Friedman 1980.
Methods | Randomised controlled trial 2‐arm parallel‐group design Trial duration: 8 weeks |
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Participants | 34 participants with knee osteoarthritis were randomised 34 participants were reported at baseline Number of females: Not reported Mean age: 60.0 years |
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Interventions |
Experimental intervention 20 mg triamcinolone hexacetonide, single intra‐articular injection Control intervention "Polysorbate, sorbitol solution, benzyl alcohol and water", single intra‐articular injection |
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Outcomes | Extracted pain outcome: Pain overall Maximum follow‐up: 8 weeks |
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Notes | Funding: Grant from the Eastern Pennsylvania Chapter of the Arthritis Foundation and by the Philadelphia Foundation | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method used to generate random sequence of allocation was not clearly reported, so the risk of selection bias was unclear. Quote: "Half of the patients, selected according to a predetermined random schedule, were treated (...)." |
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? | Low risk | Quote: "During the time of [the injection] (...), the physician and patient were positioned so that neither could see the nurse's face nor the material she injected. Thus, neither had any direct information concerning what was injected and, practically speaking, had no contact with the only person who knew" |
Blinding of health care provider(s) | Low risk | Quote: "The physician‐experimenter performed the arthrocentesis (...) a nurse‐assistant entered the room and performed the injection through the intraarticular needle, and left the room. During the time of this taking place, the physician and patient were positioned so that neither could see the nurse's face nor the material she injected. Thus, neither had any direct information concerning what was injected and, practically speaking, had no contact with the only person who knew" |
Intention‐to‐treat analysis performed? Pain | Low risk | All randomised participants included in the analysis. Quote: "All patients were seen 1 wk, 4 wk, 6 wk and 8 wk post‐injection except those whose pain scores at any subsequent evaluation were the same as their pre‐treatment scores; they were not seen further. It was assumed that their scores would no longer improve and they were counted as remaining at their pre‐treatment level throughout the experiment". |
Intention‐to‐treat analysis performed? Function | Unclear risk | Not applicable, no function outcome reported |