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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: unclear
n = 32
Age: 53.4 (SD 8.9) years
Duration of symptoms: condition 1: 8.4 (SD 9.3) years; condition 2: 10.0 (SD 7.8) years; condition 3: 8.1 (SD 7.5) years
Gender distribution: 32 F
Interventions Stimulation type: tDCS
Stimulation parameters: intensity 2 mA, 35 cm2 electrodes, duration 20 min
Stimulation location: condition 1: DLPFC; condition 2: M1; condition 3: sham M1. All conditions contralateral to most painful side or dominant hand
Number of treatments: 5, x 1 daily on consecutive days
Control type: sham tDCS (switched off after 30 s stimulation)
Outcomes Primary: pain VAS 0‐10 cm, anchors not specified
When taken: at the end of the stimulation period and at 21‐day follow‐up
Secondary: QoL: FIQ
Notes COI: no declaration made
Sources of support: support from Harvard Medical School Scholars in Clinical Science programme/ NIH
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Randomization was performed using the order of entry into the study and a previous computer‐generated randomisation list, using random blocks of 6 patients (for each 6 patients, 2 were randomised to each group) in order to minimize the risk of unbalanced group sizes."
Allocation concealment (selection bias) Low risk Comment: the use of a pre‐generated 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 Quote: "One patient (in the M1 group) withdrew, and the few missing data were considered to be missing at random. We analyzed data using the intent‐to‐treat method and the conservative last observation carried forward approach."
Selective reporting (reporting bias) Unclear risk Comment: pain score numerical values not provided clearly with measures of variance for most time points in the study report. On request data were available for the primary outcome at 1 follow‐up point but not for other follow‐up points
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