Methods | Parallel RCT | |
Participants | Country of study: France Setting: hospital pain units Condition: lumbar radicular pain Prior management details: stable pharmacological treatment for pain and sleep disorders for at least 1 month prior to study n = 36 Age, mean (SD): active group 53.4 (8) years, sham group 51.5 (13) years Duration of symptoms: not reported Gender distribution: 17 F 18 M |
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Interventions | Stimulation type: rTMS and tDCS (order randomised in active group) Stimulation parameters: rTMS frequency 10 Hz; coil orientation anteroposterior induced current; 80% RMT; number of trains 30; duration of trains 10 s; ITI 20 s; total number of pulses 3000 tDCS: 2 mA intensity, 30 min Stimulation location: M1 contralateral to painful side Number of treatments: 3 stimulation visits on 3 consecutive days for each stimulation type. 3 week washout period. Control type: sham coil ‐ same sound and appearance, no control for sensory cues |
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Outcomes | Primary: pain NRS anchors 0 = no pain, 10 = maximal pain imaginable When taken: postintervention Secondary: BPI interference scale AEs |
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Notes | Funding source: The study received financial support from the Institut National de la Sante´ et de la Recherche Médicale (INSERM) COI: the 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 2 successive randomisations were prepared by a study nurse not involved in the running of the study or in data analysis, using validated software and a centralised randomisation schedule.” |
Allocation concealment (selection bias) | Low risk | Quote: “The treatment allocation code was kept in a sealed envelope until the completion of the study.” |
Adequate blinding of participants? | Unclear risk | Comment: rTMS sham described as controlling for sensory, auditory and visual cues. tDCS 2 mA intensity ‐ evidence that blinding can be inadequate at intensity of 2 mA. No formal assessment of blinding success |
Adequate blinding of assessors? | Unclear risk | tDCS 2 mA intensity ‐ evidence that blinding can be inadequate at intensity of 2 mA. No formal assessment of blinding success |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: ITT analysis used and low dropout |
Selective reporting (reporting bias) | High risk | Comment: point estimates for pain scores not provided ‐ only a responder analysis was presented |
Free from carry‐over effects? | Unclear risk | Comment: the order of active stimulation types was randomised but it is not clear that there were not baseline differences between pre‐rTMS and pre tDCS from the presented data |
Study Size | High risk | n = 36 |
Study duration | High risk | Comment: 5 days post intervention was the longest follow up |
Other bias | Low risk | Comment: no other bias detected |