The Diagnostic Accuracy of the Clinical Examination

The Diagnostic Accuracy of the Clinical Examination in Common Musculoskeletal Pathologies

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

Study Overview

• Status: Terminated
• Conditions: Musculoskeletal Pain; Musculoskeletal Injury
• Intervention / Treatment: Diagnostic test: clinical examination; Other: MRI

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 Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • High Point University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

These will be patients with musculoskeletal pain or dysfunction that report to one of our several clinics as a normal part of procedure

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with Musculoskeletal Pain; 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	Diagnostic test: clinical examination; Thorough examination including history, screening, motion testing, strength testing, special testing; Other: MRI; Low field MRI .25 Tesla

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
likelihood ratios	combination of sensitivity	5 years
Area under the curve	measure of accuracy of the clinical exam	5 years

Collaborators and Investigators

• Sponsor: High Point University
• Investigators: Principal Investigator: Eric J Hegedus, PhD, Professor

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 15, 2018
• Primary Completion (ACTUAL): August 1, 2021
• Study Completion (ACTUAL): August 1, 2021

Study Registration Dates

• First Submitted: February 20, 2019
• First Submitted That Met QC Criteria: February 20, 2019
• First Posted (ACTUAL): February 21, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 27, 2021
• Last Update Submitted That Met QC Criteria: August 23, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: back; knee; ankle; Diagnostic accuracy; neck; shoulder; hip; foot; Clinical examination; stress fracture
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Musculoskeletal Pain
• Other Study ID Numbers: 201802-695

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be shared only with those submitted to and approved by our IRB. There are no plans to share any data outside of our research group

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No