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 |
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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 |
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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) |
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Notes | COI: no declaration made Sources of support: no declaration made |
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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 |