Methods | Cross‐over RCT; 3 conditions | |
Participants | Country of study: France Setting: laboratory Condition: neuropathic pain (mixed central, peripheral and facial) Prior management details: refractory to drug management, candidates for invasive MCS n = 14 Age: 31‐66 years; mean 53 (SD 11) Duration of symptoms: mean 6.9 years (SD 4) Gender distribution: 10 M, 4 F |
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Interventions | Stimulation type: rTMS figure‐of‐8 coil Stimulation parameters: Condition 1: frequency 20 Hz; coil orientation posteroanterior; 90% RMT; number of trains 20; duration of trains 4 s; ITI 84 s; total number of pulses 1600 Condition 2: frequency 1 Hz; coil orientation lateromedial; number of trains 1; duration of trains 26 min, total number of pulses 1600 Condition 3: sham ‐ same as for condition 2 with coil angled away perpendicular to scalp Stimulation location: M1 contralateral to painful side Number of treatments: 1 for each condition |
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Outcomes | Primary: VAS 0‐10 cm, anchors "no pain" to "unbearable pain" When taken: immediately poststimulation then daily for 1 week Secondary: none |
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Notes | Data requested from study authors and received Sources of support: Supported in part by a Grant from the Fondation pour la Recherche Médicale (FRM), France COI: no declaration made |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Participants were consecutively assigned to a randomization scheme generated on the web site Randomization.com (Dallal GE, http://www.randomization.com, 2008). We used the second generator, with random permutations for a 3‐group trial. The randomization sequence was concealed until interventions were assigned." |
Adequate blinding of participants? | Unclear risk | Comment: sham credibility assessment 'suboptimal'. Coil angled away from scalp and not in contact in sham condition. Did not control for sensory characteristics of active stimulation and was visually distinguishable |
Adequate blinding of assessors? | Low risk | Quote: "To ensure the double‐blind evaluation effects, the physician applying magnetic stimulation was different from the one collecting the clinical data, who in turn was not aware of the modality of rTMS that had been used in each session." |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 2 participants lost to follow‐up and not accounted for in the data analysis. Given the small sample size it may influence the results |
Selective reporting (reporting bias) | Low risk | Pain outcomes reported for all participants. Change from baseline figures given; point measures requested from study authors and received |
Free from carry‐over effects? | Low risk | Comment: a 2‐week washout period was observed between stimulation conditions and possible carry‐over effects were checked and ruled out in the analysis |
Study Size | High risk | Comment: < 50 participants per treatment arm |
Study duration | High risk | < 2 weeks' follow‐up |
Other bias | Low risk | Comment: no significant other bias detected |