The Effect of a Custom Pillow on Sleep Quality in Patients With Nonoperative Rotator Cuff Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MedCline Shoulder Relief System.
- Who it may be relevant to
- Registry conditions: Rotator Cuff Injuries. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of a Custom Pillow on Sleep Quality in Patients With Nonoperative Rotator Cuff Syndrome: a Prospective Randomized Study
Overview
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.
Interventions
- Device MedCline Shoulder Relief System
Patients will receive a customized pillow to aid with sleep
Primary outcome measures
- 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]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University Orthopedics — East Providence
Identifiers
NCT: NCT05011331 · 1620695