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. 2018 Mar 16;2018(3):CD008208. doi: 10.1002/14651858.CD008208.pub4
Methods Parallel, quasi‐RCT
Participants Country of study: Egypt
Setting: Dept of Neurology, hospital‐based
Condition: chronic phantom limb pain
Prior management details: unresponsive to various pain medications
n = 27, 17 active and 10 sham
Age, mean (SD): active group 52.01 (12.7) years, sham group 53.3 (13.3) years
Duration of symptoms, mean (SD) months: active group 33.4 (39.3), sham group 31.9 (21.9)
Gender distribution: active group 13 M, 4 F; sham group 6 M, 4 F
Interventions Stimulation type: rTMS
Stimulation parameters: frequency 20 Hz; coil orientation not specified, number of trains 10; duration of trains 10 s; ITI 50 s; total number of pulses 2000
Stimulation location: M1 stump region
Number of treatments: x 5, daily
Control type: sham ‐ coil angled away from scalp
Outcomes Primary: pain VAS (anchors not reported), LANNS
When taken: poststimulation session 1 and 5 and at 1 month and 2 months post‐treatment
Secondary: none relevant
Notes AEs: not reported
COI: not reported
Sources of support: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Comment: not true randomisation
Quote: "patients were randomly assigned to 2 groups depending on the day of the week on which they were recruited"
Allocation concealment (selection bias) High risk Comment: given method of randomisation allocation concealment not viable
Adequate blinding of participants? Unclear risk Comment: sham credibility assessment ‐ suboptimal. Coil angled away from scalp. Did not control for sensory characteristics of active stimulation and was visually distinguishable
Adequate blinding of assessors? Low risk Quote: "The second author evaluated these measures blindly, without knowing the type of TMS"
Incomplete outcome data (attrition bias) All outcomes Unclear risk Comment: levels of dropout not reported
Selective reporting (reporting bias) Low risk Comment: primary outcomes presented in full
Study Size High risk Comment: < 50 participants per treatment arm
Study duration Low risk > 8 weeks' follow‐up
Other bias Low risk Comment: no other bias detected