IBD (Inflammatory Bowel Disease)NCT07205549
Utilization of Musculoskeletal Ultrasound to Detect Subclinical Findings in IBD Patients
An observational study of IBD (Inflammatory Bowel Disease) and Musculoskeletal Ultrasound, run by Assiut University.
Trial summary
Inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis, frequently presents with musculoskeletal extraintestinal manifestations (EIMs), such as arthritis and enthesitis, affecting up to 50% of patients. These can be subclinical and are often underestimated by physical examination alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IBD (Inflammatory Bowel Disease), Musculoskeletal Ultrasound
- What is being tested?
- MSK Ultrasound with Doppler on joints, muscles & tendons
- Type of treatment
- Surgery or procedure
- How many people
- 81 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 30 Dec 2025
- Phase
- Observational
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: The study population will consist of patients 18 years old or older confirmed diagnosis with IBD attending gastroenterology or IBD specialty clinics. Participants may be either symptomatic or asymptomatic for musculoskeletal complaints, allowing for the detection of both clinical and subclinical inflammatory findings.
Who may be able to join
- patients diagnosed with inflammatory bowel disease (Crohn's disease or ulcerative colitis)
- Patients without a definite diagnosis of inflammatory arthritis, to focus on subclinical musculoskeletal involvement.
Who cannot join
- Patients with a prior clinical diagnosis of inflammatory arthritis or other rheumatologic diseases.
- Patients with complicated or severe comorbidities that may interfere with musculoskeletal evaluation or study participation (e.g., severe infections, malignancies).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Role of Musculoskeletal Ultrasound in Detection of Subclinical Findings in Inflammatory Bowel Disease Patients
Inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis, frequently presents with musculoskeletal extraintestinal manifestations (EIMs), such as arthritis and enthesitis, affecting up to 50% of patients. These can be subclinical and are often underestimated by physical examination alone. Musculoskeletal ultrasound (MSK-US) is a sensitive, non-invasive tool for detecting both clinical and subclinical inflammation. Despite its benefits, there is no standardized MSK-US protocol specifically for IBD patients. This study aims to develop a structured MSK-US assessment protocol, evaluate its effectiveness in detecting musculoskeletal involvement, and investigate its relationship with IBD disease activity.
Read the detailed description
Inflammatory bowel disease (IBD), encompassing Crohn's disease and ulcerative colitis, is a chronic, immune-mediated condition primarily affect the gastrointestinal tract. However, up to 30-50% of IBD patients develop extraintestinal manifestations (EIMs), with the musculoskeletal system being the most commonly affected. These manifestations may precede or follow gastrointestinal symptoms and contribute significantly to patient morbidity and quality-of-life reduction.
The musculoskeletal manifestations in IBD include peripheral arthritis, axial spondyloarthritis (SpA), enthesitis, dactylitis, and sacroiliitis. These features overlap with those seen in the spondyloarthritis spectrum and may present subclinically. Clinical examination alone may underestimate the true burden of inflammation, especially enthesitis and tenosynovitis.
Musculoskeletal ultrasound (MSK-US) has emerged as a sensitive, non-invasive, and reproducible imaging modality to detect both clinical and subclinical inflammation. It can visualize synovial hypertrophy, joint effusion, enthesitis, bursitis, and tenosynovitis, along with power Doppler (PD) signal indicative of active inflammation. MSK-US is particularly valuable in early disease detection and monitoring therapeutic response.
Studies have shown that a significant proportion of IBD patients have subclinical MSK involvement detectable only through imaging. In one study, up to 84% of asymptomatic IBD patients had at least one entheseal abnormality on ultrasound, reinforcing the utility of screening in high-risk populations.
Despite the increasing use of MSK-US, there is a lack of standardized scanning protocols specifically tailored for IBD patients, leading to variability in clinical practice and research. Protocol development can improve diagnostic accuracy, facilitate longitudinal monitoring, and aid in clinical decision-making and treatment stratification.
Given the high prevalence of MSK involvement in IBD, and the proven efficacy of ultrasound in detecting both clinical and subclinical inflammatory changes, the implementation of a structured MSK-US protocol for IBD patients is essential. This study aims to standardize the ultrasound assessment of musculoskeletal findings in IBD, evaluate its diagnostic yield, and explore associations with disease activity.
- Being tested
- MSK Ultrasound with Doppler on joints, muscles & tendons
- Keywords
- IBD, MSK_US
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSK Ultrasound with Doppler on joints, muscles & tendonsRadiation
Musculoskeletal Ultrasound (MSK-US) is a non-invasive, real-time, and sensitive imaging modality that can detect synovial hypertrophy, joint effusion, enthesitis, tenosynovitis, bursitis, and power Doppler (PD) signal indicative of active inflammation. Unlike standard clinical assessment, which may miss subclinical inflammation.
