Musculoskeletal DiseasesNCT05303974
Competency-based Assessment of Ultrasound-guided Joint Injection Skills
A study testing Ultrasound guided joint injection in people with Musculoskeletal Diseases, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Ultrasound-guided joint injections and aspirations are frequently used in the treatment of rheumatological diseases. Studies have shown that intra-articular glucocorticoid injections (IAGCs) in the early treatment of rheumatoid arthritis is essential and leads to improved disease control and earlier achievement of… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Musculoskeletal Diseases
- What is being tested?
- Ultrasound guided joint injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 29 May 2022to 30 Jun 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Physicians attending the yearly international conference EULAR (Denmark 2022)
- Novices: No or little experience with ultrasound guided joint injections.
- Intermediates: Participated and completed at least one formal musculoskeletal ultrasound course and performed more than 100 ultrasound guided joint injections.
- Experts: Physicians with a long experience with musculoskeletal ultrasound and ultrasound guided joint injections doing the procedure almost daily and providing teaching and/or research within this field.
Who cannot join
- No informed consent
- Novices/Intermediates: extensive experience with musculoskeletal ultrasound and/or ultrasound guided joint injections.
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: Competency-based Assessment of Ultrasound-guided Joint Injection Skills: A Validity Study
Ultrasound-guided joint injections and aspirations are frequently used in the treatment of rheumatological diseases. Studies have shown that intra-articular glucocorticoid injections (IAGCs) in the early treatment of rheumatoid arthritis is essential and leads to improved disease control and earlier achievement of remission. Unfortunately, many rheumatologists feel insecure performing IAGC due to poor and unstructured training opportunities, which can result in suboptimal treatment and potentially poorer patient outcome.
Nowadays, the gold standard training method has shifted towards competency-based education were objective assessment tools are necessary. A previous study has developed a scale for assessment of invasive ultrasound procedures, the Interventional Ultrasound Skills Evaluation (IUSE) tool. Although expert consensus supports evidence of content validity of the assessment tool, it is not known if the tool can discriminate differences in performance scores between the different levels of experience.
- Conditions
- Musculoskeletal Diseases
- Being tested
- Ultrasound guided joint injection
- Keywords
- Training, Ultrasound, Medical education
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided joint injectionOther
The participants will perform two ultrasound guided joint injections on a mannequin. The performance of both procedures are videorecorded. All videos will be rated by two blinded raters using the modified IUSE assessment tool.
| Study group | Role | What they receive |
|---|---|---|
| Novices | Experimental | Measurement of competence Receives: Other: Ultrasound guided joint injection |
| Intermediates | Experimental | Measurement of competence Receives: Other: Ultrasound guided joint injection |
| Experts | Experimental | Measurement of competence Receives: Other: Ultrasound guided joint injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance score
Performance score assessed by blinded raters using the modified IUSE assessment tool
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start29 May 2022
- Primary completion4 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 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 D Carstensen, MD, Principal investigator, Afdeling for Rygkirurgi, Led- og Bindevævssygdomme, COPECARE (Copenhagen Center for Arthritis Research) Rigshospitalet, Glostrup Valdemar Hansens vej 17 2600 Glostrup
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05303974
- Sponsor's protocol ID
- 2022-003
- Status last verified
- Oct 2022
- First submitted
- 22 Mar 2022
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kahr Rasmussen N, Nayahangan LJ, Carlsen J, Ekberg O, Brabrand K, Albrecht-Beste E, Nielsen MB, Konge L. Evaluation of competence in ultrasound-guided procedures-a generic assessment tool developed through the Delphi method. Eur Radiol. 2021 Jun;31(6):4203-4211. doi: 10.1007/s00330-020-07280-z. Epub 2020 Nov 17.
PubMed 33201282Mandl P, Naredo E, Conaghan PG, D'Agostino MA, Wakefield RJ, Bachta A, Backhaus M, Hammer HB, Bruyn GA, Damjanov N, Filippucci E, Grassi W, Iagnocco A, Jousse-Joulin S, Kane D, Koski JM, Moller I, De Miguel E, Schmidt WA, Swen WA, Szkudlarek M, Terslev L, Ziswiler HR, Ostergaard M, Balint PV. Practice of ultrasound-guided arthrocentesis and joint injection, including training and implementation, in Europe: results of a survey of experts and scientific societies. Rheumatology (Oxford). 2012 Jan;51(1):184-90. doi: 10.1093/rheumatology/ker331. Epub 2011 Nov 24.
PubMed 22120466Hetland ML, Ostergaard M, Ejbjerg B, Jacobsen S, Stengaard-Pedersen K, Junker P, Lottenburger T, Hansen I, Andersen LS, Tarp U, Svendsen A, Pedersen JK, Skjodt H, Ellingsen T, Lindegaard H, Podenphant J, Horslev-Petersen K; CIMESTRA study group. Short- and long-term efficacy of intra-articular injections with betamethasone as part of a treat-to-target strategy in early rheumatoid arthritis: impact of joint area, repeated injections, MRI findings, anti-CCP, IgM-RF and CRP. Ann Rheum Dis. 2012 Jun;71(6):851-6. doi: 10.1136/annrheumdis-2011-200632. Epub 2012 Feb 1.
PubMed 22302316Bruyn GA, Schmidt WA. How to perform ultrasound-guided injections. Best Pract Res Clin Rheumatol. 2009 Apr;23(2):269-79. doi: 10.1016/j.berh.2008.11.001.
