knee osteoarthritis
Conditions
Interventions
Patients will be allocated to either intra-articular corticosteroid injection
or intramuscular corticosteroid injection.
Sponsors
Huisartsgeneeskunde
Eligibility
Age
18 Years to 99 Years
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 last week (0-10; 0
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 KOOS pain scale 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 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 *improvement* 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 with a patients* perceived recovery | — |
Countries
Netherlands
Outcome results
None listed