Methods | Cross‐over RCT | |
Participants | Country of study: Canada Setting: outpatient rehabilitation centre Condition: post‐SCI neuropathic pain Prior management details: almost all participants in various medications n = 18 Age: range 31‐69 years, mean (SD) 50 (9) Duration of symptoms: not reported Gender distribution: 11 M, 5 F |
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Interventions | Stimulation type: rTMS Stimulation parameters: frequency 10 Hz; coil orientation 45º posterolateral, 90% RMT for hand, 110% RMTA for leg, number of trains 40; duration of trains 5 s; ITI 25 s; total number of pulses 2000 Stimulation location: M1 hand or leg area with neuronavigation Number of treatments: single session per condition, 1 session of sham Control type: sham coil ‐ same sound and appearance and sensation |
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Outcomes | Primary: pain NRS anchors 0 = no pain, 10 = worst possible pain When taken: immediately poststimulation, 20 min poststimulation Secondary: AEs ‐ though no formal assessment reported |
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Notes | Funding source: supported by the Canadian Institutes of Health Research (CIHR), Grant Number MOP‐79370. C. Mercier was supported by salary awards from the CIHR and the Fonds de recherche du Québec, Santé (FRQS). F. Jetté was supported by a fellowship from Université Laval and H. B. Meziane by a fellowship from the Réseau Provincial de Recherche en Adaptation‐Réadaptation (REPAR‐FRQS). Support was provided by the Consortium d’Imagerie en Neuroscience et Santé Mentale de Québec (CINQ) for MRI acquisition COI: the study authors declared no potential COI |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote “2 active rTMS sessions (hand/leg M1 area) and 1 sham rTMS session in a randomized, counterbalanced order.” Comment: method of randomisation not described |
Adequate blinding of participants? | Low risk | Quote “Sham rTMS, using a sham coil (mimicking the noise and scalp sensations), was applied over the hand area using the same parameters |
Adequate blinding of assessors? | Low risk | Quote “The researcher running the pre‐post assessment (as well as data analysis) was blind relative to the applied rTMS protocol(as was the participant), with the rTMS application being performed by a different researcher |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: dropout levels low ‐ 2 in total |
Selective reporting (reporting bias) | Low risk | Comment: data provided upon author request |
Free from carry‐over effects? | Unclear risk | Comment: 2‐week washout period observed but no analysis or data presented to confirm baseline comparability |
Study Size | High risk | Comment: n = 16 |
Study duration | High risk | Comment: immediate poststimulation measurement only |
Other bias | Low risk | Comment: no other bias detected |