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. 2018 Mar 16;2018(3):CD008208. doi: 10.1002/14651858.CD008208.pub4
Methods Parallel RCT
Participants Country of study: Brazil
Setting: laboratory
Condition: fibromyalgia
Prior management details: excluded if undergoing physical treatment or were on stable pain control medication for "less than 2 months"
n = 45 (of which 30 relevant to this review)
Age, mean (SD): active group 44.5 (14) years, sham group 48 (11.8) years
Duration of symptoms, mean (SD): active group 140.6 (72.2) months, sham group 149.3 (111.1)
Gender distribution: 29 F, 1 M
Interventions Stimulation type: tDCS
Stimulation parameters: intensity 2 mA, 35 cm2 electrodes, duration 20 min
Stimulation location: anode L M1, cathode right supraorbital area
Number of treatments: x 1 daIly for 5 days
Control type: sham tDCS
Outcomes Primary: pain VAS, anchors 0 = no pain, 10 = worst pain imaginable
When taken: postintervention, 1 month postintervention, 2 months postintervention
Secondary: QoL SF‐36
AEs
Notes Study authors declared that there were no COI
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: “Randomization was performed by a blinded therapist using sealed envelopes for each individual.”
Comment: no description of the actual allocation sequence generation
Allocation concealment (selection bias) Low risk Quote: “Randomization was performed by a blinded therapist using sealed envelopes for each individual.”
Comment: likely to be a concealed process
Adequate blinding of participants? Unclear risk Quote: “Participants were blinded to the intervention groups, as were the therapists who performed the evaluation.”
Comment: evidence that blinding can be inadequate at intensity of 2 mA.
No formal assessment of blinding success
Adequate blinding of assessors? Unclear risk Quote: “Participants were blinded to the intervention groups, as were the therapists who performed the evaluation.”
Comment: Evidence that assessor blinding can be inadequate at intensity of 2 mA. No formal assessment of blinding success
Incomplete outcome data (attrition bias) All outcomes Unclear risk Comment: ITT analysis using LOCF. Low for postintervention (< 10%) and high for 2/12 follow‐up
Selective reporting (reporting bias) Low risk Comment: adequate reporting of core outcomes
Study Size High risk n = 45 in 3 groups of which n = 30 relevant to this review
Study duration Low risk 2‐month postintervention follow‐up
Other bias Low risk Comment: no other bias detected