Methods | Parallel RCT; 3 conditions | |
Participants | Country of study: Russia Setting: unclear Condition: hip and knee OA Prior management details: unclear n = 64 Age: unclear Duration of symptoms: unclear Gender distribution: unclear |
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Interventions | Stimulation type: CES Stimulation parameters: frequency not specified; pulse width not specified; intensity 11‐15 mA; waveform shape: condition 1 symmetric, condition 2 asymmetric; duration 40 min Stimulation location: appears to be 1 electrode attached to either mastoid process and 1 to the forehead Number of treatments: 5, x 1 daily for 5 consecutive Control type: sham unit ‐ visually indistinguishable from active units |
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Outcomes | Primary: 0‐10 NRS, anchors "no pain" to "very painful" When taken: unclear. Likely to be pre and post each stimulation session and then daily for 1 week after Secondary: none |
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Notes | AEs: not reported COI: no declaration made Sources of support: no declaration made |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "If subjects passed all criteria they were randomly assigned to one of the two active treatments or the sham treatment." Comment: method of randomisation not specified |
Allocation concealment (selection bias) | Unclear risk | Comment: not specified |
Adequate blinding of participants? | Low risk | Quote: "The physicians, like all other participants in the study, were unaware of which treatment each subject received." |
Adequate blinding of assessors? | Low risk | Quote: "The physicians, like all other participants in the study, were unaware of which treatment each subject received." |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: dropout level not specified |
Selective reporting (reporting bias) | High risk | Comment: it is unclear in the report which time points were reported for primary outcomes |
Study Size | High risk | Comment: < 50 participants per treatment arm |
Study duration | High risk | Comment: < 2 weeks' follow‐up |
Other bias | Unclear risk | Comment: the reporting of baseline group characteristics is insufficient |