Goodkin 1990.
Study characteristics | ||
Methods | Design: parallel Duration: 6 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: ≥ 4 on 0‐10 VAS Inclusion criteria
Exclusion criteria
Total participants randomised: 42 Age in years (mean, SD): 53.6 (12.9) Gender: 16/42 were female Pain duration in years (mean, SD): 20.3 (16.0) |
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Interventions | Placebo
Trazodone ≤ 600 mg
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Outcomes | Pain intensity Physical function Mood Withdrawal |
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Missing data methods | ITT with LOCF | |
Funding source | Partly funded by pharmaeutical: "This work was supported by NIH grants MH18764 and MH16744 and NIMH Mental Health Clinical Research Center grant MH41115, a grant from the Procter and Gamble Company, a grant from the Stanford University Health Sciences Research and Development Fund, and a grant from the Western Research and Development Office of the Veterns Administration." | |
Conflicts of interest | NR | |
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 | Participants were randomised to either trazodone or placebo groups by the Stanford University pharmacist who never interacted with participants |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind, identical appearance of study drugs and matched dosing schedule |
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: 13/42 (31.0%) Placebo: 4/20 (20.0%) Trazodone ≤ 600 mg: 9/22 (40.9%) |
Selective reporting (reporting bias) | Unclear risk | No protocol or trial registration found |
Other bias | Low risk | No other sources of bias were identified. |