Atkinson 1999.
Study characteristics | ||
Methods | Design: parallel Duration: 8 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: 103 Age in years (mean, SD): NR Gender: 40/103 were female Pain duration in years (mean, SD): 14.5 (11.1) |
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Interventions | Maprotiline 50‐150 mg
Paroxetine 10 to 30 mg
Placebo (diphenhydramine 37.5 mg)
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Outcomes | Pain intensity AEs Withdrawal |
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Missing data methods | ITT using LOCF | |
Funding source | Non‐pharmaceutical: funded by the United States Department of Veterans Affairs and the National Institutes of Health | |
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 random number table |
Allocation concealment (selection bias) | Low risk | Randomisation was performed by a research pharmacist not otherwise involved in the trial |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blinded, active placebo, all capsules had identical appearance |
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 using LOCF. Unequal dropout across arms Attrition Total: 29/103 (28.2%) Maprotiline 50‐150 mg: 13/33 (39.4%) Paroxetine 10‐30 mg: 12/34 (35.3%) Placebo: 4/36 (11.1%) |
Selective reporting (reporting bias) | Unclear risk | No protocol or trial registration found. Only report data for primary outcome despite collecting post‐intervention data for other outcomes |
Other bias | Low risk | No other sources of bias were identified |