An observational study in Spondyloarthropathy and Fibromyalgia, sponsored by Sohag University. Recruiting at 1 site in Egypt. Open to participants aged 19 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-11-29.
Sponsored by Sohag University · Observational
Seronegative spondyloarthropathies are a family of joint disorders that classically include ankylosing spondylitis (AS), psoriatic arthritis (PsA), inflammatory bowel disease (IBD) associated arthritis, reactive arthritis (formerly Reiter syndrome; ReA), and undifferentiated SpA. Enthesitis, or inflammation of the sites where the tendons or ligaments insert into the bone, is a key pathological finding in SpA . It is considered the hallmark and characteristic feature of spondyloarthritis (SpA). Entheses could be classified as fibrous entheses and fibrocartilaginous entheses. Regional structural damage, such as tendon injuries and bone erosions, are frequently caused by persistent enthesitis. The healing process that follows may result in the emergence of enthesophytes and, eventually, functional impairment of related anatomic structures. Imaging modalities for evaluating entheseal lesions include conventional radiology, bone scintigraphy, magnetic resonance imaging (MRI) and power Doppler (PD) ultrasound (US). US has its own unique advantage in the diagnosis of enthesitis in AS; it uses a high-frequency or ultra-high-frequency probe that effectively visualizes the internal structure of the tendon and is recognized as the gold standard for tendon involvement.
It is superior to clinical examination in the detection of peripheral enthesitis.
Manifestations of tendon enthesitis in SpA on US include a thickened tendon, hypoechoicity, local calcification and bony erosion. Abnormal blood flow in tendon entheseal sites can be detected by Power Doppler US. Fibromyalgia (FM) is a syndrome characterized by chronic musculoskeletal pain. The main symptoms of which are muscle stiffness, joint stiffness, insomnia, fatigue, mood disorders, cognitive dysfunction, anxiety, depression, general sensitivity and the inability to carry out normal daily activities [8, 9]. It can also be associated with specific diseases, such as infections, diabetes, rheumatic diseases and psychiatric or neurological disorders. Smythe and Moldofsky later developed the name "fibromyalgia" after identifying "pain points," which are areas of severe tenderness. These points are defined as areas of hyperalgesia/allodynia when a pressure of about 4 kg causes pain.
68 studies on the registry are indexed under Spondylarthropathies; 10 are open to participants now.
This study's planned enrollment of 70 is below the median of 120 across 27 observational studies indexed under Spondylarthropathies.
Browse Spondylarthropathies studies →Sohag University is the lead sponsor of 1,232 studies on the registry; 638 are open to participants now.
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Inclusion Criteria:
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Exclusion Criteria:
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
cases already diagnosed as seronegative spondyloarthropathy by application of ASAS classificatin criteria for axial SpA and have concomitant fibromyalgia according to 2016 ACR criteria.
Radiation: ultrasound
cases already diagnosed as seronegative spondyloarthropathy by application of ASAS classificatin criteria for axial SpA and do not match with 2016 ACR criteria for fibromyalgia.
Radiation: ultrasound
control individuals will be matched for sex, age, and level of schooling without history of inflammatory joint disorders or any systemic active disease.
Radiation: ultrasound
Ultrasound finding of entheseal sites of upper \& lower limbs of all groups and scoring according to enthesitis scoring system
Comparison of ultrasound detected enthesitis among both groups and controls
Comparison of ultrasound detected enthesitis among patients with spondyloarthropathy with secondary fibromyalgia and those with isolated spondyloarthropathy without fibromyalgia and among controls. Cases of Spondyloarthropathy will be already diagnosed using ASAS classification criteria. All patients will be subjected to the following: 1. Full medical history from the patients including Demographic data (Age Sex - Marital status - Occupation - Residence), duration of disease - The treatments that patients receive. 2. Full clinical examination and assessment including: (a) General examination and Complete rheumatological examination. (b) ASDAS. (c) Application of 2016 ACR criteria for fibromyalgia on all SpA patients to detect cases with secondary fibromyalgia. 3. Laboratory investigations: (complete blood picture, erythrocyte sedimentation rate, C- reactive protein). 4. Ultrasound finding of entheseal sites of upper \& lower limbs.
Time frame: 12 months
Plan to share: Undecided
Started Aug 2024 (actual). Primary completion is estimated for Aug 2025, 12 months after the start.
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