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 |
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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) |
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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 |
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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." |
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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 |