Musculoskeletal; AnomalyECHOSTEOMNCT06068595
Evaluation of the Contribution of Musculoskeletal Ultrasound to the General Practitioner's Overall Decision-making Strategy
A study testing musculoskeletal ultrasound in people with Musculoskeletal; Anomaly, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Musculoskeletal; Anomaly
- What is being tested?
- musculoskeletal ultrasound
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2024to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Central Hospital
Nancy, Vandoeuvre Lès Nancy, 54500
Boris Gass, Dr, boris.gass@univ-lorraine.fr
Paolo Di Patrizio, Pr, paolo.di-patrizio@univ-lorraine.fr
About this study
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
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).
Read the detailed description
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.
- Conditions
- Musculoskeletal; Anomaly
- Being tested
- musculoskeletal ultrasound
- Keywords
- musculoskeletal anomaly, ultrasonography, general practitioners
- Medical subject headings
- Musculoskeletal Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
musculoskeletal ultrasoundOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Other | Patient with musculoskeletal anomalies Receives: Other: musculoskeletal ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 years
Secondary outcomes (12)
Frequency of the anatomical sites
Frequency of the different anatomical sites (shoulder, elbow, arm, etc.) and structures (osteoarticular pathologies, tendon and retinacular pathologies, etc.) concerned
Measured: 3 years
Frequency of modifications
Frequency of different modifications for each axis and within each axis
Measured: 3 years
Frequency of diagnoses of post-CTA confirmation
List and frequency of diagnoses in the case of post-CTA confirmation
Measured: 3 years
Frequency of diagnoses of post-CTA modifications
List and frequency of diagnoses in the case of post-CTA modifications
Measured: 3 years
Frequency of incidental diagnoses discovered at CTA
Frequency and description of incidental diagnoses discovered at CTA
Measured: 3 years
Frequency of modifications per patient
Frequency of different modifications for each axis and within each axis per patient
Measured: 3 years
Calculation of the cost
Calculation of the cost before and after CTA estimated a posteriori on the basis of the consultation rate
Measured: 3 years
Rates for the examinations and therapies
the rates for the examinations and therapies described
Measured: 3 years
Frequency with which CTA
For each doctor: the frequency with which CTA is carried out in his professional practice
Measured: 3 years
Time taken to carry out the CTA
For each doctor: the time taken to carry out the CTA
Measured: 3 years
Average number of ultrasound prints
For each doctor: the average number of ultrasound image prints
Measured: 3 years
Time taken to produce an CTA report
For each doctor: the time taken to produce an CTA report
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study startApr 2024 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal; AnomalyStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lorraine
- Responsible party
- Principal investigator, GASS Boris, Central Hospital, Nancy, France
- Investigators
- Boris Gass, Pr, Principal investigator, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06068595
- Sponsor's protocol ID
- 2023-A01995-40
- Acronym
- ECHOSTEOM
- Status last verified
- Sep 2023
- First submitted
- 22 Sep 2023
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31749019Meyer 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.
PubMed 33675099Nazarian 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.
PubMed 18492916Narula 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.
PubMed 29490335Andersen 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.
PubMed 31253102
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06068595
- Acronym / sponsor ID
- ECHOSTEOM / 2023-A01995-40
- Conditions
- Musculoskeletal; Anomaly
- Keywords
- musculoskeletal anomaly, ultrasonography, general practitioners
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- University of Lorraine
- Study start
- Apr 2024 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 5 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | Other | Other: musculoskeletal ultrasoundPatient with musculoskeletal anomalies |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| musculoskeletal ultrasoundAfter 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. | Other | Patients |
Primary outcome
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)
12 secondary outcomes
Frequency of the anatomical sites
Time frame: 3 years
Frequency of modifications
Time frame: 3 years
Frequency of diagnoses of post-CTA confirmation
Time frame: 3 years
Frequency of diagnoses of post-CTA modifications
Time frame: 3 years
Frequency of incidental diagnoses discovered at CTA
Time frame: 3 years
Frequency of modifications per patient
Time frame: 3 years
Calculation of the cost
Time frame: 3 years
Rates for the examinations and therapies
Time frame: 3 years
Frequency with which CTA
Time frame: 3 years
Time taken to carry out the CTA
Time frame: 3 years
Average number of ultrasound prints
Time frame: 3 years
Time taken to produce an CTA report
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Background: PubMed 31749019Sorensen 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.
- Background: PubMed 33675099Meyer 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.
- Background: PubMed 18492916Nazarian 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.
- Background: PubMed 29490335Narula 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.
- Background: PubMed 31253102Andersen 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.
Related trials for Musculoskeletal; Anomaly
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
RecruitingPhase 3
Efficacy, Safety, and Tolerability of Zeleciment Basivarsen (DYNE-101) in Participants With Myotonic Dystrophy Type 1
Myotonic Dystrophy Type 1 (DM1), DM1
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
RecruitingPhase 4
Treat-to-Target Serum Urate Versus Treat-to-Avoid Symptoms in Gout
Gout
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Boris Gass, Pr principal investigator
Central Hospital, Nancy, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing musculoskeletal ultrasound in people with Musculoskeletal; Anomaly, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Boris Gass, Dr (67467111 ext. 33, boris.gass@univ-lorraine.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06068595, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2023.