Friedmann 2011.
Methods | Randomised controlled trial 2‐arm parallel group design Trial duration: 14 weeks Multicentre trial with 61 centres Power calculation reported | |
Participants | Participants with moderate‐to‐severe osteoarthritis pain using NSAIDs or opioids were eligible 412 participants were randomised 412 participants with knee or hip osteoarthritis were reported at baseline Affected joints: 323 knees and 89 hips Number of females: 288 of 412 (70%) Mean age: 58 years | |
Interventions |
Experimental intervention
Oral extended‐release oxycodone (Remoxy), 5‐20 mg twice daily Control intervention Placebo, twice daily Treatment duration: 12 weeks Unclear whether analgesics other than study drugs allowed |
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Outcomes | Extracted pain outcome: global pain after 14 weeks No function outcome reported Primary outcome: change in pain intensity score | |
Notes | Sponsor: Pain Therapeutics, King, Pfizer | |
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 reported, so the risk of selection bias was unclear |
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 |
Described as double‐blind? | Low risk | Quote: "...a double‐blind, multicenter, placebo‐controlled trial..." |
Blinding of patients? | Unclear risk | It was unclear if method used to blind participants was appropriate |
Blinding of physicians? | Unclear risk | Physicians were not explicitly described as blinded, so the risk of performance bias was unclear |
Blinding of outcome assessors? | Unclear risk | Because outcomes were self reported, and because it was unclear whether participants were properly blinded, it was unclear whether outcome assessors were blinded |
Interventions reported as indistinguishable? | High risk | Interventions were not reported as indistinguishable |
Double‐dummy technique used? | Unclear risk | Description of intervention is not detailed enough to assess whether double‐dummy technique was used |
Intention‐to‐treat analysis performed? Pain | High risk | 2 of 205 participants excluded in experimental group, 0 of 207 participants excluded in control group |
Intention‐to‐treat analysis performed? Function | Unclear risk | Not applicable, no function outcome reported |