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. 2015 Oct 22;2015(10):CD005328. doi: 10.1002/14651858.CD005328.pub3

Raynauld 2003.

Methods Randomised controlled trial
2‐arm parallel‐group design
Trial duration: 54 weeks
Participants 68 participants with knee osteoarthritis were randomised
68 participants were reported at baseline
Number of females: 42 out of 68 (68%)
Mean age: 63.2 years
Interventions Experimental intervention
40 mg triamcinolone acetonide (1 ml), 8 intra‐articular injections, interval 3 months, over 21 months
Control intervention
1 ml saline intra‐articularly, 8 intra‐articular injections, interval 3 months, over 21 months
Outcomes Extracted pain outcome: WOMAC Pain. After end of treatment (during follow‐up)
Extracted function outcome: WOMAC Function. After end of treatment (during follow‐up)
Maximum follow‐up: 12.9 weeks
Notes Funding: Fonds de la recherche en santé du Québec
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Patients were randomly assigned to the IA steroid or IA saline group based on a table of randomly assorted digits."
Allocation concealment (selection bias) Unclear risk Method used to conceal the random sequence of allocation was not reported, so the risk of selection bias was unclear
Blinding of participants? Unclear risk Study described as double‐blind but no description of method of blinding provided
Blinding of health care provider(s) High risk Study described as double‐blind. The following statements indicate that "double‐blind" in this trial means that only patients and outcome assessors were blinded: "In order to preserve the blind, the injections were given by a rheumatologist (DC or BH) other than the evaluators." "Investigators performed these evaluations in a blinded manner using validated measures."
Intention‐to‐treat analysis performed? Pain High risk 1 of 34 participants excluded in experimental group, 1 of 34 participants excluded in control group
Intention‐to‐treat analysis performed? Function High risk 1 of 34 participants excluded in experimental group, 1 of 34 participants excluded in control group