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. 2018 Mar 16;2018(3):CD008208. doi: 10.1002/14651858.CD008208.pub4
Methods Parallel RCT
Participants Country of study: Germany
Setting: laboratory
Condition: chronic abdominal pain with inflammatory bowel disease
Prior management details: participants allowed to continue anti‐inflammatory drugs and acute pain medication
n = 20
Age, mean (SD) active group 40.6 (12.5) years, sham group 34.4 (13.2) years
Duration of symptoms: active group 10 (8.9) years, sham group 34.4 (13.2)
Gender distribution: 13 F, 7 M
Interventions Stimulation type: tDCS
Stimulation parameters: intensity 2 mA, 35 cm2 electrodes, duration 20 min
Stimulation location: anode M1 contralateral to painful side, cathode supraorbital area, contralateral to anode
Number of treatments: x 1 daIly for 5 days
Control type: sham tDCS
Outcomes Primary: pain VAS, anchors 0 = no pain, 10 = the worst pain possible
When taken: postintervention, 1 week postintervention
Secondary: inflammatory bowel disease QoL questionnaire
AEs
Notes COI: study authors declared no COI
Sources of support: "This study has been supported by the grant “Patientenorientierte Forschung bei CED 2014” of the “Deutsche Morbus Crohn/Colitis ulcerosa Vereinigung e.V.” (Not industry)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: “Randomization was performed by the unblinded researcher (A.F.) in blocks of 4 generated from a computer‐based random allocation.”
Allocation concealment (selection bias) Unclear risk Quote: “Quote: “Randomization was performed by the unblinded researcher (A.F.)”
Comment: no apparent steps to conceal allocation
Adequate blinding of participants? Unclear risk Evidence that assessor blinding can be inadequate at intensity of 2 mA. No formal assessment of blinding success
Adequate blinding of assessors? Unclear risk 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: levels of dropout, if any, not reported
Selective reporting (reporting bias) Low risk Comment: outcomes reported adequately
Study Size High risk Comment: n = 20
Study duration High risk Comment: 1‐week postintervention maximum follow‐up.
Other bias Low risk Comment: no further bias detected