Hosomi 2013

Methods	Cross‐over RCT
Participants	Country of study: Japan Setting: multicentre, laboratory‐based Condition: mixed neuropathic pain Prior management details: pain persisted despite "adequate treatments" n = 70 of whom 64 analysed Age mean (SD): 60.7 (10.6) years Duration of symptoms: 58.2 (10.6) months Gender distribution: 40 M, 24 F
Interventions	Stimulation type: rTMS Stimulation parameters: frequency 5 Hz; coil orientation parasagittal, number of trains 10; duration of trains 10 s; ITI 50 s, intensity 90% RMT, total number of pulses per session 500 Stimulation location: M1 corresponding to painful region Number of treatments: 10, x 1 daily (consecutive working days) Control type: sham coil
Outcomes	Current daily pain 0‐100 VAS (anchors not reported), SF McGill AEs
Notes	COI: study authors declared no COI Sources of support: "funded by the Japanese Ministry of Health, Labour and Welfare with a Health and Labour Sciences Research Grant. This research was partly supported by Japanese MEXT SRPBS"
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Before the patient enrolment, the independent data center developed a randomization program to assign each patient to one of 2 treatment groups (1:1). A real rTMS period was followed by a sham period in group A, and a real rTMS period came after a sham period in group B. We used Pocock and Simon’s minimization method to stratify treatment groups according to institution, age (< 60 or P60 years), sex, and underlying disease (a cerebral lesion or not), and the Mersenne twister for random number generation."
Allocation concealment (selection bias)	Low risk	Quote: "After confirmation of patient eligibility, the data center received a registration form from an assessor who collected questionnaires and assessed adverse events, and then sent an assignment notice to an investigator who conducted the rTMS intervention. Patients were identified by sequential numbers that were assigned by the data center. Patients and assessors were blind to group assignment until the study was completed. The data center was responsible for assigning patients to a treatment group, data management, central monitoring, and statistical analyses."
Adequate blinding of participants?	Low risk	Quote: "Realistic sham stimulation [32] was implemented in this study. Ten trains of electrical stimuli at 2 times the intensity of the sensory threshold (one train, 50 stimuli at 5 Hz; inter train interval, 50 s) were delivered with a conventional electrical stimulator through the electrodes fixed on the head. The cortical effect of the cutaneous electrical stimulation was considered to be negligible at this intensity because of the high electrical resistance of the skull and brief duration of the stimulation [32]. A figure‐8 coil, which did not connect to a magnetic stimulator, was placed on the head in the same manner as a real rTMS session. Another coil, which discharged simultaneously with the electrical stimuli, was placed near the unconnected coil to produce the same sound as real rTMS, but not to stimulate the brain." Comment: sham controls for sensory auditory and visual cues
Adequate blinding of assessors?	Low risk	Quote: "Patients and assessors were blind to group assignment until the study was completed."
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: dropout low (total 6 from recruited 70 participants) Quote: "Seventy patients were enrolled and randomly assigned to 2 groups. Of these patients, one patient never came to the hospital after the registration, and a suicidal wish became apparent before the start of the intervention in another patient. Sixty‐eight patients received the interventions and 64 patients were included in the intention‐to‐treat analysis after excluding 4 patients without any data collection."
Selective reporting (reporting bias)	Low risk	Comment: while full numerical means and SDs were not reported for all time points all data were made available upon request to the study authors
Free from carry‐over effects?	Low risk	Quote: "To evaluate carry‐over effects, Grizzle’s test for carry‐over effect was applied to the values at day 0 for each period ... Grizzle's test showed no carry‐over effects in VAS and SF‐MPQ"
Study Size	Unclear risk	Comment: > 50 but < 200 participants per treatment condition
Study duration	Unclear risk	Comment: ≥ 2 weeks but < 8 weeks' follow‐up
Other bias	Low risk	Comment: no other bias detected