Civelek 2012.
Methods | RCT | |
Participants | Setting unknown, Turkey (N = 100) Inclusion criteria
Exclusion criteria
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Interventions |
Experiment group
Control group
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Outcomes |
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Notes | Dropouts: incomplete information on participant flow and follow‐up | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random assignment to 2 groups performed by random number generation, with balance after every 10 participants |
Allocation concealment (selection bias) | Unclear risk | Remained unclear from text |
Blinding (performance bias and detection bias) All outcomes ‐ patients? | High risk | No stimulation in injection group before treatment; impossible to blind participants |
Blinding (performance bias and detection bias) All outcomes ‐ providers? | Unclear risk | Remained unclear from text |
Blinding (performance bias and detection bias) All outcomes ‐ outcome assessors? | High risk | Participant reported outcome measures |
Incomplete outcome data (attrition bias) All outcomes ‐ drop‐outs? | Unclear risk | Incomplete information on participant flow and follow‐up |
Incomplete outcome data (attrition bias) All outcomes ‐ ITT analysis? | Low risk | Data from all participants incorporated into the analysis |
Selective reporting (reporting bias) | Unclear risk | Remained unclear from text |
Baseline characteristics similar? | Low risk | Groups comparable on relevant demographic and clinical variables |
Co‐interventions avoided or similar? | Unclear risk | Remained unclear from text |
Compliance acceptable? | Low risk | Irrelevant; intervention performed only once |
Timing of outcome assessments similar? | Low risk | Meaured pre‐procedure, post procedure and at 1, 6 and 12 months post procedure |