Custom Pillow for Rotator Cuff Syndrome Sleep Quality
This study is looking at whether a special pillow, called the MedCline Shoulder Relief System, can help improve sleep for people with shoulder pain from a rotator cuff injury that isn't being treated with surgery. Researchers want to see if using this pillow leads to better sleep, less pain, and a better quality of life. You might be able to join if you are over 18, have a rotator cuff injury not requiring surgery, and meet other specific health criteria. The study will measure changes in your sleep difficulty, pain levels, and overall quality of life over six weeks. The current status of this study is unclear, but it plans to enroll 80 participants.
- Study design
- This interventional study will involve two groups: one receiving the MedCline Shoulder Relief System pillow and one not. It plans to enroll 80 participants.
- What's involved
- You would be assessed at the beginning of the study, then again at two weeks and six weeks. If you are in the control group, you may be offered a pillow at the end of the trial and surveyed at similar intervals.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your sleep quality, pain, and quality of life will be measured for six weeks after the start of the study.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
The Effect of a Custom Pillow on Sleep Quality in Patients With Nonoperative Rotator Cuff Syndrome
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- E S Paxton, MD · PRINCIPAL_INVESTIGATOR · University Orthopedics
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Change in Sleep Difficulty as Assessed as Assessed Using the Insomnia Severity Index (ISI)Baseline, two weeks, six weeks
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)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)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 American Shoulder and Elbow Surgeons Shoulder Score (ASES)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 Shoulder Function as Assessed Using the Single Assessment Numeric Evaluation (SANE)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)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