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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: pain clinic
Condition: chronic pain (mixed musculoskeletal and neuropathic)
Prior management details: "intractable"
n = 12
Age: 33‐67 years, mean 51.3 (SD 12.6)
Duration of symptoms: mean 2.7 (SD 2.4)
Gender distribution: 6 M, 6 F
Interventions Stimulation type: rTMS, circular coil for arm symptoms, double cone coil for leg symptoms
Stimulation parameters: frequency 20 Hz; coil orientation not specified; 80% RMT; number of trains 20; duration of trains 2 s; ITI not specified; total number of pulses 800; treatment duration 20 min
Stimulation location: M1 (midline)
Number of treatments: x 1 for each condition
Control type: coil angled 45º away from the scalp
Outcomes Primary: 0‐100 mm VAS pain intensity, anchors "no pain" to "unbearable pain"
When taken: 0, 5, 10 and 20 min post‐stimulation
Secondary: none
Notes Sources of support: supported by Deutsche Forschungsgemeinschaft
COI: no declaration made
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "sham and active stimulation were given in a random order"
Comment: method of randomisation not specified but less critical in cross‐over design
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 over the scalp and was visually distinguishable. Given that stimulation was delivered at 110% RMT active stimulation, but not sham, likely to have elicited muscle twitches in peripheral muscles
Adequate blinding of assessors? Unclear risk Comment: blinding of assessors not reported
Incomplete outcome data (attrition bias) All outcomes Low risk Comment: only 1 participant withdrew due to "headaches". Unlikely to have strongly influenced the findings
Selective reporting (reporting bias) Low risk Comment: while pain score numerical values not provided clearly with measures of variance for all time points in the study report, the study authors provided the requested data
Free from carry‐over effects? Low risk Comment: not clearly demonstrated in the study report but clear from unpublished data provided by the study authors (baseline mean group pain scores: active stimulation 65.1 (SD 16), sham stimulation 66.9 (SD 17.4))
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