NCT05303974

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

May 29, 2022

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 4, 2022

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

October 27, 2022

Status Verified

October 1, 2022

Enrollment Period

6 days

First QC Date

March 22, 2022

Last Update Submit

October 25, 2022

Conditions

Keywords

TrainingUltrasoundMedical education

Outcome Measures

Primary Outcomes (1)

  • Performance score

    Performance score assessed by blinded raters using the modified IUSE assessment tool

    Up to 12 months

Study Arms (3)

Novices

EXPERIMENTAL

Measurement of competence

Other: Ultrasound guided joint injection

Intermediates

EXPERIMENTAL

Measurement of competence

Other: Ultrasound guided joint injection

Experts

EXPERIMENTAL

Measurement of competence

Other: Ultrasound guided joint injection

Interventions

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.

ExpertsIntermediatesNovices

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • No informed consent
  • Novices/Intermediates: extensive experience with musculoskeletal ultrasound and/or ultrasound guided joint injections.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

COPECARE (Copenhagen Center for Arthritis Research)

Glostrup Municipality, 2600, Denmark

Location

Related Publications (5)

  • 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.

  • 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, 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.

  • Hetland 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.

  • 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.

  • Carstensen 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.

MeSH Terms

Conditions

Musculoskeletal Diseases

Study Officials

  • Stine Maya D Carstensen, MD

    Afdeling for Rygkirurgi, Led- og Bindevævssygdomme, COPECARE (Copenhagen Center for Arthritis Research) Rigshospitalet, Glostrup Valdemar Hansens vej 17 2600 Glostrup

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD fellow, Principal investigator

Study Record Dates

First Submitted

March 22, 2022

First Posted

March 31, 2022

Study Start

May 29, 2022

Primary Completion

June 4, 2022

Study Completion

June 30, 2022

Last Updated

October 27, 2022

Record last verified: 2022-10

Locations