Methods | Parallel RCT, 3 conditions | |
Participants | Country of study: Brazil Setting: laboratory Condition: fibromyalgia Prior management details: refractory to medical intervention n = 41 Age: mean 54.8 (SD 9.6) years Duration of symptoms: condition 1: 7.54 (SD 3.93) years; condition 2: 8.39 (SD 2.06) years; condition 3: 8.69 (SD 3.61) years Gender distribution: 0 M, 41 F |
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Interventions | Stimulation type: tDCS Stimulation parameters: intensity 2 mA, 35 cm2 electrodes, duration 20 min Stimulation location: condition 1: L DLPFC; condition 2: L M1, condition 3; sham L M1 Number of treatments: 10, x 1 daily on consecutive working days Control type: sham tDCS (switched off after 30 s stimulation) |
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Outcomes | Primary: pain VAS 0‐10 cm, anchors not specified When taken: immediately post‐treatment, averaged over 3 d post‐treatment, 30 and 60 d post‐treatment Secondary: QoL; FIQ |
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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: "Randomization was performed using the order of entrance in the study and a previous randomisation list generated by a computer" |
Allocation concealment (selection bias) | Low risk | Comment: the use of a pregenerated 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 | Comment: no dropout occurred |
Selective reporting (reporting bias) | High risk | Comment: pain score numerical values not provided clearly with measures of variance for any post‐treatment time point in the study report |
Study Size | High risk | Comment: < 50 participants per treatment arm |
Study duration | Low risk | Comment: ≥ 8 weeks' follow‐up |
Other bias | Low risk | Comment: no significant other bias detected |