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. 2018 Mar 16;2018(3):CD008208. doi: 10.1002/14651858.CD008208.pub4
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
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
Outcomes Primary: 0‐10 VAS pain, anchors not specified
When taken: 5 min poststimulation
Secondary: none
Notes COI: study authors declared no COI
Sources of support: grant from the ‘Institut UPSA de la douleur’
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