- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05693311
Inflammatory Bowel Disease Related Joint Manifestations
Inflammatory Bowel Disease Related Joint Manifestations Including the Incidence, Types, Relation to Disease Activity and Types of Treatment
Study Overview
Status
Conditions
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:
A. 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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Youstina soliman, doctor
- Phone Number: 01286515639
- Email: youstinayosry.55@gmail.com
Study Contact Backup
- Name: nabawia tawfik, prof doctor
- Phone Number: 01223971418
- Email: Nabawia.tawfik@yahoo.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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:
- autoimmune disease like SLE , RA , psoriasis
- Osteoarthritis
- Gouty arthritis
- Malignancy
- Polymyalgia rheumatica
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The joint manifestations in Inflammatory bowel disease patients.
Time Frame: 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.
|
2017 to 2024
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Mohamed Ali, ass.prof doc, Assiut Univeristy
Publications and helpful links
General Publications
- Voulgari PV. Rheumatological manifestations in inflammatory bowel disease. Ann Gastroenterol. 2011;24(3):173-180.
- Fragoulis GE, Liava C, Daoussis D, Akriviadis E, Garyfallos A, Dimitroulas T. Inflammatory bowel diseases and spondyloarthropathies: From pathogenesis to treatment. World J Gastroenterol. 2019 May 14;25(18):2162-2176. doi: 10.3748/wjg.v25.i18.2162.
- Di Carlo M, Luchetti MM, Benfaremo D, Di Donato E, Mosca P, Maltoni S, Benedetti A, Gabrielli A, Grassi W, Salaffi F. The DETection of Arthritis in Inflammatory boweL diseases (DETAIL) questionnaire: development and preliminary testing of a new tool to screen patients with inflammatory bowel disease for the presence of spondyloarthritis. Clin Rheumatol. 2018 Apr;37(4):1037-1044. doi: 10.1007/s10067-017-3937-6. Epub 2017 Dec 4.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Joint manifestations in IBD
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Joint Diseases
-
Lithuanian University of Health SciencesEnrolling by invitation
-
Surgalign Spine TechnologiesUnknownSacroiliac Joint DysfunctionUnited States
-
Gdansk University of Physical Education and SportNot yet recruiting
-
Gazi UniversityCompletedGeneralized Joint HypermobilityTurkey
-
Benha UniversityNot yet recruitingAcromioclavicular Joint Dislocation | Acromioclavicular Joint
-
Zyga Technology, Inc.TerminatedSacroiliac Joint DysfunctionUnited States
-
Sahmyook UniversityCompletedMusculoskeletal Manipulations | Chronic Instability of Joint | Ankle JointKorea, Republic of
-
Foundation University IslamabadRecruitingSacroiliac JointPakistan
-
Hacettepe UniversityBaskent University Ankara HospitalCompletedHypermobility, JointTurkey
-
Smith & Nephew Orthopaedics AGCompletedInstability, JointSpain, Italy, United States, Denmark, Finland, United Kingdom