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. 2023 May 10;2023(5):CD014682. doi: 10.1002/14651858.CD014682.pub2

Tétreault 2016.

Study characteristics
Methods Design: parallel
Duration: 16 weeks
Assessment: baseline and post‐intervention
Country: USA
Participants Pain condition: knee OA
Population: adults aged 45‐80 with knee OA
Minimum pain intensity: ≥ 5 on 0‐10 scale
Inclusion criteria
  • Diagnosed by a clinician for knee OA, fulfilled ACR criteria, and had knee pain for at least 1 year

  • Knee pain intensity of at least 4/10


Exclusion criteria
  • Physical and mental health comorbidities


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)
Interventions Placebo
  • n = 21

  • Inert

  • Identical appearance to duloxetine, matched dosing


Duloxetine 60 mg
  • n = 19

  • SNRI

  • Fixed dose, forced titration

Outcomes Pain intensity
Physical function
Mood
AEs
SAEs
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