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. 2011 Sep 7;2011(9):CD007312. doi: 10.1002/14651858.CD007312.pub2

Xu 2006.

Methods A randomised, parallel group study comparing radiofrequency thermocoagulation (RFT) using the VectorVision navigation system to Hartel's technique of facial measurement. It is not clear if this study was double blind, and unclear if an independent observer was used. Day stay setting
Participants Intervention: Gasserian RFT with navigation
Diagnostic criteria of patients included in the trial            
TN fulfilling criteria of International Association for the Study of Pain, no prior surgery MRI
Age mean (range, SD) 
63 (48 to 79, 5)     
Gender
12 female, 14 male         
Severity (mean, SD) 
Not available
Duration of condition years mean, range, SD) 
5.3 (3 to 10, 1.2) years          
Number           
26          
Control: Gasserian RFT without navigation
Diagnostic criteria of patients included in the trial            
TN fulfilling criteria of International Association for the Study of Pain, no prior surgery MRI
Age mean (range, SD) 
59 (45 to 73, 7)
Gender              
15 female, 13 male
Severity (mean, SD) 
No indication
Duration of condition years mean, ( range, SD) 
4.9 (2.5 to 12, 1.5) years
Number         
28
Interventions Intervention: Gasserian RFT with navigation
Type of intervention      
VectorVision navigation system had frame attached 
 8 to 10 gauge needle, 1 mm exposed  
 Test with 2 Hz , 50 Hz, temperature of 45 °C for 30 s, repeated with further lesion temperature 75 °C for 60 s
Repeated 2 to 3 more times till blunt to touch
Antibiotics 3 to 4 days, other medications stopped
Length of follow‐up
13 to 58, mean 36 + 7 months
Control: Gasserian RFT without navigation
Type of intervention      
Hartel’s technique with measurement on the face
8 to 10 gauge needle, 1 mm exposed 
Test with 2 Hz , 50 Hz, temperature of 45 °C for 30 s, repeated with further lesion temperature 75 °C for  60 s
Repeated 2 to 3 more times till blunt to touch
Antibiotics 3 to 4 days, other medications stopped
Length of follow‐up
10 to 54, mean 34 + 5 months
Outcomes Primary outcomes
The patient's overall degree of improvement, that is: complete pain relief, partial satisfactory pain relief, partial unsatisfactory pain relief, no change and worse
Outcome complete pain relief on Kaplan‐Meier
Time of measurement 6 months, 1 year, yearly intervals Kaplan‐Meier
Secondary outcome
Morbidity
Adverse events
Notes A high risk of bias was identified in this study.
This is a comparative study comparing 2 techniques for performing radiofrequency thermocoagulation. Few details are provided to determine the quality of the RCT, e.g. method of randomisation, blinding, outcome assessment, and the only outcome measure used was complete pain relief ascertained by a questionnaire at 3 months. Actuarial methodology shows that both techniques provide pain relief but this is more sustained if a neuronavigation system is used. This system also decreases side effects
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk "randomly divided into two groups" no details provided
Allocation concealment (selection bias) High risk No details provided
Blinding (performance bias and detection bias) 
 All outcomes High risk Immediate effectiveness of the surgery which was based on the condition of the participants was recorded in hospital. Three months after being discharged, all the participants were sent questionnaires addressing the absence or presence of facial pain, its characteristics, duration and time of recurrence, adverse effects, complications and the need for further treatment. The data available from these records were processed and stored in a designed computer database.
Outcomes only measured once by questionnaire and timing not known. No clear data provided on blinding of either patient or assessor.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Unknown number lost to follow‐up
 
Selective reporting (reporting bias) High risk Used questionnaires at 3 months but not other times and study continued beyond this time
Other bias Unclear risk Not clear

TN: trigeminal neuralgia; VAS: visual analogue scale; SD: standard deviation; MRI: magnetic resonance imaging; RCT: randomised controlled trial; CT scan: computerised tomography scan.