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

Atkinson 2007.

Study characteristics
Methods Design: parallel
Duration: 12 weeks
Assessment: baseline and post‐intervention
Country: USA
Participants Pain condition: low back pain
Population: adults with low back pain
Minimum pain intensity: NR
Inclusion criteria
  • Aged 21‐65

  • Low back pain (T‐6 or below) present on a daily basis for at least 6 months


Exclusion criteria
  • Comorbid physical and mental health conditions


Total participants randomised: 121
Age in years (mean, SD): NR
Gender: NR
Pain duration in years (mean, SD): NR
Interventions Placebo (benzotropine mesylate 0.5 mg)
  • n = 26

  • Identical

  • Active placebo ‐ anticholinergic

  • Fixed dose of 0.5 mg


Desipramine 50 mg
  • n = 17

  • TCA

  • Fixed dose


Desipramine 100 mg
  • n = 17

  • TCA

  • Fixed dose


Desipramine 150 mg
  • n = 18

  • TCA

  • Fixed dose


Fluoxetine 20 mg
  • n = 14

  • SSRI

  • Fixed dose


Fluoxetine 40 mg
  • n = 14

  • SSRI

  • Fixed dose


Fluoxetine 60 mg
  • n = 15

  • SSRI

  • Fixed dose

Outcomes No useable data provided
Missing data methods ITT with LOCF
Funding source Non‐pharmaceutical: US Department of Veterans Affairs
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 computerised random number generator
Allocation concealment (selection bias) Low risk Randomisation was completed by a research pharmacist not involved in other aspects of the study
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐blinded, double‐dummy design, no significant difference in participants guessing allocation
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 with LOCF
Attrition:
Total: 38/121 (31.4%)
Attrition by arm NR
Selective reporting (reporting bias) Unclear risk Only 1 outcome prespecified in protocol. Do not perform their original analysis
Other bias Low risk No other sources of bias were identified.