Ginsberg 1996.
Study characteristics | ||
Methods | Design: parallel Duration: 8 weeks Assessment: baseline, 4 weeks (halfway point), post‐intervention Country: Belgium |
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Participants | Pain condition: fibromyalgia Population: people with fibromyalgia Minimum pain intensity: no Inclusion criteria
Exclusion criteria
Total participants randomised: 51 Age in years (mean): 46 Gender: 38/51 were female Pain duration in years (mean): 3.2 |
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Interventions | Placebo
Amitriptyline 25 mg
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Outcomes | Pain intensity Sleep AEs Withdrawal |
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Missing data methods | ITT but no information regarding imputation methods given | |
Funding source | NR | |
Conflicts of interest | NR | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No information given, just says patients were "randomised" |
Allocation concealment (selection bias) | Unclear risk | Allocation procedures not specified |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Double‐blind, identical study drugs and matched dosing |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Self‐reported outcomes from blinded participants |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | State ITT but no imputation methods reported Attrition Total: 6/51 (11.8%) Placebo: 3/25 (12.0%) Amitriptyline 25 mg: 3/26 (11.5%) |
Selective reporting (reporting bias) | Unclear risk | No protocol or trial registration found |
Other bias | Low risk | No other sources of bias identified |