ClinicalTrials.gg
Not yet recruitingNCT07553910Updated Apr 28, 2026

Tenosynovitis in Polyarticular and Oligoarticular Juvenile Idiopathic Arthritis

An observational study in Juvenile Idiopathic Arthritis, Tenosynovitis and Polyarticular Juvenile Idiopathic Arthritis, sponsored by Assiut University. Not yet recruiting. Open to participants aged Up to 16 Years. Per ClinicalTrials.gov, last updated 2026-04-28.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
106
Ages
Up to 16 Years
Sex
All
01

Study summary

Juvenile Idiopathic Arthritis (JIA) is a chronic condition that causes joint inflammation in children. In some cases, the inflammation also affects the protective sheath surrounding the tendons, a condition known as tenosynovitis. Because tenosynovitis can be difficult to distinguish from regular joint swelling during a standard physical exam, specialized imaging tools like ultrasound are highly useful for an accurate diagnosis.

This observational study aims to determine how frequently tenosynovitis occurs in children and adolescents diagnosed with two specific subtypes of the disease: polyarticular and oligoarticular JIA.

Researchers will evaluate participants up to 16 years of age receiving care at Assiut University Children Hospital. During the study, patients will undergo a standard clinical assessment, which includes a medical history review and a thorough physical examination of their joints and tendons. Routine laboratory blood tests will also be reviewed. To precisely detect any hidden tendon inflammation, doctors will perform a musculoskeletal ultrasound, which is a safe, radiation-free imaging procedure, on major tendon and joint sites. By comparing the clinical exams with the ultrasound findings, researchers hope to improve the early recognition and management of tendon inflammation in pediatric JIA patients.

Read the detailed description

Juvenile Idiopathic Arthritis (JIA) encompasses a heterogeneous group of diseases characterized by chronic joint inflammation. While synovitis is the hallmark of JIA, tenosynovitis is a frequent yet often under-recognized manifestation that can significantly contribute to a patient's clinical burden. Clinical examination alone is frequently insufficient to distinguish true tenosynovitis from joint synovitis or soft tissue edema, particularly in pediatric patients with ankle involvement. Consequently, Musculoskeletal Ultrasound (MSK-US) has emerged as a critical tool for identifying peritendinous fluid and sheath thickening, allowing for targeted therapeutic interventions such as ultrasound-guided steroid injections.

This cross-sectional observational study is designed to systematically evaluate the clinical and sonographic characteristics of tenosynovitis in pediatric patients diagnosed with polyarticular and oligoarticular JIA.

Enrolled participants will undergo a comprehensive single-visit evaluation consisting of the following components:

  • Clinical Evaluation: A detailed medical history will be recorded, including age of arthropathy onset, detailed therapeutic history, and family history of genetic, metabolic, or skeletal disorders. A thorough musculoskeletal physical examination will evaluate the number of tender and swollen joints, specific enthesitis sites, localized tendon tenderness or swelling, and overall functional status.
  • Laboratory Investigations: Routine baseline laboratory tests will be collected, including Erythrocyte Sedimentation Rate (ESR), C-Reactive Protein (CRP), Complete Blood Count (CBC), Rheumatoid Factor (RF), Antinuclear Antibody (ANA), and Anti-cyclic citrullinated peptide antibodies (Anti-CCP) if clinically indicated.

To detect both clinical and subclinical tenosynovitis, patients will undergo a standardized MSK-US examination using a high-frequency linear probe.

  • Targeted Sites: High-resolution B-mode and Power Doppler (PD) ultrasound will examine major entheseal sites including the Achilles tendon insertion, plantar fascia, patellar tendons, and quadriceps tendon insertions. Specific attention will be given to the tendon sheaths of the tibialis posterior, peroneus longus, and peroneus brevis.
  • Ankle Protocol: The ankle region will be scanned using anterior, perimalleolar medial, and lateral approaches to ensure comprehensive visualization.
  • Sonographic Assessments: The ultrasound will evaluate enthesis thickness, hypoechogenicity, tendon sheath effusion, synovial hypertrophy, and Power Doppler signals indicating active inflammation.
  • Diagnostic Criteria for Tenosynovitis: Tenosynovitis will be sonographically diagnosed by the presence of hypoechoic or anechoic thickened tissue detected in two perpendicular planes. The presence of fluid within the tendon sheath and an active Doppler signal will serve as confirmatory markers of active inflammation.
02

