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 |
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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 |
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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 |
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Notes | Sources of support: supported by Deutsche Forschungsgemeinschaft COI: no declaration made |
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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 |