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

NCT06068595 | Not Yet Recruiting

• 1 other identifier: 2023-A01995-40
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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).

Conditions

Musculoskeletal; Anomaly

Keywords

musculoskeletal anomaly; ultrasonography; general practitioners

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Frequency of the anatomical sites

  3 years

• Frequency of modifications

  3 years

• Frequency of diagnoses of post-CTA confirmation

  3 years

• Frequency of diagnoses of post-CTA modifications

  3 years

• Frequency of incidental diagnoses discovered at CTA

  3 years

Study Arms (1)

Patients

OTHER

Patient with musculoskeletal anomalies

Other: musculoskeletal ultrasound

Interventions

musculoskeletal ultrasound OTHER

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.

Patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead
• University of Lorraine: collaborator

Study Sites (1)

Central Hospital

Nancy, Vandoeuvre Lès Nancy, 54500, France

Location

Related Publications (5)

• 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.

  PMID: 31749019 BACKGROUND

• 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.

  PMID: 33675099 BACKGROUND

• 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.

  PMID: 18492916 BACKGROUND

• 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.

  PMID: 29490335 BACKGROUND

• 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.

  PMID: 31253102 BACKGROUND

MeSH Terms

Conditions

Musculoskeletal Abnormalities

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Boris Gass, Pr

  Central Hospital, Nancy, France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Boris Gass, Dr

CONTACT

67467111; boris.gass@univ-lorraine.fr

Paolo Di Patrizio, Pr

CONTACT

608376920; paolo.di-patrizio@univ-lorraine.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: October 5, 2023
• Study Start: April 1, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: October 5, 2023

Record last verified: 2023-09

Locations

FR (1)