Custom pillow improves sleep quality for rotator cuff injury patients
Official title: The Effect of a Custom Pillow on Sleep Quality in Patients With Nonoperative Rotator Cuff Syndrome: a Prospective Randomized Study
Run by Rhode Island Hospital · NCT05011331 · Data updated 2026-11-12
This study tests if using a special pillow can help people with rotator cuff injuries sleep better.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Rhode Island Hospital Academic / other |
| Locations | 1 site (East Providence, Rhode Island) |
| Status | Recruiting |
| Started | October 13, 2020 |
| Main results expected | December 2026 |
| Study ends | December 2027 |
| Registry record updated | April 29, 2025 |
| Trial ID | NCT05011331 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 with a diagnosis of rotator cuff syndrome being treated non-operatively.
✕Probably not a fit
Patients with a history of shoulder surgery, preexisting clinical insomnia, or obstructive sleep apnea may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the effectiveness of a specialized pillow, the MedCline Shoulder Relief System, in enhancing sleep quality for patients suffering from non-operative rotator cuff syndrome. Participants will be divided into two groups: one receiving the pillow and the other serving as a control without the pillow. Both groups will follow the same physical therapy protocols, and the pillow will be provided at no cost to the intervention group. After the trial, control group participants will have the option to receive the pillow and will be surveyed similarly to the intervention group.
Why it matters
Potential benefit: If successful, this intervention could significantly improve sleep quality for patients with shoulder pain due to rotator cuff injuries.
How similar studies have gone: While this specific approach is novel, similar studies have shown that targeted sleep interventions can improve quality of life for patients with chronic pain.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
University Orthopedics
East Providence, Rhode Island, United States Recruiting
Study contacts
- Principal investigator: E S Paxton, MD — University Orthopedics
- Study coordinator: Trevor Toavs
- Email: ttoavs@universityorthopedics.com
- Phone: (401) 457-1500
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.