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 |
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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 |
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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 |
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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 |
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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 |