The Diagnostic Accuracy of the Clinical Examination

Terminated

• Conditions: Musculoskeletal Pain; Musculoskeletal Injury
• Interventions: Diagnostic Test: clinical examination; Other: MRI

• Registration Number: NCT03850470
• Lead Sponsor: High Point University

Brief Summary

This study examines the diagnostic accuracy of the clinical examination as compared to MRI findings

Detailed Description

When patients get musculoskeletal pain and seek care, the healthcare professional performs a detailed clinical examination to determine a diagnosis and determine a plan of care which often includes imaging. There are only a few studies that have looked at the accuracy of the clinical examination in a primary care setting, most studies having been performed in a specialty practice treating Orthopedic or Sports injuries. In these practices, surgery has become and remains the gold standard. However, in primary care, often imaging like Magnetic Resonance Imaging (MRI) has become the the criterion standard. This double blind study will compare the diagnosis reached by clinical exam to the results found on MRI. In addition, the examining clinician will report their recommended plan of care after the examination.

Study Timeline

• Study Start: 2018-11-15
• Study First Submitted: 2019-02-20
• Study First Submitted QC: 2019-02-20
• Study First Posted: 2019-02-21
• Status Verified: 2021-08
• Primary Completion: 2021-08-01
• Study Completion: 2021-08-01
• Last Update Submitted: 2021-08-23
• Last Update Posted: 2021-08-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Subjects 18-80 years old with musculoskeletal pain/dysfunction

Exclusion Criteria

• Outside the inclusion age range, pain/dysfunction of other than musculoskeletal origin, those in whom MRI is contraindicated for example, with shrapnel in the body

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with Musculoskeletal Pain	clinical examination	Subjects reporting for care with complaints of musculoskeletal pain will be examined and a diagnosis and plan of care will be established. The accuracy of the clinical examination will be compared to pathology detected by MRI
Patients with Musculoskeletal Pain	MRI	Subjects reporting for care with complaints of musculoskeletal pain will be examined and a diagnosis and plan of care will be established. The accuracy of the clinical examination will be compared to pathology detected by MRI

Primary Outcome Measures

Name	Time	Method
Area under the curve	5 years	measure of accuracy of the clinical exam
likelihood ratios	5 years	combination of sensitivity

Trial Locations

Locations (1)

High Point University; 🇺🇸 High Point, North Carolina, United States