We hypothesize that intramuscular gluteal corticosteroid injection is non-inferior to intra-articular corticosteroid injection in reducing knee pain in patients with knee osteoarthritis.
ID
Bron
Verkorte titel
Aandoening
Osteoarthritis, Knee, Corticosteroid, Intramuscular
In Dutch: Atrose, Knie, Corticosteroiden, Intramusculair
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
We hypothesize that intramuscular gluteal corticosteroid injection is non-inferior to intra-articular corticosteroid injection in reducing knee pain in patients with knee osteoarthritis.
Onderzoeksopzet
Outcome measures will be obtained at baseline and 2, 4, 8, 12 and 24 weeks after corticosteroid injection.
Onderzoeksproduct en/of interventie
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.
Publiek
Marianne F. Mol
PO Box 2040, Na-1818
Rotterdam 3000 CA
The Netherlands
+31 10 703 52 58
m.f.mol@erasmusmc.nl
Wetenschappelijk
Marianne F. Mol
PO Box 2040, Na-1818
Rotterdam 3000 CA
The Netherlands
+31 10 703 52 58
m.f.mol@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL6784 |
| NTR-old | NTR6968 |
| Ander register | METC Erasmus MC : Eudra CT 2017-003513-25 |