Patient Performed Examination for Patients With Intra-articular Hip Pain

Not Applicable

Completed

• Conditions: Hip Pain Chronic; Hip Disease

• Registration Number: NCT03248934
• Lead Sponsor: Duke University

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-18
• Study First Submitted: 2017-08-10
• Study First Submitted QC: 2017-08-10
• Study First Posted: 2017-08-15
• Primary Completion: 2018-03-13
• Study Completion: 2018-03-13
• Status Verified: 2019-05
• Last Update Submitted: 2019-12-16
• Last Update Posted: 2019-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Sensitivity	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 Outcome Measures

Name	Time	Method
Specificity	End of clinician examination, 20 minutes	As measured by the discriminatory ability of the diagnostic test to identify if the disease or condition is absent when in actuality it is truly absent (i.e. true negative).
Diagnostic accuracy measure of negative likelihood ratio	End of clinician examination, 20 minutes	As measured by sensitivity and specificity values.
Diagnostic accuracy measure of post-test probabilities	End of clinician examination, 20 minutes	As measured by analysis of the pre-test prevalence of the condition and determination of the post-test shift in probability of the condition.
Diagnostic accuracy measure of positive likelihood ratio	End of clinician examination, 20 minutes	As measured by sensitivity and specificity values.

Trial Locations

Locations (1)

Duke University Health System; 🇺🇸 Durham, North Carolina, United States