PubMed 19393570Carstensen SMD, Just SA, Pfeiffer-Jensen M, Ostergaard M, Konge L, Terslev L. Development and validation of a new tool for assessment of trainees' interventional musculoskeletal ultrasound skills. Rheumatology (Oxford). 2025 Feb 1;64(2):484-492. doi: 10.1093/rheumatology/keae050.
PubMed 38273715
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
- Competency-based Assessment of Ultrasound-guided Joint Injection Skills: A Validity Study
- ClinicalTrials.gov ID
- NCT05303974
- Acronym / sponsor ID
- 2022-003
- Conditions
- Musculoskeletal Diseases
- Keywords
- Training, Ultrasound, Medical education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 29 May 2022 (actual)
- Primary completion
- 4 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 31 Mar 2022 (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.
Ultrasound-guided joint injections and aspirations are frequently used in the treatment of rheumatological diseases. Studies have shown that intra-articular glucocorticoid injections (IAGCs) in the early treatment of rheumatoid arthritis is essential and leads to improved disease control and earlier achievement of remission. Unfortunately, many rheumatologists feel insecure performing IAGC due to poor and unstructured training opportunities, which can result in suboptimal treatment and potentially poorer patient outcome.
Nowadays, the gold standard training method has shifted towards competency-based education were objective assessment tools are necessary. A previous study has developed a scale for assessment of invasive ultrasound procedures, the Interventional Ultrasound Skills Evaluation (IUSE) tool. Although expert consensus supports evidence of content validity of the assessment tool, it is not known if the tool can discriminate differences in performance scores between the different levels of experience.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Novices | Experimental | Other: Ultrasound guided joint injectionMeasurement of competence |
| Intermediates | Experimental | Other: Ultrasound guided joint injectionMeasurement of competence |
| Experts | Experimental | Other: Ultrasound guided joint injectionMeasurement of competence |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Physicians attending the yearly international conference EULAR (Denmark 2022)
Key exclusion criteria (2 listed)
- No informed consent
- Novices/Intermediates: extensive experience with musculoskeletal ultrasound and/or ultrasound guided joint injections.
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 |
|---|---|---|
| Ultrasound guided joint injectionThe participants will perform two ultrasound guided joint injections on a mannequin. The performance of both procedures are videorecorded. All videos will be rated by two blinded raters using the modified IUSE assessment tool. | Other | Experts, Intermediates, Novices |
Primary outcome
Performance score
Time frame: Up to 12 months
Performance score assessed by blinded raters using the modified IUSE assessment tool
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.
- Results publication: PubMed 33201282Kahr Rasmussen N, Nayahangan LJ, Carlsen J, Ekberg O, Brabrand K, Albrecht-Beste E, Nielsen MB, Konge L. Evaluation of competence in ultrasound-guided procedures-a generic assessment tool developed through the Delphi method. Eur Radiol. 2021 Jun;31(6):4203-4211. doi: 10.1007/s00330-020-07280-z. Epub 2020 Nov 17.
- Results publication: PubMed 22120466Mandl P, Naredo E, Conaghan PG, D'Agostino MA, Wakefield RJ, Bachta A, Backhaus M, Hammer HB, Bruyn GA, Damjanov N, Filippucci E, Grassi W, Iagnocco A, Jousse-Joulin S, Kane D, Koski JM, Moller I, De Miguel E, Schmidt WA, Swen WA, Szkudlarek M, Terslev L, Ziswiler HR, Ostergaard M, Balint PV. Practice of ultrasound-guided arthrocentesis and joint injection, including training and implementation, in Europe: results of a survey of experts and scientific societies. Rheumatology (Oxford). 2012 Jan;51(1):184-90. doi: 10.1093/rheumatology/ker331. Epub 2011 Nov 24.
- Results publication: PubMed 22302316Hetland ML, Ostergaard M, Ejbjerg B, Jacobsen S, Stengaard-Pedersen K, Junker P, Lottenburger T, Hansen I, Andersen LS, Tarp U, Svendsen A, Pedersen JK, Skjodt H, Ellingsen T, Lindegaard H, Podenphant J, Horslev-Petersen K; CIMESTRA study group. Short- and long-term efficacy of intra-articular injections with betamethasone as part of a treat-to-target strategy in early rheumatoid arthritis: impact of joint area, repeated injections, MRI findings, anti-CCP, IgM-RF and CRP. Ann Rheum Dis. 2012 Jun;71(6):851-6. doi: 10.1136/annrheumdis-2011-200632. Epub 2012 Feb 1.
- Results publication: PubMed 19393570Bruyn GA, Schmidt WA. How to perform ultrasound-guided injections. Best Pract Res Clin Rheumatol. 2009 Apr;23(2):269-79. doi: 10.1016/j.berh.2008.11.001.
- Derived from this study: PubMed 38273715Carstensen SMD, Just SA, Pfeiffer-Jensen M, Ostergaard M, Konge L, Terslev L. Development and validation of a new tool for assessment of trainees' interventional musculoskeletal ultrasound skills. Rheumatology (Oxford). 2025 Feb 1;64(2):484-492. doi: 10.1093/rheumatology/keae050.
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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 D Carstensen, MD principal investigator
Afdeling for Rygkirurgi, Led- og Bindevævssygdomme, COPECARE (Copenhagen Center for Arthritis Research) Rigshospitalet, Glostrup Valdemar Hansens vej 17 2600 Glostrup
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided joint injection 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 4 inclusion and 2 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?
Performance score (time frame: Up to 12 months). 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 NCT05303974, which also lists 5 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.