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 |
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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 |
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Outcomes | Primary: pain VAS, anchors not reported When taken: 5 months postintervention, no data reported from formal study period Secondary: QoL WHO‐QoL, AEs |
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Notes | Sources of support: study was carried out without funding COI: study authors decare no COI |
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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 |