What we do
About our project
Background
The knee is the most affected joint in osteoarthritis. In the Netherlands and other Western countries knee osteoarthritis is mainly managed by general practitioners. An intra-articular glucocorticoid injection is recommended in the (inter)national guidelines for patients with knee osteoarthritis as an option for an interim aggravation of knee pain and/or for those who are not responding well to paracetamol/NSAIDs treatment. An innovative approach that could replace the intra-articular injection is an intramuscular gluteal glucocorticoid injection. An intramuscular injection is easier to perform than an intra-articular injection with lesser risk of severe local adverse reactions.
Hypothesis
We hypothesize that intramuscular gluteal glucocorticoid injection is non-inferior in reducing knee pain compared to intra-articular glucocorticoid injection, with a potentially longer lasting effect for at least 12 weeks.
Methods
A total of 140 patients aged 45 years and older with knee osteoarthritis who contacted their general practitioner and have persistent knee pain (score ≥3 on 0-10 numerical rating scale; 0=no knee pain) will be included. Patients will be randomly allocated to an injection of 40 mg triamcinolone acetonide intra-articular in the knee joint or in the in the ipsilateral ventrogluteal area. The effect of treatment will be evaluated by questionnaires at 2, 4, 8, 12, and 24 weeks after injection. Statistical analysis will be based on both the intention-to-treat and the per-protocol principle.
The knee is the most affected joint in osteoarthritis. In the Netherlands and other Western countries knee osteoarthritis is mainly managed by general practitioners. An intra-articular glucocorticoid injection is recommended in the (inter)national guidelines for patients with knee osteoarthritis as an option for an interim aggravation of knee pain and/or for those who are not responding well to paracetamol/NSAIDs treatment. An innovative approach that could replace the intra-articular injection is an intramuscular gluteal glucocorticoid injection. An intramuscular injection is easier to perform than an intra-articular injection with lesser risk of severe local adverse reactions.
Hypothesis
We hypothesize that intramuscular gluteal glucocorticoid injection is non-inferior in reducing knee pain compared to intra-articular glucocorticoid injection, with a potentially longer lasting effect for at least 12 weeks.
Methods
A total of 140 patients aged 45 years and older with knee osteoarthritis who contacted their general practitioner and have persistent knee pain (score ≥3 on 0-10 numerical rating scale; 0=no knee pain) will be included. Patients will be randomly allocated to an injection of 40 mg triamcinolone acetonide intra-articular in the knee joint or in the in the ipsilateral ventrogluteal area. The effect of treatment will be evaluated by questionnaires at 2, 4, 8, 12, and 24 weeks after injection. Statistical analysis will be based on both the intention-to-treat and the per-protocol principle.
Our research focus
Primary outcome
The primary outcome is patients’ reported severity of knee pain measured with the pain subscale of the Knee injury and Osteoarthritis Outcome Score 4 weeks after injection.
Secondary outcomes
Secondary outcomes are patients’ reported adverse events, disability measured with the KOOS subscale function in daily living, co-interventions, severity of knee pain over the past week measured with an 11-point numerical rating scale, severity of global osteoarthritis pain measured with the WOMAC pain score, severity of intermittent and constant osteoarthritis pain (ICOAP), health related quality of life measured with the EQ-5D-5L, perceived recovery measured with a 7-point Likert scale that will be dichotomized in recovered (‘complete recovery’, ‘much improved, and ‘slightly improved’) and not-recovered (‘no change’ to ‘worse than ever’), and the OMERACT-OARSI responder criteria. Outcomes are measured 2, 4, 8, 12 and 24 weeks after administration of the injection.
The primary outcome is patients’ reported severity of knee pain measured with the pain subscale of the Knee injury and Osteoarthritis Outcome Score 4 weeks after injection.
Secondary outcomes
Secondary outcomes are patients’ reported adverse events, disability measured with the KOOS subscale function in daily living, co-interventions, severity of knee pain over the past week measured with an 11-point numerical rating scale, severity of global osteoarthritis pain measured with the WOMAC pain score, severity of intermittent and constant osteoarthritis pain (ICOAP), health related quality of life measured with the EQ-5D-5L, perceived recovery measured with a 7-point Likert scale that will be dichotomized in recovered (‘complete recovery’, ‘much improved, and ‘slightly improved’) and not-recovered (‘no change’ to ‘worse than ever’), and the OMERACT-OARSI responder criteria. Outcomes are measured 2, 4, 8, 12 and 24 weeks after administration of the injection.
Funds & Grants
ZonMw HGOG
Collaborations
Internal collaborations
Department of Orthopaedic Surgery
Department of Rheumatology
External collaboration
Department of Public Health and Primary Care, Leiden University Medical Center
Our team
Dr. J. Runhaar, j.runhaar@erasmusmc.nl
Dr. D.M.J. Dorleijn, desireedorleijn@hotmail.com
Dr. P.K. Bos, p.k.bos@erasmusmc.nl
Dr. M. Vis, marijn.vis@erasmusmc.nl
Prof. Dr. J. Gussekloo, J.Gussekloo@lumc.nl
Prof. Dr. P.J.E. Bindels, p.bindels@erasmusmc.nl
Prof. S.M.A. Bierma-Zeinstra, s.bierma-zeinstra@erasmusmc.nl
Contact address for the project: m.f.mol@erasmusmc.nl.
Dr. D.M.J. Dorleijn, desireedorleijn@hotmail.com
Dr. P.K. Bos, p.k.bos@erasmusmc.nl
Dr. M. Vis, marijn.vis@erasmusmc.nl
Prof. Dr. J. Gussekloo, J.Gussekloo@lumc.nl
Prof. Dr. P.J.E. Bindels, p.bindels@erasmusmc.nl
Prof. S.M.A. Bierma-Zeinstra, s.bierma-zeinstra@erasmusmc.nl
Contact address for the project: m.f.mol@erasmusmc.nl.
