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 |
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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 |
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Outcomes | Primary: pain NRS anchors 0 = no pain, 10 = most severe pain When taken: end of intervention Secondary: WHQoL‐BREF |
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Notes | Funding source: none reported COI: the study authors declared no COI |
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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 |