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

NCT05011331 | Recruiting FDA Device

• 1 other identifier: 1620695
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rotator Cuff Injuries

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

MedCline Shoulder Relief System

EXPERIMENTAL

Patients who will receive the MedCline Shoulder Relief System pillow

Device: MedCline Shoulder Relief System

Control

ACTIVE COMPARATOR

Patients who will not receive the MedCline Shoulder Relief System pillow

Device: MedCline Shoulder Relief System

Interventions

MedCline Shoulder Relief System DEVICE

Patients will receive a customized pillow to aid with sleep

Control; MedCline Shoulder Relief System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \>18 and a diagnosis of rotator cuff syndrome which is being treated non-operatively.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rhode Island Hospital: lead
• Amenity Health, Inc.: collaborator

Study Sites (1)

University Orthopedics

East Providence, Rhode Island, 02915, United States

RECRUITING

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• E S Paxton, MD

  University Orthopedics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Trevor Toavs

CONTACT

(401) 457-1500; ttoavs@universityorthopedics.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2021
• First Posted: August 18, 2021
• Study Start: October 13, 2020
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)