Patient Performed Examination for Patients With Intra-articular Hip Pain

NCT ID: NCT03248934

Last Updated: 2019-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-18

Study Completion Date

2018-03-13

Brief Summary

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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).

Detailed Description

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Conditions

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Hip Pain Chronic Hip Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Patient Self-Administered Diagnostic Exam

Intervention Type 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 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.

Group Type ACTIVE_COMPARATOR

Clinician-Performed Diagnostic Exam

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Clinician-Performed Diagnostic Exam

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard C. Mather

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke University Health System

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00082395

Identifier Type: -

Identifier Source: org_study_id