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. 2018 Mar 16;2018(3):CD008208. doi: 10.1002/14651858.CD008208.pub4
Methods Parallel RCT
Participants Country of study: USA
Setting: laboratory
Condition: chronic temperomandibular disorder
Prior management details: pain not adequately controlled by previous therapies for more than 1 year
n = 24
Age range, mean (SD): active group 34.8 (13.7) years, sham group 35.6 (16.7) years
Duration of symptoms: not reported
Gender distribution: all F
Interventions Stimulation type: HD‐tDCS
Stimulation parameters: intensity 2 mA, 4 electrodes arranged at the corners of a 4 x 4 cm square centred over M1
Stimulation location: anode ‐ M1 contralateral to painful side
Number of treatments: daily, x 5
Control type: sham tDCS
Outcomes Primary: pain VAS; anchors not reported ‐ responder analysis only reported
When taken: 1‐month follow‐up
Secondary: AEs
Notes Sources of funding: this project was funded by grants from the American Academy of Orofacial Pain and the University of Michigan Rackham Graduate School.
Potential undisclosed COI: 1 study author (Biksom) worked for stimulation device manufacturer Soterix
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote “participants were randomized to the treatment or placebo group using the Taves covariate adaptive randomization method.”
Allocation concealment (selection bias) Unclear risk Comment: no mention of allocation concealment procedures
Adequate blinding of participants? Unclear risk Comment: 2 mA intensity. Evidence that blinding can be inadequate at intensity of 2 mA
Adequate blinding of assessors? High risk Comment: study described as single blinded
Incomplete outcome data (attrition bias) All outcomes Low risk Comment: no participant dropout
Selective reporting (reporting bias) High risk Comment: pain outcomes not presented for all follow‐up time points
Study Size High risk n = 24
Study duration Unclear risk 1‐month follow‐up postintervention
Other bias Low risk Comment: no other bias detected