Methods | Parallel RCT | |
Participants | Country of study: USA Setting: laboratory Condition: chronic visceral pain (chronic pancreatitis) Prior management details: most on continuous opioid therapy, most had received surgery for their pain n = 17, 9 in active group, 8 in sham group Age mean (SD): active group 41.11 (11.27) years, sham group 46.71 (13.03) years Duration of symptoms: > 2 years Gender distribution: 14 F, 3 M |
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Interventions | Stimulation type: rTMS Stimulation parameters:frequency 1 Hz; coil orientation not specified, number of trains 1; duration of trains not specified; intensity 70% maximum stimulator output, total number of pulses 1600 Stimulation location: SII Number of treatments: 10, x 1 daily (weekdays only) Control type: sham rTMS coil |
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Outcomes | Primary: pain VAS; 0 = no pain, 10 = most intense pain imaginable When taken: daily pain logs for 3 weeks pre‐intervention, daily post‐stimulation during intervention period and at 3‐week follow‐up Secondary: none relevant |
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Notes | COI: no declaration made Sources of support: support from Harvard Thorndike Clinical Research Center/ NIH |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Patients were randomised (using a computer generated list with blocks of 4)" |
Allocation concealment (selection bias) | Unclear risk | Comment: allocation concealment not specified |
Adequate blinding of participants? | Low risk | Quote "The sham and real TMS coils looked identical and were matched for weight and acoustic artefact. This sham coil induces a similar tapping sensation and generates the same clicking noise as the real TMS coil, but without induction of a significant magnetic field and secondary current." Comment: sham appears optimal |
Adequate blinding of assessors? | Low risk | Quote: "The pain evaluation was carried out by a blinded assessor" |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: dropout/withdrawal not reported |
Selective reporting (reporting bias) | High risk | Comment: reporting of pain scores incomplete across all time points |
Study Size | High risk | Comment: < 50 participants per treatment arm |
Study duration | Unclear risk | Comment: ≥ 2 weeks but < 8 weeks' follow‐up |
Other bias | Unclear risk | Comment: baseline values not presented by group for key outcome variables |