Musculoskeletal DiseasesNCT04959162
The Effect of Theoretical Knowledge on Resident's Practical Performance in Musculoskeletal Ultrasound
A study testing E-learning and Conventional preparation in people with Musculoskeletal Diseases, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Musculoskeletal ultrasound( MSUS) is highly operator-dependent and proper training is needed to ensure appropriate use and minimize risk of incorrect image interpretation.To acquire skills in MSUS, it is mandatory to assure training in both the cognitive ability to recognize normal and pathological findings within the… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Diseases
- What is being tested?
- E-learning and Conventional preparation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteDenmark
- Study dates
- 6 Oct 2021to 20 May 2022
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- No informed consent
- Existing The Danish Society for Rheumatology (DRS) level 1 or higher.
- Participation in prior studies involving musculoskeletal ultrasound training
Trial locations and contacts
1 site in 1 country.
Denmark1 site
COPECARE (Copenhagen Center for Arthritis Research)
Glostrup Municipality, 2600
About this study
Official title: The Effect of Theoretical Knowledge on Resident's Practical Performance in Musculoskeletal Ultrasound- A Randomized Trial
Musculoskeletal ultrasound( MSUS) is highly operator-dependent and proper training is needed to ensure appropriate use and minimize risk of incorrect image interpretation.To acquire skills in MSUS, it is mandatory to assure training in both the cognitive ability to recognize normal and pathological findings within the images and the psychomotor component of the examination. This study will examine the effect of a novel developed e-learning platform "The Ultrasound LearNing plAtform (ULNA)", on pre- and post-course musculoskeletal ultrasound performance of rheumatology residents. Moreover, to examine the resident's satisfaction with the e-learning platform ULNA.
- Conditions
- Musculoskeletal Diseases
- Being tested
- E-learning, Conventional preparation
- Keywords
- Training, Ultrasound, E-learning
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-learningDevice
Development of theoretical knowledge using a E-learning platform before attending a hands-on course in musculoskeletal ultrasound
Conventional preparationDevice
Attending a hands-on course in musculoskeletal ultrasound with no preparation before course start
| Study group | Role | What they receive |
|---|---|---|
| E-learning preparation | Experimental | Will receive e-learning prior to a hands-on course in musculoskeletal ultrasound Receives: Device: E-learning |
| Conventional preparation | Active comparator | Will receive standard information (time, place etc) prior to a hands-on course in musculoskeletal ultrasound Receives: Device: Conventional preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in The Objective Structures Assessment of Ultrasound skills (OSAUS) score in percent between pre- and post-course assessment for the intervention group and the control group.
Scale (5-25 points). 25 is the maximum score, i.e. the best score
Measured: 1 year
Secondary outcomes (1)
Difference in time used to complete the MSUS examination between the groups.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2021
- Study start6 Oct 2021
- Primary completion20 May 2022
- Study completion20 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal DiseasesStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stine Maya Dreier Carstensen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Stine Maya Carstensen, MD, Principal investigator, Copenhagen Center for Arthritis Research (COPECARE)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04959162
- Sponsor's protocol ID
- 2021-001
- Status last verified
- Oct 2022
- First submitted
- 1 Jul 2021
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Widener BB, Cannella A, Martirossian L, Kissin EY. Modern Landscapes and Strategies for Learning Ultrasound in Rheumatology. Rheum Dis Clin North Am. 2020 Feb;46(1):61-71. doi: 10.1016/j.rdc.2019.09.002.
PubMed 31757287Carstensen SMD, Terslev L, Jensen MP, Ostergaard M. Future use of musculoskeletal ultrasonography and magnetic resonance imaging in rheumatoid arthritis. Curr Opin Rheumatol. 2020 May;32(3):264-272. doi: 10.1097/BOR.0000000000000709.
PubMed 32205568Brown AK, Roberts TE, O'connor PJ, Wakefield RJ, Karim Z, Emery P. The development of an evidence-based educational framework to facilitate the training of competent rheumatologist ultrasonographers. Rheumatology (Oxford). 2007 Mar;46(3):391-7. doi: 10.1093/rheumatology/kel415. Epub 2007 Jan 30.
PubMed 17264091Brown AK, O'Connor PJ, Wakefield RJ, Roberts TE, Karim Z, Emery P. Practice, training, and assessment among experts performing musculoskeletal ultrasonography: toward the development of an international consensus of educational standards for ultrasonography for rheumatologists. Arthritis Rheum. 2004 Dec 15;51(6):1018-22. doi: 10.1002/art.20844.
PubMed 15593176Kang TL, Berona K, Elkhunovich MA, Medero-Colon R, Seif D, Chilstrom ML, Mailhot T. Web-based teaching in point-of-care ultrasound: an alternative to the classroom? Adv Med Educ Pract. 2015 Mar 13;6:171-5. doi: 10.2147/AMEP.S72159. eCollection 2015.
PubMed 25792863Filippucci E, Meenagh G, Ciapetti A, Iagnocco A, Taggart A, Grassi W. E-learning in ultrasonography: a web-based approach. Ann Rheum Dis. 2007 Jul;66(7):962-5. doi: 10.1136/ard.2006.064568. Epub 2007 Feb 28.
PubMed 17329310Carstensen SMD, Just SA, Velander M, Konge L, Hubel MS, Rajeeth Savarimuthu T, Pfeiffer Jensen M, Ostergaard M, Terslev L. E-learning and practical performance in musculoskeletal ultrasound: a multicentre randomized study. Rheumatology (Oxford). 2023 Nov 2;62(11):3547-3554. doi: 10.1093/rheumatology/kead121.
