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NCT03906630 Clinical Trial

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

Rotator Cuff Tear Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03906630
Other study ID # Pro00101866
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 19, 2019
Est. completion date November 5, 2020

Study information
Verified date November 2020
Source Duke University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 65
Est. completion date November 5, 2020
Est. primary completion date November 5, 2020
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Telehealth clinical exam
This is a pseudo telehealth clinical exam for patients presenting with shoulder pain
• Standard clinical exam
This is a standard in-person clinical exam for patients presenting with shoulder pain

Locations
Country Name City State
United States Southeastern Orthopedics Shoulder Center Raleigh North Carolina
United States Duke Health Heritage Wake Forest North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Duke University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Bradley KE, Cook C, Reinke EK, Mather RC 3rd, Riboh J, Lassiter T, Wittstein JR. Comparison of the accuracy of telehealth examination versus clinical examination in the detection of shoulder pathology. J Shoulder Elbow Surg. 2020 Aug 29. pii: S1058-2746(2 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Agreement with MRI findings as they pertain to presence or absence of a rotator cuff tear % of exams that agreed with the MRI findings Within 1 month of exam
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