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. 2018 Mar 16;2018(3):CD008208. doi: 10.1002/14651858.CD008208.pub4
Methods Cross‐over RCT
Participants Country of study: Italy
Setting: laboratory
n = 25
Condition: neuropathic pain from diabetic neuropathy
Prior management details: resistant to standard therapies for at least 1 year
Age mean (SD): 70.6 (8.5) years
Duration of symptoms (months mean (SD)): not reported
Gender distribution: 9 F, 14 M
Interventions Stimulation type: rTMS using H‐coil
Stimulation parameters: frequency 20 Hz; coil orientation H coil, number of trains 30; duration of trains 2.5 s; ITI 30 s, intensity 100% RMT, total number of pulses 1500
Stimulation location: M1 lower limb (deep in central sulcus)
Number of treatments: 5 per condition on consecutive days
Control type: sham coil, controlled for scalp sensory, auditory and visual cues
Outcomes Primary: pain VAS 0‐100, no pain to worst possible pain
When taken: immediately poststimulation, 3 weeks poststimulation
Secondary: none relevant
Notes COI: 2 authors have links to the manufacturer of the H‐coil
Sources of support: no declaration made
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "After enrolment, patients were randomly assigned in a 1:1 ratio to two counterbalanced arms by receiving a sequential number from a computer‐generated random list."
Adequate blinding of participants? Low risk Quote: "Sham stimulation was delivered with a sham coil placed in the helmet encasing the active rTMS coil. The sham coil produced a similar acoustic artefact and scalp sensation as the active coil and could also mimic the facial muscle activation induced by the active coil. It induced only a negligible electric field inside the brain because its non‐tangential orientation on the scalp and components cancelling the electric field ensured that it rapidly reduced the field as a function of distance"
Comment: controlled for visual auditory and sensory aspects of stimulation
Adequate blinding of assessors? Unclear risk Comment: while study described as "double blind" there was no specific mention of blinding assessors
Incomplete outcome data (attrition bias) All outcomes Low risk Comment: only 2 participants lost to follow‐up
Selective reporting (reporting bias) High risk Comment: data not presented by stimulation condition ‐ rather they were grouped by the order in which interventions were delivered. No SDs presented. Data requested
Free from carry‐over effects? Low risk Comment: 5‐week washout period observed with no difference at T3
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 other bias detected