NCT00980798.
| Methods | Randomised controlled trial 2‐arm parallel group design Trial duration unclear Power calculation reported | |
| Participants | Participants with insufficient pain relief using NSAIDs, paracetamol, or a weak opioid were eligible 88 participants with knee or hip osteoarthritis were reported at baseline Number of females: 208 of 288 (72%) Mean age: 65 years | |
| Interventions |
Experimental intervention
Oral hydromorphone (OROS), 4‐32 mg once daily Control intervention Placebo, once daily Treatment duration: 16 weeks Analgesics other than study drugs allowed, but it was unclear whether intake was similar between groups |
|
| Outcomes | Extracted pain outcome: global pain after 16 weeks No function outcome reported Primary outcome: mean pain (Item 5 of Brief Pain Inventory) | |
| Notes | Sponsor: Janssen‐Cilag | |
| 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 from ClinicalTrials.gov: "Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)" |
| Blinding of patients? | Low risk | Because the study used indistinguishable interventions, we considered participants to be blinded Quote from ClinicalTrials.gov: "the control group receives an optically identical tablet with no active ingredient, a so‐called placebo." |
| Blinding of physicians? | Low risk | Quote from ClinicalTrials.gov: "Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)" |
| Blinding of outcome assessors? | Low risk | Because participants were blinded and outcomes were participant‐reported, the risk of detection bias was considered low |
| Interventions reported as indistinguishable? | Low risk | Quote from ClinicalTrials.gov: "the control group receives an optically identical tablet with no active ingredient, a so‐called placebo" |
| Double‐dummy technique used? | Unclear risk | No information available |
| Intention‐to‐treat analysis performed? Pain | High risk | 13 randomised participants were excluded from the analyses |
| Intention‐to‐treat analysis performed? Function | Unclear risk | Not applicable, no function outcome reported |