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. 2018 Mar 16;2018(3):CD008208. doi: 10.1002/14651858.CD008208.pub4
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
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)
Outcomes Primary: VAS 0‐10 anchors "no pain" to "worst possible pain"
When taken: pre and post each stimulation
Secondary: none
Notes Sources of support: not declared
COI: not declared
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