Methods | Cross‐over RCT; 3 conditions | |
Participants | Country of study: France Setting: laboratory‐based Condition: neuropathic pain (mixed central, peripheral and facial) Prior management details: refractory to drug management, candidates for invasive MCS n = 30 Age: 31‐72 years, mean 55 (SD 10.5) Duration of symptoms: mean 5 years (SD 3.9) Gender distribution: 23 M, 7 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 20 Hz, coil orientation lateromedial; number of trains 20; duration of trains 4 s; ITI 84 s; total number of pulses 1600 Condition 3: sham ‐ same as for active conditions 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: 0‐10 NRS (anchors "no pain" to "unbearable pain") When taken: daily for 2 weeks poststimulation Secondary: none |
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Notes | Data requested from study authors Sources of support: supported in part by a Grant from the Fondation pour la Recherche Médicale (FRM), France COI: study authors declared no COI |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "the order of sessions was randomised (by computerized random‐number generation)" |
Adequate blinding of participants? | Unclear risk | Comments: 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: "The physician who applied the procedure received from a research assistant one sealed envelope containing the order of the rTMS sessions for a given patient. The order remained unknown to the physician collecting clinical data." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: 2 participants apparently lost to follow‐up and not obviously accounted for in the analysis. However, this is less than 10% and is unlikely to have strongly influenced the results |
Selective reporting (reporting bias) | Low risk | Comment: medial‐lateral coil orientation condition data not presented but provided by study authors on request |
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 | Unclear risk | Comment: ≥ 2 weeks but < 8 weeks' follow‐up |
Other bias | Low risk | Comment: no significant other bias detected |