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OpenTrials
Completed

NCT Number: NCT03248934

Patient Performed Examination for Patients With Intra-articular Hip Pain

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).

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Key information

Conditions

Hip Pain Chronic Hip Disease

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Health System

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient Self-Administered Diagnostic Exam

Other

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

Other

A clinician-performed diagnostic exam will be completed on the patients.

Primary outcomes

  1. 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

  1. 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).

  2. Diagnostic accuracy measure of positive likelihood ratio

    Time frame: End of clinician examination, 20 minutes

    As measured by sensitivity and specificity values.

  3. Diagnostic accuracy measure of negative likelihood ratio

    Time frame: End of clinician examination, 20 minutes

    As measured by sensitivity and specificity values.

  4. 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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 15, 2017
Registry last updated
Dec 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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