Conditions studied

  • Juvenile Idiopathic Arthritis
  • Tenosynovitis
  • Polyarticular Juvenile Idiopathic Arthritis
  • Oligoarticular Juvenile Idiopathic Arthritis

Keywords

  • Musculoskeletal Ultrasound
  • JIA
  • Pediatric Rheumatology
  • Enthesitis
  • Joint Inflammation
03

In context

Arthritis, Juvenile

365 studies on the registry are indexed under Arthritis, Juvenile; 101 are open to participants now.

This study's planned enrollment of 106 is below the median of 120 across 118 observational studies indexed under Arthritis, Juvenile.

Browse Arthritis, Juvenile 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
Up to 16 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

The study population consists of children and adolescents under 16 years of age diagnosed with either the polyarticular or oligoarticular subtypes of Juvenile Idiopathic Arthritis (JIA). Participants will be recruited from the inpatient wards and the outpatient clinic of the Allergy, Immunology, and Rheumatology unit at Assiut University Children Hospital over a two-year period.

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

  • Children and adolescents (typically under 16 years of age at the time of onset) diagnosed with Juvenile Idiopathic Arthritis (JIA).
  • Patients of both genders.
  • Patients or their legal guardians who provide written /assent to participate in the study.

Exclusion criteria

Exclusion Criteria:

  • Patients more than 16 years of age.
  • Patients with arthritis secondary to other known causes (e.g., trauma, infectious arthritis, , or other systemic diseases like Systemic Lupus Erythematosus).
  • Patients with a history of major orthopedic surgery at the examined entheseal sites.
  • Active infection or metabolic disease that may affect musculoskeletal structures.
  • Patients who decline participation or fail to provide .
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

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.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
106 participants (estimated)
Patient registry
No

Groups and cohorts

  • Polyarticular Juvenile Idiopathic Arthritis

    Children and adolescents under 16 years of age diagnosed with the polyarticular subtype of Juvenile Idiopathic Arthritis. Participants will undergo a comprehensive clinical musculoskeletal assessment and high-resolution B-mode and Power Doppler musculoskeletal ultrasound (MSK-US) of major entheseal sites and tendon sheaths to evaluate the presence of tenosynovitis.

  • Oligoarticular Juvenile Idiopathic Arthritis

    Children and adolescents under 16 years of age diagnosed with the oligoarticular subtype of Juvenile Idiopathic Arthritis. Participants will undergo a comprehensive clinical musculoskeletal assessment and high-resolution B-mode and Power Doppler musculoskeletal ultrasound (MSK-US) of major entheseal sites and tendon sheaths to evaluate the presence of tenosynovitis.

06

What researchers measure

Primary outcomes

  1. Number of Participants Diagnosed with Tenosynovitis

    The presence of tenosynovitis will be evaluated using a clinical musculoskeletal examination and confirmed via high-resolution B-mode and Power Doppler musculoskeletal ultrasound (MSK-US). Tenosynovitis is sonographically defined as the presence of hypoechoic or anechoic thickened tissue detected in two perpendicular planes, which may be accompanied by fluid within the tendon sheath and a positive Doppler signal.

    Time frame: At the time of baseline clinical and ultrasound assessment (Day 1)

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for May 2026; primary completion for May 2027, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 21, 2026
First posted
Apr 28, 2026
StartEst.
May 2026
Primary completionEst.
May 2027
CompletionEst.
Jun 2027
Last update
Apr 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07553910
Lead sponsor
Assiut University
Responsible party
Irène Zakaria Demian (Resident at Pediatric Department, Assiut University, Assiut University) — Principal investigator
First posted
Apr 28, 2026
Start date
May 2026 (estimated)
Primary completion
May 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Apr 28, 2026
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion