Methods | Cross‐over RCT | |
Participants | Country of study: Germany Setting: laboratory Condition: CRPS type I Prior management details: drug management ceased for 48 h prior to study n = 10 Age: 29‐72 years, mean 51 Duration of symptoms: 24‐72 months, mean 35 Gender distribution: 3 M, 7 F |
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Interventions | Stimulation type: rTMS Stimulation parameters: frequency 10 Hz; coil orientation unspecified; 110% RMT; number of trains 10; duration of trains 1.2 s; ITI 10 s; total number of pulses 120 Stimulation location: M1 hand area Number of treatments: 1 for each condition Control type: coil angled 45º away from scalp |
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Outcomes | Primary: 0‐10 VAS current pain intensity, anchors "no pain" to "most extreme pain" When taken: 30 s, 15, 45 and 90 min poststimulation Secondary: none When taken: 30 s, 15, 45 and 90 min poststimulation |
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Notes | AEs: not reported COI: no declaration made Sources of support: "grant from the BMBF (NR. 01EM0102) and by a grant of the Scientific Research Council of BG‐Kliniken Bergmannsheil, Bochum." |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Using a computerized random generator, five patients were first assigned to the placebo group (sham rTMS), while the others were treated using verum rTMS" |
Adequate blinding of participants? | Unclear risk | Comments: sham credibility assessment ‐ suboptimal. Coil angled 45º away from scalp. Did not control for sensory characteristics of active stimulation and was visually distinguishable |
Adequate blinding of assessors? | Unclear risk | Comment: blinding of assessors not reported |
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 sham group results not presented in the study report, the study authors provided the requested data |
Free from carry‐over effects? | Low risk | Quote: "The initial pain intensities (VAS) were similar prior to verum and sham rTMS (Student’s paired t‐test, P = 0.47). The level of intensity was also independent of whether the patients were first subjected to sham or verum rTMS (P > 0.05)." |
Study Size | High risk | Comment: < 50 participants per treatment arm |
Study duration | High risk | Comment: < 2 weeks' follow‐up |
Other bias | Low risk | Comment: no significant other bias detected |