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

Grace 1985.

Study characteristics
Methods Design: parallel
Duration: 12 weeks
Assessment: baseline, 4 weeks, 8 weeks, and post‐intervention
Country: Canada
Participants Pain condition: RA
Population: adults with RA
Minimum pain intensity: no
Inclusion criteria
  • Patients with 'definite' or 'classical' RA, as defined by the ACR criteria


Exclusion criteria: NR
Total participants randomised: 36
Age in years (mean, range): 58 (27‐76)
Gender: 29/36 were female
Pain duration in years (mean, SD): NR
Interventions Placebo
  • n = 18

  • Inert

  • Identical appearance to antidepressants


Amitriptyline 50‐75 mg
  • n = 18

  • TCA

  • Flexible doses dependent upon tolerability

Outcomes Withdrawal
Missing data methods Completer‐only 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 not specified
Allocation concealment (selection bias) Unclear risk Allocation procedures not specified
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐blind, identical tablets with 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 High risk Completer analysis only
Attrition
Total: 8/36 (22.2%)
Placebo: 4/18 (22.2%)
Amitriptyline 50‐75 mg: 4/18 (22.2%)
Selective reporting (reporting bias) Unclear risk No protocol or trial registration found
Other bias Low risk No other sources of bias were identified.