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. 2018 Mar 16;2018(3):CD008208. doi: 10.1002/14651858.CD008208.pub4
Methods Parallel RCT
Participants Country of study: Israel
Setting: outpatient department
Condition: post‐SCI central neuropathic pain
Prior management details: refractory to drug, physical therapy and complementary therapy management
n = 12
Age: 44‐60 years; mean 54 (SD 6)
Duration of symptoms: > 12 months
Gender distribution: 7 M, 4 F
Interventions Stimulation type: rTMS, figure‐of‐8 coil
Stimulation parameters: frequency 5 Hz; coil orientation not specified; 115% RMT; number of trains 500; duration of trains 10 s; ITI 30 s; total number of pulses 500 reported, likely to have been 25,000 judging by these parameters
Stimulation location: M1 ‐ midline
Number of treatments: x 10, x 1 daily on consecutive days
Control type: sham coil ‐ visually the same and makes similar background noise
Outcomes Primary: 15 cm 0‐10 VAS pain intensity, anchors "no pain sensation" to "most intense pain sensation"
When taken: pre and post each stimulation session
Secondary: McGill pain questionnaire
When taken: 2‐ and 6‐week follow‐up period
Notes AEs: not reported
Sources of support: supported by the National Association of the insurance companies.
COI: study authors declared no COI
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comment: method of randomisation not specified
Quote: "Patients were randomised into 2 groups that received either real or sham rTMS"
Allocation concealment (selection bias) Unclear risk Comment: allocation concealment not specified
Adequate blinding of participants? Unclear risk Quote: "Two coils were used; real and sham, both of which were identical in shape and produced a similar background noise."
Comment: sham credibility assessment ‐ suboptimal. Sham coil controlled for auditory cues and was visually indistinguishable from active stimulation, but did not control for sensory characteristics of active stimulation over the scalp. Given that stimulation was delivered at 110% RMT active stimulation, but not sham, it is likely to have elicited muscle twitches in peripheral muscles
Adequate blinding of assessors? Low risk Quote: "The patients as well as the person conducting the outcome measurements were blind to the type of treatment received."
Incomplete outcome data (attrition bias) All outcomes Low risk Comment: only 1 participant withdrew for "logistic reasons". Unlikely to have strongly influenced the findings
Selective reporting (reporting bias) Low risk Comment: while group means/SD were not presented in the study report, the study authors provided the requested data
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 differences observed in pain intensity levels (higher in active group)