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. 2018 Mar 16;2018(3):CD008208. doi: 10.1002/14651858.CD008208.pub4
Methods Cross‐over RCT; 2 conditions
Participants Country of study: USA
Setting: laboratory
Condition: peripheral neuropathic pain
Prior management details: not specified
n = 4
Age: 33‐58 years; mean 46 (SD 11)
Duration of symptoms: 5‐12 years; mean 10.25 (SD 3.5)
Gender distribution: 1 M, 3 F
Interventions Stimulation type: rTMS, figure‐of‐8 coil
Stimulation parameters: frequency 10 Hz; coil orientation not specified; 100% RMT; number of trains 40; duration of trains 10 s; ITI 20 s; total number of pulses 4000
Stimulation location: L PFC
Number of treatments: 3 over a 5‐d period
Control type: neuronetics sham coil (looks and sounds identical)
Outcomes Primary: average daily pain 0‐10 Likert scale, anchors "no pain at all" to "worst pain imaginable"
When taken: post‐stimulation for each condition (unclear how many days post) and daily for 3 weeks poststimulation
Secondary: none
Notes AEs: not reported
Sources of support: no separate statement provided
COI: "Dr. Borckardt receives research funding from the National Institute for Neurological Disorders and Stroke at NIH, Cyberonics Inc, the Neurosciences Institute at MUSC, and is a consultant for Neuropace; however, he has no equity ownership in any device or pharmaceutical company. Dr. George receives research funding from the National Institute for Mental Health, NIDA, and NIAAA at NIH, Jazz Pharmaceuticals, GlaxoSmithKline, and Cyberonics Inc. He is a consultant for Aspect Biomedical, Argolyn, Aventis, Abbott, Bristol‐Meyers Squibb, Cephos, Cyberonics, and Neuropace; however, he has no equity ownership in any device or pharmaceutical company. Dr. Nahas receives research funding from the National Institute for Mental Health at NIH and Cyberonics Ind, and is a consultant for Neuropace. Dr. Kozel receives research funding from the National Institute for Mental Health at NIH and the U.S. Department of Defense. MUSC has filed six patents or invention disclosures in one or more of the authors’ names regarding brain imaging and stimulation."
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "The order (real first or sham first) was randomised"
Comment: method of randomisation not specified but less critical in cross‐over design
Adequate blinding of participants? Unclear risk Quote: "Two of the four participants (50%) correctly guessed which treatment periods were real and sham, which is equal to chance. All four of the participants initially said that they did not know which was which, and it was not until they were pushed to "make a guess" that they were able to offer an opinion about which sessions were real and which were sham."
Comments: 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
Adequate blinding of assessors? Unclear risk Comment: not specified
Incomplete outcome data (attrition bias) All outcomes Low risk Comment: no dropout
Selective reporting (reporting bias) Low risk Comment: all results reported clearly and in full
Free from carry‐over effects? Low risk Comment: a 3‐week washout period was observed. Presented average pain values were very similar pre‐ each condition
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 significant other bias detected