillow on Sleep Quality in Patients With Nonoperative Rotator Cuff Syndrome: a Prospective Randomized Study

Conditions
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Rotator Cuff Injuries

Intervention / Treatment
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* Device: MedCline Shoulder Relief System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age >18 and a diagnosis of rotator cuff syndrome which is being treated non-operatively. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MedCline Shoulder Relief System<br>Patients who will receive the MedCline Shoulder Relief System pillow | Device: MedCline Shoulder Relief System<br>* Patients will receive a customized pillow to aid with sleep<br>|
| Active Comparator: Control<br>Patients who will not receive the MedCline Shoulder Relief System pillow | Device: MedCline Shoulder Relief System<br>* Patients will receive a customized pillow to aid with sleep<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline, two weeks, six weeks | 
| 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 | Baseline, two weeks, six weeks | 
| 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. | Baseline, two weeks, six weeks | 
| 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 | Baseline, two weeks, six weeks | 
| Change in Shoulder Function as Assessed Using the Single Assessment Numeric Evaluation (SANE) | SANE assesses shoulder function via 1 question as a percentage of normal (0-100 scale with 100 being normal) | Baseline, two weeks, six weeks | 
| Change in Shoulder Function as Assessed Using the Western Ontario Rotator Cuff Index (WORC) | 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 | Baseline, two weeks, six weeks |