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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: back pain clinic
Condition: chronic nonspecific low back pain
Prior management details: excluded if had spinal surgery in previous 6 months
n = 135
Age range: 26‐64 years, mean (SD) active group 45(9), sham group 44 (10)
Duration of symptoms, mean (SD) active group 45 (9) months, sham group 44 (10)
Gender distribution: 63 F, 72 M
Interventions Stimulation type: tDCS
Stimulation parameters: intensity 2 mA, 35 cm2 electrodes, duration 20 min
Stimulation location: anode L M1, cathode right supraorbital area
Number of treatments: x1 daIly for 5 d
Control type: sham tDCS
Outcomes Primary: pain VAS anchors not reported
When taken: end of intervention, 4, 12 and 24 weeks postintervention
Secondary: Oswestry Disability Index
Notes Sources of support: "This study was funded by the Deutsche Forschungsgemeinschaft DFG (MA 1862/10‐1)."
Competing interests: "AM, TJ, KL, and AP had financial support from DFG (MA 1862/10‐1) and NeuroImageNord for the submitted work."
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: “We randomised 160 stimulation codes (80 triggering active stimulation, 80 triggering sham stimulation) by custom written software into two separate lists.”
Allocation concealment (selection bias) Low risk Quote: “An independent researcher created the randomisation lists. To achieve allocation concealment the recruiter provided participants with the next unused stimulation code from the randomised lists. The recruiter had no access to the randomisation list.”
Adequate blinding of participants? Low risk Quote: “Blinding of participants and the treating physiotherapist was achieved by using a sham paradigm identical to the anodal stimulation procedure…. “ kappa agreement ‐0.120.
Comment While 2 mA intensity can be inadequately blinded, assessment suggests blinding successful
Adequate blinding of assessors? Low risk Comment: while 2 mA intensity can be inadequately blinded, formal assessment suggests blinding successful
Incomplete outcome data (attrition bias) All outcomes Low risk Comment: only 3 in each group discontinued in stimulation period. ITT approach
Selective reporting (reporting bias) Low risk Comment: reporting of all core outcomes
Study Size Unclear risk Comment: n = 67 and 68 per group
Study duration Low risk Comment: 24‐week follow‐up
Other bias Low risk Comment: no other bias detected