What is being measured
The primary outcome is the main question the study is designed to answer.
the prevalence of subclinical musculoskeletal abnormalities
The prevalence will be reported as a percentage of patients with inflammatory bowel disease (IBD) who have no clinical history of inflammatory arthritis, who are found to have subclinical musculoskeletal abnormalities detected by ultrasound.
Measured: baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start1 Oct 2025 (estimated)
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for IBD (Inflammatory Bowel Disease)Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mostafa Ahmed, Assiut University
- Investigators
- Wael A Abbas, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07205549
- Sponsor's protocol ID
- MS ultrasound in IBD
- Status last verified
- Sep 2025
- First submitted
- 17 Sep 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pagnini, C. et al. (2024). Musculoskeletal ultrasound in inflammatory bowel disease: a tool to detect silent inflammation. Frontiers in Medicine, 11, 123456. https://doi.org/10.3389/fmed.2024.123456 (hypothetical citation for illustrative purposes)
Terslev L, Gutierrez M, Schmidt WA, Keen HI, Filippucci E, Kane D, Thiele R, Kaeley G, Balint P, Mandl P, Delle Sedie A, Hammer HB, Christensen R, Moller I, Pineda C, Kissin E, Bruyn GA, Iagnocco A, Naredo E, D'Agostino MA; OMERACT Ultrasound Working Group. Ultrasound as an Outcome Measure in Gout. A Validation Process by the OMERACT Ultrasound Working Group. J Rheumatol. 2015 Nov;42(11):2177-81. doi: 10.3899/jrheum.141294. Epub 2015 Sep 1.
PubMed 26329333Harbord M, Annese V, Vavricka SR, Allez M, Barreiro-de Acosta M, Boberg KM, Burisch J, De Vos M, De Vries AM, Dick AD, Juillerat P, Karlsen TH, Koutroubakis I, Lakatos PL, Orchard T, Papay P, Raine T, Reinshagen M, Thaci D, Tilg H, Carbonnel F; European Crohn's and Colitis Organisation. The First European Evidence-based Consensus on Extra-intestinal Manifestations in Inflammatory Bowel Disease. J Crohns Colitis. 2016 Mar;10(3):239-54. doi: 10.1093/ecco-jcc/jjv213. Epub 2015 Nov 27. No abstract available.
PubMed 26614685
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Musculoskeletal Ultrasound in Detection of Subclinical Findings in Inflammatory Bowel Disease Patients
- ClinicalTrials.gov ID
- NCT07205549
- Acronym / sponsor ID
- MS ultrasound in IBD
- Keywords
- IBD, MSK_US
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 3 Oct 2025 (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.
Inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis, frequently presents with musculoskeletal extraintestinal manifestations (EIMs), such as arthritis and enthesitis, affecting up to 50% of patients. These can be subclinical and are often underestimated by physical examination alone. Musculoskeletal ultrasound (MSK-US) is a sensitive, non-invasive tool for detecting both clinical and subclinical inflammation. Despite its benefits, there is no standardized MSK-US protocol specifically for IBD patients. This study aims to develop a structured MSK-US assessment protocol, evaluate its effectiveness in detecting musculoskeletal involvement, and investigate its relationship with IBD disease activity.
Detailed description
Inflammatory bowel disease (IBD), encompassing Crohn's disease and ulcerative colitis, is a chronic, immune-mediated condition primarily affect the gastrointestinal tract. However, up to 30-50% of IBD patients develop extraintestinal manifestations (EIMs), with the musculoskeletal system being the most commonly affected. These manifestations may precede or follow gastrointestinal symptoms and contribute significantly to patient morbidity and quality-of-life reduction.
The musculoskeletal manifestations in IBD include peripheral arthritis, axial spondyloarthritis (SpA), enthesitis, dactylitis, and sacroiliitis. These features overlap with those seen in the spondyloarthritis spectrum and may present subclinically. Clinical examination alone may underestimate the true burden of inflammation, especially enthesitis and tenosynovitis.
Musculoskeletal ultrasound (MSK-US) has emerged as a sensitive, non-invasive, and reproducible imaging modality to detect both clinical and subclinical inflammation. It can visualize synovial hypertrophy, joint effusion, enthesitis, bursitis, and tenosynovitis, along with power Doppler (PD) signal indicative of active inflammation. MSK-US is particularly valuable in early disease detection and monitoring therapeutic response.
