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 |
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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 |
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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 |
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Notes | COI: study authors declared no COI Sources of support: University of Sao Paolo, Brazil |
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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 |