Added Value of Diffusion Weighted MRI in Evaluation of Sacroiliitis in Newly Diagnosed Patients of Spondyloarthropathy.

Not yet recruiting

• Conditions: Spondyloarthropathy and Sacroilitis
• Interventions: Diagnostic Test: Magnetic resonance Imaging scanners of sacroiliac joints.

• Registration Number: NCT05655533
• Lead Sponsor: Assiut University

Brief Summary

Spondyloarthropathy encompasses a group of chronic immune-mediated rheumatic inflammatory diseases characterized by axial joint inflammation, peripheral arthritis, enthesitis, dactylitis and extra-articular features.

Axial spondyloarthritis (SpA) has significant social and psychiatric impacts \[2, 3\] and affects quality-of-life (4-5).Early disease diagnosis is becoming more important as it will facilitate early therapeutic interventions (6).

There's no "gold standard" feature for diagnosing axSpA. It's diagnosed through a combination of patient history, clinical examination, laboratory findings a and imaging tests, such as X-ray and MRI.

Sacroiliitis is commonly the first manifestation and an important indicator of the diagnosis and classification of the the disease. (7) Radiographic sacroiliitis is a key criterion. However, sole reliance on radiographs is associated with significant diagnostic delay \[8\]. Magnetic Resonance Imaging (MRI) can detect axial inflammation before radiographic changes.

Diffusion-weighted imaging (DWI) offers a new approach to assess inflammation. Recently several studies have shown that DWI is an effective tool in early diagnosis of axSpA (14-16). Furthermore, the ADC value may serve as a quantitative biomarker of disease activity, allowing monitoring and guiding treatment. (17-18)

Detailed Description

Spondyloarthropathy encompasses a group of chronic immune-mediated rheumatic inflammatory diseases characterized by axial joint inflammation, peripheral arthritis, enthesitis, dactylitis and extra-articular features such as psoriasis, uveitis, inflammatory bowel disease (crohns and ulcerative colitis) \[1\].

Axial spondyloarthritis (SpA) has significant social and psychiatric impacts \[2, 3\] and affects quality-of-life (4-5). Patients often experience prolonged delays in diagnosis. Early disease diagnosis is becoming more important as it will facilitate early therapeutic interventions (6).

There's no "gold standard" feature for diagnosing axSpA. It's diagnosed through a combination of patient history, clinical examination, laboratory findings as blood tests (both for HLA-B27 and for markers of inflammation, such as C-reactive protein), and imaging tests, such as X-ray and MRI.

Sacroiliitis is commonly the first manifestation and an important indicator of the diagnosis and classification of the the disease. (7) Radiographic sacroiliitis is a key criterion. However, sole reliance on radiographs is associated with significant diagnostic delay \[8\]. Magnetic Resonance Imaging (MRI) can detect axial inflammation before radiographic changes. (9) So with the development of Assessment of Spondyloarthritis International Society (ASAS) classification criteria for ax-SpA, MRI is increasingly being used to early diagnose and monitor disease activity. (10) Diffusion-weighted imaging (DWI) offers a new approach to assess inflammation. It is a functional MRI technique that can non-invasively asses the random movements of water molecules through the measurements of the ADC value. (11). Inflammation produces an increase in the apparent diffusion coefficient (ADC) of water molecules in affected tissues, probably owing to an increase in the ratio of extracellular to intracellular water. (12-13) Recently several studies have shown that DWI is an effective tool in early diagnosis of axSpA (14-16). Furthermore, the ADC value may serve as a quantitative biomarker of disease activity, allowing monitoring and guiding treatment. (17-18)

Study Timeline

• Status Verified: 2022-12
• Study First Submitted: 2022-12-09
• Study First Submitted QC: 2022-12-09
• Last Update Submitted: 2022-12-09
• Study Start: 2022-12-10
• Study First Posted: 2022-12-19
• Last Update Posted: 2022-12-19
• Primary Completion: 2024-05-10
• Study Completion: 2024-10-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• All adult patients who are suspected clinically to have early spondyloarthropathy with acute sacroiliitis.

Exclusion Criteria

• Known patients with chronic spondyloarthropathy under medical treatment.
• Patients with previous surgical operations and metallic screws fixation at pelvic region.
• Patients refused the examination.
• Patients with contraindication to MRI as claustrophobia, pacemaker.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adult patients who clinically suspected to have early spondyloarthropathy	Magnetic resonance Imaging scanners of sacroiliac joints.	Adult patients who clinically suspected to have early spondyloarthropathy in acute stage. At least 4 of 5 criteria for inflammatory low back pain have to be fulfilled

Primary Outcome Measures

Name	Time	Method
value of diffusion weighted MRI in evaluation of sacroiliitis in newly diagnosed patients of spondyloarthropathy.	one year	Diagnostic value of Diffusion weighted MRI of Sacroiliac joint compared to Conventional sequence MRI of sacroiliac joint for the diagnosis of sacroiliitis.

Secondary Outcome Measures

Name	Time	Method
Early diagnosis of spondyloarthropathy	one year	Early diagnosis of spondyloarthropathy by early detection of sacroiliitis in clinically suspected patients will facilitate early therapeutic interventions thus lead to dramatic improvements in the management of axial SpA by reducing symptoms and preserving functional status.