Dickens 2000.
Study characteristics | ||
Methods | Design: parallel Duration: 8 weeks Assessment: baseline and post‐intervention Country: UK |
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Participants | Pain condition: low back pain Population: adults with chronic low back pain and depression Minimum pain intensity: NR Inclusion criteria
Exclusion criteria
Total participants randomised: 98 Age in years (mean, SD): 45.2 (10.2) Gender: 53/98 were female Pain duration in years (mean, SD): NR |
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Interventions | Placebo
Paroxetine 20 mg
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Outcomes | Pain intensity Physical function Mood |
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Missing data methods | ITT with LOCF | |
Funding source | Pharmaceutical: SmithKline Beecham | |
Conflicts of interest | NR | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation of order of treatment allocation was achieved using a computer‐generated randomisation list in which treatments were balanced. |
Allocation concealment (selection bias) | Low risk | Sequentially numbered treatment packs containing the medication were held in and distributed by the hospital pharmacy. The packs were allocated to consecutive participants in strict sequential order. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind, appearance of both placebo and antidepressant was identical |
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 | ITT with LOCF, but very low dropout Attrition Total: 6/98 (6.1%) Attrition per arm NR |
Selective reporting (reporting bias) | Unclear risk | No protocol or trial registration found |
Other bias | Low risk | No other sources of bias were identified. |