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

Przeklasa‐Muszynska 2006.

Methods A parallel group, randomised prospective study
Participants Intervention: radiofrequency thermocoagulation (RFT) + steroid
Diagnostic criteria of patients included in the trial            
Not available
Age mean (range) 
65 (49 to 83)
Gender
14 female, 8 male
Severity
VAS 0 to 10, 8.4
McGill Pain Questionnaire 38.9 ± 11.5
Duration of condition mean (range) years
9.8 (0.8 to 40) years
Number  
22         
Intervention: RFT + pentoxyphilline
Diagnostic criteria of patients included in the trial            
Not available
Age mean (range) 
65 (49 to 83)
Gender
13 female, 8 male
Severity
VAS 8.5
McGill Pain Questionnaire 43.4 ± 14.9
Duration of condition mean (range) years
9.8 (0.8 to 40)
Number  
21         
Control: RFT only
Diagnostic criteria of patients included in the trial            
Not available
Age mean (range) 
65 (49 to 83)
Gender
14 female, 8 male
Severity
VAS 8.1
McGill Pain Questionnaire 41.1 ± 11.4
Duration of condition mean (range) years
9.8 (0.8 to 40)
Number  
22         
Interventions Intervention: RFT + steroid
Type of intervention      
Radiofrequency thermocoagulation at Gasserian ganglion using 5 mm needle, 3 x 30 s 21 mV at 50 mA with 40 mg methylprednisolone
Length of follow‐up mean
2 hrs, 7 days, 30 days, 90 days
Intervention: RFT + pentoxyphilline
Type of intervention  
Radiofrequency thermocoagulation at Gasserian ganglion using 5 mm needle, 3 x 30 s 21 mV at 50 mA with 10 mg pentoxyphilline
Length of follow‐up mean
2 hrs, 7 days, 30 days, 90 days
Control: RFT only
Type of intervention  
Radiofrequency thermocoagulation at Gasserian ganglion using 5 mm needle, 3 x 30 s 21 mV at 50 mA with 2 ml normal saline
Length of follow‐up mean
2 hrs, 7 days, 30 days, 90 days
Outcomes Primary outcome
Pain relief on the VAS
Time of measurement: 6 months, one year and at yearly intervals (Kaplan‐Meier)
Secondary outcome
VAS McGill Pain Questionnaire
Adverse events
Notes This RCT determines whether the injection of a steroid or pentoxyphilline ( agent to reduce inflammatory response) at the time of the radiofrequency thermocoagulation affects outcome at 90 days. Nearly 30% of patients received no benefit from RFT but this was reduced in the pentoxyphilline group at 90 days. There was some reduction in side effects in terms of swelling and sensory change when using pentoxyphilline. There are no details provided on randomisation, how bias was removed or of completeness of follow‐up. A power calculation was not done.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk In English abstract say “ randomly divided” in Polish abstract and text “ divided” but no mention of the word random
Allocation concealment (selection bias) Unclear risk No mention of concealment
Blinding (performance bias and detection bias) 
 All outcomes Unclear risk Not mentioned
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk No mention of completeness of follow‐up
Selective reporting (reporting bias) Unclear risk Incomplete data
Other bias Unclear risk None mentioned