Tétreault 2016.
Study characteristics | ||
Methods | Design: parallel Duration: 16 weeks Assessment: baseline and post‐intervention Country: USA |
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Participants | Pain condition: knee OA Population: adults aged 45‐80 with knee OA Minimum pain intensity: ≥ 5 on 0‐10 scale Inclusion criteria
Exclusion criteria
Total participants randomised: 40 Age in years (mean, SD): 58.7 (7.6) Gender: 21/40 were female Pain duration in years (mean, SD): 10.54 (9.1) |
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Interventions | Placebo
Duloxetine 60 mg
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Outcomes | Pain intensity Physical function Mood AEs SAEs |
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Missing data methods | Completer‐only analysis | |
Funding source | Partly pharmaceutical: Eli Lilly Pharmaceuticals (IIT number: F1J‐US‐XO61). This research was also partially supported by grants from National Institute of Neurological Disorders and Stroke, ninds.nih.gov (NS035115), and National Center for Complementary and Integrative Health, nccih.nih.gov (AT007987) of the US National Institutes of Health. PT was supported by postdoctoral fellowships from the Canadian Institutes of Health Research (CIHR), cihr‐irsc.gc.ca. | |
Conflicts of interest | No financial or other relationships that might lead to a COI | |
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 | Low risk | Double‐blind, identical study drugs, matched dosing |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Self‐reported outcomes from blinded participants |
Incomplete outcome data (attrition bias) All outcomes | High risk | Completer analysis only Attrition Total: 21/60 (35.0%) Attrition per arm NR |
Selective reporting (reporting bias) | Low risk | Outcomes match those in the protocol |
Other bias | Low risk | No other sources of bias identified |