Skip to main content
. 2023 May 10;2023(5):CD014682. doi: 10.1002/14651858.CD014682.pub2

Dickens 2000.

Study characteristics
Methods Design: parallel
Duration: 8 weeks
Assessment: baseline and post‐intervention
Country: UK
Participants Pain condition: low back pain
Population: adults with chronic low back pain and depression
Minimum pain intensity: NR
Inclusion criteria
  • Aged 18‐65

  • Chronic low back pain for > 6 months

  • Significant depressive symptoms as measured with the MADRS scale

  • Significant disability in daily living tasks as measured by the ODI


Exclusion criteria
  • Any other significant physical or mental health condition


Total participants randomised: 98
Age in years (mean, SD): 45.2 (10.2)
Gender: 53/98 were female
Pain duration in years (mean, SD): NR
Interventions Placebo
  • n = 48

  • Inert

  • Identical in appearance to antidepressant


Paroxetine 20 mg
  • n = 44

  • SSRI

  • Fixed dose

Outcomes Pain intensity
Physical function
Mood
Missing data methods ITT with LOCF
Funding source Pharmaceutical: SmithKline Beecham
Conflicts of interest NR
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation of order of treatment allocation was achieved using a computer‐generated randomisation list in which treatments were balanced.
Allocation concealment (selection bias) Low risk Sequentially numbered treatment packs containing the medication were held in and distributed by the hospital pharmacy. The packs were allocated to consecutive participants in strict sequential order.
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐blind, appearance of both placebo and antidepressant was identical
Blinding of outcome assessment (detection bias)
All outcomes Low risk Self‐reported outcomes from blinded participants
Incomplete outcome data (attrition bias)
All outcomes Low risk ITT with LOCF, but very low dropout
Attrition
Total: 6/98 (6.1%)
Attrition per arm NR
Selective reporting (reporting bias) Unclear risk No protocol or trial registration found
Other bias Low risk No other sources of bias were identified.