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 |