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

Urquhart 2018.

Study characteristics
Methods Design: parallel
Duration: 24 weeks
Assessment: baseline, 3 months, post‐intervention
Country: Australia
Participants Pain condition: low back pain
Population: people aged 18‐75 with chronic non‐specific low back pain
Minimum pain intensity: no
Inclusion criteria
  • Aged 18–75 years with chronic, nonspecific low back pain lasted > 3 months


Exclusion criteria
  • Current physical or mental health comorbidities

  • Previously diagnosed depression


Total participants randomised: 146
Age in years (mean, SD): 54.8 (13.7)
Gender: 53/146 were female
Pain duration in years (mean): 14.3
Interventions Placebo (benzotropine mesylate 1 mg)
  • n = 74

  • Active placebo

  • Identical appearance, matched dosing


Amitriptyline 25 mg
  • n = 72

  • TCA

  • Fixed dose, no titration

Outcomes Pain intensity
Physical function
Mood
Quality of life
AEs
Withdrawal
Missing data methods ITT using multiple imputation with chained equations
Funding source Non‐pharmaceutical: "This work was supported by theNational Health and Medical Research Council(NHMRC, Australia, ID 1024401). Drs Urquhart, Wluka, and Wang are recipients of NHMRC Career Development Fellowships (Clinical Level 1 No.1011975; Clinical Level 2 No. 1063574; Clinical Level1 No. 1065464, respectively)"
Conflicts of interest None reported
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "Randomisation was based on computer‐generated random numbers prepared by a statistician who had no involvement in trial conduct."
Allocation concealment (selection bias) Low risk "The use of a central allocation that involved pharmacy‐controlled randomisation ensured that the allocation could not be accessed by research personnel."
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐blind, active placebo, identical appearance, matched dosing
Blinding of outcome assessment (detection bias)
All outcomes Low risk Self‐reported outcomes by blinded participants
Incomplete outcome data (attrition bias)
All outcomes Low risk Uses multiple imputation by chained equations, presents comparisons with no multiple imputation
Attrition
Total: 28/146 (19.2%)
Placebo: 15/74 (20.3%)
Amitriptyline 25 mg: 13/72 (18.1%)
Selective reporting (reporting bias) Low risk Matches protocol. Explains why Descriptor Differential Scale is NR (participants had difficulty filling it in)
Other bias Low risk No other sources of bias