M08.0 M08.3 M08.4
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Diagnosis of JIA, oligo- or polyarthritis category according to ILAR criteria - Therapeutic use of forearm crutches and/or therapy rollers possible - IACSI knee - Consent
Exclusion criteria
Exclusion criteria: - Additional IACSI on other joints of the lower extremity (ankle/hip) - Cortisone shock treatment within four weeks before/after the procedure - Bony damage to the joint - Surgery on the knee - Lack of understanding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 'Time to flare' or time period until thrust. A flare is defined as evidence of of fluid or signs of inflammation (painful restriction of movement or effusion) more than two weeks after the intra-articular corticosteroid injection (IACSI), after the signs of inflammation have completely subsided in the meantime. By means of sonography (evaluation according to OMERACT criteria) to detect an effusion, pain by means of a visual analog scale (VAS), range of motion of the knee joint/range of motion (ROM) by means of a goniometer at the following measurement times: T0: before IACSI T1: 12-20 weeks after IACSI T2: 40-60 weeks after IACSI And, if necessary, at further measurement times if interim examinations are required due to medical necessity (recurrence of pain, swelling, movement restrictions) outside the set time windows of T1 and T2. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Range of motion knee joint (goniometer) - Swelling/knee circumference measurement (measuring tape) - Stiffness (Visual Analog Scale (VAS)) - Walking speed (50ft) - Pain (VAS) - Findings of knee joint sonography (assessment according to OMERACT criteria) at the following measurement times: T0: before IACSI T1: 12-20 weeks after IACSI T2: 40-60 weeks after IACSI And, if necessary, at further measurement times if interim examinations are required due to medical necessity (recurrence of pain, swelling, movement restrictions) outside the set time windows of T1 and T2. | — |
Countries
Germany