Methods | Parallel RCT | |
Participants | Country of study: Korea Setting: outpatient clinic Condition: fibromyalgia Prior management details: none reported n = 22 Age mean (SD): low‐frequency group 45.6 (9.6) years, high‐frequency group 53 (4.2) years, sham group 51.3 (6.2) years Duration of symptoms (months mean (SD)): low‐frequency group: 47.2 (20.1), high‐frequency group 57.1 (6.4), sham group 44.7 (10.3) Gender distribution: all F |
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Interventions | Stimulation type: rTMS Stimulation parameters: Low‐frequency group: frequency 1 Hz; coil orientation not specified, number of trains 2; duration of trains 800 s; ITI 60 s; total number of pulses 1600 High‐frequency group: frequency 10 Hz; coil orientation not specified, number of trains 25; duration of trains 8 s; ITI 10 s; total number of pulses 2000 Stimulation location: right DLPFC (low‐frequency), L M1 (high‐frequency) Number of treatments: 10, x 1 daily (weekdays only) for 2 weeks Control type: sham ‐ coil orientated away from scalp |
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Outcomes | Primary: 0‐100 mm pain VAS; 0 = none, 100 = an extreme amount of pain When taken: post‐treatment and at 1 month follow‐up Secondary: FIQ |
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Notes | Comment: no information on AEs given relating to those participants who did not complete all sessions COI: study authors declared no COI Sources of support: no declaration made |
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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 | Comment: sham credibility assessment ‐ suboptimal. Coil angled away from scalp. Did not control for sensory characteristics of active stimulation and was visually distinguishable |
Adequate blinding of assessors? | Unclear risk | Comment: blinding of assessors not specified |
Incomplete outcome data (attrition bias) All outcomes | High risk | Comment: no ITT analysis described ‐ appears to be per protocol. 3/8 in low‐frequency group, 2/5 in high‐frequency group and 2/5 in sham group |
Selective reporting (reporting bias) | Low risk | Comment: point measures presented in full for all outcomes |
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 other biases detected |