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. 2018 Mar 16;2018(3):CD008208. doi: 10.1002/14651858.CD008208.pub4
Methods Parallel RCT
Participants Country of study: Brazil
Setting: laboratory
Condition: chronic temporomandibular disorder
Prior management details: excluded if received any type of physiotherapy in preceding month
n = 32
Age, mean (SD): active group 23.80 (7.3) years sham group 25.5 (6.3) years
Duration of symptoms, months mean (SD): active group 29.8 (17.1), sham group 33.7 (22.8)
Gender distribution: 3 M, 29 F
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: daily sessions for 5 consecutive days. Then twice a week for 3 weeks, up to 10 sessions
Control type: sham tDCS
Outcomes Primary: pain VAS, anchors not reported
When taken: 5 months postintervention, no data reported from formal study period
Secondary: QoL WHO‐QoL, AEs
Notes Sources of support: study was carried out without funding
COI: study authors decare no COI
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: “After the first comprehensive evaluation, the secretary of the clinical facility, who was not involved with any other procedures of the study, randomised participants who fulfilled the inclusion criteria for treatment and accepted to participate in the study. Randomisation occurred by the simple random method, in which each subject was invited to remove a small sealed envelope from a larger opaque envelope indicating two treatment groups.”
Allocation concealment (selection bias) Low risk Quote: “After the first comprehensive evaluation, the secretary of the clinical facility, who was not involved with any other procedures of the study, randomised participants who fulfilled the inclusion criteria for treatment and accepted to participate in the study."
Adequate blinding of participants? Unclear risk Comment: evidence that blinding can be inadequate at intensity of 2 mA. 15 guessed stimulation condition correctly in active group vs 7 in sham group
Adequate blinding of assessors? Unclear risk Comment: 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 Low risk Comment: no attrition noted for core follow‐up points
Selective reporting (reporting bias) Low risk Comment: no numeric reporting of point estimates for most outcomes but data provided upon request
Study Size High risk Comment: n = 32
Study duration Unclear risk Comment: formal follow‐up for 3 weeks postintervention
Other bias Low risk Commet: no other bias detected