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 |
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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 |
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Outcomes | Primary: pain VAS 0‐100, no pain to worst possible pain When taken: immediately poststimulation, 3 weeks poststimulation Secondary: none relevant |
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Notes | COI: 2 authors have links to the manufacturer of the H‐coil Sources of support: no declaration made |
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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 |