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

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2024

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

Arms, Groups and Cohorts

  • Experimental: MedCline Shoulder Relief System
    • Patients who will receive the MedCline Shoulder Relief System pillow
  • Active Comparator: Control
    • Patients who will not receive the MedCline Shoulder Relief System pillow

Clinical Trial Outcome Measures

Primary Measures

  • Change in Sleep Difficulty as Assessed as Assessed Using the Insomnia Severity Index (ISI)
    • Time Frame: Baseline, two weeks, six weeks
    • 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)
    • Time Frame: Baseline, two weeks, six weeks
    • 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)
    • Time Frame: Baseline, two weeks, six weeks
    • 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)
    • Time Frame: Baseline, two weeks, six weeks
    • 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)
    • Time Frame: Baseline, two weeks, six weeks
    • 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)
    • Time Frame: Baseline, two weeks, six weeks
    • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Rhode Island Hospital
  • Collaborator
    • Amenity Health, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • E S Paxton, MD, Principal Investigator, University Orthopedics
  • Overall Contact(s)
    • Oscar Covarrubias, (401) 457-1500, ocovarrubias@universityorthopedics.com

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