Methods | Cross‐over RCT | |
Participants | Country of study: Germany Setting: laboratory setting Condition: mixed chronic pain, neuropathic and non‐neuropathic Prior management details: therapy‐resistant n = 23, 10 in parallel (6 active, 4 sham), 13 crossed over Age: active‐only group 28‐70 years, sham‐only group 50‐70 years, cross‐over group 41‐70 years Duration of symptoms: chronic 1.5‐25 years (mean 7.4) Gender distribution: 6 M, 17 F |
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Interventions | Stimulation type: tDCS Stimulation parameters: intensity 1 mA, 35 cm2 electrodes, duration 20 min Stimulation location: anode ‐ L M1 hand area, cathode right supraorbital Number of treatments: x 5, daily Control type: sham tDCS |
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Outcomes | Primary: pain VAS 0‐10; VAS anchors 0 = no pain, 10 = the worst pain possible When taken: x 3, daily ‐ averaged for daily pain Secondary: none relevant |
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Notes | Funding: government funding COI: none declared |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Randomization was performed using the order of entrance into the study." Comment: may not be truly random from description |
Allocation concealment (selection bias) | Unclear risk | Comment: not mentioned though unlikely given the randomisation technique. This is a potentially significant source of bias given that only the parallel results were used in this review due to high levels of attrition after the first phase |
Adequate blinding of participants? | Low risk | Comment: see above |
Adequate blinding of assessors? | Low risk | Comment: 1 mA intensity and operator blinded Quote: "The stimulators were coded using a five letter code, programmed by one of the department members who otherwise did not participate in the study. Therefore neither the investigator not the patient knew the type of the stimulation" |
Incomplete outcome data (attrition bias) All outcomes | High risk | Comment: the high level of dropout renders the cross‐over results at high risk of bias. This is less of an issue where only the parallel results from the first phase were used ‐ first‐phase data only used in the analysis |
Selective reporting (reporting bias) | Low risk | Comment: while not all outcomes at all time points were included in the study report the authors have provided all requested data |
Free from carry‐over effects? | Low risk | Comment: participants were excluded if pain had not returned to normal. This, however, represents a threat with regard to attrition bias |
Study Size | High risk | Comment: < 50 participants per treatment arm |
Study duration | Unclear risk | Comment: ≥ 2 weeks but < 8 weeks' follow‐up |
Other bias | Low risk | Comment: no other sources of bias detected |