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Status unknownNCT04329182Updated Apr 1, 2020

Color Doppler Ultrasonography in Evaluation of Active Sacroiliitis in Ankylosing Spondylitis

An observational study in Active Sacroiliitis in Ankylosing Spondylitis, sponsored by Assiut University. Status unknown. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-04-01.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Mar 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
40
Ages
18 Years to 65 Years
Sex
All
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Study summary

Evaluate the role of color Doppler ultrasonography (CDUS) in detection of active sacroiliitis in Ankylosing Spondylitis patients using MRI of the sacroiliac joints as a gold standard.

Evaluate the relation of active sacroiliitis detected by color Doppler ultrasonography (CDUS) with disese activity in patients with ankylosing spondylitis

Read the detailed description

Ankylosing spondylitis (AS) is the prototype of the spondyloarthropathies as a chronic inflammatory rheumatic disease presenting mainly with inflammation of the axial skeleton, peripheral arthritis, and enthesitis.

Sacroiliitis is an important sign of AS, and it is used to describe unilateral or bilateral involvement of the sacroiliac joint (SIJ) .

Early diagnosis of AS is important, since some changes associated with the disease are irreversible, and early diagnosis can also improve the ultimate clinical outcomes.

X-ray and magnetic resonance imaging (MRI) are frequently used as image tools to investigate sacroiliitis in AS patients. X-ray could show the structural lesion of sacroiliac joints (SIJs), but could not show the lesions in the early stage of disease. MRI can quantify active in¬flammatory lesions of SIJs.

However, MRI is relatively expensive and time-consuming, and its routine use in patient visits during ther¬apy would be difficult. Another factor that limits usage of MRI is that an important proportion of AS patients have prostheses. Therefore, an easier and cheaper method is needed to detect the degree of spinal inflammation.

Ultrasonography (US) is an inexpensive, non-invasive and non-radiating technique, which can be used in daily clinical practice .

Musculoskeletal ultrasonography (US) has gained increasing attention in many areas of rheumatology . In the area of spondyloarthropathy, Doppler US has been used frequently to assess enthesitis . It was demonstrated that signs of active sacroiliitis could be detected by the color Doppler ultrasonograpy (CDUS) method including increased vascularization in the posterior SIJ and a lower resistance index (RI). The RI could be a quantitative indicator of active sacroiliitis.

Treatment options to AS are limited and mainly consist of non-steroidal anti-inflammatory drugs (NSAIDs) and physical therapy .Efficacy of dis¬ease-modifying anti-rheumatic drugs (DMARDs) such as methotrexate is uncertain to AS.

The introduction of biologic drugs for treatment of AS has led to effective treatment of disease symptoms and signs. However, the effect of these costly drugs on structural damage in addition to the clinical findings is not clear .

02

Conditions studied

  • Active Sacroiliitis in Ankylosing Spondylitis
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In context

Sacroiliitis

42 studies on the registry are indexed under Sacroiliitis; 11 are open to participants now.

This study's planned enrollment of 40 is below the median of 120 across 13 observational studies indexed under Sacroiliitis.

Browse Sacroiliitis studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients involved in the study will be recruited from outpatient clinics and inpatients of Rheumatology, Rehabilitation and Physical Medicine Department, Assiut University Hospitals, Faculty of Medicine.

Diagnosed as Ankylosing Spondylitis defined by the modified New York criteria , and classified as axial Spondyloarthritis according to Assessment in SpondyloArthritis International Society classification criteria

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age of patients (≥18 and ≤65 years old).
  • Diagnosed as Ankylosing Spondylitis defined by the modified New York criteria , and classified as axial Spondyloarthritis according to Assessment in SpondyloArthritis International Society classification criteria.

Exclusion criteria

Exclusion Criteria:

  • Diseases mimicking as AS such as :

    • Flourosis of spine,
    • Diffuse idiopathic skeletal hyperostosis (DISH)
    • Degenerative spinal diseases (spondylosis deformans)
  • Other seronegative spondyloarthropathy :

    • Psoriatic arthritis ,
    • Reactive Arthritis,
    • Enteropathic Arthritis,
    • Undifferentiated spondyloarthropathy.
  • Other causes of sacroiliitis:

    • Osteoarthritis
    • Trauma
    • Infection
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Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
40 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. color Doppler ultrasonography (CDUS) in detection of active sacroiliitis in Ankylosing Spondylitis patients

    • Evaluate the role of color Doppler ultrasonography (CDUS) in detection of active sacroiliitis in Ankylosing Spondylitis patients using MRI of the sacroiliac joints as a gold standard

    Time frame: two years

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04329182
Lead sponsor
Assiut University
Responsible party
Hassan Salah Eldin Hassan Mohamed Elesseily (Principal investigator, Assiut University) — Principal investigator
First posted
Apr 1, 2020
Start date
May 2020 (estimated)
Primary completion
Jan 2022 (estimated)
Completion
May 2022 (estimated)
Last update
Apr 1, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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