Juvenile Idiopathic ArthritisNCT07553910
Tenosynovitis in Polyarticular and Oligoarticular Juvenile Idiopathic Arthritis
An observational study of Juvenile Idiopathic Arthritis and Tenosynovitis, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Juvenile Idiopathic Arthritis, Tenosynovitis, Polyarticular Juvenile Idiopathic Arthritis
- How many people
- 106 participants
- Where
- No sites listed yet
- Study dates
- May 2026to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 16 years
- All sexes
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Tenosynovitis in Juvenile Idiopathic Arthritis: Insights From Polyarticular and Oligoarticular Subtypes
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.
- Conditions
- Juvenile Idiopathic Arthritis, Tenosynovitis, Polyarticular Juvenile Idiopathic Arthritis, Oligoarticular Juvenile Idiopathic Arthritis
- Keywords
- Musculoskeletal Ultrasound, JIA, Pediatric Rheumatology, Enthesitis, Joint Inflammation
- Medical subject headings
- Arthritis, Juvenile, Tenosynovitis, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the time of baseline clinical and ultrasound assessment (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study startMay 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juvenile Idiopathic ArthritisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irène Zakaria Demian, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07553910
- Sponsor's protocol ID
- Tenosynovitis in JIA Subtypes
- Status last verified
- Apr 2026
- First submitted
- 21 Apr 2026
- Last updated
- 28 Apr 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tenosynovitis in Juvenile Idiopathic Arthritis: Insights From Polyarticular and Oligoarticular Subtypes
- ClinicalTrials.gov ID
- NCT07553910
- Acronym / sponsor ID
- Tenosynovitis in JIA Subtypes
- Conditions
- Juvenile Idiopathic Arthritis, Tenosynovitis, Polyarticular Juvenile Idiopathic Arthritis, Oligoarticular Juvenile Idiopathic Arthritis
- Keywords
- Musculoskeletal Ultrasound, JIA, Pediatric Rheumatology, Enthesitis, Joint Inflammation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 28 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants Diagnosed with Tenosynovitis
Time frame: At the time of baseline clinical and ultrasound assessment (Day 1)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Juvenile Idiopathic Arthritis and Tenosynovitis, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Diagnosed with Tenosynovitis (time frame: At the time of baseline clinical and ultrasound assessment (Day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.