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

Sofat 2017.

Study characteristics
Methods Design: parallel
Duration: 12 weeks
Assessment: baseline and post‐intervention
Country: UK
Participants Pain condition: hand OA
Population: adults aged 40–75 with hand OA
Minimum pain intensity: ≥ 5 on 0‐10 scale
Inclusion criteria
  • Aged 40‐75

  • Fulfilling the ACR criteria for the diagnosis of hand OA

  • Receiving usual care for hand OA including paracetamol (acetaminophen) and/or NSAIDs


Exclusion criteria
  • History of depression and current uncontrolled depression/anxiety as scored by HADS excluded


Total participants randomised: 65
Age in years (mean, SD): NR
Gender: 52/65 were female
Pain duration in years (mean, SD): NR
Interventions Placebo
  • n = 22

  • Inert

  • Identical appearance and matched dosing to intervention arms


Pregabalin 300 mg
  • n = 22

  • Anticonvulsant

  • Fixed dose, forced titration


Duloxetine 60 mg
  • n = 21

  • SNRI

  • Fixed dose, forced titration

Outcomes Pain intensity
Physical function
Mood
Withdrawal
Missing data methods ITT with LOCF
Funding source Non‐pharmaceutical: "This work was supported by The Rosetrees’ Trust, grant number M11‐F1, by the UK National Institute of Health (NIHR) Clinical Research Network and an NIHR Clinical Academic Fellowship to MR"
Conflicts of interest Disclosure: the authors report no conflicts of interest in this work.
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) Low risk The random allocation sequence, with a block size of nine, was generated by the manufacturer and implemented through sequentially numbered containers.
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 ITT with LOCF
Attrition
Total: 13/65 (20.0%)
Placebo: 3/22 (13.6%)
Pregabalin 300 mg: 5/22 (22.7%)
Duloxetine 60 mg: 5/21 (23.8%)
Selective reporting (reporting bias) High risk 2 protocols found registed, which have different primary outcomes. The protocol was submitted 2.5 years after recruitment started.
Other bias Unclear risk Small baseline difference in groups "prior analgesic use", there was slightly less paracetamol (acetaminophen) use at baseline before enrollment in the duloxetine group than in the pregabalin and placebo groups, but for other NSAIDs and opiates, analgesic use was similar in all 3 groups.