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NCT Number: NCT06068595

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

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).

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

The study circuit takes place in a single visit.

  • The investigating physician suspects a musculoskeletal anomaly following an initial clinical examination.
  • The patient (who meets the inclusion criteria and has no non-inclusion criteria) gives consent to participate, after receiving information about the study.
  • 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.
  • The investigator fills in the e-CRF with the results of the targeted ultrasound scan and indicates any modifications to the decision axes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. Frequency of the anatomical sites

    Time frame: 3 years

    Frequency of the different anatomical sites (shoulder, elbow, arm, etc.) and structures (osteoarticular pathologies, tendon and retinacular pathologies, etc.) concerned

  2. Frequency of modifications

    Time frame: 3 years

    Frequency of different modifications for each axis and within each axis

  3. Frequency of diagnoses of post-CTA confirmation

    Time frame: 3 years

    List and frequency of diagnoses in the case of post-CTA confirmation

  4. Frequency of diagnoses of post-CTA modifications

    Time frame: 3 years

    List and frequency of diagnoses in the case of post-CTA modifications

  5. Frequency of incidental diagnoses discovered at CTA

    Time frame: 3 years

    Frequency and description of incidental diagnoses discovered at CTA

  6. Frequency of modifications per patient

    Time frame: 3 years

    Frequency of different modifications for each axis and within each axis per patient

  7. Calculation of the cost

    Time frame: 3 years

    Calculation of the cost before and after CTA estimated a posteriori on the basis of the consultation rate

  8. Rates for the examinations and therapies

    Time frame: 3 years

    the rates for the examinations and therapies described

  9. Frequency with which CTA

    Time frame: 3 years

    For each doctor: the frequency with which CTA is carried out in his professional practice

  10. Time taken to carry out the CTA

    Time frame: 3 years

    For each doctor: the time taken to carry out the CTA

  11. Average number of ultrasound prints

    Time frame: 3 years

    For each doctor: the average number of ultrasound image prints

  12. Time taken to produce an CTA report

    Time frame: 3 years

    For each doctor: the time taken to produce an CTA report

Study contacts

Contact information is provided by the study sponsor or research team.

Boris Gass, Dr

CONTACT

[email protected]

67467111 ext. 33

Paolo Di Patrizio, Pr

CONTACT

[email protected]

608376920 ext. 33

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Collaborators

  • University of Lorraine

Registry information

Official study 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

Acronym: ECHOSTEOM

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 5, 2023
Registry last updated
Oct 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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