Project Summary
PCORI has identified the need for large studies that look at real-life questions facing diverse patients, caregivers, and clinicians. In 2014, PCORI launched the Pragmatic Clinical Studies initiative to support large-scale comparative effectiveness studies focusing on everyday care for a wide range of patients. The Pragmatic Clinical Studies initiative funded this research project.
This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.
What is the research about?
The rotator cuff is a group of muscles and tendons around the shoulder joint. Rotator cuff tears are the most common cause of shoulder pain. Patients with rotator cuff tears have difficulty doing daily activities such as cooking, combing hair, or reaching behind their back. Treatment includes surgery and physical therapy. But the research on how well these treatments work compared with each other is not consistent.
In this study, the research team is comparing physical therapy alone with surgery plus physical therapy to treat rotator cuff tears. The team is comparing the effect of these two treatments on shoulder pain and function.
Who can this research help?
Results may help doctors and patients when choosing treatment for rotator cuff tears.
What is the research team doing?
The research team is recruiting 700 patients ages 50 to 84 with rotator cuff tears. Patients are receiving care at one of 12 sites across the United States. The team is assigning patients by chance to receive surgery plus physical therapy or physical therapy alone. One year after treatment, the team is surveying patients about their shoulder pain and function and how well they can perform daily activities. Also, the team is looking to see how tear size and patient age affect pain and function. The team is working on a website to share results of the study and provide resources for patients with shoulder pain.
Patients, insurers, surgeons, physical therapists, and medical and rehabilitation organizations are helping plan and conduct this study.
Research methods at a glance
| Design Elements | Description |
|---|---|
| Design | Randomized controlled trial |
| Population |
700 adults ages 50 to 84 with MRI-confirmed partial- or full-thickness supraspinatus and/or infraspinatus tear of 4 cm or less in longitudinal dimension who are medically fit for surgery |
| Interventions/ Comparators |
|
| Outcomes |
Primary: shoulder pain and function Secondary: shoulder pain and activities of daily living |
| 1-year follow-up for primary outcomes |