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. 2018 Mar 16;2018(3):CD008208. doi: 10.1002/14651858.CD008208.pub4
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
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
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
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."
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