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. 2023 May 10;2023(5):CD014682. doi: 10.1002/14651858.CD014682.pub2

Goodkin 1990.

Study characteristics
Methods Design: parallel
Duration: 6 weeks
Assessment: baseline and post‐intervention
Country: USA
Participants Pain condition: low back pain
Population: adults with low back pain
Minimum pain intensity: ≥ 4 on 0‐10 VAS
Inclusion criteria
  • Minmum of 1 year of back pain or 2 prior episodes low back pain of at least 2 weeks in duration with a current episode of at least 2 weeks

  • ≥ 4 on 0‐10 pain intensity VAS


Exclusion criteria
  • ≥ 4 additional pain sites

  • Physical and mental health comorbidities


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)
Interventions Placebo
  • n = 20

  • Inert

  • Identical appearance and taste, and matched dosing schedule


Trazodone ≤ 600 mg
  • n = 22

  • SARI

  • Forced titration to maximum tolerable dose

  • Mean dose: 201 mg/day

Outcomes Pain intensity
Physical function
Mood
Withdrawal
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.