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NCT03850470 Clinical Trial

The Diagnostic Accuracy of the Clinical Examination

Musculoskeletal Pain Clinical Trial

Official title:
The Diagnostic Accuracy of the Clinical Examination in Common Musculoskeletal Pathologies

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03850470
Other study ID # 201802-695
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date November 15, 2018
Est. completion date August 1, 2021

Study information
Verified date August 2021
Source High Point University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study examines the diagnostic accuracy of the clinical examination as compared to MRI findings

Description:

When patients get musculoskeletal pain and seek care, the healthcare professional performs a detailed clinical examination to determine a diagnosis and determine a plan of care which often includes imaging. There are only a few studies that have looked at the accuracy of the clinical examination in a primary care setting, most studies having been performed in a specialty practice treating Orthopedic or Sports injuries. In these practices, surgery has become and remains the gold standard. However, in primary care, often imaging like Magnetic Resonance Imaging (MRI) has become the the criterion standard. This double blind study will compare the diagnosis reached by clinical exam to the results found on MRI. In addition, the examining clinician will report their recommended plan of care after the examination.

Recruitment information / eligibility
Status Terminated
Enrollment 25
Est. completion date August 1, 2021
Est. primary completion date August 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Subjects 18-80 years old with musculoskeletal pain/dysfunction Exclusion Criteria: - Outside the inclusion age range, pain/dysfunction of other than musculoskeletal origin, those in whom MRI is contraindicated for example, with shrapnel in the body

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• clinical examination
Thorough examination including history, screening, motion testing, strength testing, special testing
Other:
• MRI
Low field MRI .25 Tesla

Locations
Country Name City State
United States High Point University High Point North Carolina

Sponsors (1)
Lead Sponsor Collaborator
High Point University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary likelihood ratios combination of sensitivity 5 years
Primary Area under the curve measure of accuracy of the clinical exam 5 years
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