Manjunath 2008.
Methods | Randomised, double blind, active control Radiofrequency lesioning carried out at 80ºC for 90 s at each site; phenol ablation carried out with 7% phenol. For both procedures, radiofrequency cannula was positioned, with stimulation at 50 and 2 Hz to identify proximity to sensory and motor nerves, and maintain blinding. Participants remained in prone position for 30 minutes Participants monitored on ward for 24 hours. Follow up at 1 and 7 days, and 2 and 4 months |
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Participants | Complex regional pain syndrome. History of failure to respond (pain intensity > 6/10) to treatment with oral pregabalin, amitriptyline, carbamazepine over >6 months, and response (pain intensity < 4/10) after diagnostic sympathetic block with lidocaine on three occasions N = 20 Males/females not reported Mean age 52 years in radiofrequency group, 39 years in phenol group |
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Interventions | Radiofrequency lumbar sympathectomy, n = 10 Phenol lumbar sympathectomy, n = 10 |
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Outcomes | Nine pain outcomes, each assessed on a 0 to 10 scale Adverse events Withdrawals |
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Notes | Oxford Quality Score: R = 2, DB = 2, W = 1; Total = 5/5 Oxford Pain Validity Score: 13/16 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "computer‐generated" random numbers |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding (performance bias and detection bias) All outcomes | Low risk | Participants blinded by creating similar scene for both procedures. Investigator collecting data not involved in procedures and unaware of the groups to which participants were assigned |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | One participant in the phenol group was not included in the efficacy analysis |
Size | High risk | < 50 participants per treatment group |
DB = double blinding; N = number of participants in study; n = number of participants in treatment group; R = randomisation; W = withdrawals