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. 2018 Mar 16;2018(3):CD008208. doi: 10.1002/14651858.CD008208.pub4
Methods Cross‐over RCT; 3 conditions
Participants Country of study: France
Setting: laboratory‐based
Condition: neuropathic pain (mixed central, peripheral and facial)
Prior management details: refractory to drug management, candidates for invasive MCS
n = 30
Age: 31‐72 years, mean 55 (SD 10.5)
Duration of symptoms: mean 5 years (SD 3.9)
Gender distribution: 23 M, 7 F
Interventions Stimulation type: rTMS, figure‐of‐8 coil
Stimulation parameters:
Condition 1: frequency 20 Hz; coil orientation posteroanterior; 90% RMT; number of trains 20; duration of trains 4 s; ITI 84 s; total number of pulses 1600
Condition 2: frequency 20 Hz, coil orientation lateromedial; number of trains 20; duration of trains 4 s; ITI 84 s; total number of pulses 1600
Condition 3: sham ‐ same as for active conditions with coil angled away perpendicular to scalp
Stimulation location: M1 contralateral to painful side
Number of treatments: 1 for each condition
Outcomes Primary: 0‐10 NRS (anchors "no pain" to "unbearable pain")
When taken: daily for 2 weeks poststimulation
Secondary: none
Notes Data requested from study authors
Sources of support: supported in part by a Grant from the Fondation pour la Recherche Médicale (FRM), France
COI: study authors declared no COI
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "the order of sessions was randomised (by computerized random‐number generation)"
Adequate blinding of participants? Unclear risk Comments: sham credibility assessment ‐ suboptimal. Coil angled away from scalp and not in contact in sham condition. Did not control for sensory characteristics of active stimulation and was visually distinguishable
Adequate blinding of assessors? Low risk Quote: "The physician who applied the procedure received from a research assistant one sealed envelope containing the order of the rTMS sessions for a given patient. The order remained unknown to the physician collecting clinical data."
Incomplete outcome data (attrition bias) All outcomes Low risk Comment: 2 participants apparently lost to follow‐up and not obviously accounted for in the analysis. However, this is less than 10% and is unlikely to have strongly influenced the results
Selective reporting (reporting bias) Low risk Comment: medial‐lateral coil orientation condition data not presented but provided by study authors on request
Free from carry‐over effects? Low risk Comment: a 2‐week washout period was observed between stimulation conditions and possible carry‐over effects were checked and ruled out in the analysis
Study Size High risk Comment: < 50 participants per treatment arm
Study duration Unclear risk Comment: ≥ 2 weeks but < 8 weeks' follow‐up
Other bias Low risk Comment: no significant other bias detected