NCT07553910

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for all trials

Timeline
13mo left

Started May 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
May 2026Jun 2027

First Submitted

Initial submission to the registry

April 21, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 28, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

April 21, 2026

Last Update Submit

April 21, 2026

Conditions

Keywords

Musculoskeletal UltrasoundJIAPediatric RheumatologyEnthesitisJoint Inflammation

Outcome Measures

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.

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

Study Arms (2)

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.

Eligibility Criteria

AgeUp to 16 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • 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 informed consent/assent to participate in the study.

You may not qualify if:

  • Patients more than 16 years of age.
  • Patients with arthritis secondary to other known causes (e.g., trauma, infectious arthritis, malignancy, or other systemic autoimmune 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 informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Arthritis, JuvenileTenosynovitisArthritis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesTendinopathyMuscular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident at Pediatric Department, Assiut University

Study Record Dates

First Submitted

April 21, 2026

First Posted

April 28, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

April 28, 2026

Record last verified: 2026-04