NL-OMON48857CompletedPhase 4
Effectiveness in knee osteoarthritis of an intramuscular gluteal corticosteroid injection versus an intra-articular corticosteroid injection in general practice: a multicenter pragmatic randomized trial - Knee Osteoarthritis Injection Trial
Huisartsgeneeskunde0 sites140 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 140
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
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<=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
- •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.
Investigators
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