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. 2018 Mar 16;2018(3):CD008208. doi: 10.1002/14651858.CD008208.pub4
Methods Parallel RCT, 3 conditions
Participants Country of study: Brazil
Setting: laboratory
Condition: fibromyalgia
Prior management details: refractory to medical intervention
n = 41
Age: mean 54.8 (SD 9.6) years
Duration of symptoms: condition 1: 7.54 (SD 3.93) years; condition 2: 8.39 (SD 2.06) years; condition 3: 8.69 (SD 3.61) years
Gender distribution: 0 M, 41 F
Interventions Stimulation type: tDCS
Stimulation parameters: intensity 2 mA, 35 cm2 electrodes, duration 20 min
Stimulation location: condition 1: L DLPFC; condition 2: L M1, condition 3; sham L M1
Number of treatments: 10, x 1 daily on consecutive working days
Control type: sham tDCS (switched off after 30 s stimulation)
Outcomes Primary: pain VAS 0‐10 cm, anchors not specified
When taken: immediately post‐treatment, averaged over 3 d post‐treatment, 30 and 60 d post‐treatment
Secondary: QoL; FIQ
Notes COI: no declaration made
Sources of support: no declaration made
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 randomisation list generated by a computer"
Allocation concealment (selection bias) Low risk Comment: the use of a pregenerated randomisation list should have adequately ensured this
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 dropout occurred
Selective reporting (reporting bias) High risk Comment: pain score numerical values not provided clearly with measures of variance for any post‐treatment time point in the study report
Study Size High risk Comment: < 50 participants per treatment arm
Study duration Low risk Comment: ≥ 8 weeks' follow‐up
Other bias Low risk Comment: no significant other bias detected