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OpenTrials
Completed

NCT Number: NCT03906630

Comparison of the Accuracy of Telehealth Examination Versus Clinical Examination in the Detection of Rotator Cuff Tears

The purpose of this study is to compare how accurately a pseudo-telehealth shoulder examination diagnoses rotator cuff tears compared to a regular clinical examination. MRI is used as the gold standard.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Southeastern Orthopedics Shoulder Center, Raleigh, North Carolina, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 40 years of age or older, presenting with shoulder pain, and seen in the Duke Sports Medicine clinic by Dr. Wittstein or Dr. Lassiter

Exclusion criteria

  • Patient cannot have had prior shoulder arthroplasty, instability or history of fracture/dislocation. Pregnant women will be excluded from the study because there will be an MRI. Anyone unable or unwilling to have an MRI will be excluded from the study.

Treatment and study plan

Telehealth clinical exam

Diagnostic Test

This is a pseudo telehealth clinical exam for patients presenting with shoulder pain

Standard clinical exam

Diagnostic Test

This is a standard in-person clinical exam for patients presenting with shoulder pain

Primary outcomes

  1. Agreement with MRI findings as they pertain to presence or absence of a rotator cuff tear

    Time frame: Within 1 month of exam

    % of exams that agreed with the MRI findings

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 8, 2019
Registry last updated
Nov 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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