跳至主要内容
临床试验/NCT06068595
NCT06068595尚未招募不适用

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, France2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
300
试验地点
2
主要终点
Percentage of patients

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Percentage of patients

时间窗: 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)

次要结局

  • 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)

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Principal Investigator
主要研究者

GASS Boris

Principal Investigator

Central Hospital, Nancy, France

研究点 (2)

Loading locations...

相似试验