PubMed 36943374
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Theoretical Knowledge on Resident's Practical Performance in Musculoskeletal Ultrasound- A Randomized Trial
- ClinicalTrials.gov ID
- NCT04959162
- Acronym / sponsor ID
- 2021-001
- Conditions
- Musculoskeletal Diseases
- Keywords
- Training, Ultrasound, E-learning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 6 Oct 2021 (actual)
- Primary completion
- 20 May 2022 (actual)
- Study completion
- 20 May 2022 (actual)
- First posted
- 13 Jul 2021 (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.
Musculoskeletal ultrasound( MSUS) is highly operator-dependent and proper training is needed to ensure appropriate use and minimize risk of incorrect image interpretation.To acquire skills in MSUS, it is mandatory to assure training in both the cognitive ability to recognize normal and pathological findings within the images and the psychomotor component of the examination. This study will examine the effect of a novel developed e-learning platform "The Ultrasound LearNing plAtform (ULNA)", on pre- and post-course musculoskeletal ultrasound performance of rheumatology residents. Moreover, to examine the resident's satisfaction with the e-learning platform ULNA.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| E-learning preparation | Experimental | Device: E-learningWill receive e-learning prior to a hands-on course in musculoskeletal ultrasound |
| Conventional preparation | Active comparator | Device: Conventional preparationWill receive standard information (time, place etc) prior to a hands-on course in musculoskeletal ultrasound |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- No informed consent
- Existing The Danish Society for Rheumatology (DRS) level 1 or higher.
- Participation in prior studies involving musculoskeletal ultrasound training
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 |
|---|---|---|
| E-learningDevelopment of theoretical knowledge using a E-learning platform before attending a hands-on course in musculoskeletal ultrasound | Device | E-learning preparation |
| Conventional preparationAttending a hands-on course in musculoskeletal ultrasound with no preparation before course start | Device | Conventional preparation |
Primary outcome
Difference in The Objective Structures Assessment of Ultrasound skills (OSAUS) score in percent between pre- and post-course assessment for the intervention group and the control group.
Time frame: 1 year
Scale (5-25 points). 25 is the maximum score, i.e. the best score
1 secondary outcome
Difference in time used to complete the MSUS examination between the groups.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
- Background: PubMed 31757287Widener BB, Cannella A, Martirossian L, Kissin EY. Modern Landscapes and Strategies for Learning Ultrasound in Rheumatology. Rheum Dis Clin North Am. 2020 Feb;46(1):61-71. doi: 10.1016/j.rdc.2019.09.002.
- Background: PubMed 32205568Carstensen SMD, Terslev L, Jensen MP, Ostergaard M. Future use of musculoskeletal ultrasonography and magnetic resonance imaging in rheumatoid arthritis. Curr Opin Rheumatol. 2020 May;32(3):264-272. doi: 10.1097/BOR.0000000000000709.
- Background: PubMed 17264091Brown AK, Roberts TE, O'connor PJ, Wakefield RJ, Karim Z, Emery P. The development of an evidence-based educational framework to facilitate the training of competent rheumatologist ultrasonographers. Rheumatology (Oxford). 2007 Mar;46(3):391-7. doi: 10.1093/rheumatology/kel415. Epub 2007 Jan 30.
- Background: PubMed 15593176Brown AK, O'Connor PJ, Wakefield RJ, Roberts TE, Karim Z, Emery P. Practice, training, and assessment among experts performing musculoskeletal ultrasonography: toward the development of an international consensus of educational standards for ultrasonography for rheumatologists. Arthritis Rheum. 2004 Dec 15;51(6):1018-22. doi: 10.1002/art.20844.
- Background: PubMed 25792863Kang TL, Berona K, Elkhunovich MA, Medero-Colon R, Seif D, Chilstrom ML, Mailhot T. Web-based teaching in point-of-care ultrasound: an alternative to the classroom? Adv Med Educ Pract. 2015 Mar 13;6:171-5. doi: 10.2147/AMEP.S72159. eCollection 2015.
- Background: PubMed 17329310Filippucci E, Meenagh G, Ciapetti A, Iagnocco A, Taggart A, Grassi W. E-learning in ultrasonography: a web-based approach. Ann Rheum Dis. 2007 Jul;66(7):962-5. doi: 10.1136/ard.2006.064568. Epub 2007 Feb 28.
- Derived from this study: PubMed 36943374Carstensen SMD, Just SA, Velander M, Konge L, Hubel MS, Rajeeth Savarimuthu T, Pfeiffer Jensen M, Ostergaard M, Terslev L. E-learning and practical performance in musculoskeletal ultrasound: a multicentre randomized study. Rheumatology (Oxford). 2023 Nov 2;62(11):3547-3554. doi: 10.1093/rheumatology/kead121.
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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.
Stine Maya Carstensen, MD principal investigator
Copenhagen Center for Arthritis Research (COPECARE)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E-learning and Conventional preparation in people with Musculoskeletal Diseases, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 0 inclusion and 3 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: finished, as of the sponsor's last update on 27 Oct 2022. 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 Denmark. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Difference in The Objective Structures Assessment of Ultrasound skills (OSAUS) score in percent between pre- and post-course assessment for the intervention group and the control group. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04959162, which also lists 7 linked publications.
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 Oct 2022.