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van CCT (UK)

van CCT (UK)

Effectiveness of corticosteroid injection in the buttock compared with corticosteroid injection in the knee joint in patients with knee osteoarthritis

- candidate number28481
- NTR NumberNTR6968
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-jan-2018
- Secondary IDsEudra CT 2017-003513-25 
- Public TitleEffectiveness of corticosteroid injection in the buttock compared with corticosteroid injection in the knee joint in patients with knee osteoarthritis
- Scientific TitleEffectiveness in knee osteoarthritis of an intramuscular gluteal corticosteroid injection versus an intra-articular corticosteroid injection: a multicenter, randomized, 24 weeks non-inferiority trial
- hypothesisWe hypothesize that intramuscular gluteal corticosteroid injection is non-inferior to intra-articular corticosteroid injection in reducing knee pain in patients with knee osteoarthritis.
- Healt Condition(s) or Problem(s) studiedKnee osteoarthritis, Corticosteroids, Intramuscular
- Inclusion criteria1) 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 year;
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 criteria1) 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2018
- planned closingdate1-jun-2019
- Target number of participants140
- InterventionsPatients will be allocated to either intramuscular gluteal injection with 40mg triamcinolone acetonide or intra-articular injection of 40mg triamcinolon acetonide in the knee joint.
- Primary outcomeThe 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 outcome1) 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.
- TimepointsOutcome measures will be obtained at baseline and 2, 4, 8, 12 and 24 weeks after corticosteroid injection.
- Trial web
- statusplanned
- Sponsor/Initiator Erasmus Medical Center, Department of General Practice
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsNot yet available.
- Brief summaryThis 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.
- Main changes (audit trail)
- RECORD22-jan-2018 - 31-mei-2018

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