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 |
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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 |
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Outcomes | Primary: pain VAS anchors not reported When taken: end of intervention, 4, 12 and 24 weeks postintervention Secondary: Oswestry Disability Index |
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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." |
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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 |