Uchio 2018.
Study characteristics | ||
Methods | Design: parallel Duration: 14 weeks Assessment: baseline and post‐intervention Country: Japan |
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Participants | Pain condition: knee OA Population: adults aged 40‐80 with chronic knee pain due to OA Minimum pain intensity: ≥ 4 on 0‐10 scale Inclusion criteria
Exclusion criteria
Total participants randomised: 354 Age in years (mean): 65.9 Gender: 274/354 were female Pain duration in years (mean, SD): NR |
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Interventions | Placebo
Duloxetine 60 mg
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Outcomes | Pain intensity Sleep Quality of life Mood Physical function Moderate pain relief Substantial pain relief PGIC AEs SAEs Withdrawal |
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Missing data methods | ITT with LOCF and BOCF | |
Funding source | Pharmaceutical: Eli Lilly and Company and Shionogi | |
Conflicts of interest | TT is an employee of and owns stock in Shionogi Co. Ltd. HE, SF, NS, and HT are employees of Eli Lilly Japan K.K. SF and HE own stock in Eli Lilly and Company. YU has been a member of a Board of Directors and Speakers' Bureau and had a consulting role with Eli Lilly Japan K.K. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomised participants an Interactive Web Response System and stochastic minimisation method |
Allocation concealment (selection bias) | Low risk | Participants were allocated using an Interactive Web Response System |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind, identical capsules for study drugs, matched doses |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Self‐reported outcomes by blinded participants |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Low attrition. Missing data were imputed using the LOCF, BOCF, or the modified BOCF. These findings were consistent for all missing data imputation methods. Attrition Total: 31/354 (8.8%) Placebo: 14/176 (8.0%) Duloxetine 60 mg: 17/178 (10.0%) |
Selective reporting (reporting bias) | Low risk | Some results for outcomes (BDI, Patient Global Assessment of Illness) reported on clinicaltrials.gov but not in the paper |
Other bias | Low risk | No other sources of bias were identified. |