Methods | Parallel RCT | |
Participants | Country of study: Canada Setting: laboratory Condition: mixed chronic pain (in the over 60s) Prior management details: not reported n = 16 Age, mean (SD): active group 72 (6) years, sham group 71 (8) years Duration of symptoms mean (SD) years: active group 26 (24), sham group 15 (11) Gender distribution: 11 F, 3 M |
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Interventions | Stimulation type: tDCS Stimulation parameters: tDCS: 2 mA 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 imaginable pain When taken: postintervention Secondary: none relevant AEs not reported |
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Notes | Funding source: G Léonard is supported by the Fonds de Recherche en Santé (FRQ‐S, Montréal, QC, Canada). This project was partially supported by the Neuroscience Centre of Excellence of the Université de Sherbrooke (CeNUS, Sherbrooke, QC, Canada) and an internal start‐up fund from the Research Centre on Aging (Initiatives stratégiques du Centre de recherche sur le vieillissement, Sherbrooke, QC, Canada). COI: study authors report no COI |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: “Randomization to sham or active tDCS was performed using a random numbers table with a ratio of 1:1, based on order of entry of the participants in the study.” |
Allocation concealment (selection bias) | Unclear risk | Comment: allocation concealment not reported |
Adequate blinding of participants? | Unclear risk | Comment: blinding can be compromised at 2 mA intensity. No formal blinding assessment reported |
Adequate blinding of assessors? | Unclear risk | Comment: blinding can be compromised at 2 mA intensity. No formal blinding assessment reported |
Incomplete outcome data (attrition bias) All outcomes | High risk | Comment: 2/8 (25%) in active group withdrew. Data appear to have been excluded from analysis |
Selective reporting (reporting bias) | Low risk | Comment: outcomes reported adequately |
Study Size | High risk | Comment: n = 14 |
Study duration | High risk | Comment: 1 week postintervention follow‐up |
Other bias | High risk | Comment: baseline imbalance in average daily pain |