Grace 1985.
Study characteristics | ||
Methods | Design: parallel Duration: 12 weeks Assessment: baseline, 4 weeks, 8 weeks, and post‐intervention Country: Canada |
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Participants | Pain condition: RA Population: adults with RA Minimum pain intensity: no Inclusion 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 |
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Interventions | Placebo
Amitriptyline 50‐75 mg
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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. |