Methods | Cross‐over RCT | |
Participants | Country of study: France Setting: laboratory Condition: intractable neuropathic pain (mixed central and facial) Prior management details: refractory to drug management n = 14 Age: 34‐80 years, mean 57.2 Duration of symptoms: not specified "chronic" Gender distribution: 6 M, 8 F |
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Interventions | Stimulation type: rTMS, figure‐of‐8 coil Stimulation parameters: frequency 10 Hz; coil orientation not specified; 80% RMT; number of trains 20; duration of trains 5 s; ITI 55 s; total number of pulses 1000 Stimulation location: M1, contralateral to painful side Number of treatments: x 1 for each condition Control type: sham coil used (? inert) |
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Outcomes | Primary: 0‐10 VAS, anchors not specified When taken: daily for 12 days poststimulation Secondary: none |
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Notes | 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: "Two different sessions of rTMS separated by 3 weeks at least were randomly performed in each patient." 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 coil as that used in 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 not reported |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: no dropout apparent 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 report but were provided by study authors on request |
Free from carry‐over effects? | Low risk | Comment: 3/52 washout period makes carry‐over effects unlikely |
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 |