Radiofrequency lesioning of dorsal root ganglia for chronic lumbosacral radicular pain: a randomised, double-blind, controlled trial.

BACKGROUND: Results of observational studies have shown pain reduction with percutaneous radiofrequency lesioning of dorsal root ganglia for lumbosacral radicular pain, but there are few randomised controlled trials. We aimed to assess the efficacy of radiofrequency lesioning of dorsal root ganglia for lumbosacral radicular pain.
METHODS: We screened 1001 patients, who were mostly referred by their family doctor, in four hospitals for a double-blind randomised trial. 83 patients met inclusion criteria and thus were randomly assigned to receive a radiofrequency lesion or control treatment of the involved dorsal root ganglion. Control treatment was done in the same way as radiofrequency lesioning, but without radiofrequency current. Preoperatively and during 3-month follow-up, patients reported visual analogue leg-pain and back-pain scores, physical impairment, and use of analgesics in a diary. Primary outcome was success or failure of treatment, defined by a multidimensional decision rule, which included median outcome variables from the diary. Post-hoc analysis for possible covariate interference with outcome variables was done. Primary outcome data were analysed on an intention-to-treat basis.
FINDINGS: 45 patients were assigned radiofrequency lesioning and 38 control treatment. Three patients dropped out before 3 months. After 3 months, seven (16%) of 44 patients treated with radiofrequency lesioning and nine (25%) of 36 in the control group had successful treatment (difference -9.1% [95% CI -33.0 to 12.0], p=0.43). No differences between groups in side-effects were seen.
INTERPRETATION: Lumbosacral radiofrequency lesioning of dorsal root ganglia failed to show advantage over control treatment with local anaesthetics. Thus, its use as routine treatment in lumbosacral radicular pain should not be advocated.

RCT Entities:   Population Interventions Outcomes