NCT01510457.
Study characteristics | ||
Methods | Design: parallel Duration: approximately 8 weeks Assessment: baseline and post‐intervention Country: USA |
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Participants | Pain condition: knee OA Population: adults with knee OA Minimum pain intensity: ≥ 4 on 0‐10 scale Inclusion criteria
Exclusion criteria
Total participants randomised: 46 Age in years (mean, SD): 56 (8) Gender: 23/46 were female Pain duration in years (mean, SD): NR |
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Interventions | Placebo
Milnacipran 100 mg‐200 mg
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Outcomes | Pain intensity Mood Physical function AEs SAEs Withdrawal |
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Missing data methods | Completer analysis only | |
Funding source | Pharmaceutical: Forest Laboratories | |
Conflicts of interest | NR | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomisation methods not specified |
Allocation concealment (selection bias) | Unclear risk | Allocation procedures not specified |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Blinded procedures, but 0 placebo participants reported AEs and 34% of milnacipran participants did report AEs, somewhat unblinding |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Self‐reported outcomes from participants, unsure of blinding |
Incomplete outcome data (attrition bias) All outcomes | High risk | Completer‐only analysis Attrition Total: 8/46 (17.4%) Placebo: 5/17 (29.4%) Milnacipran 100‐200 mg: 3/29 (10.3%) |
Selective reporting (reporting bias) | Unclear risk | As we're using all outcomes from trial they report all registered outcomes BUT they first posted the trial in 2012, the trial started in 2010. |
Other bias | High risk | Not published ‐ trial registry report only |