Methods | Cross‐over RCT | |
Participants | Country of study: USA Setting: laboratory Condition: postburn neuropathic pain Prior management details: varied n = 3 Age range: 34‐52 years Duration of symptoms: > 6 months Gender distribution: 2 F, 1 M |
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Interventions | Stimulation type: tDCS Stimulation parameters: intensity 2 mA, duration 20 min Stimulation location: M1 contralateral to most painful side Number of treatments: 1 per condition Control type: sham tDCS (switched off after 30 s stimulation) |
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Outcomes | Primary: pain VAS; 0 = "no pain", 10 = "worst pain ever felt" When taken: before and after stimulation Secondary: none relevant |
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Notes | COI: study authors declared no COI Sources of support: departmentally funded |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "subjects were randomized to either active tDCS or sham stimulation." Comment: method of randomisation not specified but less critical in cross‐over design |
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 | 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) |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: all 3 participants completed study |
Selective reporting (reporting bias) | High risk | Comment: no numeric data provided for pain outcomes |
Free from carry‐over effects? | Unclear risk | Comment: 1‐week washout observed but no data reported for pain outcome so unable to assess this issue |
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 other bias detected |