Methods | Cross‐over RCT; 3 conditions | |
Participants | Country of study: Brazil Setting: laboratory Condition: neuropathic pain (mixed central, peripheral and facial) Prior management details: refractory to drug management n = 8 Age: 40‐82 years; mean 63.3 (SD 5.6) Duration of symptoms: 1‐20 years; mean 8.3 (SD 5.6) Gender distribution: 2 M, 6 F |
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Interventions | Stimulation type: tDCS Stimulation parameters: intensity 2 mA, 35 cm2 electrodes, duration 30 min Condition 1: active tDCS/active TENS Condition 2: active tDCS/sham TENS Condition 3: sham tDCS/sham TENS Stimulation location: M1 contralateral to painful side Number of treatments: 1 for each condition Control type: sham tDCS (switched off after 30 s stimulation) |
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Outcomes | Primary: VAS 0‐10 anchors "no pain" to "worst possible pain" When taken: pre and post each stimulation Secondary: none |
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Notes | Sources of support: not declared COI: not declared |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "All the patients received the 3 treatments.... in a randomised order (we used a computer generated randomisation list with the order of entrance)." |
Adequate blinding of participants? | Unclear risk | Comment: there is evidence that participant blinding of tDCS may be inadequate at 2 mA intensity (see Assessment of risk of bias in included studies) |
Adequate blinding of assessors? | Unclear risk | Quote: "All evaluations were carried out by a blinded rater" Comment: there is evidence that assessor blinding of tDCS may be inadequate at 2 mA intensity (see Assessment of risk of bias in included studies) |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: 2 participants lost to follow‐up. It is unclear how these data were accounted for as there were no missing data apparent in the results tables. However, this may have an impact given the small sample size |
Selective reporting (reporting bias) | Low risk | Comment: primary outcome data presented clearly and in full |
Free from carry‐over effects? | Low risk | Comment: a 48‐h washout period was observed between stimulation conditions and possible carry‐over effects were checked and ruled out in the analysis Quote: "To analyze whether there was a carryover effect, we initially performed and showed that the baselines for the 3 conditions were not significantly different (P = 0.51). We also included the variable order in our model and this model also showed that order is not a significant term (P = 0.7)." |
Study Size | High risk | Comment: < 50 participants per treatment arm |
Study duration | High risk | Comment: < 2 weeks' follow‐up |
Other bias | Low risk | Comment: no significant other bias detected |