Methods | Cross‐over RCT, 3 conditions | |
Participants | Country of study: France Setting: laboratory Condition: unilateral chronic neuropathic pain (mixed central and peripheral) Prior management details: refractory to drug management n = 22 Age: 28‐75 years, mean 56.5 (SD 2.9) Duration of symptoms: 2‐18 years, mean 5.4 (SD 4.1) Gender distribution: 12 M, 10 F |
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Interventions | Stimulation type: rTMS, figure‐of‐8 coil Stimulation parameters: Condition 1: frequency 10 Hz; coil orientation posteroanterior; 90% RMT; number of trains 20; duration of trains 6 s; ITI 54 s; total number of pulses 1200 Condition 2: frequency 1 Hz; coil orientation posteroanterior; 90% RMT; number of trains 1; duration of trains 20 min; total number of pulses 1200 Condition 3: sham coil Stimulation location: M1 contralateral to painful side Number of treatments: x 1 for each condition |
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Outcomes | Primary: 0‐10 VAS pain, anchors not specified When taken: pre‐ and poststimulation Secondary: none |
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Notes | AEs: not reported COI: no declaration made Sources of support: grant from the ‘Institut UPSA de la douleur’ |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Three sessions of motor cortex rTMS, separated by at least 3 weeks, were performed in random order" Comment: method of randomisation not specified but less critical in cross‐over design |
Adequate blinding of participants? | Unclear risk | Comments: sham credibility assessment ‐ suboptimal. This study used the same sham as Lefaucheur 2004, which in that paper was stated as not meeting the criteria for an ideal sham |
Adequate blinding of assessors? | Unclear risk | Comment: blinding of assessors only reported for measures of cortical excitability |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: level of dropout not reported and unclear from the data presented |
Selective reporting (reporting bias) | Low risk | Comment: pain score numerical values not provided clearly with measures of variance for any time point in the study report but were provided by the study authors on request |
Free from carry‐over effects? | Low risk | Quote: "Post hoc tests did not reveal any differences between the three pre‐rTMS assessments regarding excitability values or pain levels" |
Study Size | High risk | Comment: < 50 participants per treatment arm |
Study duration | High risk | Comment: < 2 weeks' follow‐up |
Other bias | Low risk | Comment: no significant other bias detected |