Delineating the Concurrent Validity and Diagnostic Accuracy of a Patient Performed Examination for Patients With Intra-Articular Hip Pain: A Proof of Concept Study

Duke University1 site in 1 country80 target enrollmentJuly 18, 2017

ConditionsHip Disease Hip Pain Chronic

Overview

Phase: N/A
Intervention: Not specified
Conditions: Hip Disease
Sponsor: Duke University
Enrollment: 80
Locations: 1
Primary Endpoint: Sensitivity
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of this study is evaluate the diagnostic accuracy of a patient self-administered clinical examination of the hip compared with a traditional clinical examination (i.e. index test).

Registry

clinicaltrials.gov

Start Date

July 18, 2017

End Date

March 13, 2018

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Duke University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age: 18-80 years
•Seeking care for hip related pain and/or clicking, catching, giving way or stiffness
•Able to sign or verbalize study consent
•No other medical conditions (e.g. gynecological or urinary pathology) that may affect study results
•English speaking

Exclusion Criteria

•Patients with primary lumbar spine, sacro-iliac or other non-hip related pain as determined with clinical examination
•Previous hip surgery
•Previous hip injury that would normally exclude from examination as standard practice
•Unable to sign or verbalize consent
•Other non-musculoskeletal pathology that may affect study results (e.g. gynecological or urinary pathology)
•Non-English speaking

Outcomes

Primary Outcomes

Sensitivity

Time Frame: End of clinician examination, 20 minutes

As measured by a questionnaire evaluating the diagnostic test's ability to identify a positive finding when the targeted diagnosis is actually present (i.e. true positive).

Secondary Outcomes

Diagnostic accuracy measure of positive likelihood ratio(End of clinician examination, 20 minutes)
Specificity(End of clinician examination, 20 minutes)
Diagnostic accuracy measure of negative likelihood ratio(End of clinician examination, 20 minutes)
Diagnostic accuracy measure of post-test probabilities(End of clinician examination, 20 minutes)