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

Atkinson 1999.

Study characteristics
Methods Design: parallel
Duration: 8 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 between 21 and 65

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


Exclusion criteria
  • Comorbid physical and mental health conditions


Total participants randomised: 103
Age in years (mean, SD): NR
Gender: 40/103 were female
Pain duration in years (mean, SD): 14.5 (11.1)
Interventions Maprotiline 50‐150 mg
  • n = 33

  • TeCA

  • Fixed doses of 50 mg, 100 mg, or 150 mg depending on tolerability


Paroxetine 10 to 30 mg
  • n = 34

  • SSRI

  • Fixed doses of 10 mg, 20 mg, or 30 mg depending on tolerability


Placebo (diphenhydramine 37.5 mg)
  • n = 36

  • Identical appearance and matched dosing

  • Active placebo ‐ antihistamine

Outcomes Pain intensity
AEs
Withdrawal
Missing data methods ITT using LOCF
Funding source Non‐pharmaceutical: funded by the United States Department of Veterans Affairs and the National Institutes of Health
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 random number table
Allocation concealment (selection bias) Low risk Randomisation was performed by a research pharmacist not otherwise involved in the trial
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐blinded, active placebo, all capsules had identical appearance
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 using LOCF. Unequal dropout across arms
Attrition
Total: 29/103 (28.2%)
Maprotiline 50‐150 mg: 13/33 (39.4%)
Paroxetine 10‐30 mg: 12/34 (35.3%)
Placebo: 4/36 (11.1%)
Selective reporting (reporting bias) Unclear risk No protocol or trial registration found. Only report data for primary outcome despite collecting post‐intervention data for other outcomes
Other bias Low risk No other sources of bias were identified