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 |
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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 |
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Outcomes | Primary: pain VAS anchors not reported When taken: postintervention, 1 month postintervention Secondary: none relevant AEs |
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Notes | Funding source: no statement provided regarding funding COI: the study authors declared no COI |
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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 |