Utilization of Musculoskeletal Ultrasound to Detect Subclinical Findings in IBD Patients

Official title

Role of Musculoskeletal Ultrasound in Detection of Subclinical Findings in Inflammatory Bowel Disease Patients

Overview

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.

Interventions

• Radiation 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.

Primary outcome measures

• the prevalence of subclinical musculoskeletal abnormalities [Time frame: baseline.]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model

Cohort

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 26329333
• 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 PMID 26614685

Identifiers

NCT: NCT07205549 · MS ultrasound in IBD

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