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Clinical Trials/NCT06068595
NCT06068595
Not yet recruiting
Not Applicable

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

Central Hospital, Nancy, France1 site in 1 country300 target enrollmentApril 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Musculoskeletal; Anomaly
Sponsor
Central Hospital, Nancy, France
Enrollment
300
Locations
1
Primary Endpoint
Percentage of patients
Status
Not yet recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2024
End Date
October 2027
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Central Hospital, Nancy, France
Responsible Party
Principal Investigator
Principal Investigator

GASS Boris

Principal Investigator

Central Hospital, Nancy, France

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-
  • Pregnant women
  • Nursing mothers

Outcomes

Primary Outcomes

Percentage of patients

Time Frame: 3 years

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)

Secondary Outcomes

  • Frequency of the anatomical sites(3 years)
  • Time taken to produce an CTA report(3 years)
  • Frequency of modifications(3 years)
  • Frequency with which CTA(3 years)
  • Frequency of incidental diagnoses discovered at CTA(3 years)
  • Rates for the examinations and therapies(3 years)
  • Time taken to carry out the CTA(3 years)
  • Average number of ultrasound prints(3 years)
  • Frequency of diagnoses of post-CTA confirmation(3 years)
  • Frequency of diagnoses of post-CTA modifications(3 years)
  • Frequency of modifications per patient(3 years)
  • Calculation of the cost(3 years)

Study Sites (1)

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