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

NCT01510457.

Study characteristics
Methods Design: parallel
Duration: approximately 8 weeks
Assessment: baseline and post‐intervention
Country: USA
Participants Pain condition: knee OA
Population: adults with knee OA
Minimum pain intensity: ≥ 4 on 0‐10 scale
Inclusion criteria
  • Confirmed knee OA

  • Chronic pain for ≥ 6 months

  • Average pain rating of worse knee is ≥ 4 on a 0‐10 scale


Exclusion criteria
  • Severe or untreated psychiatric disorder (e.g. depression, anxiety)

  • Severe ongoing or unaddressed medical conditions


Total participants randomised: 46
Age in years (mean, SD): 56 (8)
Gender: 23/46 were female
Pain duration in years (mean, SD): NR
Interventions Placebo
  • n = 17

  • Inert

  • Identical appearance and matched dosing


Milnacipran 100 mg‐200 mg
  • n = 29

  • SNRI

  • Forced titration to fixed doses

Outcomes Pain intensity
Mood
Physical function
AEs
SAEs
Withdrawal
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