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 |
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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 |
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Outcomes | Primary: pain VAS; anchors not reported ‐ responder analysis only reported When taken: 1‐month follow‐up Secondary: AEs |
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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 |
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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 |