Frequency of Sacroiliitis in Inflammatory Bowel Disease Patients Using MRI

September 18, 2023 updated by: Magy Wageeh Abdelmalak, Assiut University
  1. to determine the overall frequency of Inflammatory sacroiliitis among patients with Inflammatory bowel disease using magnetic resonance imaging
  2. identify the association of sacroliitis in IBD patients clinical and laboratory markers

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

INFLAMMATORY BOWEL DISEASE (IBD) is a disorder in which an inappropriate response to an unknown antigen, combined with genetic and environmental factors, result in inflammation of the small bowel and colon . The two main forms of IBD are Crohn's disease (CD) and ulcerative colitis (UC) which are both associated with spondyloarthropathy (SpA), an inflammatory arthritis characterized by sacroiliitis and inflammatory back pain .

Articular manifestations of inflammatory bowel disease(IBD), comprising Crohn's disease (CD) and ulcerative colitis (UC), were first described in 1930 and have been considered as spondylarthropathies since 1978. They include peripheral arthritis and inflammatory axial involvement.

Extra-intestinal musculoskeletal manifestations associated with Inflammatory bowel disease, can be divided into axial and peripheral arthropathy, which can be a cause of significant morbidity that can adversely affect the quality of life in these patients. Peripheral arthropathy represent the most frequent (40%) extra-intestinal manifestation in IBD. These manifestations occur more frequently in patients with Crohn's disease.

Sacroiliitis (SI) is considered one of the common axial arthropathies with an estimated prevalence of around 10% of Crohn's patients.

It is crucial to differentiate inflammatory back pain due to axial SpA from other causes of chronic low back pain as they have different treatments and prognosis.

The diagnosis is based upon the presence of characteristic inflammatory type back pain with evidence of SI on imaging . Both clinical examination and plain radiographs have their own limitations of only detecting advanced disease.

Importantly, sacroiliitis, which is the hallmark of the spondyloarthropathies, may be clinically silent with an ambiguous or equivocal physical examination tests so imaginghas important role in its diagnosis Imaging findings in sacroiliitis are divided into acute and structural changes.The acute findings of sacroiliitis can be observed on magnetic resonance imaging (MRI) and include periarticular sacroiliac joint (SIJ) bone marrow edema(BME), soft tissue edema, and contrast enhancement. Structural changes including SIJ erosions, subchondral sclerosis and bony bridges appear relatively late in the disease .Indeed, findings compatible with acute inflammation may be seen on MRI years before late structural findings are evident.

MRI is a promising technology with a higher sensitivity and specificity for the diagnosis of SI. As MRI is being utilized more frequently in patients with Crohn's disease, more and more patients are found to have a positive MRI evidence of SI without clinical signs or symptoms so MRI is necessary for diagnosing and evaluating patients with early disease.

Incorporation of magnetic resonance imaging (MRI) to assess axial SpA allows early recognition of axial SpA in CD, especially when patients do not present with classic IBP symptoms.

The introduction of biological drugs from the tumor necrosis factor-alpha (TNF-a) receptor blocker group, has further emphasized the need for early diagnosis of sacroiliitis in patients with IBD, many of which, can be asymptomatic, nonradiographic, or both. These drugs, when administered early in the disease, are capable of changing the course, alleviating the symptoms and even producing withdrawal of early imaging findings, including BME and contrast enhancement.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Mohammad Alyamany Kobeisy, Prof
  • Phone Number: 01002228914
  • Email: yamany1@yahoo.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

All patients were selected from outpatient clinic of IBD of Elraghi hospital.

Description

Inclusion Criteria:

  • subjects between 18 and 65 years.
  • subjects met clinical, pathological or radiological criteria of IBD.

Exclusion Criteria:

  1. Patients who refuse enter the study
  2. Patients who not diagnosed as IBD
  3. other inflammatory arthritis (e.g. rheumatoid arthritis, systemic lupus erythematosus, psoriatic or reactive arthritis)
  4. co-existent autoimmune diseases (e.g. celiac disease, Behcets disease)
  5. malignancy less than 5 years in remission .
  6. having a contraindication to MRI.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary (main)
Time Frame: through study completion, an average of 1 year

Incidence of sacroliitis in inflammatory bowel disease patients using MRI

with Inflammatory bowel disease using magnetic resonance imaging.
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary
Time Frame: through study completion, an average of 1 year

association of sacroliitis in IBD patients assessed by clinical and laboratory markers .

  • clinical examination including sacroiliac joint examination
  • Laboratory investigations
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2023

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

September 2, 2023

First Submitted That Met QC Criteria

September 11, 2023

First Posted (Actual)

September 13, 2023

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 18, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sacroliitis in IBD using MRI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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