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NCT Number: NCT06495866

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

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.

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Key information

Age range

19 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sohag University hospitals

Sohag, Sohag Governorate, Egypt

Location status: Recruiting

Location contact

Magdy M Amin, Professor

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ultrasound

Radiation

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

Primary outcomes

  1. Comparison of ultrasound detected enthesitis among both groups and controls

    Time frame: 12 months

    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:

    • Full medical history from the patients including Demographic data (Age Sex - Marital status - Occupation - Residence), duration of disease - The treatments that patients receive.
    • 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.
    • Laboratory investigations: (complete blood picture, erythrocyte sedimentation rate, C- reactive protein).
    • Ultrasound finding of entheseal sites of upper & lower limbs.

Study contacts

Contact information is provided by the study sponsor or research team.

Aalaa A El-Sayed, Master

CONTACT

[email protected]

01155442188

Ahmed R Al-Agamy, MD

CONTACT

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 11, 2024
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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