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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date October 2022
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Ultrasound guided joint injection
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.

Locations

Country Name City State
Denmark COPECARE (Copenhagen Center for Arthritis Research) Glostrup

Sponsors (1)

Lead Sponsor Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (4)

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

Outcome

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
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