Effectiveness in knee osteoarthritis of an intramuscular gluteal corticosteroid injection versus an intra-articular corticosteroid injection in general practice: a multicenter pragmatic randomized trial

Phase 4

Completed

• Conditions: knee osteoarthritis; 10023213

• Registration Number: NL-OMON48857
• Lead Sponsor: Huisartsgeneeskunde

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 140

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
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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is patient reported severity of pain measured with the KOOS<br /><br>pain scale 4 weeks after the injection.</p><br>