Sofat 2017.
Study characteristics | ||
Methods | Design: parallel Duration: 12 weeks Assessment: baseline and post‐intervention Country: UK |
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Participants | Pain condition: hand OA Population: adults aged 40–75 with hand OA Minimum pain intensity: ≥ 5 on 0‐10 scale Inclusion criteria
Exclusion criteria
Total participants randomised: 65 Age in years (mean, SD): NR Gender: 52/65 were female Pain duration in years (mean, SD): NR |
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Interventions | Placebo
Pregabalin 300 mg
Duloxetine 60 mg
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Outcomes | Pain intensity Physical function Mood Withdrawal |
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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. |