Recruiting

Custom Pillow

Sponsor:

Rhode Island Hospital

Code:

NCT05011331

Conditions

Rotator Cuff Injuries

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MedCline Shoulder Relief System

Study Details

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

Study ID

NCT05011331

Start date

Oct 13, 2020

Status verified date

Apr, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: MedCline Shoulder Relief System

Patients who will receive the MedCline Shoulder Relief System pillow

active comparator: Control

Patients who will not receive the MedCline Shoulder Relief System pillow

Interventions

MedCline Shoulder Relief System

Patients will receive a customized pillow to aid with sleep

Primary outcome measure

  • Change in Sleep Difficulty as Assessed as Assessed Using the Insomnia Severity Index (ISI) [ Time Frame: Baseline, two weeks, six weeks ]
  • Change from Baseline in Pain Scores on the Visual Analog Scale (VAS) [ Time Frame: Baseline, two weeks, six weeks ]
  • Change in Quality of Life as Assessed Using the Euroqol (EQ-5D) [ Time Frame: Baseline, two weeks, six weeks ]
  • Change in Shoulder Function as Assessed Using the American Shoulder and Elbow Surgeons Shoulder Score (ASES) [ Time Frame: Baseline, two weeks, six weeks ]
  • Change in Shoulder Function as Assessed Using the Single Assessment Numeric Evaluation (SANE) [ Time Frame: Baseline, two weeks, six weeks ]
  • Change in Shoulder Function as Assessed Using the Western Ontario Rotator Cuff Index (WORC) [ Time Frame: Baseline, two weeks, six weeks ]

Central Contacts and Locations

Central contacts

Trevor Toavs

(401) 457-1500ttoavs@universityorthopedics.com

Locations

University Orthopedics

Recruiting

East Providence, Rhode Island, United States, 02915

Contacts

Trevor Toavs

(401)443-4278ttoavs@universityorthopedics.com

More Information

Sponsor

Rhode Island Hospital

Last update posted

Apr 29, 2025

Last verified

Apr, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rhode Island Hospital on 2025-04-29.