Isomeri 1993.
Study characteristics | ||
Methods | Design: parallel Duration: 12 weeks Assessment: baseline and post‐intervention Country: Finland |
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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): 43.7 Gender: 39/51 were female Pain duration in years (mean): 7.9 |
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Interventions | Physiotherapy and amitriptyline 25 mg
Physical fitness training
Physical fitness training and amitriptyline 25 mg
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Outcomes | Withdrawal | |
Missing data methods | NR | |
Funding source | Non‐pharmaceutical: supported by grants from the Rheumatism Research Foundation | |
Conflicts of interest | NR | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomisation methods NR |
Allocation concealment (selection bias) | Unclear risk | Allocation procedures NR |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not able to be double‐blinded due to nature of interventions. Doesn't mention sham dosing or placebo for group not receiving amitriptyline |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Self‐reported outcomes from unblinded participants |
Incomplete outcome data (attrition bias) All outcomes | High risk | Completer‐only analysis, no information given about withdrawal reasons Attrition Total: 6/51 (11.8%) Physiotherapy + amitriptyline 25 mg: 1/17 (5.9%) Physical fitness training: 2/17 (11.8%) Physical fitness training + amitriptyline 25 mg: 3/17 (17.7%) |
Selective reporting (reporting bias) | Unclear risk | No protocol or trial registration found |
Other bias | Low risk | No other sources of bias were identified. |