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

NCT ID: NCT03906630

Last Updated: 2020-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

65 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-19

Study Completion Date

2020-11-05

Brief Summary

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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

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Conditions

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Rotator Cuff Tear

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Shoulder patients

Telehealth clinical exam

Intervention Type DIAGNOSTIC_TEST

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

Standard clinical exam

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Telehealth clinical exam

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

Intervention Type DIAGNOSTIC_TEST

Standard clinical exam

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jocelyn Wittstein, MD

Role: PRINCIPAL_INVESTIGATOR

Duke Health

Locations

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Southeastern Orthopedics Shoulder Center

Raleigh, North Carolina, United States

Site Status

Duke Health Heritage

Wake Forest, North Carolina, United States

Site Status

Countries

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United States

References

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Bradley KE, Cook C, Reinke EK, Vinson EN, 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. 2021 May;30(5):1042-1052. doi: 10.1016/j.jse.2020.08.016. Epub 2020 Aug 29.

Reference Type RESULT
PMID: 32871264 (View on PubMed)

Other Identifiers

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Pro00101866

Identifier Type: -

Identifier Source: org_study_id