Methods | Cross‐over RCT | |
Participants | Country of study: France Setting: laboratory Condition: neuropathic pain (mixed central, peripheral and facial) Prior management details: refractory to drug management n = 60 Age: 27‐79 years, mean 54.6 Duration of symptoms: not specified "chronic" Gender distribution: 28 M, 32 F |
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Interventions | Stimulation type: rTMS, figure‐of‐8 coil Stimulation parameters: frequency 10 Hz; coil orientation posteroanterior; 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 |
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Outcomes | Primary: 0‐10 VAS pain, anchors not specified When taken: 5 min poststimulation Secondary: none |
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Notes | COI: study authors declared no COI 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: "one of the following two protocols was applied in a random order" Comment: method of randomisation not specified but less critical in cross‐over design |
Adequate blinding of participants? | Unclear risk | Quote: "ideal sham...which should be performed by means of a coil similar to the real one in shape, weight, and location on the scalp, producing a similar sound and similar scalp skin sensation, but generating no electrical field within the cortex. Such a sham coil has not yet been designed, and at present, the sham coil used in this study is to our knowledge the more valid for clinical trials." Comments: sham credibility assessment ‐ suboptimal |
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: results for primary outcomes reported clearly and in full |
Free from carry‐over effects? | Low risk | Comment: 3‐week washout observed and no clear imbalance in pre‐stimulation pain scores between conditions |
Study Size | Unclear risk | Comment: > 50 but < 200 participants per treatment condition |
Study duration | High risk | Comment: < 2 weeks' follow‐up |
Other bias | Low risk | Comment: no significant other bias detected |