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. 2018 Mar 16;2018(3):CD008208. doi: 10.1002/14651858.CD008208.pub4
Methods Parallel RCT
Participants Country of study: USA
Setting: laboratory
Condition: OA knee
Prior management details: not reported
n = 41 randomised, 40 analysed
Age, mean (SD): active group 60.6 (9.8) years, sham group 59.3 (8.6) years
Duration of symptoms: not reported
Gender distribution: 19 M, 21 F
Interventions Stimulation type: tDCS
Stimulation parameters: tDCS 2mA intensity, 20 min
Stimulation location: M1 contralateral to painful side
Number of treatments: x 1 daily for 5 days
Control type: sham tDCS
Outcomes Primary: pain NRS anchors 0 = no pain, 10 = worst pain imaginable
When taken: 1 d postintervention, 3 weeks postintervention
Secondary: WOMAC function score
AEs
Notes Funding source: supported in part by the Claude D. Pepper Older American's Independence Center (P30 AG028740), the Universityof Florida Center for Cognitive Aging and Memory, and NIA
Grants K07AG04637 and K01AG050707, and R01AG054077. This Work was also partially supported by VA HSR&D Houston Center for Innovations in Quality, Effectiveness and Safety (CIN# 13‐413), Michael E. DeBakey VA Medical Center, Houston, TX.
COI: study authors declared no COI
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: “randomly assigned with a ratio of 1 to 1 to either the active tDCS (n ¼ 20) or sham tDCS group (n ¼ 20) using a covariate adaptive randomization procedure so that the two groups had approximately equal distribution regarding age, gender and race.”
Allocation concealment (selection bias) Low risk Quote “Allocation concealment was ensured as the randomization codes were released only after all the interventions and assessments were completed.”
Adequate blinding of participants? Unclear risk Comment: evidence that participant blinding can be inadequate at intensity of 2 mA. No assessment of blinding success. No formal assessment of blinding success
Adequate blinding of assessors? Unclear risk Comment: evidence that assessor blinding can be inadequate at intensity of 2 mA. No assessment of blinding success. No formal assessment of blinding success
Incomplete outcome data (attrition bias) All outcomes Low risk Comment: only one participant withdrew.
Selective reporting (reporting bias) Low risk Comment: outcomes reported adequately
Study Size High risk Comment: n = 20
Study duration Unclear risk Comment: 3‐week follow‐up
Other bias Unclear risk Comment: statistically significant between‐group difference in pain NRS scores at baseline