Custom pillow improves sleep quality for rotator cuff injury patients
The Effect of a Custom Pillow on Sleep Quality in Patients With Nonoperative Rotator Cuff Syndrome: a Prospective Randomized Study
NA · Rhode Island Hospital · NCT05011331
This study tests if using a special pillow can help people with rotator cuff injuries sleep better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rhode Island Hospital (other) |
| Locations | 1 site (East Providence, Rhode Island) |
| Trial ID | NCT05011331 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with a diagnosis of rotator cuff syndrome being treated non-operatively.
Not a fit: Patients with a history of shoulder surgery, preexisting clinical insomnia, or obstructive sleep apnea may not benefit from this study.
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 performed: While this specific approach is novel, similar studies have shown that targeted sleep interventions can improve quality of life for patients with chronic pain.
Eligibility criteria
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 this trial is running
East Providence, Rhode Island
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Rotator Cuff Injuries