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. 2018 Mar 16;2018(3):CD008208. doi: 10.1002/14651858.CD008208.pub4
Methods Parallel RCT
Participants Country of study: Italy
Setting: laboratory
Condition: neuropathic pain secondary to multiple sclerosis
Prior management details: refractory to drug management and medication discontinued over previous month
n = 19
Age: 23‐69 years, mean 44.8 (SD 27.5)
Duration of symptoms: 1‐10 years, mean 2.79 (SD 2.64)
Gender distribution: 8 M, 11 F
Interventions Stimulation type: tDCS
Stimulation parameters: intensity 2 mA, 35 cm2 electrodes, duration 20 min
Stimulation location: M1, contralateral to painful side
Number of treatments: 5, x 1 daily on consecutive days
Control type: sham tDCS (switched off after 30 s stimulation)
Outcomes Primary: 0‐100 mm VAS pain, anchors "no pain" to "worst possible pain"
When taken: end of treatment period and x 1 weekly over 3‐week follow‐up
Secondary: QoL, multiple sclerosis QoL‐54 scale (MSQoL‐54)
When taken: as for primary outcome
Notes AEs: none
COI: no declaration made
Sources of support: "Italian National Ministero dell’Universita` e della Ricerca, by the Italian National Ministero della Salute, by the Fondazione Italiana Sclerosi Multipla (FISM) to DC, and by the Agenzia Spaziale Italiana to GB"
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Randomization was performed using the order of entrance in the study and a previous randomization list generated by a computer."
Allocation concealment (selection bias) Low risk Comment: likely given that the randomisation list was generated pre‐study
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 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 Low risk Comment: no dropouts observed
Quote: "... none of the patients enrolled discontinued the study."
Selective reporting (reporting bias) Low risk Comment: between‐group means not presented clearly to allow meta‐analysis but data provided on request
Study Size High risk Comment: < 50 participants per treatment arm
Study duration Unclear risk Comment: ≥ 2 weeks but < 8 weeks' follow‐up
Other bias Low risk Comment: no significant other bias detected