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 |
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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) |
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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 |
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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" |
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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 |