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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: not reported
Condition: fibromyalgia
Prior management details: no improvement in cases of using medical treatment for fibromyalgia for at least 3 months
n = 28
Age mean (SD): active group 45.25 (9.33) years, sham group 43 (7.63) years
Duration of symptoms, mean(SD): active group 53 (29.15) months, sham group 54.92 (30.44)
Gender distribution: all F
Interventions Stimulation type: rTMS
Stimulation parameters: frequency 1 Hz; coil orientation not reported, 90% RMT, number of trains 20; duration of trains 60 s; ITI 45 s; total number of pulses 1200
Stimulation location: L M1, no neuronavigation
Number of treatments: 10 sessions, weekdays for 2 weeks
Control type: sham coil ‐ same sound and appearance, no control for sensory cues
Outcomes Primary: pain NRS anchors 0 = no pain, 10 = maximum pain imaginable
When taken: end of intervention, 1 month, 3 months
Secondary: FIQ
AEs
Notes Funding source: the study authors declared that this study received no financial support
COI: no COI was declared by the authors
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comment: method of randomisation not outlined
Quote: “patients were randomly assigned to be in either a real stimulation group or a sham stimulation group by another clinician”
Allocation concealment (selection bias) Low risk Quote: “masked clinician evaluated the patients clinically and provided the diagnosis of FM. The patients were randomly assigned to be in either a real stimulation group or a sham stimulation group by another clinician.”
Adequate blinding of participants? Unclear risk Comment: sham coil did not control for sensory aspects of stimulation.
Quote: “Sham stimulation was carried out with the same parabolic coil, which was placed at 90° angles to the motor cortex area”
Adequate blinding of assessors? Low risk Quote: “A masked clinician evaluated the patients clinically and provided the diagnosis of FM [fibromyalgia]”
Incomplete outcome data (attrition bias) All outcomes Unclear risk Comment: 3 participants dropped out though this exceeds 10% of total number, the group they withdrew from and point of withdrawal were not clear
Selective reporting (reporting bias) Low risk Comment: outcomes adequately reported
Study Size High risk N = 28 (per protocol 25)
Study duration Low risk Comment: 3‐month follow‐up
Other bias Low risk Comment: no other risk of bias detected