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. 2018 Mar 16;2018(3):CD008208. doi: 10.1002/14651858.CD008208.pub4
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
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
Outcomes Primary: pain NRS anchors 0 = no pain, 10 = maximal pain imaginable
When taken: postintervention
Secondary: BPI interference scale
AEs
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
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