NCT03850470

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 21, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

August 27, 2021

Status Verified

August 1, 2021

Enrollment Period

2.7 years

First QC Date

February 20, 2019

Last Update Submit

August 23, 2021

Conditions

Keywords

Diagnostic accuracyClinical examinationneckbackshoulderhipkneefootanklestress fracture

Outcome Measures

Primary Outcomes (2)

  • likelihood ratios

    combination of sensitivity

    5 years

  • Area under the curve

    measure of accuracy of the clinical exam

    5 years

Study Arms (1)

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 examinationOther: MRI

Interventions

clinical examinationDIAGNOSTIC_TEST

Thorough examination including history, screening, motion testing, strength testing, special testing

Patients with Musculoskeletal Pain
MRIOTHER

Low field MRI .25 Tesla

Patients with Musculoskeletal Pain

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

High Point University

High Point, North Carolina, 27262, United States

Location

MeSH Terms

Conditions

Musculoskeletal PainFractures, Stress

Interventions

Physical Examination

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsFractures, BoneWounds and Injuries

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Eric J Hegedus, PhD

    Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2019

First Posted

February 21, 2019

Study Start

November 15, 2018

Primary Completion

August 1, 2021

Study Completion

August 1, 2021

Last Updated

August 27, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

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

Locations