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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-13

Study Completion Date

2027-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Rotator Cuff Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MedCline Shoulder Relief System

Patients who will receive the MedCline Shoulder Relief System pillow

Group Type EXPERIMENTAL

MedCline Shoulder Relief System

Intervention Type DEVICE

Patients will receive a customized pillow to aid with sleep

Control

Patients who will not receive the MedCline Shoulder Relief System pillow

Group Type ACTIVE_COMPARATOR

MedCline Shoulder Relief System

Intervention Type DEVICE

Patients will receive a customized pillow to aid with sleep

Interventions

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MedCline Shoulder Relief System

Patients will receive a customized pillow to aid with sleep

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No