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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03248934
Enrollment
80
Registered
2017-08-15
Start date
2017-07-18
Completion date
2018-03-13
Last updated
2019-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Disease, Hip Pain Chronic

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).

Interventions

OTHERPatient 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.

OTHERClinician-Performed Diagnostic Exam

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

Sponsors

Duke University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
SensitivityEnd of clinician examination, 20 minutesAs 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

MeasureTime frameDescription
SpecificityEnd of clinician examination, 20 minutesAs 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 ratioEnd of clinician examination, 20 minutesAs measured by sensitivity and specificity values.
Diagnostic accuracy measure of negative likelihood ratioEnd of clinician examination, 20 minutesAs measured by sensitivity and specificity values.
Diagnostic accuracy measure of post-test probabilitiesEnd of clinician examination, 20 minutesAs measured by analysis of the pre-test prevalence of the condition and determination of the post-test shift in probability of the condition.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026