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Patient Performed Examination for Patients With Intra-articular Hip Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03248934
Recruitment Status : Completed
First Posted : August 15, 2017
Last Update Posted : December 17, 2019
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Hip Pain Chronic Hip Disease Other: Patient Self-Administered Diagnostic Exam Other: Clinician-Performed Diagnostic Exam Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : July 18, 2017
Actual Primary Completion Date : March 13, 2018
Actual Study Completion Date : March 13, 2018

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03248934


Locations
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United States, North Carolina
Duke University Health System
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Richard C. Mather Duke University
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03248934    
Other Study ID Numbers: Pro00082395
First Posted: August 15, 2017    Key Record Dates
Last Update Posted: December 17, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No