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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Rotator Cuff Injuries
• Intervention / Treatment: Device: MedCline Shoulder Relief System

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Trevor Toavs; Phone Number: 4278 (401) 457-1500; Email: ttoavs@universityorthopedics.com

Study Locations

• United States
  • Rhode Island
    • East Providence, Rhode Island, United States, 02915
      • Recruiting
      • University Orthopedics
      • Contact: Trevor Toavs; Phone Number: (401)443-4278; Email: ttoavs@universityorthopedics.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rhode Island Hospital
• Collaborators: Amenity Health, Inc.
• Investigators: Principal Investigator: E S Paxton, MD, University Orthopedics

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2020
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: August 2, 2021
• First Submitted That Met QC Criteria: August 10, 2021
• First Posted (Actual): August 18, 2021

Study Record Updates

• Last Update Posted (Actual): April 29, 2025
• Last Update Submitted That Met QC Criteria: April 24, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Shoulder Injuries; Wounds and Injuries; Rupture; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: 1620695

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes