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

Vranken 2011.

Study characteristics
Methods Design: parallel
Duration: 8 weeks
Assessment: baseline and post‐intervention
Country: Netherlands
Participants Pain condition: neuropathic pain caused by spinal cord injury or stroke
Population: people with severe neuropathic pain caused by spinal cord injury or stroke
Minimum pain intensity: ≥ 6 on 0‐10 scale
Inclusion criteria
  • Severe neuropathic pain caused by lesion or dysfunction in the central nervous system

  • Pain persisting for ≥ 6 months

  • Pain intensity of ≥ 6 on 0‐10 scale


Exclusion criteria
  • Known history of significant hepatic, renal, or psychiatric disorder; using antidepressants for treatment of depression


Total participants randomised: 48
Age in years (mean, SD): NR
Gender: NR
Pain duration in years (mean, SD): NR
Interventions Placebo
  • n = 24

  • Inert

  • Identical appearance to duloxetine

  • Sham dosing matching duloxetine arm procedure


Duloxetine 60‐120 mg
  • n = 24

  • SNRI

  • Flexible dosing of 1‐2 capsules of 60 mg a day. Patients started with 1 capsule per day and were titrated at a 1‐week interval; if relief was insufficient (> 1.8 on a VAS) then participants were given 2 capsules to take.

Outcomes Pain intensity
Quality of life
Physical function
Mood
PGIC
Withdrawal
Missing data methods State ITT but no methods
Funding source Non‐pharmaceutical: "Academic Medical Center": assuming the author's institution: Medical Center Alkmaar
Conflicts of interest There are no conflicts of interest.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Participants were randomised using computerised random sampling (clorandm.exe)
Allocation concealment (selection bias) Low risk At baseline each coded medication bottle was supplied by the hospital pharmacist to the blinded treating physician.
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐blind, identical study drugs, sham dosing of placebo to match intervention arm
Blinding of outcome assessment (detection bias)
All outcomes Low risk Self‐reported outcomes from blinded participants
Incomplete outcome data (attrition bias)
All outcomes Low risk Low attrition. State ITT but do not report methods
Attrition
Total: 4/48 (8.3%)
Placebo: 1/24 (4.2%)
Duloxetine 60‐120 mg: 3/24 (12.5%)
Selective reporting (reporting bias) Low risk Matches what's registered in protocol: https://www.trialregister.nl/trial/1125
Other bias Low risk No other sources of bias were identified.