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NCT Number: NCT07205549

Utilization of Musculoskeletal Ultrasound to Detect Subclinical Findings in IBD 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.

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Key information

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

MSK Ultrasound with Doppler on joints, muscles & tendons

Radiation

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 outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed M A tayeh, MSc

CONTACT

[email protected]

+201119384297

Ayat S Ahmed, MD

CONTACT

[email protected]

+201026860251

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Oct 3, 2025
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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