Methods | Parallel RCT | |
Participants | Country of study: Egypt Setting: university hospital neurology department Condition: neuropathic pain, mixed central (poststroke) and facial (trigeminal neuralgia) pain Prior management details: refractory to drug management n = 48 Age: poststroke 52.3 (SD 10.3) years, trigeminal neuralgia 51.5 (SD 10.7) years Duration of symptoms: poststroke 39 months (SD 31), trigeminal neuralgia 18 months (SD 17) Gender distribution: 8 M, 16 F |
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Interventions | Stimulation type: rTMS Stimulation parameters: frequency 20 Hz; coil orientation not specified; 80% RMT; number of trains 10; duration of trains 10 s; ITI 50 s; total number of pulses 2000 Stimulation location: M1 contralateral to the side of worst pain Number of treatments: 5, x 1 on consecutive days Control type: coil elevated and angled away from scalp |
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Outcomes | Primary: pain VAS, anchors not specified When taken: post 1st, 4th and 5th stimulation session and 15 days after the last session Secondary: none |
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Notes | AEs: not reported COI: study authors declared no COI Sources of support: no declaration made |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Quote: "Patients were randomly assigned to one of the two groups, depending on the day of the week on which they were recruited." Comment: not truly random |
Allocation concealment (selection bias) | High risk | Comment: the method of sequence generation makes concealment of allocation unlikely |
Adequate blinding of participants? | Unclear risk | Comments: sham credibility assessment ‐ suboptimal. Coil angled away from scalp and not in contact in sham condition. 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—that is, without knowing the type of rTMS" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: no dropout apparent from the data presented |
Selective reporting (reporting bias) | Low risk | Comment: while pain score numerical values were not provided clearly with measures of variance for all time points in the study report, the study authors have provided the requested data |
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 |