Ignite Creation Date:
2025-12-24 @ 1:39 PM
Ignite Modification Date:
2025-12-27 @ 9:16 PM
Study NCT ID:
NCT06068595
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-05
First Post:
2023-09-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Contribution of Musculoskeletal Ultrasound to the General Practitioner's Overall Decision-making Strategy
Sponsor:
Central Hospital, Nancy, France
Organization:
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ECHOSTEOM
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).
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: