- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07709026
Short-Term Effects of Intra-Articular Corticosteroid Injection on Knee Function in Juvenile Idiopathic Arthritis
Short-Term Effects of Intra-Articular Corticosteroid Injection on Knee Function in Juvenile Idiopathic Arthritis: A Prospective Cohort Study
The purpose of this study is to evaluate the short-term clinical effects of intra-articular corticosteroid injections on knee joint functions in children and adolescents diagnosed with Juvenile Idiopathic Arthritis (JIA).
Patients who receive a corticosteroid injection into the knee joint as part of their routine medical treatment will be monitored prospectively. The study aims to assess changes in range of motion, functional status, and pain levels before the injection and during the early follow-up period after the procedure. This will help healthcare providers better understand the immediate benefits and functional outcomes of this treatment in youth sports and daily physical activities.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Konya, Turkey (Türkiye)
- Necmettin Erbakan University, Faculty of Health Sciences
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients diagnosed with juvenile idiopathic arthritis (JIA) according to standard criteria (arthritis with onset before the age of 16 years and duration longer than 6 weeks with no other identifiable cause).
- Having unilateral or bilateral active knee joint arthritis.
- Undergoing knee intra-articular corticosteroid injection (IACI) for the active knee joint involvement.
- Provision of written informed consent by both patients and their caregivers.
Exclusion Criteria:
- Presence of other chronic rheumatological diseases.
- Initiation or discontinuation of systemic steroids, conventional disease-modifying anti-rheumatic drugs (DMARDs) (e.g., methotrexate, sulfasalazine), or biologic DMARDs (e.g., inhibitors of TNF, IL-1, or IL-6) within the 3 months before knee IACI and during the follow-up period.
- History of severe adverse reactions to steroids.
- Presence of neurological diseases.
- History of lower extremity surgery.
- Missing data.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline in Pain Intensity
Time Frame: Baseline (T0), 2 weeks (T1), and 2 months (T2) post-injection
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Pain intensity assessed at rest and during physical activity using a standard assessment scale.
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Baseline (T0), 2 weeks (T1), and 2 months (T2) post-injection
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022/311
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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