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. 2018 Mar 16;2018(3):CD008208. doi: 10.1002/14651858.CD008208.pub4
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
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
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
Notes AEs: not reported
COI: no declaration made
Sources of support: no declaration made
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