Raynauld 2003.
Methods | Randomised controlled trial 2‐arm parallel‐group design Trial duration: 54 weeks |
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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 |
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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 |
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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 |
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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 |