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 |
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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 |
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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 |
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Notes | AEs: not reported Sources of support: supported by the National Association of the insurance companies. COI: study authors declared no COI |
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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 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) |