Evaluation of the Contribution of Musculoskeletal Ultrasound to the General Practitioner's Overall Decision-making Strategy (ECHOSTEOM)

The Contribution of Targeted Musculoskeletal Ultrasound to the General Practitioner's Overall Decision-making Strategy for Patients With Suspected Musculoskeletal Pathology: a Before/After Study

The hypothesis of this study is that musculoskeletal point of care ultrasonography would support the GP's decision and ultimately improve patient management.

The aim of this study is to evaluate, in the context of suspected musculoskeletal abnormality, the contribution of musculoskeletal point of care ultrasonography to the general practitioner's overall decision-making strategy, defined according to the following 5 axes: diagnosis (I), therapy (II), patient orientation (III), prescription of complementary examinations (IV) and follow-up (V).

Study Overview

• Status: Not yet recruiting
• Conditions: Musculoskeletal; Anomaly
• Intervention / Treatment: Other: musculoskeletal ultrasound

Detailed Description

The study circuit takes place in a single visit.

1. The investigating physician suspects a musculoskeletal anomaly following an initial clinical examination.
2. The patient (who meets the inclusion criteria and has no non-inclusion criteria) gives consent to participate, after receiving information about the study.
3. The investigator fills in the e-CRF (appendix III), clinical examination, medical interrogation and his or her decisions according to the 5 axes, which cannot be modified, as the structure of the e-CRF planned in advance does not allow backtracking. The investigator performs the targeted musculoskeletal ultrasound with his or her personal ultrasound machine, following his or her usual operating procedure.
4. The investigator fills in the e-CRF with the results of the targeted ultrasound scan and indicates any modifications to the decision axes.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Boris Gass, Dr; Phone Number: 33 67467111; Email: boris.gass@univ-lorraine.fr
• Study Contact Backup: Name: Paolo Di Patrizio, Pr; Phone Number: 33 608376920; Email: paolo.di-patrizio@univ-lorraine.fr

Study Locations

• France
  • Vandoeuvre Lès Nancy
    • Nancy, Vandoeuvre Lès Nancy, France, 54500
      • Central Hospital
      • Contact: Boris Gass, Dr; Email: boris.gass@univ-lorraine.fr
      • Contact: Paolo Di Patrizio, Pr; Email: paolo.di-patrizio@univ-lorraine.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Person who has received full information on the organization of the research and has given his/her consent
• Be over 18 years of age
• Present a symptomatology leading to suspicion of musculoskeletal pathology
• Be able to give consent
• Be affiliated to a social security scheme or benefit from such a scheme

Exclusion Criteria:

• Chronic inflammatory rheumatism (rheumatoid arthritis, spondylitis, psoriatic arthritis, rheumatoid pseudo-polyarthritis, juvenile idiopathic arthritis, lupus, etc.).
• Subjects benefiting from a legal protection measure (guardianship, curatorship, safeguard of justice).
• Persons deprived of their liberty by judicial or administrative decision, persons under psychiatric care under articles L3212-1 and L3213-1.
• Pregnant women
• Nursing mothers

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Patients; Patient with musculoskeletal anomalies

Other: musculoskeletal ultrasound; After clinical examination and medical interrogation, The investigating physician gives her decisions in the e-CRF according to the 5 axes: diagnosis (I), therapy (II), patient referral (III), prescription of additional tests (IV) and follow-up (V). The investigator performs the targeted musculoskeletal ultrasound with his personal ultrasound machine, following his usual operating procedure and give/keep the final diagnostic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients	Percentage of patients for whom the musculoskeletal point of care ultrasonography led to a change in the GP's overall decision-making strategy (binary yes/no variable) of patients for whom led to a change in the GP's overall decision-making strategy (binary yes/no variable)	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of the anatomical sites	Frequency of the different anatomical sites (shoulder, elbow, arm, etc.) and structures (osteoarticular pathologies, tendon and retinacular pathologies, etc.) concerned	3 years
Frequency of modifications	Frequency of different modifications for each axis and within each axis	3 years
Frequency of diagnoses of post-CTA confirmation	List and frequency of diagnoses in the case of post-CTA confirmation	3 years
Frequency of diagnoses of post-CTA modifications	List and frequency of diagnoses in the case of post-CTA modifications	3 years
Frequency of incidental diagnoses discovered at CTA	Frequency and description of incidental diagnoses discovered at CTA	3 years
Frequency of modifications per patient	Frequency of different modifications for each axis and within each axis per patient	3 years
Calculation of the cost	Calculation of the cost before and after CTA estimated a posteriori on the basis of the consultation rate	3 years
Rates for the examinations and therapies	the rates for the examinations and therapies described	3 years
Frequency with which CTA	For each doctor: the frequency with which CTA is carried out in his professional practice	3 years
Time taken to carry out the CTA	For each doctor: the time taken to carry out the CTA	3 years
Average number of ultrasound prints	For each doctor: the average number of ultrasound image prints	3 years
Time taken to produce an CTA report	For each doctor: the time taken to produce an CTA report	3 years

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Collaborators: University of Lorraine
• Investigators: Principal Investigator: Boris Gass, Pr, Central Hospital, Nancy, France

Publications and helpful links

General Publications

• Narula J, Chandrashekhar Y, Braunwald E. Time to Add a Fifth Pillar to Bedside Physical Examination: Inspection, Palpation, Percussion, Auscultation, and Insonation. JAMA Cardiol. 2018 Apr 1;3(4):346-350. doi: 10.1001/jamacardio.2018.0001.
• Sorensen B, Hunskaar S. Point-of-care ultrasound in primary care: a systematic review of generalist performed point-of-care ultrasound in unselected populations. Ultrasound J. 2019 Nov 19;11(1):31. doi: 10.1186/s13089-019-0145-4.
• Andersen CA, Davidsen AS, Brodersen J, Graumann O, Jensen MB. Danish general practitioners have found their own way of using point-of-care ultrasonography in primary care: a qualitative study. BMC Fam Pract. 2019 Jun 28;20(1):89. doi: 10.1186/s12875-019-0984-x.
• Meyer R, Lin C, Yenokyan G, Ellen M. Diagnostic Utility of Ultrasound Versus Physical Examination in Assessing Knee Effusions: A Systematic Review and Meta-analysis. J Ultrasound Med. 2022 Jan;41(1):17-31. doi: 10.1002/jum.15676. Epub 2021 Mar 5.
• Nazarian LN. The top 10 reasons musculoskeletal sonography is an important complementary or alternative technique to MRI. AJR Am J Roentgenol. 2008 Jun;190(6):1621-6. doi: 10.2214/AJR.07.3385.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: September 22, 2023
• First Submitted That Met QC Criteria: September 28, 2023
• First Posted (Actual): October 5, 2023

Study Record Updates

• Last Update Posted (Actual): October 5, 2023
• Last Update Submitted That Met QC Criteria: September 28, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: ultrasonography; general practitioners; musculoskeletal anomaly
• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Musculoskeletal Abnormalities
• Other Study ID Numbers: 2023-A01995-40

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No