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. 2018 Mar 16;2018(3):CD008208. doi: 10.1002/14651858.CD008208.pub4
Methods Parallel randomised clinical trial
Participants Country of study: Spain
Setting: outpatient clinic
Condition: fibromyalgia (with major depression)
Prior management details: unclear
n = 26
Age: active group 47.5 (SD 5.7) years, sham group 54.9 (SD 4.9) years
Duration of symptoms: unclear "chronic"
Gender distribution: 2 M, 24 F
Interventions Stimulation type: rTMS
Stimulation parameters: frequency 1 Hz; coil orientation not specified; 110% RMT; number of trains 20; duration of trains 60 s; ITI 45 s; number of pulses 1200
Stimulation location: R DLPFC
Number of treatments: up to 20 on consecutive working days
Control type: coil angled 45º from the scalp
Outcomes Primary: Likert pain scale 0‐10, anchors "no pain" to "extreme pain"
When taken: 2 weeks, 4 weeks and 8 weeks from commencement of study
Secondary: none
Notes COI: no declaration made
Sources of support: IUNICS Institute, Research Institute of Health Sciences
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comment: method of randomisation not specified
Allocation concealment (selection bias) Unclear risk Comment: allocation concealment not specified
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? Low risk Quote: "patients and raters (but not the treating physician) were blind to the procedure"
Incomplete outcome data (attrition bias) All outcomes Low risk Comment: only 1 participant in each group did not complete the study. Unlikely to have strongly influenced the findings
Selective reporting (reporting bias) Low risk Comment: outcomes presented clearly and in full
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