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

Primary Purpose

Rotator Cuff Injuries

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

MedCline Shoulder Relief System

About this trial

This is an interventional treatment trial for Rotator Cuff Injuries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University Orthopedics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MedCline Shoulder Relief System

Control

Arm Description

Patients who will receive the MedCline Shoulder Relief System pillow

Patients who will not receive the MedCline Shoulder Relief System pillow

Outcomes

Primary Outcome Measures

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

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

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.

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

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)

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05011331

First Posted

August 2, 2021

Last Updated

October 26, 2022

Sponsor

Rhode Island Hospital

Collaborators

Amenity Health, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05011331

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

October 13, 2020 (Actual)

Primary Completion Date

November 2023 (Anticipated)

Study Completion Date

November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rhode Island Hospital

Collaborators

Amenity Health, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rotator Cuff Injuries

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

MedCline Shoulder Relief System

Arm Type

Experimental

Arm Description

Patients who will receive the MedCline Shoulder Relief System pillow

Arm Title

Control

Arm Type

Active Comparator

Arm Description

Patients who will not receive the MedCline Shoulder Relief System pillow

Intervention Type

Device

Intervention Name(s)

MedCline Shoulder Relief System

Intervention Description

Patients will receive a customized pillow to aid with sleep

Primary Outcome Measure Information:

Title

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

Description

The ISI assesses sleep difficulty using a 5 point Likert Scale, where a lower score is better

Time Frame