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 |