Shanthanna 2014.
Methods | RCT | |
Participants | St Joseph's Healthcare Hamilton, Ontario, Canada (N = 31) Inclusion criteria
Exclusion criteria
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Interventions |
Experiment group
Control group
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Outcomes | PRF group achieved 32% (5 out of 16 participants) more than 50% decrease in VAS score (0 to 10) compared with 25% more (3 out of 15 participants) in placebo group | |
Notes | Dropouts: 2 (6%) | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Allocation was given to the assistant in a sealed opaque envelope to be handed over to the nurse operating the RF machine |
Allocation concealment (selection bias) | Low risk | Enrolled participants were randomly assigned on the day of the study intervention at a central location by a single research person, who was not involved in any other part of the study |
Blinding (performance bias and detection bias) All outcomes ‐ patients? | Low risk | Participants in control group had low‐intensity sensory stimulation, with no active treatment for the same duration. This was done to ensure participant blinding |
Blinding (performance bias and detection bias) All outcomes ‐ providers? | Low risk | Allocation was given to the assistant in a sealed opaque envelope to be handed over to the nurse operating the RF machine All other operating room personnel, including the physician performing the intervention and the participant, were blinded to randomisation and treatment |
Blinding (performance bias and detection bias) All outcomes ‐ outcome assessors? | Low risk | Assessor (blinded to randomisation code) met with all participants in recovery |
Incomplete outcome data (attrition bias) All outcomes ‐ drop‐outs? | Low risk | Dropouts: 2 of 31 participants |
Incomplete outcome data (attrition bias) All outcomes ‐ ITT analysis? | Low risk | As the study was analysed using the intention‐to‐treat principle, missing outcomes were imputed using 'multiple imputation' |
Selective reporting (reporting bias) | Low risk | Protocol showed same outcomes |
Baseline characteristics similar? | Low risk | Table 1. Groups comparable on relevant demographic and clinical variables |
Co‐interventions avoided or similar? | Unclear risk | Remained unclear from text |
Compliance acceptable? | Low risk | Irrelevant: single intervention |
Timing of outcome assessments similar? | Low risk | 1 month and 3 months of follow‐up |