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

NCT03906630 | Completed

• 1 other identifier: Pro00101866
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 2

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.

Conditions

Rotator Cuff Tear

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Shoulder patients

Diagnostic Test: Telehealth clinical exam; Diagnostic Test: Standard clinical exam

Interventions

Telehealth clinical exam DIAGNOSTIC_TEST

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

Shoulder patients

Standard clinical exam DIAGNOSTIC_TEST

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

Shoulder patients

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients over 40 with shoulder pain that can be MRIed

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead

Study Sites (2)

Southeastern Orthopedics Shoulder Center

Raleigh, North Carolina, 27609, United States

Location

Duke Health Heritage

Wake Forest, North Carolina, 27587, United States

Location

Related Publications (1)

• 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.

  PMID: 32871264 RESULT

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Jocelyn Wittstein, MD

  Duke Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2019
• First Posted: April 8, 2019
• Study Start: August 19, 2019
• Primary Completion: November 5, 2020
• Study Completion: November 5, 2020
• Last Updated: November 16, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)