Patient Performed Examination for Patients With Intra-articular Hip Pain

NCT03248934 | Completed

• 1 other identifier: Pro00082395
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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).

Conditions

Hip Pain Chronic; Hip Disease

Outcome Measures

Primary Outcomes (1)

• Sensitivity

  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).

  End of clinician examination, 20 minutes

Secondary Outcomes (4)

• Specificity

  End of clinician examination, 20 minutes

• Diagnostic accuracy measure of positive likelihood ratio

  End of clinician examination, 20 minutes

• Diagnostic accuracy measure of negative likelihood ratio

  End of clinician examination, 20 minutes

• Diagnostic accuracy measure of post-test probabilities

  End of clinician examination, 20 minutes

Study Arms (2)

Patient Self-Administered Exam Group

EXPERIMENTAL

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

Clinician-Performed Exam Group

ACTIVE COMPARATOR

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

Interventions

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.

Patient Self-Administered Exam Group

Clinician-Performed Diagnostic Exam OTHER

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

Clinician-Performed Exam Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Health System

Durham, North Carolina, 27710, United States

Location

Study Officials

• Richard C. Mather

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2017
• First Posted: August 15, 2017
• Study Start: July 18, 2017
• Primary Completion: March 13, 2018
• Study Completion: March 13, 2018
• Last Updated: December 17, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)