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. 2018 Mar 16;2018(3):CD008208. doi: 10.1002/14651858.CD008208.pub4
Methods Cross‐over RCT
Participants Country of study: USA
Setting: laboratory
Condition: fibromyalgia
Prior management details: pain refractory to common analgesics and muscle relaxants
n = 18 randomised of which 17 allocated
Age mean (SD): 50.3 (8.5) years
Duration of symptoms (years) mean (SD): 10.7 (6.8)
Gender distribution: 15 F, 3 M
Interventions Stimulation type: HD‐tDCS
Stimulation parameters: intensity 2 mA, duration 20 min, anodal/cathodal/sham 4 x 1‐ring configuration
Stimulation location: L M1
Number of treatments: x 1 per condition
Control type: sham tDCS
Outcomes Primary: pain visual numerical scale; 0 = complete absence of pain, 10 = worst pain imaginable
When taken: baseline, immediately poststimulation, 30 min poststimulation
Secondary: adapted QoL scale for persons with chronic illness (7 points: 1 = terrible, 7 = delighted)
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: "the order of stimulation was counterbalanced and randomly assigned for each individual"
Comment: method of randomisation not specified but less likely to introduce bias in a cross‐over design
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 participant 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: only 1 loss to follow‐up and multiple imputation used
Selective reporting (reporting bias) Low risk Comment: primary outcomes reported in full
Free from carry‐over effects? Low risk Comment: 7‐day washout periods observed. Data similar at baseline
Study Size High risk Comment: < 50 participants per treatment arm
Study duration High risk Comment: < 2 weeks' follow‐up
Other bias Low risk Comment: no other bias detected