Inflammatory Bowel Disease Related Joint Manifestations

Sponsor
Youstina Yosry Soliman (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05693311
Collaborator
(none)
217
24

Study Details

Study Description

Brief Summary

The main purpose of this research is to identify incidence of jiunt manifestations by its both types axial and periphral in IBD patients, its types , relation to IBD activity, lines of treatment using and how they are effective in prevention and in treatment of these joint manifestations.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Inflammatory bowel disease (IBD) is a chronic immune-mediated disorder divided into two large types Crohn disease and ulcerative colitis. Crohn disease may affect any part of the gastrointestinal tract (GIT), whereas Ulcerative colitis affects the large intestine . IBD is also described to cause remissions and relapses or activity. IBD is a multisystem condition that affects mainly the gastrointestinal, musculoskeletal, ocular, and cutaneous systems. Those complications that arise outside the intestinal inflammation are known as extra intestinal manifestations (EIMs) of IBD, EIMs present in 5% to 50% of all IBD patients these may be :skin, eyes, kidneys, liver, anaemia.

    In a focused point musculoskeletal manifestations being the most common EIM with a incidence about 40%. It was divided into:

    1. Axial type (spondyloarthropathy) B. Peripheral type divided into : 1.Type 1 (pauciarticular). 2.Type 2 (polyarticular) In this research we shall focus on the confirmed data for diagnosis of IBD by history , lab investigations & colonoscopy and biopsy including disease location . Then onset of joint manifestations in relation to both intestinal & other extra intestinal manifestations . The effect of disease activity on routine lab investigations including CBC, kidney function , liver function , ESR, CRP & on imaging like x-ray .

    Also the effect of disease activity on joint manifestations is an important point to be discussed .

    For this purpose, a validated detailed questionnaire according to farisoğullari 2021 consisting of six questions was asked (1). Have you ever had swelling or pain in fingers , toes or any other joint with no apparent reason? (2).Has an entire finger or toe becomes swollen, making it look like a 'sausage' ? (3). Have you had pain in your heels? (4). Have you ever had back pain lasting at least 3 months that was not injury related? (5). Do you have low back pain in the morning after resting that improves with exercise? (6). Do you wake up at night because of low back pain?.

    The response of joint manifestations to different routes of treatment of IBD is also of great importance , A good response of back pain to a full dose of non-steroidal anti-inflammatory drugs was defined as "not anymore present "or "much better". Immunomodulators have been efficacious in patients with peripheral arthritis and other extra-intestinal manifestations, but they are not effective for the treatment of axial symptoms of spondylitis.

    The treatment of peripheral involvement and/or enthesitis and/or dactylitis is based on local steroid injections, while sulfasalazine and/or low doses of systemic steroids may be useful in case of inadequate response to intra-articular steroids. Sulfasalazine induces only a little improvement in peripheral arthritis. Immunomodulators such as methotrexate, azathioprine, cyclosporine and leflunomide were also effective.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    217 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Inflammatory Bowel Disease Related Joint Manifestations Including the Incidence, Types, Relation to Disease Activity and Types of Treatment
    Anticipated Study Start Date :
    Mar 1, 2023
    Anticipated Primary Completion Date :
    Dec 31, 2024
    Anticipated Study Completion Date :
    Mar 1, 2025

    Outcome Measures

    Primary Outcome Measures

    1. The joint manifestations in Inflammatory bowel disease patients. [2017 to 2024]

      The main purpose of this research is to identify incidence of joint manifestations by its both types axial and peripheral in crohns disease and ulcerative colitis patients, relation to the disease activity,other extra intestinal manifestations, lines of treatment used and how they are effective in prevention and in treatment of these joint manifestations.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • Patients previously diagnosed by colonoscopy and biopsy of IBD either crhons disease or ulcerative colitis from2017 to 2022 attending IBD clinic in EL-RAGHY LIVERHOSPITAL.
    Exclusion Criteria:
    • Patients with a known diagnosis of any other joint disease like:
    1. autoimmune disease like SLE , RA , psoriasis

    2. Osteoarthritis

    3. Gouty arthritis

    4. Malignancy

    5. Polymyalgia rheumatica

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Youstina Yosry Soliman

    Investigators

    • Study Director: Mohamed Ali, ass.prof doc, assiut univeristy

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Youstina Yosry Soliman, resident doctor, Assiut University
    ClinicalTrials.gov Identifier:
    NCT05693311
    Other Study ID Numbers:
    • Joint manifestations in IBD
    First Posted:
    Jan 20, 2023
    Last Update Posted:
    Jan 20, 2023
    Last Verified:
    Jan 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Youstina Yosry Soliman, resident doctor, Assiut University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 20, 2023