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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: CRPS type I
Prior management details: refractory to best medical treatment
n = 23
Age mean (SD): active group 43.5 (12.1) years, sham group 40.6 (9.9) years
Duration of symptoms (months mean (SD)): active group 82.33 (34.5), sham group 79.27 (32.1)
Gender distribution: 14 F, 9 M
Interventions Stimulation type: rTMS
Stimulation parameters: frequency 10 Hz; coil orientation posteroanterior, number of trains 25; duration of trains 10 s; ITI 60 s, intensity 100% RMT, total number of pulses 2500
Stimulation location: M1 contralateral to painful limb
Number of treatments: 10, x 1 daily on consecutive weekdays
Control type: sham coil ‐ did not control for sensory cues
Outcomes Primary: pain VAS; 0 = "no pain", 10 = "most severe pain"
When taken: after first and last session then 1 and 3 months post‐treatment
Secondary: QoL SF‐36, not reported
Notes COI: study authors declared no COI
Sources of support: University of Sao Paolo, Brazil
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comment: while stated "randomized" the method of randomisation not reported
Allocation concealment (selection bias) Unclear risk Allocation concealment not reported
Adequate blinding of participants? Unclear risk Comment: sham suboptimal as it did not control for scalp sensation. Study reported that number who guessed the condition correctly was similar but no formal data or analysis reported
Adequate blinding of assessors? Unclear risk Comment: study described as "double‐blinded" but assessor blinding not specifically reported
Incomplete outcome data (attrition bias) All outcomes Low risk Comment: only 1 participant dropped out at follow‐up
Selective reporting (reporting bias) Low risk Comment: data presented for primary outcome. While this was not adequate for meta‐analysis it did not really constitute selectivity. No response received to request for full data access
Study Size High risk Comment: < 50 participants per treatment arm
Study duration Low risk Comment: ≥ 8 weeks' follow‐up
Other bias Low risk Comment: no other biases detected