Osteoarthritis, Knee, Corticosteroid, Intramuscular In Dutch: Atrose, Knie, Corticosteroiden, Intramusculair
Conditions
Interventions
Patients will be allocated to either intramuscular gluteal injection with 40mg triamcinolone acetonide or intra-articular injection of 40mg triamcinolon acetonide in the knee joint.
Sponsors
Erasmus Medical Center, Department of General Practice
Eligibility
Inclusion criteria
Inclusion criteria: 1) contacted their general practitioner (consultation and/or repeat pain medication prescription) due to knee osteoarthritis (ICPC L90 or L15 with unequivocal diagnosis of osteoarthritis)) during the past five years; 2) aged 45 years and over; 3) symptomatic knee osteoarthritis for at least 3 months prior to enrolment; 4) a minimum score of 3 on the numerical rating scale asking about the severity of knee pain averaged over the past week (0-10; 0=no knee pain); 5) corticosteroid injection is indicated in this patient; 6) signed informed consent form. If a patient has bilateral knee osteoarthritis, the most painful knee according to the patient will be selected as the study knee.
Exclusion criteria
Exclusion criteria: 1) use of oral corticosteroids; 2) intra-articular injection in a knee in the previous 6 months; 3) allergy to corticosteroids; 4) local or systemic infection, after recent vaccination with live attenuated vaccine; 5) diabetes mellitus type 1, diabetes mellitus type 2 on insulin therapy, poorly controlled diabetes mellitus type 2; 6) presence of inflammatory rheumatic diseases (such as rheumatoid arthritis, psoriatic arthritis, spondylartropathies); 7) coagulopathy, use of anticoagulants, use of dual antiplatelet therapy; 8) a history of gastric/duodenal ulcer or a present gastric/duodenal ulcer; 9) under the care of an orthopaedic surgeon for osteoarthritis of the hip and/or knee; 10) corticosteroid injection is not indicated in this patient; 11) unable to complete questionnaires in Dutch; 12) unable to give informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is patient reported severity of pain measured with the Knee injury and Osteoarthritis Outcome Score (KOOS) pain subscale 4 weeks after the injection. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Patients' reported adverse events will be assessed with a questionnaire 2 weeks after injection. Patients will be asked to report hospitalization in the questionnaires at 4, 8, 12 and 24 weeks as a proxy for SAEs; 2) Knee pain (KOOS) at all time points (baseline, 2, 8, 12, 24 weeks); 3) Knee pain severity averaged over last week will be measured with an 11-point numerical rating scale (NRS:0-10; 0=no pain); 4) Severity of global osteoarthritis pain will be measured with the WOMAC pain and will be calculated from the KOOS questionnaire (0-100; 0=extreme pain); 5) Intermittent and constant osteoarthritis pain will be measured with the ICOAP (0-100: 0=no pain); 6) Knee complaint characteristics (duration of symptoms at baseline, sensation of swelling in the knee as an indicator of flare-up); 7) Disability will be measured with the KOOS Function in daily living (0-100; 0=extreme problems); 8) Health related quality of life (QoL) will be measured with the EQ-5D-5L (scores ranging from -0.446=worst health related QoL to 1.0=perfect health related QoL); 9) Patients' perceived recovery measured with a 7-point Likert scale that will be dichotomized in recovered (score 1 'complete recovery' and 2 'much improved') and not-recovered (score 3 'slightly improved' to score 7 'worse than ever'); 10) Percentage responders is defined by the OMERACT-OARSI criteria: High improvement (=50%) in KOOS pain subscale or in KOOS function in daily living subscale and absolute increase = 20 points in KOOS pain subscale or function in daily living subscale, if not then improvement in at least 2 of the 3 following domains: 1) = 20% improvement in KOOS pain subscale and = 10 points increase in KOOS pain subscale, 2) = 20% improvement in KOOS function in daily living subscale and = 10 points increase in KOOS function in daily living subscale, 3) = 20% increase in global score and = 10 points increase in global score. In this study patients' global assessment will be measured wit | — |
Contacts
Public ContactMarianne F. Mol
Erasmus Medical Center, Department of General Practice, Room Na-1924
Outcome results
None listed