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

DEVICE

MedCline Shoulder Relief System

Patients will receive a customized pillow to aid with sleep

Change in Sleep Difficulty as Assessed as Assessed Using the Insomnia Severity Index (ISI)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.