Methods | Cross‐over RCT; 3 conditions | |
Participants | Country of study: Germany Setting: laboratory Condition: PLP and CNP Prior management details: unclear n = 27 Age: (median) PLP 46.6 years, CNP 51.1 years Duration of symptoms: mean PLP 15.2 (SD 14.8), CNP 3.9 (SD 4.1) years. Gender distribution: 16 M, 11 F |
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Interventions | Stimulation type: rTMS, figure‐of‐8 coil Stimulation parameters: Condition 1: frequency 1 Hz; coil orientation not specified; 95% RMT; number of trains not specified; duration of trains not specified; ITI not specified; total number of pulses 500 Condition 2: frequency 5 Hz; coil orientation not specified; 95% RMT; number of trains not specified; duration of trains not specified; ITI not specified; total number of pulses 500 Condition 3: sham frequency 2 Hz; coil orientation not specified; number of trains not specified; duration of trains not specified; ITI not specified; total number of pulses 500 Stimulation location: M1, contralateral to painful side Number of treatments: x 1 for each condition Control type: sham coil; mimics sight and sound of active treatment |
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Outcomes | Primary: 0‐100 mm VAS pain intensity, anchors "no pain" and "most intense pain imaginable" When taken: pre‐ and post‐stimulation Secondary: none |
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Notes | Sources of support: no reporting of source of support COI: study authors decare no COI |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Comment: method of randomisation not specified but less critical in cross‐over design |
Adequate blinding of participants? | Unclear risk | 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: blinding of assessors not reported |
Incomplete outcome data (attrition bias) All outcomes | High risk | Comment: 13 of 27 participants did not complete all treatment conditions and this dropout is not clearly accounted for in the analysis |
Selective reporting (reporting bias) | Low risk | Comment: primary outcome data presented clearly and in full |
Free from carry‐over effects? | Low risk | Quote: "The VAS values before the stimulation showed no significant differences in the various types of treatment" |
Study Size | High risk | Comment: < 50 participants per treatment arm |
Study duration | High risk | Comment: < 2 weeks' follow‐up |
Other bias | Low risk | Comment: no significant other bias detected |