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 |
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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 |
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Outcomes | Primary: pain NRS anchors 0 = no pain 10 = worst pain imagined When taken: postintervention, 3 weeks postintervention Secondary: none relevant AEs |
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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. |
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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 |