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 |
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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 |
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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 |
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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 |