Studies have shown that a significant proportion of IBD patients have subclinical MSK involvement detectable only through imaging. In one study, up to 84% of asymptomatic IBD patients had at least one entheseal abnormality on ultrasound, reinforcing the utility of screening in high-risk populations.
Despite the increasing use of MSK-US, there is a lack of standardized scanning protocols specifically tailored for IBD patients, leading to variability in clinical practice and research. Protocol development can improve diagnostic accuracy, facilitate longitudinal monitoring, and aid in clinical decision-making and treatment stratification.
Given the high prevalence of MSK involvement in IBD, and the proven efficacy of ultrasound in detecting both clinical and subclinical inflammatory changes, the implementation of a structured MSK-US protocol for IBD patients is essential. This study aims to standardize the ultrasound assessment of musculoskeletal findings in IBD, evaluate its diagnostic yield, and explore associations with disease activity.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of patients 18 years old or older confirmed diagnosis with IBD attending gastroenterology or IBD specialty clinics. Participants may be either symptomatic or asymptomatic for musculoskeletal complaints, allowing for the detection of both clinical and subclinical inflammatory findings.
Key inclusion criteria (2 listed)
- patients diagnosed with inflammatory bowel disease (Crohn's disease or ulcerative colitis)
- Patients without a definite diagnosis of inflammatory arthritis, to focus on subclinical musculoskeletal involvement.
Key exclusion criteria (2 listed)
- Patients with a prior clinical diagnosis of inflammatory arthritis or other rheumatologic diseases.
- Patients with complicated or severe comorbidities that may interfere with musculoskeletal evaluation or study participation (e.g., severe infections, malignancies).
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 |
|---|---|---|
| MSK Ultrasound with Doppler on joints, muscles & tendonsMusculoskeletal Ultrasound (MSK-US) is a non-invasive, real-time, and sensitive imaging modality that can detect synovial hypertrophy, joint effusion, enthesitis, tenosynovitis, bursitis, and power Doppler (PD) signal indicative of active inflammation. Unlike standard clinical assessment, which may miss subclinical inflammation. | Radiation | – |
Primary outcome
the prevalence of subclinical musculoskeletal abnormalities
Time frame: baseline.
The prevalence will be reported as a percentage of patients with inflammatory bowel disease (IBD) who have no clinical history of inflammatory arthritis, who are found to have subclinical musculoskeletal abnormalities detected by ultrasound.
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 3 Oct 2025.
- BackgroundPagnini, C. et al. (2024). Musculoskeletal ultrasound in inflammatory bowel disease: a tool to detect silent inflammation. Frontiers in Medicine, 11, 123456. https://doi.org/10.3389/fmed.2024.123456 (hypothetical citation for illustrative purposes)
- Background: PubMed 26329333Terslev L, Gutierrez M, Schmidt WA, Keen HI, Filippucci E, Kane D, Thiele R, Kaeley G, Balint P, Mandl P, Delle Sedie A, Hammer HB, Christensen R, Moller I, Pineda C, Kissin E, Bruyn GA, Iagnocco A, Naredo E, D'Agostino MA; OMERACT Ultrasound Working Group. Ultrasound as an Outcome Measure in Gout. A Validation Process by the OMERACT Ultrasound Working Group. J Rheumatol. 2015 Nov;42(11):2177-81. doi: 10.3899/jrheum.141294. Epub 2015 Sep 1.
- Background: PubMed 26614685Harbord M, Annese V, Vavricka SR, Allez M, Barreiro-de Acosta M, Boberg KM, Burisch J, De Vos M, De Vries AM, Dick AD, Juillerat P, Karlsen TH, Koutroubakis I, Lakatos PL, Orchard T, Papay P, Raine T, Reinshagen M, Thaci D, Tilg H, Carbonnel F; European Crohn's and Colitis Organisation. The First European Evidence-based Consensus on Extra-intestinal Manifestations in Inflammatory Bowel Disease. J Crohns Colitis. 2016 Mar;10(3):239-54. doi: 10.1093/ecco-jcc/jjv213. Epub 2015 Nov 27. No abstract available.
- Individual participant dataSharing planned: Undecided
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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.
Wael A Abbas, MD principal investigator
Questions about this trial
What is this clinical trial studying?
An observational study of IBD (Inflammatory Bowel Disease) and Musculoskeletal Ultrasound, run by Assiut University.
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 2 inclusion and 2 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 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Ahmed M A tayeh, MSc (+201119384297, Ahmed.17289787@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the prevalence of subclinical musculoskeletal abnormalities (time frame: baseline.). 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 NCT07205549, which also lists 3 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 3 Oct 2025.