NCT06495866 Ultrasound Assessment of Entheseal Sites in Patients with Seronegative Spondyloarthropathy with or Without Fibromyalgia
| NCT ID | NCT06495866 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sohag University |
| Condition | Spondyloarthropathy |
| Study Type | OBSERVATIONAL |
| Enrollment | 70 participants |
| Start Date | 2024-08-10 |
| Primary Completion | 2025-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 70 participants in total. It began in 2024-08-10 with a primary completion date of 2025-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Patients fulfill the Assessment in Spondyloarthrits International Society (ASAS) classification criteria for Axial Spondyloarthritis. * Age above 18 years old. * Patient cooperative and can answer questions. * Patients who are able and willing to give written informed consent. Exclusion Criteria: * Other rheumatologic or collagen diseases. * Age below 18 years and above 60 years. * Uncooperative patients. * Patient not able and willing to give written informed consent.
Contact & Investigator
Ahmed R Al-Agamy, MD
STUDY CHAIR
Sohag University
Frequently Asked Questions
Who can join the NCT06495866 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, up to 60 Years, studying Spondyloarthropathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06495866 currently recruiting?
Yes, NCT06495866 is actively recruiting participants. Contact the research team at alaa_ahmed_post@med.sohag.edu.eg for enrollment information.
Where is the NCT06495866 trial being conducted?
This trial is being conducted at Sohag, Egypt.
Who is sponsoring the NCT06495866 clinical trial?
NCT06495866 is sponsored by Sohag University. The principal investigator is Ahmed R Al-Agamy, MD at Sohag University. The trial plans to enroll 70 participants.