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 |
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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 |
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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 |
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Notes | COI: no declaration made Sources of support: IUNICS Institute, Research Institute of Health Sciences |
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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 |