Effect of Intramuscular vs Intra-articular Glucocorticoid Injection on Pain Among Adults With Knee Osteoarthritis(Part 4)
We included in our article last week the topic on “Patients” regarding the main discussion on the Effect of Intramuscular vs Intra-articular Glucocorticoid Injection on Pain Among Adults With Knee Osteoarthritis.
To continue, the study excluded patients if they were using oral glucocorticoids, had received IA injection of glucocorticoids within the past 6 months, were allergic to glucocorticoids, had a local or systemic infection or recent vaccination with live attenuated vaccine, had type 1 or poorly controlled type 2 diabetes (assessed by the GP), had inflammatory rheumatic diseases (eg, rheumatoid arthritis, psoriatic arthritis, and spondyloarthropathies), had coagulopathy (or were receiving anticoagulants), had a history of or current gastric or duodenal ulcer, had contacted an orthopedic surgeon for potential surgical management of the knee, or were incapable of completing questionnaires in Dutch or giving informed consent.
Let us now go to the interventions done. The study says that patients in the IM group received a single intramuscular injection of triamcinolone acetonide, 40 mg (1 mL), in the ipsilateral ventrogluteal region. Patients in the IA group received a single standard IA injection (superolateral approach) of triamcinolone acetonide, 40 mg (1 mL), in the index knee. The treating GP prepared and administered all the injections within 1 week after completion of the baseline assessment. The GPs were instructed not to use local anesthetics during the injection and were offered an opportunity of IA injection training under supervision of an experienced orthopaedic surgeon (P.K.B.).
As far as “Randomization and Blinding” is concerned, it was said that an independent data manager, who was not involved in the clinical procedure, prepared a computer generalized randomization list using 1:1 allocation. To ensure concealment of allocation, the report added, random blocks of 8, 6, or 4 were used and the digital randomization list was kept on an encrypted website.
Moreover, it the study said that after the patient had provided written informed consent and finished baseline assessments, a member of the research team performed the randomization on the encrypted website and then informed the patient and GP of the randomization result. It is interesting to note that according to the study, the researchers involved in data analysis were blinded to the treatment allocation and were required to write a concrete analysis plan before conducting the data analysis.