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
Exclusion criteria
Total participants randomised: 48 Age in years (mean, SD): NR Gender: NR Pain duration in years (mean, SD): NR |
|
Interventions | Placebo
Duloxetine 60‐120 mg
|
|
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. |