Patient Performed Examination for Patients With Intra-articular Hip Pain

Overview

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).

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 13, 2018

Interventions

  • 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.
  • Other: Clinician-Performed Diagnostic Exam
    • A clinician-performed diagnostic exam will be completed on the patients.

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Specificity
    • Time Frame: 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 positive likelihood ratio
    • Time Frame: End of clinician examination, 20 minutes
    • As measured by sensitivity and specificity values.
  • Diagnostic accuracy measure of negative likelihood ratio
    • Time Frame: End of clinician examination, 20 minutes
    • As measured by sensitivity and specificity values.
  • Diagnostic accuracy measure of post-test probabilities
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Duke University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Richard C. Mather, Principal Investigator, Duke University

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