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 |
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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 |
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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 |
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Notes | AEs: not reported COI: not reported Sources of support: not reported |
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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 |