Methods | Cross‐over RCT | |
Participants | Country of study: South Korea Setting: university hospital outpatient setting Condition: post‐SCI central neuropathic pain Prior management details: resistant to drug, physical or complementary therapies n = 11 Age: 33‐75 years, mean 54.8 Duration of symptoms: chronic Gender distribution: 6 M, 5 F |
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Interventions | Stimulation type: rTMS Stimulation parameters: frequency 10 Hz; coil orientation angled 45º posterolaterally; 80% RMT; number of trains 20; duration of trains 5 s; ITI 55 s; total number pulses 1000 Stimulation location: R M1, hand area Number of treatments: 5, x 1 daily Control type: coil elevated and angled away from the scalp |
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Outcomes | Primary: NRS average pain over last 24 h, anchors "no pain sensation" to "most intense pain sensation imaginable" When taken: immediately after the 3rd and 5th treatments and 1, 3, 5 and 7 weeks after the end of the stimulation period Secondary: BPI ‐ pain interference (surrogate measure of disability) When taken: as for the NRS |
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Notes | AEs: not reported COI: studu authors declared no COI Sources of support: supported by the Seoul National University Bundang Hospital |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "The real and sham rTMS stimulations were separated by 12 weeks and performed in a random order according to the prepared allocation code." Comment: method of randomisation not specified but less critical in cross‐over design |
Adequate blinding of participants? | Unclear risk | Comments: sham credibility assessment ‐ suboptimal. Coil angled away from scalp and not in contact in sham condition. Didnot control for sensory characteristics of active stimulation and was visually distinguishable |
Adequate blinding of assessors? | Low risk | Quote: "... a different researcher collected the clinical data; the latter researcher was not aware of the type of rTMS (real or sham)" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: no participants withdrew after receiving the first treatment condition |
Selective reporting (reporting bias) | Low risk | Comment: results for primary outcomes reported clearly and in full |
Free from carry‐over effects? | Low risk | Comment: a 12‐week washout period was observed. The pre‐stimulation baseline scores closely match |
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 significant other bias detected |