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. 2018 Mar 16;2018(3):CD008208. doi: 10.1002/14651858.CD008208.pub4
Methods Parallel RCT
Participants Country of study: Turkey
Setting: Rehabilitation outpatient unit
Condition: fibromyalgia
Prior management details: no analgesic use for 1 month prior to enrolment
n = 51
Age mean (SD): active group 42.4 (78.63) years, sham group 46.5 (8.36) years
Duration of symptoms: mean (SD) active group 10.81 (6.31) years, sham group 13.33 (6.65)
Gender distribution: 47 F, 4 M
Interventions Stimulation type: rTMS
Stimulation parameters: frequency 10 Hz; coil orientation 45º angle from the midline, 100% RMT number of trains 30; duration of trains 5 s; ITI 12 s; total number of pulses 1500
Stimulation location: M1 midline, no neuronavigation
Number of treatments: 10 sessions daily ‐ unclear whether only work days
Control type: sham coil ‐ same sound and appearance, no control for sensory cues
Outcomes Primary: pain NRS anchors 0 = no pain, 10 = most severe pain
When taken: end of intervention
Secondary: WHQoL‐BREF
Notes Funding source: none reported
COI: the study authors declared no COI
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote “Randomisation was completed with the help of a software programme that produces random allocation”
Allocation concealment (selection bias) Unclear risk Comment: allocation concealment not reported
Adequate blinding of participants? Unclear risk Comment: placebo coil did not control for the sensory aspects of stimulation. No formal assessment of blinding success reported
Adequate blinding of assessors? Low risk Quote: “the investigator who conducted the clinical evaluation received no information about patient admission, randomisation or mode of treatment”
Incomplete outcome data (attrition bias) All outcomes Low risk Comment: only 1 participant lost to follow‐up
Selective reporting (reporting bias) Low risk Comment: no suggestion of selective outcome reporting
Study Size High risk Comment: 25 and 27 participants in each group
Study duration High risk Comment: only immediate postintervention follow‐up
Other bias Low risk Comment: no other bias detected