Patient Performed Examination for Patients With Intra-articular Hip Pain

Sponsor

Duke University (Other)

Overall Status

Completed

CT.gov ID

NCT03248934

Collaborator

(none)

Enrollment

Location

Arms

7.8

Actual Duration (Months)

10.2

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

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 :

Jul 18, 2017

Actual Primary Completion Date :

Mar 13, 2018

Actual Study Completion Date :

Mar 13, 2018

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Sensitivity [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

Specificity [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 [End of clinician examination, 20 minutes]
As measured by sensitivity and specificity values.
Diagnostic accuracy measure of negative likelihood ratio [End of clinician examination, 20 minutes]
As measured by sensitivity and specificity values.
Diagnostic accuracy measure of post-test probabilities [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke University Health System	Durham	North Carolina	United States	27710

Sponsors and Collaborators

Duke University

Investigators

Principal Investigator: Richard C. Mather, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Duke University

ClinicalTrials.gov Identifier:

NCT03248934

Other Study ID Numbers:

Pro00082395

First Posted:

Aug 15, 2017

Last Update Posted:

Dec 17, 2019

Last Verified:

May 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Dec 17, 2019