Utilization of Musculoskeletal Ultrasound to Detect Subclinical Findings in IBD Patients

NCT07205549 | Not Yet Recruiting

• 1 other identifier: MS ultrasound in IBD
• Study Type: observational
• Target: 81
• Locations: 0 countries
• Sites: N/A

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.

Conditions

IBD (Inflammatory Bowel Disease); Musculoskeletal Ultrasound

Keywords

IBD; MSK_US

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline.

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Assiut University: lead

Related Publications (3)

• 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)

  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.

  PMID: 26329333 BACKGROUND

• 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.

  PMID: 26614685 BACKGROUND

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Wael A Abbas, MD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed M A tayeh, MSc

CONTACT

+201119384297; Ahmed.17289787@med.aun.edu.eg

Ayat S Ahmed, MD

CONTACT

+201026860251; rheumatologist.ayat@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident physician of internal medicine in Assiut university hospitals

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: October 3, 2025
• Study Start: October 1, 2025
• Primary Completion: November 30, 2025
• Study Completion: December 30, 2025
• Last Updated: October 3, 2025

Record last verified: 2025-09