Patient Performed Examination for Patients With Intra-articular Hip Pain

Hip Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03248934
• Other study ID #: Pro00082395
• Status: Completed
• Phase: N/A
• Start date: July 18, 2017
• Est. completion date: March 13, 2018

Study information

• Verified date: May 2019
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 13, 2018
• Est. primary completion date: March 13, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hip Disease
• Hip Pain Chronic

Intervention

Other:
• Patient Self-Administered Diagnostic Exam
Participants will complete a patient self-administered diagnostic exam. A physician will be available to monitor the patient and record findings but will not physically assist the participants.
• Clinician-Performed Diagnostic Exam
A clinician-performed diagnostic exam will be completed on the patients.

Locations

Country	Name	City	State
United States	Duke University Health System	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity	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).	End of clinician examination, 20 minutes
Secondary	Specificity	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).	End of clinician examination, 20 minutes
Secondary	Diagnostic accuracy measure of positive likelihood ratio	As measured by sensitivity and specificity values.	End of clinician examination, 20 minutes
Secondary	Diagnostic accuracy measure of negative likelihood ratio	As measured by sensitivity and specificity values.	End of clinician examination, 20 minutes
Secondary	Diagnostic accuracy measure of post-test probabilities	As measured by analysis of the pre-test prevalence of the condition and determination of the post-test shift in probability of the condition.	End of clinician examination, 20 minutes