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Ultrasound Assessment of Entheseal Sites in Patients with Seronegative Spondyloarthropathy with or Without Fibromyalgia

NCT ID: NCT06495866

Last Updated: 2024-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-10

Study Completion Date

2025-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Spondyloarthropathy Fibromyalgia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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cases of seronegative spondyloarthropathy with fibromyalgia

cases already diagnosed as seronegative spondyloarthropathy by application of ASAS classificatin criteria for axial SpA and have concomitant fibromyalgia according to 2016 ACR criteria.

ultrasound

Intervention Type RADIATION

Ultrasound finding of entheseal sites of upper \& lower limbs of all groups and scoring according to enthesitis scoring system

cases of seronegative spondyloarthropathy without fibromyalgia

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.

ultrasound

Intervention Type RADIATION

Ultrasound finding of entheseal sites of upper \& lower limbs of all groups and scoring according to enthesitis scoring system

controls

control individuals will be matched for sex, age, and level of schooling without history of inflammatory joint disorders or any systemic active disease.

ultrasound

Intervention Type RADIATION

Ultrasound finding of entheseal sites of upper \& lower limbs of all groups and scoring according to enthesitis scoring system

Interventions

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ultrasound

Ultrasound finding of entheseal sites of upper \& lower limbs of all groups and scoring according to enthesitis scoring system

Intervention Type RADIATION

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Aalaa Ahmed El-Sayed

resident of Physical medicine, Rheumatology and Rehabilitation Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed R Al-Agamy, MD

Role: STUDY_CHAIR

Sohag University

Ola M Mohammed, MD

Role: STUDY_DIRECTOR

Sohag University

Locations

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Sohag University hospitals

Sohag, Sohag Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Aalaa A El-Sayed, Master

Role: CONTACT

[email protected]
01155442188

Ahmed R Al-Agamy, MD

Role: CONTACT

Facility Contacts

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Magdy M Amin, Professor

Role: primary

[email protected]

References

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Healy PJ, Helliwell PS. Classification of the spondyloarthropathies. Curr Opin Rheumatol. 2005 Jul;17(4):395-9. doi: 10.1097/01.bor.0000167753.01168.bd.

Reference Type BACKGROUND
PMID: 15956834 (View on PubMed)

Kehl AS, Corr M, Weisman MH. Review: Enthesitis: New Insights Into Pathogenesis, Diagnostic Modalities, and Treatment. Arthritis Rheumatol. 2016 Feb;68(2):312-22. doi: 10.1002/art.39458. No abstract available.

Reference Type BACKGROUND
PMID: 26473401 (View on PubMed)

Dougados M, van der Linden S, Juhlin R, Huitfeldt B, Amor B, Calin A, Cats A, Dijkmans B, Olivieri I, Pasero G, et al. The European Spondylarthropathy Study Group preliminary criteria for the classification of spondylarthropathy. Arthritis Rheum. 1991 Oct;34(10):1218-27. doi: 10.1002/art.1780341003.

Reference Type BACKGROUND
PMID: 1930310 (View on PubMed)

D'Agostino MA, Terslev L. Imaging Evaluation of the Entheses: Ultrasonography, MRI, and Scoring of Evaluation. Rheum Dis Clin North Am. 2016 Nov;42(4):679-693. doi: 10.1016/j.rdc.2016.07.012. Epub 2016 Sep 7.

Reference Type BACKGROUND
PMID: 27742021 (View on PubMed)

Other Identifiers

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Soh-Med-24-06-19MS

Identifier Type: -

Identifier Source: org_study_id