Musculoskeletal Diseases Clinical Trial
Official title:
Competency-based Assessment of Ultrasound-guided Joint Injection Skills: A Validity Study
| NCT number | NCT05303974 |
| Other study ID # | 2022-003 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | May 29, 2022 |
| Est. completion date | June 30, 2022 |
| Verified date | October 2022 |
| Source | Rigshospitalet, Denmark |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | June 30, 2022 |
| Est. primary completion date | June 4, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | Inclusion Criteria: - Physicians attending the yearly international conference EULAR (Denmark 2022) 1. Novices: No or little experience with ultrasound guided joint injections. 2. Intermediates: Participated and completed at least one formal musculoskeletal ultrasound course and performed more than 100 ultrasound guided joint injections. 3. 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. Exclusion Criteria: - No informed consent - Novices/Intermediates: extensive experience with musculoskeletal ultrasound and/or ultrasound guided joint injections. |
| Country | Name | City | State |
|---|---|---|---|
| Denmark | COPECARE (Copenhagen Center for Arthritis Research) | Glostrup |
| Lead Sponsor | Collaborator |
|---|---|
| Rigshospitalet, Denmark |
Denmark,
Bruyn 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. Review. — View Citation
Hetland ML, Østergaard M, Ejbjerg B, Jacobsen S, Stengaard-Pedersen K, Junker P, Lottenburger T, Hansen I, Andersen LS, Tarp U, Svendsen A, Pedersen JK, Skjødt H, Ellingsen T, Lindegaard H, Pødenphant J, Hørslev-Petersen K; CIMESTRA study group. Short- an — View Citation
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):420 — View Citation
Mandl 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, Möller I, De Miguel E, Schmidt WA, Swen WA, Szkudlarek M, Terslev L, — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Performance score | Performance score assessed by blinded raters using the modified IUSE assessment tool | Up to 12 months |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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