Atkinson 2007.
Study characteristics | ||
Methods | Design: parallel Duration: 12 weeks Assessment: baseline and post‐intervention Country: USA |
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Participants | Pain condition: low back pain Population: adults with low back pain Minimum pain intensity: NR Inclusion criteria
Exclusion criteria
Total participants randomised: 121 Age in years (mean, SD): NR Gender: NR Pain duration in years (mean, SD): NR |
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Interventions | Placebo (benzotropine mesylate 0.5 mg)
Desipramine 50 mg
Desipramine 100 mg
Desipramine 150 mg
Fluoxetine 20 mg
Fluoxetine 40 mg
Fluoxetine 60 mg
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Outcomes | No useable data provided | |
Missing data methods | ITT with LOCF | |
Funding source | Non‐pharmaceutical: US Department of Veterans Affairs | |
Conflicts of interest | NR | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants were randomised using a computerised random number generator |
Allocation concealment (selection bias) | Low risk | Randomisation was completed by a research pharmacist not involved in other aspects of the study |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blinded, double‐dummy design, no significant difference in participants guessing allocation |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Self‐reported outcomes by blinded participants |
Incomplete outcome data (attrition bias) All outcomes | High risk | ITT with LOCF Attrition: Total: 38/121 (31.4%) Attrition by arm NR |
Selective reporting (reporting bias) | Unclear risk | Only 1 outcome prespecified in protocol. Do not perform their original analysis |
Other bias | Low risk | No other sources of bias were identified. |