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

Lifespan

Status: Enrolling

Conditions: Rotator Cuff Injuries

Treatments: Device: MedCline Shoulder Relief System

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05011331

1620695

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

MedCline Shoulder Relief System

Experimental group

Description:

Patients who will receive the MedCline Shoulder Relief System pillow

Treatment:

Device: MedCline Shoulder Relief System

Control

Active Comparator group

Description:

Patients who will not receive the MedCline Shoulder Relief System pillow

Treatment:

Device: MedCline Shoulder Relief System