Clinical trial NCT06068595: Evaluation of the Contribution of Musculoskeletal Ultrasound to the General Practitioner's Overall Decision-making Strategy
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Musculoskeletal; Anomaly
Keywords: musculoskeletal anomaly
ultrasonography
general practitioners
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
Collaborators: name: University of Lorraine
First posted: 2023-10-05
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of patients
timeFrame: 3 years
Secondary outcomes:
measure: Frequency of the anatomical sites
timeFrame: 3 years
measure: Frequency of modifications
timeFrame: 3 years
measure: Frequency of diagnoses of post-CTA confirmation
timeFrame: 3 years
measure: Frequency of diagnoses of post-CTA modifications
timeFrame: 3 years
measure: Frequency of incidental diagnoses discovered at CTA
timeFrame: 3 years
measure: Frequency of modifications per patient
timeFrame: 3 years
measure: Calculation of the cost
timeFrame: 3 years
measure: Rates for the examinations and therapies
timeFrame: 3 years
measure: Frequency with which CTA
timeFrame: 3 years
measure: Time taken to carry out the CTA
timeFrame: 3 years
measure: Average number of ultrasound prints
timeFrame: 3 years
measure: Time taken to produce an CTA report
timeFrame: 3 years
Other outcomes:
Locations:
city: Nancy
country: France
facility: Central Hospital
state: Vandoeuvre Lès Nancy
Study officials:
affiliation: Central Hospital, Nancy, France
name: Boris Gass, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.