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

Completed

• Conditions: Rotator Cuff Tear
• Interventions: Diagnostic Test: Telehealth clinical exam; Diagnostic Test: Standard clinical exam

• Registration Number: NCT03906630
• Lead Sponsor: Duke University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-05
• Study First Submitted QC: 2019-04-05
• Study First Posted: 2019-04-08
• Study Start: 2019-08-19
• Status Verified: 2020-11
• Primary Completion: 2020-11-05
• Study Completion: 2020-11-05
• Last Update Submitted: 2020-11-13
• Last Update Posted: 2020-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Shoulder patients	Telehealth clinical exam	-
Shoulder patients	Standard clinical exam	-

Primary Outcome Measures

Name	Time	Method
Agreement with MRI findings as they pertain to presence or absence of a rotator cuff tear	Within 1 month of exam	% of exams that agreed with the MRI findings

Trial Locations

Locations (2)

Southeastern Orthopedics Shoulder Center; 🇺🇸 Raleigh, North Carolina, United States

Duke Health Heritage; 🇺🇸 Wake Forest, North Carolina, United States