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. 2018 Mar 16;2018(3):CD008208. doi: 10.1002/14651858.CD008208.pub4
Methods Cross‐over RCT
Participants Country of study: UK
Setting: laboratory
Condition: mixed refractory neuropathic pain
Prior management details: no benefit from medication or other stimulation approaches
n = 40 (27 after loss to follow‐up)
Age, range: 27‐79 years
Duration of symptoms: not reported
Gender distribution: 23 M, 17 F
Interventions Stimulation type: rTMS
Stimulation parameters: frequency 10 Hz; coil orientation AP direction, 90% RMT, number of trains 20; duration of trains 10 s; ITI 1 min; total number of pulses 2000
Stimulation location: Site A: M1 hotspot, Site B M1 reorganised area, Site C (sham) occipital fissure
Number of treatments: 3‐5 sessions per week for 5 sessions
Control type: sham active stimulation of occipital fissure
Outcomes Primary: pain NRS anchors 0 = no pain 10 = worst pain imagined
When taken: postintervention, 3 weeks postintervention
Secondary: none relevant
AEs
Notes Funding source: research funded by the National Institute for Health Research (NIHR) under Research for Patient Benefit (RfPB) Programme (Grant Reference Number PB‐PG‐0110‐20321).
COI: Prof. Nurmikko has received travel sponsorship from Nexstim Ltd. None of the other authors report any COI.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: “Patients were randomly allocated to receive three cycles of rTMS in 5 sessions at sites A, B, and SHAM. Randomization order was computer generated."
Adequate blinding of participants? Low risk Comment: sham was active stimulation of a non target brain area‐ likely indistinguishable from active stimulation
Adequate blinding of assessors? Low risk Comment: outcomes self‐reported via pain diaries
Incomplete outcome data (attrition bias) All outcomes High risk Comment: 40 randomised, 38 received rTMS, 27 included in per‐protocol analysis (33% attrition). Responder analysis n = 33 (17% dropout)
Reasons for dropout not reported
Selective reporting (reporting bias) Low risk Comment: outcomes reported adequately
Free from carry‐over effects? Low risk Comment: 3 weeks washout period observed. Baseline pain levels for each condition appear equivalent
Study Size High risk Comment: n = 40, 27 after loss to follow‐up
Study duration Unclear risk Comment: 3 week follow‐up
Other bias Low risk Comment: no other bias detected