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ID
Source
Brief title
Health condition
Osteoarthritis, Knee, Corticosteroid, Intramuscular
In Dutch: Atrose, Knie, Corticosteroiden, Intramusculair
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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 with a patients' perceived recovery
score measured on a 7-point Likert scale. This domain is considered improved if a patient fills in score 1
'complete recovery', score 2 'much improved', or score 3 'slightly improved';
11) Co-interventions including medication, non-drug therapies such as physiotherapy, referrals and surgery will be measured with the modified iMCQ;
12) Experienced painfulness of injection.
Background summary
This study will evaluate non-inferiority of intramuscular corticosteroid injection compared to intra-articular corticosteroid injection for knee osteoarthritis. Statistical analysis will be based on both the intention-to-treat and the per-protocol principle.
Study objective
We hypothesize that intramuscular gluteal corticosteroid injection is non-inferior to intra-articular corticosteroid injection in reducing knee pain in patients with knee osteoarthritis.
Study design
Outcome measures will be obtained at baseline and 2, 4, 8, 12 and 24 weeks after corticosteroid injection.
Intervention
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.
Marianne F. Mol
PO Box 2040, Na-1818
Rotterdam 3000 CA
The Netherlands
+31 10 703 52 58
m.f.mol@erasmusmc.nl
Marianne F. Mol
PO Box 2040, Na-1818
Rotterdam 3000 CA
The Netherlands
+31 10 703 52 58
m.f.mol@erasmusmc.nl
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
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
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL6784 |
| NTR-old | NTR6968 |
| Other | METC Erasmus MC : Eudra CT 2017-003513-25 |