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
  • Arthroscopic rotator cuff surgery follwed by physical therapy
  • Physical therapy alone
Outcomes

Primary: shoulder pain and function

Secondary: shoulder pain and activities of daily living

Timeframe 1-year follow-up for primary outcomes

Project Information

Nitin Jain, MD, MS
Vanderbilt University Medical Center
$7,582,001

Key Dates

60 months
March 2017
June 2023
2017

Study Registration Information

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Project Status
Award Type
Health Conditions

Health Conditions

These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them.

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Populations

Populations

PCORI is interested in research that seeks to better understand how different clinical and health system options work for different people. These populations are frequently studied in our portfolio or identified as being of interest by our stakeholders.

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Funding Opportunity Type
Intervention Strategy

Intervention Strategies

PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care.

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State

State

The state where the project originates, or where the primary institution or organization is located.

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Last updated: February 20, 2020