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. 2018 Mar 16;2018(3):CD008208. doi: 10.1002/14651858.CD008208.pub4
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
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
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
Notes COI: no declaration made
Sources of support: support from Harvard Thorndike Clinical Research Center/ NIH
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