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NCT Number: NCT05011331

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

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.

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Key information

Conditions

Rotator Cuff Injuries Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Orthopedics

East Providence, Rhode Island, 02915, United States

Location status: Recruiting

Location contact

Trevor Toavs

CONTACT

[email protected]

(401)443-4278

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MedCline Shoulder Relief System

Device

Patients will receive a customized pillow to aid with sleep

Primary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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

  5. 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)

  6. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Trevor Toavs

CONTACT

[email protected]

(401) 457-1500 ext. 4278

Sponsors and collaborators

Lead sponsor

Rhode Island Hospital

Other

Collaborators

  • Amenity Health, Inc.

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2026
Study completion
2027
First posted
Aug 18, 2021
Registry last updated
Apr 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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