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

Ward 1986.

Study characteristics
Methods Design: parallel
Duration: 4 weeks
Assessment: baseline and post‐intervention
Country: USA
Participants Pain condition: low back pain
Population: adults with chronic low back pain and diagnosed with depressive mood (major affective disorder, unipolar depression, dysthymic disorder)
Minimum pain intensity: ≥ 4 on 0‐10 scale
Inclusion criteria
  • Hamilton Depression Rating Scale scores of ≥ 18 and were diagnosed as having major affective disorder, unipolar depression or dysthymic disorder

  • Stable, chronic low back pain lasting ≥ 6 months, for ≥ 40% of waking hours, with an average severity of ≥ 4 on a scale of 0 (no pain) to 10 (worst pain imaginable)


Exclusion criteria
  • Candidate for back surgery


Total participants randomised: NR
Age in years (mean): 40.2
Gender: 17/35 were female
Pain duration in years (mean, SD): NR
Interventions Doxepin
  • TCA

  • Flexible dosing: started at 50 mg/day

  • Mean dose: 188 mg/day


Desipramine
  • TCA

  • Flexible dosing: started at 50 mg/day

  • Mean dose: 173 mg/day

Outcomes Study reports no useable data
Missing data methods Completer analysis
Funding source NR
Conflicts of interest NR
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Randomisation methods NR
Allocation concealment (selection bias) Unclear risk Allocation procedures NR
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk No information given regarding blinding procedures
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Self‐reported outcomes by participants but unsure of blinding procedures
Incomplete outcome data (attrition bias)
All outcomes High risk Completer analysis only. Do not report number of participants randomised, reasons for dropouts, from which arms, etc.
Selective reporting (reporting bias) High risk No protocol or trial registration found. Didn't plan to combine data from both arms until they found no significant differences between arms.
Other bias Unclear risk Combined data from both arms in the paper