Skip to main content
. 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
Condition: neuropathic pain (mixed central, peripheral and facial)
Prior management details: refractory to drug management, candidates for invasive MCS
n = 14
Age: 31‐66 years; mean 53 (SD 11)
Duration of symptoms: mean 6.9 years (SD 4)
Gender distribution: 10 M, 4 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 1 Hz; coil orientation lateromedial; number of trains 1; duration of trains 26 min, total number of pulses 1600
Condition 3: sham ‐ same as for condition 2 with coil angled away perpendicular to scalp
Stimulation location: M1 contralateral to painful side
Number of treatments: 1 for each condition
Outcomes Primary: VAS 0‐10 cm, anchors "no pain" to "unbearable pain"
When taken: immediately poststimulation then daily for 1 week
Secondary: none
Notes Data requested from study authors and received
Sources of support: Supported in part by a Grant from the Fondation pour la Recherche Médicale (FRM), France
COI: no declaration made
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Participants were consecutively assigned to a randomization scheme generated on the web site Randomization.com (Dallal GE, http://www.randomization.com, 2008). We used the second generator, with random permutations for a 3‐group trial. The randomization sequence was concealed until interventions were assigned."
Adequate blinding of participants? Unclear risk Comment: 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: "To ensure the double‐blind evaluation effects, the physician applying magnetic stimulation was different from the one collecting the clinical data, who in turn was not aware of the modality of rTMS that had been used in each session."
Incomplete outcome data (attrition bias) All outcomes Unclear risk 2 participants lost to follow‐up and not accounted for in the data analysis. Given the small sample size it may influence the results
Selective reporting (reporting bias) Low risk Pain outcomes reported for all participants. Change from baseline figures given; point measures requested from study authors and received
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 High risk < 2 weeks' follow‐up
Other bias Low risk Comment: no significant other bias detected