Utilization of Musculoskeletal Ultrasound to Detect Subclinical Findings in IBD Patients

NCT ID: NCT07205549

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 81 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2025-12-30

Brief 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. 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.

Conditions

IBD (Inflammatory Bowel Disease); Musculoskeletal Ultrasound

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Interventions

MSK Ultrasound with Doppler on joints, muscles & tendons

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.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Mostafa Ahmed

Resident physician of internal medicine in Assiut university hospitals

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wael A Abbas, MD

Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Ahmed M A tayeh, MSc

Role: CONTACT

Ahmed.17289787@med.aun.edu.eg

+201119384297

Ayat S Ahmed, MD

Role: CONTACT

rheumatologist.ayat@aun.edu.eg

+201026860251

References

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)

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 26329333 (View on PubMed)

Harbord 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.

Reference Type: BACKGROUND

PMID: 26614685 (View on PubMed)

Other Identifiers

MS ultrasound in IBD

Identifier Type: -

Identifier Source: org_study_id