Patient Performed Examination for Patients With Intra-articular Hip Pain

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

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).

Study Overview

• Status: Completed
• Conditions: Hip Pain Chronic; Hip Disease
• Intervention / Treatment: Other: Patient Self-Administered Diagnostic Exam; Other: Clinician-Performed Diagnostic Exam

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient Self-Administered Exam Group; Participants with hip pain presenting in the hip preservation clinics will be asked to complete two diagnostic exams. Participants with hip pain will first complete a patient self-administered diagnostic exam.	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.
Active Comparator: Clinician-Performed Exam Group; Participants with hip pain presenting in the hip preservation clinics will be asked to complete two diagnostic exams. Participants with hip pain will next complete a clinician-performed diagnostic exam.	Other: Clinician-Performed Diagnostic Exam; A clinician-performed diagnostic exam will be completed on the patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Diagnostic accuracy measure of positive likelihood ratio	As measured by sensitivity and specificity values.	End of clinician examination, 20 minutes
Diagnostic accuracy measure of negative likelihood ratio	As measured by sensitivity and specificity values.	End of clinician examination, 20 minutes
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

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Richard C. Mather, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2017
• Primary Completion (Actual): March 13, 2018
• Study Completion (Actual): March 13, 2018

Study Registration Dates

• First Submitted: August 10, 2017
• First Submitted That Met QC Criteria: August 10, 2017
• First Posted (Actual): August 15, 2017

Study Record Updates

• Last Update Posted (Actual): December 17, 2019
• Last Update Submitted That Met QC Criteria: December 16, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: Pro00082395

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No