Su 2009.
Methods |
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Participants |
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Interventions | Treatment group
Control group
Duration of intervention: 12 weeks |
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Outcomes |
Time points measured (or reported) in the study: 4, 8, 12 weeks for ANS activity; 12 weeks for QOL |
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Notes |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not reported |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | The heat pad control intervention was regarded as sham intervention of FIR therapy, because of its heat property similar to FIR therapy. However, appearances of two interventions were not identical. Results of credibility test of the control intervention were not reported |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Only participants who had completed the study were analysed (3 from FIR group and 5 in control group were withdrawn from 69 randomised patients for unknown reasons) |
Selective reporting (reporting bias) | Unclear risk | No study protocol available |
Other bias | Low risk | Study appears free of other biases |