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. 2018 Mar 16;2018(3):CD008208. doi: 10.1002/14651858.CD008208.pub4
Methods Parallel RCT
Participants Country of study: Italy and Austria
Setting: laboratory
Condition: below level post SCI, predominantly neuropathic pain
Prior management details: > 4/10 pain despite rehabilitation and pharmacological treatment. All participants previously treated with antidepressant, anticonvulsants and analgesics for a minimum period of 6 months
n = 12
Age, mean (range): active group 43.7 (26‐56) years, sham group 42.5 (24‐62) years
Duration of symptoms: not reported
Gender distribution: 9 M, 3 F
Interventions Stimulation type: rTMS
Stimulation parameters: frequency 10 Hz; coil orientation AP direction, 120% RMT, number of trains 25; duration of trains 5 s; ITI 25s; total number of pulses 1250
Stimulation location: L PFC (no neuronavigation)
Number of treatments: 10 sessions daily x 5 per week for 2 weeks
Control type: sham coil ‐ same sound and appearance, no control for sensory cues
Outcomes Primary: pain VAS anchors not reported
When taken: postintervention, 1 month postintervention
Secondary: none relevant
AEs
Notes Funding source: no statement provided regarding funding
COI: the study authors declared no COI
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comment: method of randomisation not reported
Allocation concealment (selection bias) Unclear risk Comment: allocation concealment not reported
Adequate blinding of participants? Unclear risk Quote: “Sham stimulation was carried out with a sham coil of identical size color and shape emitting a sound similar to that emitted by the active coil.”
Comment: Sham suboptimal ‐ no control for cutaneous sensation associated with stimulation
Adequate blinding of assessors? Low risk Quote “Pain was assessed by an investigator blinded to the type of rTMS subjects were receiving.”
Incomplete outcome data (attrition bias) All outcomes Low risk Comment: no loss to follow‐up
Selective reporting (reporting bias) Low risk Comment: data reported adequately
Study Size High risk Comment: n = 12
Study duration Unclear risk Comment: 1 month postintervention follow‐up
Other bias Low risk Comment: no other bias detected