Clinical trial NCT05011331: 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
Overall status: RECRUITING
Phase: NA
Conditions: Rotator Cuff Injuries
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
Collaborators: name: Amenity Health, Inc.
First posted: 2021-08-18
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Sleep Difficulty as Assessed as Assessed Using the Insomnia Severity Index (ISI)
timeFrame: Baseline, two weeks, six weeks
measure: Change from Baseline in Pain Scores on the Visual Analog Scale (VAS)
timeFrame: Baseline, two weeks, six weeks
measure: Change in Quality of Life as Assessed Using the Euroqol (EQ-5D)
timeFrame: Baseline, two weeks, six weeks
measure: Change in Shoulder Function as Assessed Using the American Shoulder and Elbow Surgeons Shoulder Score (ASES)
timeFrame: Baseline, two weeks, six weeks
measure: Change in Shoulder Function as Assessed Using the Single Assessment Numeric Evaluation (SANE)
timeFrame: Baseline, two weeks, six weeks
measure: Change in Shoulder Function as Assessed Using the Western Ontario Rotator Cuff Index (WORC)
timeFrame: Baseline, two weeks, six weeks
Secondary outcomes:
Other outcomes:
Locations:
city: East Providence
country: United States
facility: University Orthopedics
state: Rhode Island
Study officials:
affiliation: University Orthopedics
name: E S Paxton, MD
role: PRINCIPAL_INVESTIGATOR
References: