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. 2018 Mar 16;2018(3):CD008208. doi: 10.1002/14651858.CD008208.pub4
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
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
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
Notes AEs: not reported
COI: studu authors declared no COI
Sources of support: supported by the Seoul National University Bundang Hospital
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