Musculoskeletal PainNCT03850470
The Diagnostic Accuracy of the Clinical Examination
An observational study of Musculoskeletal Pain and Musculoskeletal Injury, run by High Point University at 1 site in United States.
Trial summary
This study examines the diagnostic accuracy of the clinical examination as compared to MRI findings Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Musculoskeletal Pain, Musculoskeletal Injury
- What is being tested?
- clinical examination and MRI
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2018to 1 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Subjects 18-80 years old with musculoskeletal pain/dysfunction
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
High Point University
High Point, North Carolina, 27262
About this study
Official title: 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
Read the 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.
- Conditions
- Musculoskeletal Pain, Musculoskeletal Injury
- Being tested
- clinical examination, MRI
- Keywords
- Diagnostic accuracy, Clinical examination, neck, back, shoulder, hip, knee, foot, ankle, stress fracture
- Medical subject headings
- Musculoskeletal Pain, Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical examinationDiagnostic test
Thorough examination including history, screening, motion testing, strength testing, special testing
MRIOther
Low field MRI .25 Tesla
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: clinical examination; Other: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
likelihood ratios
combination of sensitivity
Measured: 5 years
Area under the curve
measure of accuracy of the clinical exam
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start15 Nov 2018
- Primary completion1 Aug 2021
- Study completion1 Aug 2021
Why it stopped: PI left the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- High Point University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric J Hegedus, PhD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03850470
- Sponsor's protocol ID
- 201802-695
- Status last verified
- Aug 2021
- First submitted
- 20 Feb 2019
- Last updated
- 27 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diagnostic Accuracy of the Clinical Examination in Common Musculoskeletal Pathologies
- ClinicalTrials.gov ID
- NCT03850470
- Acronym / sponsor ID
- 201802-695
- Conditions
- Musculoskeletal Pain, Musculoskeletal Injury
- Keywords
- Diagnostic accuracy, Clinical examination, neck, back, shoulder, hip, knee, foot
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI left the institution
- Enrolment
- 25 participants (actual)
- Lead sponsor
- High Point UniversityUniversity, hospital or other
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 21 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Musculoskeletal Pain | – | Diagnostic Test: clinical examination, Other: MRISubjects 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Subjects 18-80 years old with musculoskeletal pain/dysfunction
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clinical examinationThorough examination including history, screening, motion testing, strength testing, special testing | Diagnostic test | Patients with Musculoskeletal Pain |
| MRILow field MRI .25 Tesla | Other | Patients with Musculoskeletal Pain |
Primary outcome
likelihood ratios
Time frame: 5 years
combination of sensitivity
Area under the curve
Time frame: 5 years
measure of accuracy of the clinical exam
Results and safety
The study was stopped early (reason given: PI left the institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2021.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric J Hegedus, PhD principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Musculoskeletal Pain and Musculoskeletal Injury, run by High Point University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: PI left the institution). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
likelihood ratios (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2021.